Nerve Capping Device

K152684 · Polyganics Innovations BV · JXI · Jan 13, 2016 · Neurology

Device Facts

• Record ID: K152684
• Device Name: Nerve Capping Device
• Applicant: Polyganics Innovations BV
• Product Code: JXI · Neurology
• Decision Date: Jan 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Nerve Capping Device is a sterile, single-use, bioresorbable tubular implant composed of poly(DL-lactide-co-ε-caprolactone). It features one open end and one sealed end with a fixation hole. Used by surgeons in a clinical setting, the device is placed over a peripheral nerve stump to isolate it from the surrounding environment. The nerve end is pulled into the tube and sutured; the sealed end is then sutured to surrounding tissue. By providing a physical barrier for up to 10 weeks, the device prevents nerve stump dislocation and reduces the formation of symptomatic neuromas. The device is provided in various diameters to accommodate different nerve sizes.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, implantation/local tolerance, degradation, genotoxicity, carcinogenicity), in vitro degradation assessment, suture retention strength testing, tip dimensional verification, and usability testing with intended end users. Results demonstrate the device is non-pyrogenic, biocompatible, and maintains barrier function for up to 10 weeks, consistent with predicate performance.

Technological Characteristics

Material: poly(DL-lactide-co-ε-caprolactone) (synthetic bioresorbable copolyester). Form factor: tubular device with one closed end, 3cm length, various diameters (1.5mm–8.0mm). Barrier function: non-permeable for up to 10 weeks. Sterilization: Ethylene oxide (SAL 10^-6). Mechanical: suture-fixable. Packaging: Polycarbonate tray and Tyvek pouch.

Indications for Use

Indicated for patients requiring protection of a peripheral nerve end to reduce the development of a symptomatic neuroma.

Regulatory Classification

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).

Predicate Devices

• NEUROLAC® Nerve Guide (K050573)
• NEUROLAC® Nerve Guide (K112267)
• Flexible Collagen Nerve Cuff (K131541)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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 [phone] or [phone] 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 [phone] or [phone] 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 : [phone] : [phone] Fax E-mail : [e-mail]

