(117 days)
The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
The Nerve Capping Device is a sterile biodegradable nerve cuff composed of the bioresorbable copolyester poly(DL-lactide-s-caprolactone). It is a tubular device with one open end and one sealed end which functions as a cap, isolating the nerve end. The capping device prevents dislocation of the stump by pulling the nerve end into the tube and suturing in the nerve within the cap. Consequently, the end of the cap will be sutured to surrounding tissue. One hole at the sealed end of the tube allows easy fixation with a suture to the surrounding tissue. The size of the product is 3cm in length, and is available in different diameters for different sized nerves. The Nerve Capping Device is sterilized in a pouch package. The device is single-use, cannot be re-sterilized, and is a prescription product.
The provided text describes a 510(k) premarket notification for a medical device called the "Nerve Capping Device." This FDA document focuses on establishing substantial equivalence to previously cleared devices rather than a standalone clinical study demonstrating the device's absolute effectiveness or performance against specific acceptance criteria in a clinical setting.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies generally does not apply to this type of regulatory submission in the way you've outlined for algorithms or diagnostic tools.
However, I can extract and present the performance data provided in the document, which primarily consists of biocompatibility and other physical/mechanical testing, and reframe it to best fit your request.
Here's an attempt to answer your questions based on the provided text, with clear indications where the requested information is not available:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Nerve Capping Device's substantial equivalence was established through non-clinical performance data, primarily focusing on biocompatibility, physical degradation, usability, and mechanical strength, comparing it to predicate devices. The "acceptance criteria" in this context are implicitly met if the device demonstrates comparable biocompatibility and functional characteristics to existing, legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission seeking substantial equivalence, specific numerical acceptance criteria (e.g., "sensitivity > 90%") for clinical performance are not present. Instead, the "acceptance criteria" are implied by demonstrating that the device meets safety and performance standards generally, and is comparable to predicate devices. The reported "performance" are the results of these non-clinical tests.
| Test Parameter / Implied Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|
| Biocompatibility (Compliance with ISO 10993 for permanent contact device) | Cytotoxicity: No biological reactivity (Grade 0) observed. Conclusion: No cytotoxic potential. |
| Sensitization: No significant evidence of causing delayed dermal contact sensitization. Conclusion: Non-sensitizing. | |
| Irritation: No erythema or edema observed. Conclusion: Non-irritating. | |
| Acute systemic toxicity: Test article did not induce a significantly greater biological reaction than control. Conclusion: Not considered systemically toxic. | |
| Pyrogenicity: Endotoxins not detected. Conclusion: Non-pyrogenic (Endotoxin ≤ 0.6 EU/device). | |
| Hemocompatibility: Hemolysis: 0.0% hemolysis observed. Conclusion: Non-hemolytic. | |
| Hemocompatibility: Prothrombin Time Assay: No adverse effect on prothrombin coagulation time. Conclusion: Compatible with blood. | |
| Implantation/local tolerance: Relatively mild foreign body response. Conclusion: Relatively mild foreign body response. | |
| (Bio)degradation: After 16 months very small fragments of material were found. Conclusion: Biodegradable. | |
| (Sub)acute/subchronic toxicity: No toxic responses observed. Conclusion: No subchronic toxicity. | |
| Genotoxicity: No statistical increase found in mutation frequency. Conclusion: Non-mutagenic. | |
| Carcinogenicity: No significant carcinogenic potential. Conclusion: No significant carcinogenic potential. | |
| EO and ECH residues: EO: ≤0.0016 mg/device; ECH: ≤0.00045 mg/device. Conclusion: Residual levels acceptable. | |
| In vitro degradation (Comparable to predicate, maintain shape integrity for up to 10 weeks, comparable pattern) | The in vitro degradation at 37 °C behavior for Nerve Capping Device is comparable to the predicate NEUROLAC®, and the shape integrity will be intact for up 10 weeks to form a barrier and separate the nerve stump from the surrounding environment. The degradation pattern is comparable to that of NEUROLAC®. |
| Usability (Can be used to cover a nerve end quickly and easily, less invasive, sufficient dimensions, convenient fixation) | Overall result is that the device can be used to cover a nerve end in a fast and easy manner and that the procedure is less invasive than currently used techniques. The range of dimensions is sufficient and the flat tube end with fixation hole was found to be convenient to fixate the device into the tissue. |
| Suture retention strength (Pass acceptance criteria, comparable to NEUROLAC®) | All samples passed the acceptance criteria and are comparable to NEUROLAC® regarding retention forces. The suture retention of a suture placed in the tip section is higher compared to a suture placed in the tube section. |
| Tip dimensional verification (Specified dimensions of the tip met) | All samples passed the acceptance criteria. The dimensions of the tip of the device (closed part) are within the tolerances as specified. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for each individual test (e.g., number of devices tested for suture retention or in vitro degradation) are not provided in this summary. The biocompatibility tests for cytotoxicity, pyrogenicity, and EO residues were conducted for the Nerve Capping Device. Other biocompatibility tests (sensitization, irritation, acute systemic toxicity, hemocompatibility, implantation, degradation, subchronic toxicity, genotoxicity, carcinogenicity) were leveraged from predicate NEUROLAC® data due to identical materials and similar manufacturing processes.
