(58 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® (4-10 mm) is designed to be a flexible and transparent resorbable poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm).
The provided text describes a 510(k) premarket notification for the Neurolac® (4-10 mm) nerve guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, specific performance studies with sample sizes, expert involvement, and ground truth establishment are not typically part of a 510(k) submission and are not present in the provided documents.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document because this is a 510(k) submission demonstrating substantial equivalence to predicate devices, rather than a de novo submission or PMA requiring explicit performance acceptance criteria and reporting. The "Performance Data" section in {1} outlines what kind of tests were performed (in vitro, in vivo), but doesn't list specific quantitative acceptance criteria or results in a table format.
2. Sample Size Used for the Test Set and Data Provenance
Again, this level of detail for specific test sets with sample sizes and data provenance (country, retrospective/prospective) is not explicitly provided in the context of the 510(k) submission. The document mentions "design verification tests and analyses" and "in vivo nerve function recovery," but doesn't detail the sample sizes or provenance for these tests. The primary "study" is the comparison to predicate devices and reliance on pre-existing data (K032115).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The 510(k) process for this device relies on demonstrating equivalence rather than establishing new clinical ground truth through expert consensus.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided. MRMC studies are typically for evaluating diagnostic imaging devices or other technologies where human readers interpret results, which is not directly applicable to a nerve guide.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/not provided. The Neurolac® nerve guide is a medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Neurolac® (4-10 mm) nerve guide's safety and effectiveness relies on:
- Substantial Equivalence to Predicate Devices: The primary "ground truth" is that the Neurolac® (4-10 mm) nerve guide is substantially equivalent in design, fundamental technology, and intended use to previously cleared devices:
- Pre-clinical data: "Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation." {1}
- Literature and Comparison: "Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is made, is safe for implantation." {1}
8. The Sample Size for the Training Set
This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms, which is not applicable here. The safety and effectiveness are established through reference to predicate devices and pre-clinical data, not an AI training process.
9. How the Ground Truth for the Training Set Was Established
As explained above, this concept of "training set" and associated ground truth establishment is not applicable to this device.
{0}------------------------------------------------
- 4 2005 MAY
Neurolac® (4-10 mm) nerve guide
Traditional 510(k) Premarket Notification
| Submitter | Polyganics BVL.J. Zielstraweg 19713 GX, GroningenThe Netherlandswww.polyganics.com |
|---|---|
| ContactPerson | Jan NieuwenhuisManaging DirectorTel : +31 50 588 6588Fax : +31 50 588 6599Mobile : +31 653 211 303E-mail : jan.nieuwenhuis@polyganics.com |
| DatePrepared | March 2, 2005 |
| GeneralProvisions | Trade Name: Neurolac nerve guideCommon Name: Nerve guideClassification Name: Nerve Cuff, 21 CFR 882.5275Device Classification: Class II |
| PredicateDevices | Salumedica™ nerve cuff, Salumedica, K002098Neurogen™ nerve guide, Integra life science, K011168Neurolac® nerve guide, Polyganics BV, K032115 |
| 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. |
{1}------------------------------------------------
K050-575
Traditional 510(k) Premarket Notification Neurolac® (4-10 mm) nerve guide Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable Device poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment Description for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm). The safety and effectiveness of the Neurolac nerve guides have been dem-Performance onstrated via data collected from design verification tests and analyses. The Data design verification testing consisted of the following: In vitro suture retention testing -In vitro degradation testing -In vivo nerve function recovery of The design, fundamental technology and intended use (safety and efficacy) Summary featured with the Neurolac® Nerve Guide are substantially equivalent to Substantial Equivalence those featured with the competitor devices Neurogen™ nerve guide (ref. 510(k) 011168; Integra Life Science) and the Salumedica™ nerve cuff (ref. 510(k) 002098; Salumedica). Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation. Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the
comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is
made, is safe for implantation.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.
MAY - 4 2005
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J.B. Hak, Ph.D. Manager Clinical and Regulatory Affairs Polyganics BV L.J. Zielstraweg 1 NL-9713-GX Groningen The Netherlands
Re: K050573
Trade/Device Name: Neurolac® nerve guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: March2, 2005 Received: March 7, 2005
Dear Dr. Hak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to tegans atment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in excordance with the provisions of the Federal Food, Drug, de vices that have been recise and require approval of a premarket approval application (PMA). and Cosmetion Ace (110) that the device, subject to the general controls provisions of the Act. The r ou may, dictore, mainer of the Act include requirements for annual registration, listing of general controls profitering 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), If your device is clussified (bes as c) ontrols. Existing major regulations affecting your device it may of subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA ean be fourd in the over in concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc davised that I Dr o wean that your device complies with other requirements of the Act inal I DA has made a acterimiations administered by other Federal agencies. You must of any I cutures and regularients and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quant) systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - J.B. Hak, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your maneting of your device to a legally prematics notification. "The PDF inturlight 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 If you desire specific advice for your as (240) 276-0115 . Also, please note the regulation entitled, Contact the Office of Compullios as (21 the Part 807.97). You may obtain Misolanding by release to premainters within as a many the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Ja Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
KOSOS73
Neurolac® (4-10 mm) nerve guide K050573
Traditional 510(k) Premarket Notification
Indications for Use Form
510(k) Number:
Neurolac® nerve guide Device Name:
Indications for Use:
The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve
s and and the collection in the last a boys oustsined a complete division of a The Neurolac herve guide is indicated for the roomstrained a complete division of a nerve.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF
LEE – CONTINE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF – NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
17
4/8/2005
Page 8 of 49
§ 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).