(117 days)
No
The device description and performance studies focus on the physical properties, biocompatibility, and mechanical performance of a biodegradable nerve cuff. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device's intended use is to "protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma," which describes a therapeutic effect.
No
The device is indicated to protect a peripheral nerve end and separate it from the surrounding environment to reduce the development of a symptomatic neuroma. It is a therapy device, not one for diagnosis.
No
The device description clearly states it is a sterile biodegradable nerve cuff made of bioresorbable copolyester, a physical material, and describes its physical form and function. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma." This is a therapeutic and protective function performed in vivo (within the body).
- Device Description: The device is a "sterile biodegradable nerve cuff" that is implanted to physically cover and isolate a nerve end. This is a medical device used for surgical intervention.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is designed to be implanted into the human body for a therapeutic and protective purpose.
N/A
Intended Use / 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.
Product codes
JXI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key results:
- Cytotoxicity: No biological reactivity (Grade 0) was observed, no cytotoxic potential.
- Sensitization: No significant evidence of causing delayed dermal contact sensitization in the guinea pig, non-sensitizing.
- Irritation: No erythema or edema was observed, non-irritating.
- Acute systemic toxicity: Test article did not induce a significantly greater biological 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 Time Assay: No adverse effect on prothrombin coagulation time, compatible with blood.
- Implantation/local tolerance: Relatively mild foreign body response.
- (Bio)degradation: After 16 months very small fragments of material were found, biodegradable.
- (Sub)acute/subchronic toxicity: No toxic responses were observed, no subchronic toxicity.
- Genotoxicity: No statistical increase was found in the mutation frequency, non-mutagenic.
- Carcinogenicity: No significant carcinogenic potential.
- EO and ECH residues: EO: ≤0.0016 mg/device, ECH: ≤0.00045 mg/device, residual levels acceptable.
In vitro degradation:
Study type: Assessment of physical, chemical and thermal properties of the Nerve Capping Device (pH testing, Dimensional testing, Weight (dry and wet state), Tensile testing, Intrinsic viscosity, Glass temperature, Degradation products, Blue dye leak tests, Visual inspections).
Key results: 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 testing:
Study type: Usability and specifications of the Nerve Capping Device were assessed by providing samples to the intended end users. Their opinion and experience on the usage of the product was used to evaluate the device as design verification and validation activity to determine whether or not it meets the requirements.
Key results: The 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 then current used techniques. The range of dimensions from 1.5 up to 8.0 mm 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:
Study type: To determine the force necessary to pull a suture from the device or cause the wall of the device to fail.
Key results: 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:
Study type: To verify that the specified dimensions of the tip are met.
Key results: All samples passed the acceptance criteria. The dimensions of the tip of the device (closed part) are within the tolerances as specified.
Key Metrics
Not Found
Predicate Device(s)
K050573 NEUROLAC® Nerve Guide (Polyganics), K112267 NEUROLAC® Nerve Guide (Polyganics), K131541 Flexible Collagen Nerve Cuff (Collagen Matrix, Inc)
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
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
1
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
2
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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3
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
4
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:
5
| Parameter | Nerve Capping Device (New
Device) | NEUROLAC® (K050573) | NEUROLAC® (K112267) | Flexible Collagen Nerve Cuff
(K131541) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The NEUROLAC® nerve guide is
indicated for the reconstruction of a