- Data Provenance: Not explicitly stated, but common for medical device testing to be conducted in accredited laboratories. The device developer is Polyganics Innovations BV, located in The Netherlands. The referenced FDA Blue Book Memorandum and ISO standards are international.
- Retrospective/Prospective: These are laboratory and engineering tests, not clinical studies, so the terms retrospective/prospective do not directly apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable. The "ground truth" in this context refers to established scientific methods and standards for biocompatibility, material properties, and physical performance testing (e.g., ISO standards, ASTM methods). These tests yield objective measurements rather than subjective interpretations requiring expert consensus on "ground truth" in the way a diagnostic algorithm might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically used in clinical trials or studies where subjective interpretations or ambiguous results require resolution by multiple experts to establish a definitive outcome or "ground truth." The tests reported here are largely objective physical and biological assays.
5. If a multi-reader multicase (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
- This question is not applicable. An MRMC study is designed for diagnostic tools or AI systems to evaluate their impact on human reader performance. The Nerve Capping Device is a physical implantable medical device, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The Nerve Capping Device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance evaluation is based on established scientific and engineering principles, standardized test methods (e.g., those described in ISO 10993), and comparisons to characteristics of legally marketed predicate devices. This includes objective measurements (e.g., chemical residue levels, degradation rates, force measurements) and observations of biological responses in accordance with validated protocols.
8. The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility data from the existing NEUROLAC® devices served as a "leveraged" dataset for comparison, but it's not a training set in the AI sense.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons stated above (no training set for an AI device). The "ground truth" for the leveraged predicate data would have been established through similar standardized non-clinical testing performed at the time of their original 510(k) clearances.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Polyganics Innovations BV Ms. Betty IJmker Manager OA/RA Rozenburglaan 15A Groningen 9727 DL The Netherlands
Re: K152684
Trade/Device Name: Nerve Capping Device Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 11, 2015 Received: December 14, 2015
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152684
Device Name Nerve Capping Device
Indications for Use (Describe)
The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
Image /page/3/Picture/1 description: The image shows the logo for Polyganics. The logo features a cluster of teal and blue circles on the left side. To the right of the circles, the word "POLYGANICS" is written in blue, with the words "Bioresorbable Medical Devices" written in a smaller font size underneath.
Submitter:
Polyganics Innovations BV Rozenburglaan 15A 9727 DL Groningen The Netherlands www.polyganics.com
Date Prepared: 11 December 2015
Contact Person:
Betty IJmker Manager QA/RA Tel : +31 50 588 6598 : +31 50 588 6599 Fax E-mail : b.ijmker@polyganics.com
General Provisions:
Trade Name: Nerve Capping Device Common Name: Nerve capping device Classification Name: Nerve cuff 21 CFR 882.5275 Product Code: JXI Device Class: Class II Performance Standards: None
Predicate Devices:
K050573 NEUROLAC® Nerve Guide (Polyganics) K112267 NEUROLAC® Nerve Guide (Polyganics) K131541 Flexible Collagen Nerve Cuff (Collagen Matrix, Inc)
Device Description:
The Nerve Capping Device is a sterile biodegradable nerve cuff composed of the bioresorbable copolyester poly(DL-lactide-s-caprolactone). It is a tubular device with one open end and one sealed end which functions as a cap, isolating the nerve end. The capping device prevents dislocation of the stump by pulling the nerve end into the tube and suturing in the nerve within the cap. Consequently, the end of the cap will be sutured to surrounding tissue. One hole at the sealed end of the tube allows easy fixation with a suture to the surrounding tissue. The size of the product is 3cm in length, and is available in
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different diameters for different sized nerves. The Nerve Capping Device is sterilized in a pouch package. The device is single-use, cannot be re-sterilized, and is a prescription product.
