(73 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-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.
The provided document describes a 510(k) submission for a line extension to the Neurolac® Nerve guide, with the modification being a thinner wall thickness. The study is an in vitro comparison of the new thinner-walled device to the predicate device (K032115).
Here's a breakdown of the acceptance criteria and study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each property. Instead, it demonstrates comparability to the predicate device. The implicit acceptance criterion is that the thinner-walled Neurolac nerve guides perform equivalently to the current cleared Neurolac nerve guides.
| Property | Implicit Acceptance Criteria / Target | Reported Device Performance (Neurolac with 37% wall thickness reduction) |
|---|---|---|
| Dimensional Changes | Comparable to Cleared Neurolac | |
| 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 | Comparable to Cleared Neurolac | |
| Swelling (water uptake) | Stable in initial weeks, then gradual increase | Stable in initial weeks and then gradual increase |
| Weight loss | After week 10-11 | After week 10-11 |
| Analysis | Comparable to Cleared Neurolac | |
| NMR (degradation products) | After week 12 | After week 12 |
| DSC (Tg) | Gradual decrease in Tg | Gradual decrease in Tg |
| Intrinsic Viscosity | Slow and gradual decrease | Slow and gradual decrease |
| Mechanical Properties | Comparable to Cleared Neurolac | |
| 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 | Not explicitly defined as "comparable" but notable improvement | Easy suturing (compared to "Difficult suturing" for cleared device) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the in vitro tests.
The data provenance is presented as in vitro testing, not explicitly stating country of origin, though the submitter is based in The Netherlands. It is a retrospective comparison as it compares to an already cleared predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in vitro test for material properties and device performance, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is an in vitro test for material properties and device performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm/software device. The performance data presented are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance characteristics of the predicate device (Neurolac nerve guides K032115), against which the new thinner-walled device is compared. This is based on previously established performance data for the predicate and fundamental material science.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this type of in vitro device comparison study. The study focuses on demonstrating comparability to a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied. The "ground truth" for comparison is the documented performance of the predicate device, which would have been established through its own preclinical studies and regulatory clearance process.
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OCT 2 0 2011
| K112267 | |||||
|---|---|---|---|---|---|
| page 1/3 | |||||
| Special 510(k) Summary of Safety and EffectivenessLine extension to Neurolac nerve guide | |||||
| Submitter: | Polyganics BVRozenburglaan 15A9727 DL GroningenThe Netherlandswww.polyganics.com | ||||
| Contact Person: | Betty IJmker.Manager Regulatory AffairsTel : +31 50 588 6598Fax : +31 50 588 6599E-mail : ijmker@polyganics.com | ||||
| Date Prepared: | 20 September 2011 | ||||
| GeneralProvisions: | 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 | ||||
| PerformanceStandards | For the Nerve Cuff performance, the FDA, under section 514 of the Food, Drug andCosmetic Act, has not established standards. | ||||
| Indications forUse | The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nervediscontinuity up to 20 mm in patients who have sustained a complete division of anerve. | ||||
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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 nerveguides | Neurolac with 37%wall thickness reduction | |
|---|---|---|---|
| Dimensionalchanges | Innerdiameter | Lumen maintained tillweek 10-11 | Lumen maintained tillweek 10-11 |
| Outerdiameter | Gradual increase | Gradual increase | |
| Wallthickness | Gradual increase inoutward direction | Gradual increase inoutward direction | |
| Weightchanges | Swelling(wateruptake) | Stable in initial weeks andthen gradual increase | Stable in initial weeksand then gradualincrease |
| Weight loss | After week 10-11 | After week 10-11 | |
| Analysis | NMR | Degradation prodcutsafter week 12 | Degradation productsafter week 12 |
| DSC | Gradual decrease in Tg | Gradual decrease in Tg | |
| IntrinsicViscosity | Slow and gradualdecrease | Slow and gradualdecrease | |
| Mechanicalproperties | Stable for initial 10-11weeks | Stable for initial 10-11weeks | |
| Flexuralproperties | Stable for initial 10-11weeks | Stable for initial 10-11weeks | |
| Compressionproperties | Stable for initial 10-11weeks | Stable for initial 10-11weeks | |
| Suturabilitytesting | Difficult suturing | Easy suturing |
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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 guidethinner-walls (thissubmission) | Neurolac nerve guide(K032115) | |
|---|---|---|
| Intended use | Reconstruction of aperipheral nervediscontinuity up to 20 mm inpatients who havesustained a completedivision of a nerve. | Reconstruction of aperipheral nerve discontinuityup to 20 mm in patients whohave sustained a completedivision of a nerve. |
| Material | poly(DL-lactide-co-ε-caprolactone) | poly(DL-lactide-co-ε-caprolactone) |
| Design | Tube | Tube |
| Sizes | 1.5 - 3mm ID3cm length | 1.5 - 3mm ID3cm length |
| Sterilization | EtO | EtO |
| Shelf-life | 42 months | 42 months |
| Packaging | Single use, polycar-bonatetray, single tyvek pouch,cardboard box. | Single use, polycar-bonatetray, single tyvek pouch,cardboard box. |
Differences between the devices do not raise any significant issues of safety and effectiveness.
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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
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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
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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)
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Over-The-Counter Use_
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OR
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112267
§ 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).