(73 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of a nerve guide, with no mention of AI or ML technologies.
Yes
The device is indicated for the reconstruction of a peripheral nerve and provides a protective environment for nerve regeneration, which is a therapeutic function.
No
The device, Neurolac®, is designed for the reconstruction of peripheral nerve discontinuity by creating a protective environment and guiding axonal growth. Its purpose is therapeutic (repairing a nerve) rather than diagnostic (identifying a disease or condition).
No
The device description clearly states that Neurolac® is a physical tube made of resorbable poly(DL-lactide- co-e-caprolactone), provided in sterile packaging. This indicates a physical medical device, not a software-only one.
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) to repair damaged tissue.
- Device Description: The device is a resorbable tube designed to provide a protective environment and guide axonal growth across a nerve gap. This describes a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a therapeutic device used to facilitate nerve regeneration within the body.
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 (comma separated list FDA assigned to the subject device)
JXI
Device Description
Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap.
Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.
The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing for this line extension demonstrated that the technological characteristics and performance criteria of the additional thinner-walled Neurolac nerve guides are comparable to the current cleared Neurolac nerve guides and that they can perform in a manner equivalent to Neurolac devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:
| Properties | Cleared Neurolac nerve guides | Neurolac with 37% wall thickness reduction | |
|---|---|---|---|
| Dimensional changes | Inner diameter | Lumen maintained till week 10-11 | Lumen maintained till week 10-11 |
| Outer diameter | Gradual increase | Gradual increase | |
| Wall thickness | Gradual increase in outward direction | Gradual increase in outward direction | |
| Weight changes | Swelling (water uptake) | Stable in initial weeks and then gradual increase | Stable in initial weeks and then gradual increase |
| Weight loss | After week 10-11 | After week 10-11 | |
| Analysis | NMR | Degradation prodcuts after week 12 | Degradation products after week 12 |
| DSC | Gradual decrease in Tg | Gradual decrease in Tg | |
| Intrinsic Viscosity | Slow and gradual decrease | Slow and gradual decrease | |
| Mechanical properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks | |
| Flexural properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks | |
| Compression properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks | |
| Suturability testing | Difficult suturing | Easy suturing |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 2 0 2011
| K112267 | |||||
|---|---|---|---|---|---|
| page 1/3 | |||||
| Special 510(k) Summary of Safety and Effectiveness | |||||
| Line extension to Neurolac nerve guide | |||||
| Submitter: | Polyganics BV | ||||
| Rozenburglaan 15A | |||||
| 9727 DL Groningen | |||||
| The Netherlands | |||||
| www.polyganics.com | |||||
| Contact Person: | Betty IJmker. | ||||
| Manager Regulatory Affairs | |||||
| Tel : +31 50 588 6598 | |||||
| Fax : +31 50 588 6599 | |||||
| E-mail : ijmker@polyganics.com | |||||
| Date Prepared: | 20 September 2011 | ||||
| General | |||||
| Provisions: | Trade Name: Neurolac® Nerve guide | ||||
| Common Name: Nerve guide | |||||
| Classification Name: Nerve Cuff, 21 CFR 882.5275 | |||||
| Device Classification: Class II | |||||
| Predicate Device: | • Neurolac 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
Device Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-Description co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap.
ン
Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.
The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.
In vitro testing for this line extension demonstrated that the technological Performance Data: characteristics and performance criteria of the additional thinner-walled Neurolac nerve guides are comparable to the current cleared Neurolac nerve guides and that they can perform in a manner equivalent to Neurolac devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:
| Properties | | Cleared Neurolac nerve
guides | Neurolac with 37%
wall thickness reduction |
|---------------------------|-------------------------------|------------------------------------------------------|---------------------------------------------------------|
| Dimensional
changes | Inner
diameter | Lumen maintained till
week 10-11 | Lumen maintained till
week 10-11 |
| | Outer
diameter | Gradual increase | Gradual increase |
| | Wall
thickness | Gradual increase in
outward direction | Gradual increase in
outward direction |
| Weight
changes | Swelling
(water
uptake) | Stable in initial weeks and
then gradual increase | Stable in initial weeks
and then gradual
increase |
| | Weight loss | After week 10-11 | After week 10-11 |
| Analysis | NMR | Degradation prodcuts
after week 12 | Degradation products
after week 12 |
| | DSC | Gradual decrease in Tg | Gradual decrease in Tg |
| | Intrinsic
Viscosity | Slow and gradual
decrease | Slow and gradual
decrease |
| Mechanical
properties | | Stable for initial 10-11
weeks | Stable for initial 10-11
weeks |
| Flexural
properties | | Stable for initial 10-11
weeks | Stable for initial 10-11
weeks |
| Compression
properties | | Stable for initial 10-11
weeks | Stable for initial 10-11
weeks |
| Suturability
testing | | Difficult suturing | Easy suturing |
2
//2267
page 3/3
Summary of Substantial Equivalence The design, materials, fundamental technology and intended use (safety and efficacy) featured with the Neurolac® Nerve Guide are substantially equivalent to those featured with the following cleared device: Neurolac nerve guides (K032115; Polyganics BV). The basis for equivalence is demonstrated by the comparisons in the following table:
| | Neurolac nerve guide
thinner-walls (this
submission) | Neurolac nerve guide
(K032115) |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Reconstruction of a
peripheral nerve
discontinuity up to 20 mm in
patients who have
sustained a complete
division of a nerve. | Reconstruction of a
peripheral nerve discontinuity
up to 20 mm in patients who
have sustained a complete
division of a nerve. |
| Material | poly(DL-lactide-co-ε-
caprolactone) | poly(DL-lactide-co-ε-
caprolactone) |
| Design | Tube | Tube |
| Sizes | 1.5 - 3mm ID
3cm length | 1.5 - 3mm ID
3cm length |
| Sterilization | EtO | EtO |
| Shelf-life | 42 months | 42 months |
| Packaging | Single use, polycar-bonate
tray, single tyvek pouch,
cardboard box. | Single use, polycar-bonate
tray, single tyvek pouch,
cardboard box. |
Differences between the devices do not raise any significant issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Polyganics BV c/o Betty IJmker Manager Regulatory Affairs Rozenburglaan 15A 9727 DL Groningen The Netherlands
Re: K112267
Trade/Device Name: Neurolac Nerve Guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: II Product Code: JXI Dated: September 20, 2011 Received: September 23, 2011
Dear Ms. Ijmker:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Betty IJmker
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Luke Riving
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) K112267 Number
Neurolac® nerve guide Device Name
: : !
Indications 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 for Use 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 x (Per 21 CFR 801. 109)
. "",
Over-The-Counter Use_
uanB
OR
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112267