Indications for Use:
The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
Summary / comparison of technical characteristics:
The Nerve Capping Device is similar in design and manufacturing, and identical in materials, packaging and sterilization method as its predicate NEUROLAC® (K050573 and K112267).
Table 1 contains a comparison of technological characteristics with the predicate devices:
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| Parameter | Nerve Capping Device (NewDevice) | NEUROLAC® (K050573) | NEUROLAC® (K112267) | Flexible Collagen Nerve Cuff(K131541) |
|---|---|---|---|---|
| Indications for use | The Nerve Capping Device isindicated to protect a peripheralnerve end and to separate the nervefrom surrounding environment toreduce the development of asymptomatic neuroma. | The NEUROLAC® nerve guide isindicated for the reconstruction of aperipheral nerve discontinuity up to20mm in patients who havesustained a complete division of anerve. | The NEUROLAC® nerve guide isindicated for the reconstruction of aperipheral nerve discontinuity up to20mm in patients who havesustained a complete division of anerve. | Flexible Collagen Nerve Cuff is used forthe management of peripheral nerveinjuries in discontinuities where gapclosure can be achieved by flexion ofthe extremity (e.g., to prevent ingrowthof scar tissue) or at the end of the nervein the foot to reduce the formation ofsymptomatic or painful neuroma. |
| Sterility | Sterile, SAL 10-6Ethylene oxide sterilization | Sterile, SAL 10-6Ethylene oxide sterilization | Sterile, SAL 10-6Ethylene oxide sterilization | Sterile, SAL 10-6Gamma Irradiation |
| Resorbable | Yes | Yes | Yes | Yes |
| Material | poly(DL-lactide-co-ε-caprolactone) | poly(DL-lactide-co-ε-caprolactone) | poly(DL-lactide-co-ε-caprolactone) | Type I Collagen |
| Source | Synthetic | Synthetic | Synthetic | Bovine tendon |
| Barrier function/Permeability | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Semi-permeable, permeable tonutrients and macromolecules |
| Sizes | 1.5 mm ID x 3.0 cm length2.0 mm ID x 3.0 cm length2.5 mm ID x 3.0 cm length3.0 mm ID x 3.0 cm length4.0 mm ID x 3.0 cm length5.0 mm ID x 3.0 cm length6.0 mm ID x 3.0 cm length7.0 mm ID x 3.0 cm length8.0 mm ID x 3.0 cm length | 4.0 mm ID x 3.0 cm length5.0 mm ID x 3.0 cm length6.0 mm ID x 3.0 cm length7.0 mm ID x 3.0 cm length8.0 mm ID x 3.0 cm length10.0 mm ID x 3.0 cm length | 1.5 mm ID x 3.0 cm length2.0 mm ID x 3.0 cm length2.5 mm ID x 3.0 cm length3.0 mm ID x 3.0 cm length | 2.0 mm ID x 2.5 cm length2.5 mm ID x 2.5 cm length3.0 mm ID x 2.5 cm length4.0 mm ID x 2.5 cm length5.0 mm ID x 2.5 cm length6.0 mm ID x 2.5 cm length |
| Shape | Cap (tube with one closed end)Image: Drawing of a nerve capping device | TubeImage: Drawing of a tube | TubeImage: Drawing of a tube | TubeImage: Drawing of a tube |
| Color | Transparent | Transparent | Transparent | White to Off white |
| Pyrogenicity | Non-pyrogenicEndotoxin ≤ 0.6 EU/device | Non-pyrogenicEndotoxin ≤ 0.18 EU/device | Non-pyrogenicEndotoxin ≤ 0.18 EU/device | Non-pyrogenicEndotoxin ≤ 0.5 EU/ml |
| Mechanical strength | Can be sutured | Can be sutured | Can be sutured | Can be sutured |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible |
| Packaging | Polycarbonate tray and Tyvek pouch | Polycarbonate tray and Tyvek pouch | Polycarbonate tray and Tyvek pouch | Double peel package |
Table 1: Comparison of technological characteristics
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Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Nerve Capping Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Nerve Capping Device is considered a permanent contact device: device contact exceeds 30 days.
