(309 days)
Collagen Nerve Cuff K012814, Silastic® Nerve Cuff
No
The description focuses on the material properties and physical function of a collagen nerve cuff. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the management of peripheral nerve injuries, specifically to prevent ingrowth of scar tissue or reduce the formation of symptomatic or painful neuroma, which directly addresses a health condition. It also demonstrated a 93% success rate in reducing pain, indicating a therapeutic effect.
No
The device is a resorbable, flexible collagen tubular matrix used to manage peripheral nerve injuries and prevent neuroma formation. It is a therapeutic device, not a diagnostic one, as it treats conditions rather than identifying or assessing them.
No
The device description clearly states it is a "resorbable, flexible type I collagen tubular matrix," which is a physical implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for the management of peripheral nerve injuries and the prevention of neuroma formation. This is a therapeutic and protective function, not a diagnostic one.
- Device Description: The description details a resorbable, flexible collagen tubular matrix designed to encase and protect nerves. This is a physical barrier and support, not a tool for analyzing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnostic purposes. The device is directly applied to the nerve within the patient.
Therefore, the Flexible Collagen Nerve Cuff is a medical device used for surgical intervention and protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue) or at the end of the nerve in the foot to reduce the formation of symptomatic or painful neuroma.
Product codes
JXI
Device Description
Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular matrix that provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. Flexible Collagen Nerve Cuff is designed to be an interface between the nerve and the surrounding tissue (e.g., to prevent ingrowth of scar tissue). When placed at the terminal end of a nerve, the Flexible Collagen Nerve Cuff is designed to prevent formation of neuroma. When hydrated, Flexible Collagen Nerve Cuff is a flexible collagen conduit where the crimped walls provide a kink-resistant property to the tube. It is supplied sterile, non-pyrogenic, in various sizes and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve, foot
Indicated Patient Age Range
Patient ages ranged from 16 to 77 years, with a mean of 54 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical Study:
A clinical study was submitted that evaluated the use of the Flexible Collagen Nerve Cuff in the management of painful neuromas of the foot. A total of 50 patients underwent excision of painful single or multiple neuromas with the end of the resected nerve sutured into the Flexible Collagen Nerve Cuff subject device. Each patient preoperatively was asked to describe the amount of pain he or she was experiencing on a scale from 1 to 10, with 10 indicating the most severe pain. In the telephone interview conducted during this study, the same question was asked of each patient following revision. Patient ages ranged from 16 to 77 years, with a mean of 54 years. In all, 30 right and 20 left sides were operated, and 1 patient had bilateral involvement. Mean follow-up was 36 months (6-55 months). There were a total of 60 nerves that underwent conduit procedures in the foot. The results showed a 93% success rate of reducing pain for the treatment of neuroma in the foot.
Clinical Literature Review and Meta-analysis:
A clinical literature review and meta-analysis was further conducted to compare the results of the clinical study of the Flexible Collagen Nerve Cuff subject device with published studies of the Silastic Nerve Cuff predicate device and nerve excision alone, specifically for treatment of nerve ends of the foot. The analysis showed that the Flexible Collagen Nerve Cuff performs substantially equivalent to its predicate device (Silastic Nerve Cuff) with respect to reduction of pain post-operatively. In addition, both devices show clinically significant improvement in pain reduction over the excision-only control group.
Key Metrics
93% success rate of reducing pain for the treatment of neuroma in the foot.
Predicate Device(s)
Collagen Nerve Cuff K012814, Silastic® Nerve Cuff
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).
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510(k) SUMMARY
1. Applicant Information
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Address: | 15 Thornton Road |
| Oakland, New Jersey 07436 | |
| Telephone: | (201) 405-1477 |
| Fax: | (201) 405-1355 |
| Contact Person: | Peggy Hansen, RAC |
| VP, Clinical, Regulatory, QA, and Marketing | |
| Date Prepared: | March 31, 2014 |
2. Name of the Device
Device Common Name: Device Trade Name: Device Classification Name: Nerve Cuff Flexible Collagen Nerve Cuff Nerve cuff 882.5275 JXI · Class II
3. Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s):
Collagen Nerve Cuff K012814
Silastic® Nerve Cuff Pre-amendment Device
Description of the Device 4.
Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular matrix that provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. Flexible Collagen Nerve Cuff is designed to be an interface between the nerve and the surrounding tissue (e.g., to prevent ingrowth of scar tissue). When placed at the terminal end of a nerve, the Flexible Collagen Nerve Cuff is designed to prevent formation of neuroma. When hydrated, Flexible Collagen Nerve Cuff is a flexible collagen conduit where the crimped walls provide a kink-resistant property to the tube. It is supplied sterile, non-pyrogenic, in various sizes and for single use only.
5. Indications for Use / Intended Use
Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue) or at the end of the nerve in the foot to reduce the formation of symptomatic or painful neuroma.
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6. Summary/Comparison of Technical Characteristics
Flexible Collagen Nerve Cuff is the identical product to the Company's currently marketed Neuroflex™ Collagen Nerve Cuff. The 510(k) premarket notification was submitted for expanded indications.
| Parameter | Flexible Collagen Nerve
Cuff
(This submission) | Collagen Nerve Cuff
K012814 | Silastic® Nerve Cuff |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in the
management of
peripheral nerve injuries
in discontinuities where
gap closure can be
achieved by flexion of
the extremity (e.g., to
prevent ingrowth of scar
tissue) or at the end of
the nerve in the foot to
reduce the formation of
symptomatic or painful
neuroma. | Intended for use in the
repair of peripheral nerve
discontinuities where gap
closure can be achieved
by flexion of the
extremity. | Intended to be used to
encase a nerve for aid in
repairing the nerve (e.g., to
prevent ingrowth of scar
tissue) and for capping the
end of the nerve to prevent
the formation of neuroma
(tumors). |
| Material | Type I collagen | Type I collagen | Silicone |
| Source | Bovine tendon | Bovine tendon | Synthetic |
| Form | Tubular matrix | Tubular matrix | Tubular matrix |
| Color | White to off-white | White to off-white | Opaque |
| Sizes | 2 mm ID x 2.5 cm length
2.5 mm ID x 2.5 cm length
3 mm ID x 2.5 cm length
4 mm ID x 2.5 cm length
5 mm ID x 2.5 cm length
6 mm ID x 2.5 cm length | 2 mm ID x 2.5 cm length
2.5 mm ID x 2.5 cm length
3 mm ID x 2.5 cm length
4 mm ID x 2.5 cm length
5 mm ID x 2.5 cm length
6 mm ID x 2.5 cm length | 3.3 mm ID x 1.0 cm length
4.1 mm ID x 1.0 cm length
4.8 mm ID x 1.0 cm length
5.3 mm ID x 1.3 cm length
6.1 mm ID x 1.3 cm length
7.1 mm ID x 1.3 cm length
7.9 mm ID x 1.5 cm length
8.6 mm ID x 1.5 cm length
9.9 mm ID x 1.5 cm length
10.7 mm ID x 1.5 cm length
11.7 mm ID x 1.8 cm length
13.7 mm ID x 1.8 cm length |
| Mechanical
Strength | Can be sutured | Can be sutured | Can be sutured |
| Resorbable | Yes | Yes | No |
| Crosslinked | Yes | Yes | No |
| Porosity/
Permeability | Semi-permeable.
Permeable to nutrients
and macromolecules | Semi-permeable
Permeable to nutrients
and macromolecules | Non-permeable |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Sterility | Sterile, SAL 10-6
Gamma irradiation | Sterile, SAL 10-6
Gamma irradiation | Sterile |
| Pyrogenicity | Non-pyrogenic
Endotoxin ≤ 0.5 EU/ml | Non-pyrogenic
Endotoxin ≤ 0.5 EU/ml | Unknown |
| Single Use/Reuse | Single use only | Single use only | Single use only |
| Parameter | Flexible Collagen Nerve
Cuff
(This submission) | Collagen Nerve Cuff
K012814 | Silastic® Nerve Cuff |
| Packaging | Double peel package | Double peel package | Sterile vials of distilled
water |
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Nonclinical Tests Submitted
The substantial equivalence of the Flexible Collagen Nerve Cuff and its predicate device was demonstrated based on an evaluation of the expanded indications.
In vitro characterization studies included evaluation of physical properties such as suture strength, kink resistance, and an evaluation of physicochemical properties such as product permeability and hydrothermal transition temperature. The characterization test results of the subject device were equivalent to those of the predicate device, given that there has been no change to the device itself.