peripheral nerve discontinuity up to
20mm in patients who have
sustained a complete division of a
nerve. | The NEUROLAC® nerve guide is
indicated for the reconstruction of a
peripheral nerve discontinuity up to
20mm in patients who have
sustained a complete division of a
nerve. | Flexible Collagen Nerve Cuff is used for
the management of peripheral nerve
injuries in discontinuities where gap
closure can be achieved by flexion of
the extremity (e.g., to prevent ingrowth
of scar tissue) or at the end of the nerve
in the foot to reduce the formation of
symptomatic or painful neuroma. |
| Sterility | Sterile, SAL 10-6
Ethylene oxide sterilization | Sterile, SAL 10-6
Ethylene oxide sterilization | Sterile, SAL 10-6
Ethylene oxide sterilization | Sterile, SAL 10-6
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/
Permeability | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Up to 10 weeks non permeable | Semi-permeable, permeable to
nutrients and macromolecules |
| Sizes | 1.5 mm ID x 3.0 cm length
2.0 mm ID x 3.0 cm length
2.5 mm ID x 3.0 cm length
3.0 mm ID x 3.0 cm length
4.0 mm ID x 3.0 cm length
5.0 mm ID x 3.0 cm length
6.0 mm ID x 3.0 cm length
7.0 mm ID x 3.0 cm length
8.0 mm ID x 3.0 cm length | 4.0 mm ID x 3.0 cm length
5.0 mm ID x 3.0 cm length
6.0 mm ID x 3.0 cm length
7.0 mm ID x 3.0 cm length
8.0 mm ID x 3.0 cm length
10.0 mm ID x 3.0 cm length | 1.5 mm ID x 3.0 cm length
2.0 mm ID x 3.0 cm length
2.5 mm ID x 3.0 cm length
3.0 mm ID x 3.0 cm length | 2.0 mm ID x 2.5 cm length
2.5 mm ID x 2.5 cm length
3.0 mm ID x 2.5 cm length
4.0 mm ID x 2.5 cm length
5.0 mm ID x 2.5 cm length
6.0 mm ID x 2.5 cm length |
| Shape | Cap (tube with one closed end)
Image: Drawing of a nerve capping device | Tube
Image: Drawing of a tube | Tube
Image: Drawing of a tube | Tube
Image: Drawing of a tube |
| Color | Transparent | Transparent | Transparent | White to Off white |
| Pyrogenicity | Non-pyrogenic
Endotoxin ≤ 0.6 EU/device | Non-pyrogenic
Endotoxin ≤ 0.18 EU/device | Non-pyrogenic
Endotoxin ≤ 0.18 EU/device | Non-pyrogenic
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
6
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 causing | |||
| delayed dermal contact | ||||
| sensitization in the guinea pig | Non-sensitizing | |||
| Irritation | No erythema or edema was | |||
| observed | Non-irritating | |||
| Acute systemic toxicity | Test article did not induce a | |||
| significantly greater biological | ||||
| 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 | ||||
| Time Assay | No adverse effect on prothrombin | |||
| coaqulation time | Compatible with blood | |||
| Implantation/local tolerance | Relatively mild foreign body | |||
| response | Relatively mild foreign body response | |||
| (Bio)degradation | After 16 months very small | |||
| fragments of material were found | Biodegradable | |||
| (Sub)acute/subchronic toxicity | No toxic responses were | |||
| observed | No subchronic toxicity | |||
| Genotoxicity | No statistical increase was found | |||
| in the mutation frequency | Non-mutagenic | |||
| Carcinogenicity | No significant carcinogenic | |||
| potential | No significant carcinogenic potential |
7
| EO and ECH residues | EO: ≤0.0016 mg/device
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 |
|---|---|---|
| In vitro degradation | Assessment of physical, chemical and | |
| thermal properties of the Nerve | ||
| Capping 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 °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 testing | Usability and specifications of the | |
| Nerve Capping Device were assessed | ||
| by providing samples to the intended | ||
| end users. Their opinion and | ||
| experience on the usage of the product | ||
| was used to evaluate the device as | ||
| design verification and validation | ||
| activity to determine whether or not it | ||
| meets the requirements | The 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 then current | ||
| used techniques. The range of | ||
| dimensions from 1.5 up to 8.0 mm 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 | To determine the force necessary to | |
| pull a suture from the device or cause | ||
| the wall of the device to fail | 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 | To verify that the specified dimensions | |
| of the tip are met | All samples passed the acceptance | |
| criteria. The dimensions of the tip of the | ||
| device (closed part) are within the | ||
| 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.