Rule2026-08426
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
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Published
April 30, 2026
Effective
April 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the laser-powered inferior vena cava filter retrieval catheter into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the laser-powered inferior vena cava filter retrieval catheter. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 83 (Thursday, April 30, 2026)</title>
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[Federal Register Volume 91, Number 83 (Thursday, April 30, 2026)]
[Rules and Regulations]
[Pages 23161-23163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2026-N-3946]
Medical Devices; Cardiovascular Devices; Classification of the
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
laser-powered inferior vena cava filter retrieval catheter into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for classification of the laser-powered inferior vena cava
filter retrieval catheter. We are taking this action because we have
determined that classifying the device into class II will provide a
reasonable assurance of safety and effectiveness of the device. We
believe this action will also enhance patients' access to beneficial
innovative devices, in part by reducing regulatory burdens.
DATES: This order is effective April 30, 2026. The classification was
applicable on December 21, 2021.
FOR FURTHER INFORMATION CONTACT: Brian Pullin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2112, Silver Spring, MD 20993-0002, 301-796-6455,
<a href="/cdn-cgi/l/email-protection#6e2c1c070f00403e1b020207002e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="81c3f3e8e0efafd1f4edede8efc1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the laser-
powered inferior vena cava filter retrieval catheter into class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness of the device. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
The automatic assignment of class III occurs by operation of law
and without
[[Page 23162]]
any action by FDA, regardless of the level of risk posed by the new
device. Any device that was not in commercial distribution before May
28, 1976, is automatically classified into, and remains within, class
III and requires premarket approval unless and until FDA takes an
action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We
refer to these devices as ``postamendments devices'' because they were
not in commercial distribution prior to the date of enactment of the
Medical Device Amendments of 1976, which amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On June 25, 2021, FDA received Spectranetics, Inc.'s request for De
Novo classification of the CavaClear Laser Sheath. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on December 21, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.5125.\1\ We have named the generic type of device ``laser-powered
inferior vena cava (IVC) filter retrieval catheter,'' and it is
identified as percutaneous catheter that uses a laser to ablate tissue
and is intended to facilitate in the detachment and removal of
indwelling IVC filters.
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\1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Laser-Powered
Inferior Vena Cava Filter Retrieval Catheter Risks and Mitigation
Measures
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Identified Risks to Health Mitigation Measures
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Infection.............................. Sterilization validation; Shelf
life testing; Pyrogenicity
testing; and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Device damage during use resulting in Non-clinical performance
clinical sequelae such as embolic testing; and Clinical
concern or prolonged procedure. performance testing.
Soft tissue damage from laser, such as Laser generator compatibility
IVC injury, extravasation, and testing; In-vivo safety
perforation. testing; Clinical performance
testing; Labeling; and
Training.
IVC filter damage, including fracture Non-clinical performance
and embolization, due to laser testing; Clinical testing;
interaction. Labeling; and Training.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for laser-powered inferior
vena cava filter retrieval catheters. This device is therefore subject
to premarket notification requirements under section 510(k) of the FD&C
Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 820
regarding quality management system regulation have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 regarding labeling have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 870
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.5125 to subpart F to read as follows:
Sec. 870.5125 Laser-powered inferior vena cava filter retrieval
catheter.
(a) Identification. A laser-powered inferior vena cava (IVC) filter
retrieval catheter is a percutaneous catheter that uses a laser to
ablate tissue and is intended to facilitate in the detachment and
removal of indwelling IVC filters.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must demonstrate that the device
performs as intended under anticipated conditions of use. Testing must
include:
(i) Evaluation of major and minor complications associated with IVC
filter removal; and
(ii) Evaluation of success rates of IVC filter removal.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be evaluated:
(i) Dimensional testing must demonstrate that the device is
compatible with the intended anatomy and compatible with all labeled
accessories.
(ii) Mechanical testing on all joints must demonstrate that the
device can withstand tensile and torsional forces encountered under
challenging clinical use conditions.
(iii) Simulated use testing must demonstrate that the device can be
inserted, tracked, activated, and removed without device damage and
that the device is able to function as intended (e.g., remove IVC
filter without damage) under challenging clinical use conditions.
(iv) Performance testing must demonstrate that the product is
visible under fluoroscopic techniques.
(v) Performance testing must demonstrate that the device does not
kink when subjected to clinically relevant tortuosity.
(3) Compatibility testing with laser generators must include:
(i) Electrical safety, electromagnetic compatibility testing, and
electromagnetic interference testing must be conducted for all devices
that contain electrical components.
(ii) Software verification, validation, and hazard analysis must be
conducted for all devices that contain software.
(iii) Laser output characterization and performance testing,
including verification of calibration reliability, energy output, and
repetition rate, and laser lifetime testing, must be conducted.
(4) All patient-contacting components must be demonstrated to be
biocompatible.
(5) Performance data must demonstrate the sterility and non-
pyrogenicity of patient contacting components of the device that are
provided sterile.
(6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and system
functionality over the established shelf life.
(7) In vivo safety testing must demonstrate that the device does
not cause soft tissue damage or device damage under worst case clinical
use conditions.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters and
materials of the device;
(ii) A summary of the clinical performance testing conducted with
the device; and
(iii) A shelf life.
(9) A training program must be provided to ensure that users can
safely and reliably use the device per its instructions for use.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08426 Filed 4-29-26; 8:45 am]
BILLING CODE 4164-01-P
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