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 (New<br>Device) | NEUROLAC® (K050573) | NEUROLAC® (K112267) | Flexible Collagen Nerve Cuff<br>(K131541) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Nerve Capping Device is<br>indicated to protect a peripheral<br>nerve end and to separate the nerve<br>from surrounding environment to<br>reduce the development of a<br>symptomatic neuroma. | The NEUROLAC® nerve guide is<br>indicated for the reconstruction of a<br>peripheral nerve discontinuity up to<br>20mm in patients who have<br>sustained a complete division of a<br>nerve. | The NEUROLAC® nerve guide is<br>indicated for the reconstruction of a<br>peripheral nerve discontinuity up to<br>20mm in patients who have<br>sustained a complete division of a<br>nerve. | Flexible Collagen Nerve Cuff is used for<br>the management of peripheral nerve<br>injuries in discontinuities where gap<br>closure can be achieved by flexion of<br>the extremity (e.g., to prevent ingrowth<br>of scar tissue) or at the end of the nerve<br>in the foot to reduce the formation of<br>symptomatic or painful neuroma. |
| Sterility | Sterile, SAL 10-6<br>Ethylene oxide sterilization | Sterile, SAL 10-6<br>Ethylene oxide sterilization | Sterile, SAL 10-6<br>Ethylene oxide sterilization | Sterile, SAL 10-6<br>Gamma 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/<br>Permeability | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Semi-permeable, permeable to<br>nutrients and macromolecules |
| Sizes | 1.5 mm ID x 3.0 cm length<br>2.0 mm ID x 3.0 cm length<br>2.5 mm ID x 3.0 cm length<br>3.0 mm ID x 3.0 cm length<br>4.0 mm ID x 3.0 cm length<br>5.0 mm ID x 3.0 cm length<br>6.0 mm ID x 3.0 cm length<br>7.0 mm ID x 3.0 cm length<br>8.0 mm ID x 3.0 cm length | 4.0 mm ID x 3.0 cm length<br>5.0 mm ID x 3.0 cm length<br>6.0 mm ID x 3.0 cm length<br>7.0 mm ID x 3.0 cm length<br>8.0 mm ID x 3.0 cm length<br>10.0 mm ID x 3.0 cm length | 1.5 mm ID x 3.0 cm length<br>2.0 mm ID x 3.0 cm length<br>2.5 mm ID x 3.0 cm length<br>3.0 mm ID x 3.0 cm length | 2.0 mm ID x 2.5 cm length<br>2.5 mm ID x 2.5 cm length<br>3.0 mm ID x 2.5 cm length<br>4.0 mm ID x 2.5 cm length<br>5.0 mm ID x 2.5 cm length<br>6.0 mm ID x 2.5 cm length |
| Shape | Cap (tube with one closed end)<br>Image: Drawing of a nerve capping device | Tube<br>Image: Drawing of a tube | Tube<br>Image: Drawing of a tube | Tube<br>Image: Drawing of a tube |
| Color | Transparent | Transparent | Transparent | White to Off white |
| Pyrogenicity | Non-pyrogenic<br>Endotoxin ≤ 0.6 EU/device | Non-pyrogenic<br>Endotoxin ≤ 0.18 EU/device | Non-pyrogenic<br>Endotoxin ≤ 0.18 EU/device | Non-pyrogenic<br>Endotoxin ≤ 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)<br>was observed | No cytotoxic potential | | |
| Sensitization | No significant evidence of causing<br>delayed dermal contact<br>sensitization in the guinea pig | Non-sensitizing | | |
| Irritation | No erythema or edema was<br>observed | Non-irritating | | |
| Acute systemic toxicity | Test article did not induce a<br>significantly greater biological<br>reaction than the control | Not considered systemically toxic | | |
| Pyrogenicity | Endotoxins were not detected | Non-pyrogenic | | |
| Hemocompatibility: Hemolysis | 0.0% hemolysis was observed | Non-hemolytic | | |
| Hemocompatibility: Prothrombin<br>Time Assay | No adverse effect on prothrombin<br>coaqulation time | Compatible with blood | | |
| Implantation/local tolerance | Relatively mild foreign body<br>response | Relatively mild foreign body response | | |
| (Bio)degradation | After 16 months very small<br>fragments of material were found | Biodegradable | | |
| (Sub)acute/subchronic toxicity | No toxic responses were<br>observed | No subchronic toxicity | | |
| Genotoxicity | No statistical increase was found<br>in the mutation frequency | Non-mutagenic | | |
| Carcinogenicity | No significant carcinogenic<br>potential | No significant carcinogenic potential | | |

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| EO and ECH residues | EO: ≤0.0016 mg/device<br>ECH: ≤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 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <i>In vitro</i> degradation | Assessment of physical, chemical and<br>thermal properties of the Nerve<br>Capping Device:<br>pH testing Dimensional testing Weight (dry and wet state) Tensile testing Intrinsic viscosity Glass temperature Degradation products Blue dye leak tests Visual inspections | The <i>in vitro</i> degradation at 37 °C<br>behavior for Nerve Capping Device is<br>comparable to the predicate<br>NEUROLAC®, and the shape integrity<br>will be intact for up 10 weeks to form a<br>barrier and separate the nerve stump<br>from the surrounding environment. The<br>degradation pattern is comparable to<br>that of NEUROLAC®. |
| Usability testing | Usability and specifications of the<br>Nerve Capping Device were assessed<br>by providing samples to the intended<br>end users. Their opinion and<br>experience on the usage of the product<br>was used to evaluate the device as<br>design verification and validation<br>activity to determine whether or not it<br>meets the requirements | The overall result is that the device can<br>be used to cover a nerve end in a fast<br>and easy manner and that the<br>procedure is less invasive then current<br>used techniques. The range of<br>dimensions from 1.5 up to 8.0 mm is<br>sufficient and the flat tube end with<br>fixation hole was found to be<br>convenient to fixate the device into the<br>tissue. |
| Suture retention<br>strength | To determine the force necessary to<br>pull a suture from the device or cause<br>the wall of the device to fail | All samples passed the acceptance<br>criteria and are comparable to<br>NEUROLAC® regarding retention<br>forces. The suture retention of a suture<br>placed in the tip section is higher<br>compared to a suture placed in the<br>tube section. |
| Tip dimensional<br>verification | To verify that the specified dimensions<br>of the tip are met | All samples passed the acceptance<br>criteria. The dimensions of the tip of the<br>device (closed part) are within the<br>tolerances 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.