The Flexible Collagen Nerve Cuff material was evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The representative product passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - | ||
| Agarose | ||
| Overlay | No evidence of causing any cell lysis or toxicity. | Non-cytotoxic |
| Sensitization - | ||
| Guinea Pig | ||
| Maximization | No evidence of causing delayed dermal contact | |
| sensitization in the guinea pig. The test article | ||
| was not considered a sensitizer in the guinea | ||
| pig test. | Non-sensitizer | |
| Intracutaneous | ||
| Reactivity | Under the conditions of the study, there was no | |
| irritation or toxicity from the extract injected | ||
| intracutaneously into rabbits. | Non-irritant, non-toxic | |
| Acute Systemic | ||
| Toxicity | No mortality or evidence of systemic toxicity | Non-toxic |
| (acute systemic) | ||
| Genotoxicity - | ||
| Bacterial | ||
| Reverse | ||
| Mutation | Non-mutagenic to Salmonella typhimurium and | |
| to Escherichia coli strain WP2uvra | Non-mutagenic | |
| Mouse | ||
| Lymphoma | ||
| Assay | None of the test article treatments induced | |
| substantial increases in the number of revertant | ||
| colonies. | Non-mutagenic | |
| In Vivo Mouse | ||
| Micronucleus | ||
| Assay | None of the mice treated with the test article | |
| preparations exhibited overt signs of toxicity | ||
| either immediately post-treatment or during the | ||
| induction period. The levels of micronucleated | ||
| cells were within normal negative ranges. | Non-mutagenic |
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Collagen Matrix, Inc. 510(k) Summary Flexible Collagen Nerve Cuff Page 4 of 4
| Test | Results | Conclusions |
|---|---|---|
| Pyrogenicity - | ||
| Rabbit Pyrogen | Non-pyrogenic | Non-pyrogenic |
| Muscle | ||
| Implantation | The macroscopic reaction was not significant | |
| compared with the USP negative control | ||
| implant material. Microscopically, the test | ||
| article was classified as a nonirritant as | ||
| compared to the USP negative control article. | Non-irritant | |
| Subacute/ | ||
| Subchronic/ | ||
| Chronic Toxicity | Minimum tissue reaction up to 24 weeks of | |
| implantation and no adverse tissue reaction to | ||
| the host. | Non toxic | |
| (subacute, subchronic, | ||
| chronic) |
Viral inactivation studies were performed to ensure the viral safety of the product.
Clinical Test Submitted
A clinical study was submitted that evaluated the use of the Flexible Collagen Nerve Cuff in the management of painful neuromas of the foot. A total of 50 patients underwent excision of painful single or multiple neuromas with the end of the resected nerve sutured into the Flexible Collagen Nerve Cuff subject device. Each patient preoperatively was asked to describe the amount of pain he or she was experiencing on a scale from 1 to 10, with 10 indicating the most severe pain. In the telephone interview conducted during this study, the same question was asked of each patient following revision. Patient ages ranged from 16 to 77 years, with a mean of 54 years. In all, 30 right and 20 left sides were operated, and 1 patient had bilateral involvement. Mean follow-up was 36 months (6-55 months). There were a total of 60 nerves that underwent conduit procedures in the foot. The results showed a 93% success rate of reducing pain for the treatment of neuroma in the foot.
A clinical literature review and meta-analysis was further conducted to compare the results of the clinical study of the Flexible Collagen Nerve Cuff subject device with published studies of the Silastic Nerve Cuff predicate device and nerve excision alone, specifically for treatment of nerve ends of the foot. The analysis showed that the Flexible Collagen Nerve Cuff performs substantially equivalent to its predicate device (Silastic Nerve Cuff) with respect to reduction of pain post-operatively. In addition, both devices show clinically significant improvement in pain reduction over the excision-only control group.
Conclusions Drawn from Non-clinical and Clinical Studies
The results of the material evaluation, in vitro product characterization studies, biocompatibility studies, animal and clinical studies show that the Flexible Collagen Nerve Cuff is safe and substantially equivalent to the predicate device. The expanded indication for use does not affect the safety and performance of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
Collagen Matrix, Inc. Ms. Peggy Hansen, Vice President Clinical Regulatory, QA & Marketing 15 Thornton Road Oakland, NJ 07436
Re: K131541 .
Trade/Device Name: Neuroflex TM Collagen Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: March 6, 2014 Received: March 7, 2014
Dear Ms. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please notc: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Peggy Hansen
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
fox Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131541
Device Name Flexible Collagen Nerve Cuff
Indications for Use (Describe)
Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue) or at the nerve in the foot to reduce the formation of symptomatic or painful neuroma.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Joyce M. Whang -S
FORM FDA 3881 (1/14)
PSC Publishing Services (30) ) 443-6740 FF
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