(58 days)
No
The summary describes a passive, resorbable tube for nerve regeneration and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is described as providing a "protective environment for peripheral nerve regeneration" and a "conduit to guide axonal growth across a nerve gap" for patients who have sustained a complete division of a nerve, which directly indicates a therapeutic purpose of aiding in the healing and regeneration of damaged nerves.
No
The device description and intended use clearly state that it is a nerve guide for reconstruction and regeneration of peripheral nerves, not for diagnosing nerve conditions. Its function is therapeutic, aiding in physical repair and guiding growth.
No
The device description clearly states it is a physical tube made of resorbable material, intended for surgical implantation. 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 provide a protective environment for peripheral nerve regeneration and guide axonal growth. This is a physical implant used directly on the nerve tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information. The device itself is the therapeutic intervention.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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® (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).
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 of 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 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.
Key Metrics
Not Found
Predicate Device(s)
Salumedica™ nerve cuff, Salumedica, K002098, Neurogen™ nerve guide, Integra life science, K011168, Neurolac® nerve guide, Polyganics BV, K032115
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
- 4 2005 MAY
Neurolac® (4-10 mm) nerve guide
Traditional 510(k) Premarket Notification
| Submitter | Polyganics BV
L.J. Zielstraweg 1
9713 GX, Groningen
The Netherlands
www.polyganics.com |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person | Jan Nieuwenhuis
Managing Director
Tel : +31 50 588 6588
Fax : +31 50 588 6599
Mobile : +31 653 211 303
E-mail : jan.nieuwenhuis@polyganics.com |
| Date
Prepared | March 2, 2005 |
| 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 | Salumedica™ nerve cuff, Salumedica, K002098
Neurogen™ nerve guide, Integra life science, K011168
Neurolac® nerve guide, Polyganics BV, K032115 |
| 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
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
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