The battery of testing included the following tests which were conducted for the predicate NEUROLAC® and leveraged for the Nerve Capping Device, except for cytotoxicity, pyrogenicity and EO residues which were conducted for the Nerve Capping Device.
The predicate test data was leveraged to support the substantial equivalence of the subject device as the device material is exactly the same for the subject and predicate device NEUROLAC® (bioresorbable copolyester poly(DL-lactide-s-caprolactone), and the shape is tubular as the predicate device NEUROLAC® but with one closed end. The Nerve Capping Device is manufactured with an identical production process (with the only difference being the sealing step of the tip), packaging and sterilization method, and the body contact is identical.
| BIOCOMPATIBILITY TEST | RESULTS | CONCLUSION | ||
|---|---|---|---|---|
| Cytotoxicity | No biological reactivity (Grade 0)was observed | No cytotoxic potential | ||
| Sensitization | No significant evidence of causingdelayed dermal contactsensitization in the guinea pig | Non-sensitizing | ||
| Irritation | No erythema or edema wasobserved | Non-irritating | ||
| Acute systemic toxicity | Test article did not induce asignificantly greater biologicalreaction than the control | Not considered systemically toxic | ||
| Pyrogenicity | Endotoxins were not detected | Non-pyrogenic | ||
| Hemocompatibility: Hemolysis | 0.0% hemolysis was observed | Non-hemolytic | ||
| Hemocompatibility: ProthrombinTime Assay | No adverse effect on prothrombincoaqulation time | Compatible with blood | ||
| Implantation/local tolerance | Relatively mild foreign bodyresponse | Relatively mild foreign body response | ||
| (Bio)degradation | After 16 months very smallfragments of material were found | Biodegradable | ||
| (Sub)acute/subchronic toxicity | No toxic responses wereobserved | No subchronic toxicity | ||
| Genotoxicity | No statistical increase was foundin the mutation frequency | Non-mutagenic | ||
| Carcinogenicity | No significant carcinogenicpotential | No significant carcinogenic potential |
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| EO and ECH residues | EO: ≤0.0016 mg/deviceECH: ≤0.00045 mg/device | Residual levels acceptable |
|---|---|---|
| --------------------- | -------------------------------------------------- | ---------------------------- |
The Nerve Capping Device complies with the biocompatibility requirements for its intended use.
| Other performance testing conducted for the Nerve Capping Device: | |||
|---|---|---|---|
| Test | Test Method Summary | Results |
|---|---|---|
| In vitro degradation | Assessment of physical, chemical andthermal properties of the NerveCapping Device:pH testing Dimensional testing Weight (dry and wet state) Tensile testing Intrinsic viscosity Glass temperature Degradation products Blue dye leak tests Visual inspections | The in vitro degradation at 37 °Cbehavior for Nerve Capping Device iscomparable to the predicateNEUROLAC®, and the shape integritywill be intact for up 10 weeks to form abarrier and separate the nerve stumpfrom the surrounding environment. Thedegradation pattern is comparable tothat of NEUROLAC®. |
| Usability testing | Usability and specifications of theNerve Capping Device were assessedby providing samples to the intendedend users. Their opinion andexperience on the usage of the productwas used to evaluate the device asdesign verification and validationactivity to determine whether or not itmeets the requirements | The overall result is that the device canbe used to cover a nerve end in a fastand easy manner and that theprocedure is less invasive then currentused techniques. The range ofdimensions from 1.5 up to 8.0 mm issufficient and the flat tube end withfixation hole was found to beconvenient to fixate the device into thetissue. |
| Suture retentionstrength | To determine the force necessary topull a suture from the device or causethe wall of the device to fail | All samples passed the acceptancecriteria and are comparable toNEUROLAC® regarding retentionforces. The suture retention of a sutureplaced in the tip section is highercompared to a suture placed in thetube section. |
| Tip dimensionalverification | To verify that the specified dimensionsof the tip are met | All samples passed the acceptancecriteria. The dimensions of the tip of thedevice (closed part) are within thetolerances as specified. |
Conclusion:
The non-clinical data and the device verification and validation demonstrate that the Nerve Capping Device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the Nerve Capping Device is substantially equivalent to the predicate devices.
§ 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).