(93 days)
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.
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.
The Neurolac® Nerve Guide is a medical device designed to assist in the regeneration of peripheral nerves after injury. The device manufacturer, Polyganics BV, submitted a 510(k) premarket notification to the FDA to demonstrate its substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not specify quantified acceptance criteria (e.g., specific thresholds for suture retention strength or nerve function recovery). Instead, the performance data focused on demonstrating safety and effectiveness through various tests and analyses, indicating that the device performs comparably to predicate devices. The implicit acceptance criteria were that the device's performance data, alongside biocompatibility and comparison to predicate devices, would be sufficient to establish substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device biocompatibility | Biocompatibility testing was performed. Evaluation of the Polyganics Neurolac® Nerve guide based on biocompatibility testing, animal tests, results from literature, and comparison with predicate devices showed it to be safe for implantation. |
| Adequate mechanical properties (e.g., suture retention) | In vitro suture retention testing was conducted. No specific values provided, but the inclusion implies it met internal or comparative standards. |
| Appropriate degradation profile | In vitro degradation testing was conducted. No specific values provided, but the inclusion implies it met internal or comparative standards suitable for nerve regeneration. |
| Support for nerve function recovery | In vivo nerve function recovery was evaluated in an animal model. No specific metrics or statistical results are provided within this summary, but the study implies positive outcomes demonstrating its ability to guide axonal growth and promote regeneration. Performance testing in an animal model provided reasonable scientific evidence. |
| Substantial equivalence to predicate devices in design, technology, and intended use | The Neurolac® Nerve Guide's design, fundamental technology, and intended use are substantially equivalent to Neurotube™ (K983007) and NeuroGen™ Nerve Guide (K011168). This was supported by biocompatibility, mechanical and physical property testing, in vitro degradation testing, and performance testing in an animal model, indicating its safety and efficacy are comparable to the predicate devices. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated for each test.
- For the "In vivo nerve function recovery," it states "an animal model" was used, but the number of animals or specific experimental subjects is not provided.
- For "In vitro suture retention testing" and "In vitro degradation testing," the number of samples or replicates used in these tests is not specified.
- Data Provenance: The studies were conducted by Polyganics BV, a company based in The Netherlands.
- The in vitro tests (suture retention, degradation) are laboratory-based.
- The in vivo test was conducted using "an animal model." The specific type of animal, the location of the animal study, or if it was retrospective or prospective is not detailed, but it would have been a prospective study to evaluate the device's performance.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This is a medical device for nerve repair, and the evaluation did not involve human-in-the-loop diagnostic performance or
expert interpretation of images to establish ground truth in the context of AI/diagnostic device studies. Instead, its performance was assessed through physical, chemical, and biological testing.
4. Adjudication Method for Test Set:
Not applicable. As described above, the study does not involve human readers interpreting data that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a passive nerve guide, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Neurolac® Nerve Guide is a physical medical device, not an algorithm. Its performance is inherent to its physical and biological properties.
7. Type of Ground Truth Used:
The "ground truth" for evaluating the Neurolac® Nerve Guide was established through:
- Direct measurement and observation: For in vitro tests like suture retention and degradation, the "ground truth" was empirical data derived from standardized laboratory tests.
- Biological outcomes: For in vivo nerve function recovery, the "ground truth" would be the observed biological response to the device in an animal model, such as nerve regeneration, functional recovery, and histological assessments. These would be determined by objective measurements and scientific observation in a controlled experimental setting.
- Comparison to predicate devices: The "ground truth" for substantial equivalence was the established performance and safety profiles of the legally marketed predicate devices (Neurotube™ and NeuroGen™).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning system, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth established for one.
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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.
| K032115510(k)Summary of Safety and Effectiveness | |
|---|---|
| Submitter: | Polyganics BVL.J. Zielstraweg 19713 GX, GroningenThe Netherlandswww.polyganics.com |
| ContactPerson: | Jan Bart Hak, Ph.D.Manager Clinical and Regulatory AffairsTel : +31 50 588 6588Fax : +31 50 588 6599Mobile : +31 653 211 303E-mail : hak@polyganics.com |
| DatePrepared: | May 20, 2003 |
| GeneralProvisions: | Trade Name: Neurolac® Nerve guideCommon Name: Nerve guideClassification Name: Nerve Cuff, 21 CFR 882.5275Device Classification: Class II |
| PredicateDevices: | Neurotube™ Neuroregen L.L.C. K983007NeuroGen™ Integra Life Sciences Corp. K011168 |
| PerformanceStandards | For the Nerve Cuff performance, the FDA, under section 514 of the Food,Drug and Cosmetic Act, has not established standards. |
| Indicationsfor Use | The Neurolac® nerve guide is indicated for the reconstruction of a peripheralnerve discontinuity up to 20 mm in patients who have sustained a completedivision of a nerve. |
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Neurolac® Nerve Guide Polyganics BV
Traditional 510(k) Premarket Notification
| DeviceDescription | Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-ε-caprolactone) tube to provide a protective environment forperipheral nerve regeneration after injury and to create a conduit to guideaxonal growth across a nerve gap.Neurolac® nerve guides are provided sterile in Tyvek pouch packages andretainer in a variety of sizes. |
|---|---|
| PerformanceData: | The safety and effectiveness of the Neurolac nerve guides have beendemonstrated 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 ofSubstantialEquivalence | The design, fundamental technology and intended use (safety and efficacy)featured with the Neurolac® Nerve Guide are substantially equivalent tothose 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 vitrodegradation testing, and performance testing in an animal model providereasonable 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.
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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.
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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
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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
§ 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).