(41 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of a nerve cuff, with no mention of AI or ML technologies.
Yes
The device is intended for the "repair of peripheral nerve discontinuities," which is a therapeutic intervention.
No
The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities, meaning it is a therapeutic device used for treatment, not for diagnosing a condition.
No
The device description clearly states it is manufactured from porcine small intestinal submucosa (SIS) and is a physical cuff intended for surgical repair, indicating it is a hardware 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 clearly states the device is for the "repair of peripheral nerve discontinuities." This is a surgical procedure performed in vivo (within the body) to treat a physical condition.
- Device Description: The description details a physical implantable device made from porcine tissue, designed to be surgically placed.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens for diagnostic purposes.
Therefore, the SURGIS Nerve Cuff is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
Product codes
JXI
Device Description
The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
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
The material comprising the SURGISIS® Nerve Cuff was subjected to extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, tensile strength to be sufficient as well as suture retention strength, ability to withstand compressive forces, and during in vivo use to be associated with a higher degree of axonal growth and myelination as compared to controls.
Key Metrics
Not Found
Predicate Device(s)
K980431, K011168, K002098, K012814
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).
0
K03/069/R,
9. 510(K) SUMMARY
MAY 1 5 2003
Submitted By: Mark Bleyer, President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355 April 2, 2003
Names of Device:
SURGISIS® Nerve Cuff Trade Name: Common/Usual Name: Nerve Cuff, Nerve Sheath Proposed classification name: Nerve Cuff 21 CFR 882.5275 (84 JXI) Class II
Intended Use:
The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
Predicate Devices:
The SURGIS Nerve Cuff is similar to predicate devices, including the SURGISS Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, the NeuroGen Nerve Guide (K011168) manufactured by Integra Life Sciences, the SaluBridge Nerve Cuff (K002098) manufactured by Salumedica, LLC, and the Collagen Nerve Cuff (K012814) manufactured by Collagen Matrix Incorporated.
Device Description:
The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Substantial Equivalence:
The SURGIS Nerve Cuff is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and in vivo testing.
Discussion of Tests and Test Results:
The material comprising the SURGISIS® Nerve Cuff was subjected to extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, tensile strength to be sufficient as well as suture retention strength, ability to withstand compressive forces, and during in vivo use to be associated with a higher degree of axonal growth and myelination as compared to controls.
1
510(k) Premarket Notification: SURGISIS® Nerve Cuff
K03/069/P2
Conclusions Drawn from the Tests:
Outcomes from the evaluation of the SURGISIS® Nerve Cuff provide evidence of its suitability for nerve cuff repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
2
Image /page/2/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 to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2003
Mr. Mark Blever President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906
Re: K031069
Trade/Device Name: SURGISIS® Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: April 2, 2003 Received: April 4, 2003
Dear Mr. Bleyer:
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Mark Bleyer
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), 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) you may obtain. 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,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K03
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Surgisis Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031069
Prescription Use (Per 21 CFR 801.109) ବିତା
OR
Over-The-Counter Use (Optional Format 1-2-