(30 days)
Not Found
No
The summary describes a physical device (a collagen cuff) for nerve repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the repair of peripheral nerve discontinuities and facilitates axonal growth, demonstrating a therapeutic purpose.
No
Explanation: The device description states its purpose is to provide a protective environment and conduit for nerve repair and axonal growth, not to diagnose a condition.
No
The device description clearly states it is a "flexible, resorbable and semipermeable tubular membrane matrix," which is a physical, implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of peripheral nerve discontinuities, which is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a physical implant (a tubular membrane matrix) designed to be placed within the body to facilitate nerve repair.
- 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 diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo use as a surgical implant.
N/A
Intended Use / Indications for Use
The Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device Description
The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protective environment for peripheral nerve repair after injury and to create a conduit for axonal growth across a nerve gap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Animal Data
The animal studies over the past twenty years using nerve conduit have been reviewed and have demonstrated the efficacy of peripheral nerve repair using resorbable and nonresorbable biocompatible nerve conduits .
b. Summary of Clinical Data
The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits.
c. Simulated Clinical Environment
The mechanical and physical characteristics of the Collagen Nerve Cuff were evaluated in simulated clinical environment studies. The results of the studies demonstrated that the Collagen Nerve Cuff has adequate mechanical and physical characteristics for peripheral nerve repair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NeuroGen™ Nerve Guide [510(k) #K011168], SaluMedica™ Nerve Cuff [510(k) #K002098], Fastube™ Nerve Cuff [510(k) #K850785]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
SEP 2 1 2001
KO12814
510 (k) Summary of Safety And Effectiveness
Applicant name and address:
Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, NJ 07417
Contact person and telephone number:
Shu-Tung Li, Ph.D. President & CEO Tel: (201) 405-1477
Date of summary:
Device generic name:
Device trade name:
Substantial Equivalence:
August 20, 2001
Collagen Nerve Cuff
None
NeuroGen™ Nerve Guide [510(k) #K011168] SaluMedica™ Nerve Cuff [510(k) #K002098] Fastube™ Nerve Cuff [510(k) #K850785]
Description of the device:
The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protective environment for peripheral nerve repair after injury and to create a conduit for axonal growth across a nerve gap.
Intended Use of the Device
The Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Technical Characteristics
The Collagen Nerve Cuff is designed for the repair of peripheral nerves. Specifically, the device is designed to be resorbable, flexible, suturable, biocompatible, cell occlusive, and clinically manageable.
1
Summary of Biocompatibility Studies
The Collagen Nerve Cuff is biocompatible based on the test recommended by the FDA and meets the ISO 10993 requirements for biocompatibility testing.
Performance Characteristics
a. Animal Data
The animal studies over the past twenty years using nerve conduit have been reviewed and have demonstrated the efficacy of peripheral nerve repair using resorbable and nonresorbable biocompatible nerve conduits .
b. Summary of Clinical Data
The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits.
c. Simulated Clinical Environment
The mechanical and physical characteristics of the Collagen Nerve Cuff were evaluated in simulated clinical environment studies. The results of the studies demonstrated that the Collagen Nerve Cuff has adequate mechanical and physical characteristics for peripheral nerve repair.
Conclusion
The results of biocompatibility testing, summary of published results of animal and human studies from the literature research, simulated clinical studies, and the comparison of Collagen Nerve Cuff with other predicate devices, we conclude the following.
- The Collagen Nerve Cuff is safe for implantation as demonstrated by the 1. biocompatibility studies.
2
- The Collagen Nerve Cuff is effective for bridging nerve gaps and guiding the 2. axonal growth in peripheral nerve repair procedure under the proposed conditions of use.
- The Collagen Nerve Cuff is substantially equivalent to the predicate devices. 3.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
SEP 2 1 2001
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Shu-Tung Li President and CEO Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K012814
Trade/Device Name: Collagen Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: August 21, 2001 Received: August 22, 2001
Dear Dr. Li:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
4
Page 2 -Dr. Shu-Tung Li
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walter, MD
Celia M. Witten, Ph.D., M.D. ల్లు Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O.
f/t:HFZ-410:MAdjodha:dlw:09-18-01
5
510(k) Number (if known): KO 2814
Device Name: Collagen Nerve Cuff
Indications for Use:
Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
S.N.
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO12814