(93 days)
Not Found
No
The summary describes a physical nerve guide made of resorbable material. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on material properties and biological outcomes, not algorithmic performance.
Yes
The device is indicated for the reconstruction of a peripheral nerve discontinuity and provides a protective environment for nerve regeneration, which directly treats an injured biological structure and restores its function.
No
The device is described as a nerve guide for reconstruction and regeneration of a peripheral nerve after injury, not for diagnosing a condition.
No
The device description clearly states it is a physical tube made of resorbable poly(DL-lactide-co-ε-caprolactone), 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 is for the reconstruction of a peripheral nerve discontinuity in patients. This is a surgical intervention performed in vivo (within the living body).
- Device Description: The device is a resorbable tube designed to guide axonal growth across a nerve gap. This is a physical implant used for tissue repair and regeneration in vivo.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Neurolac® nerve guide does not perform any such tests on biological samples.
Therefore, the Neurolac® nerve guide is a surgical implant used for nerve repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
Product codes
JXI
Device Description
Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-ε-caprolactone) tube to provide a protective environment for peripheral nerve regeneration after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.
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 safety and effectiveness of the Neurolac nerve guides have been demonstrated via data collected from design verification tests and analyses. The design verification testing consisted of the following:
- In vitro suture retention testing
- In vitro degradation testing
- In vivo nerve function recovery
Key Metrics
Not Found
Predicate Device(s)
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
OCT 1 0 2003
Neurolac® Nerve Guide
Polyganics BV
Traditional 510(k) Premarket Notification
Image /page/0/Picture/3 description: The image shows a logo with the word "POLyGANICS" in a serif font. Above the word is a silhouette of a person running. The image is in black and white.
| | K032115
510(k)
Summary of Safety and Effectiveness |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Polyganics BV
L.J. Zielstraweg 1
9713 GX, Groningen
The Netherlands
www.polyganics.com |
| Contact
Person: | Jan Bart Hak, Ph.D.
Manager Clinical and Regulatory Affairs
Tel : +31 50 588 6588
Fax : +31 50 588 6599
Mobile : +31 653 211 303
E-mail : hak@polyganics.com |
| Date
Prepared: | May 20, 2003 |
| General
Provisions: | Trade Name: Neurolac® Nerve guide
Common Name: Nerve guide
Classification Name: Nerve Cuff, 21 CFR 882.5275
Device Classification: Class II |
| Predicate
Devices: | Neurotube™ Neuroregen L.L.C. K983007NeuroGen™ Integra Life Sciences Corp. K011168 |
| Performance
Standards | For the Nerve Cuff performance, the FDA, under section 514 of the Food,
Drug and Cosmetic Act, has not established standards. |
| Indications
for Use | The Neurolac® nerve guide is indicated for the reconstruction of a peripheral
nerve discontinuity up to 20 mm in patients who have sustained a complete
division of a nerve. |
1
Neurolac® Nerve Guide Polyganics BV
Traditional 510(k) Premarket Notification
| Device
Description | Neurolac® is designed to be a flexible and transparent resorbable poly(DL-
lactide-co-ε-caprolactone) tube to provide a protective environment for
peripheral nerve regeneration after injury and to create a conduit to guide
axonal growth across a nerve gap.
Neurolac® nerve guides are provided sterile in Tyvek pouch packages and
retainer in a variety of sizes. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data: | The safety and effectiveness of the Neurolac nerve guides have been
demonstrated via data collected from design verification tests and analyses.
The design verification testing consisted of the following:
- In vitro suture retention testing
- In vitro degradation testing
- In vivo nerve function recovery |
| Summary of
Substantial
Equivalence | The design, fundamental technology and intended use (safety and efficacy)
featured with the Neurolac® Nerve Guide are substantially equivalent to
those featured with the competitor devices Neurotube™ (ref. 510(k) 983007;
Neuroregen L.L.C.) and the NeuroGen™ Nerve Guide (ref. 510(k) 011168;
Integra Life Sciences Corporation).
Biocompatibility, mechanical and physical property testing, in vitro
degradation testing, and performance testing in an animal model provide
reasonable scientific evidence that Neurolac® nerve guide is substantially |
equivalent to the predicate devices. Evaluation of the Polyganics Neurolac® Nerve guide based on biocompatibility testing, animal tests, results from literature and the comparison of the Neurolac® nerve guide with its predicate devices, shows that the Neurolac® nerve guide is safe for implantation.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jan Bart Hak, Ph.D. Manager, Clinical and Regulatory Affairs Polyganics BV L.J. Zielstraweg 1 9713 GX, Groningen The Netherlands
Re: K032115
Trade/Device Name: Neurolac® Nerve Guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: July 3, 2003 Received: July 17, 2003
Dear Dr. Hak:
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.
3
Page 2 - Jan Bart Hak, Ph.D.
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. 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 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.
Miriam C. Pivort
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
4
Neurolac® Nerve Guide Polyganics BV
Traditional 510(k) Premarket Notification
Image /page/4/Picture/2 description: The image shows a logo for a company called "POLYGANICS". Above the company name is a silhouette of a person running. Below the company name is the text "Polygmeric technologies of tissue recovery".
Indications for Use Form
510(k) Number:
032115
Device Name: Neurolac® Nerve Guide
Indications for Use:
The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
OR
510(k) Number
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032115
Page 8 of 57
08-Oct-03