(31 days)
The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate (Surgisis Nerve Cuff, K031069), and reference device (Nerve Cuff, K132660). Both the predicate and reference devices are also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted around an injured nerve to provide a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. In addition, the Nerve Cuff protects the damaged or severed nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in a clamshell container inside a sealed pouch.
This document describes the AxoGuard Nerve Connector (K162741), a Class II medical device intended for the repair of peripheral nerve discontinuities. The submission is a Special 510(k) focusing on a size change for shorter lengths and one narrower diameter of the existing Nerve Cuff.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a single, overarching table with specific numerical targets for the device's main function (nerve repair success). Instead, it presents various tests with their respective acceptance criteria for different aspects of the device's material, handling, and sterility. The reported device performance indicates that these criteria were met.
| Test Category | Specific Test | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|---|
| Functional Performance | User handling validation | Product possesses acceptable characteristics for handling, trimming, and suturing. | The handling characteristics of the subject device are substantially equivalent to the predicate device based on acceptability to the end-user. All samples met acceptance criteria. |
| Pre-clinical study discussion/evaluation of product line by key opinion leaders | No concerns regarding pre-clinical data and acceptable device handling characteristics. | No concerns regarding pre-clinical data and the handling characteristics of the subject device are substantially equivalent to the predicate device based on acceptability to the end-user. All samples met acceptance criteria. | |
| Bench Testing | Ultimate tensile strength | (Implied: Sufficient strength for intended use and comparable to or superior to predicate, though specific numerical criteria are not given for the subject device - the predicate's performance is the benchmark for comparison.) | The ultimate tensile strength of the material composing the subject device is greater than the predicate device. |
| Suture retention strength | Sufficient to perform the intended use. | The suture retention strength of the material composing the subject device is sufficient to perform the intended use. All samples met acceptance criteria. | |
| Compression and rebound | Ability to rebound to original diameter after compression. | All samples met acceptance criteria with performance comparable to that of the predicate device. | |
| Biocompatibility | Cytotoxicity | Non-cytotoxic. | Pass; Non-cytotoxic. |
| Sensitization | No evidence of sensitization. | Pass; No evidence of sensitization. | |
| Intracutaneous reactivity | No evidence of intracutaneous reactivity. | Pass; No evidence of intracutaneous reactivity. | |
| Acute systemic toxicity | No mortality or evidence of acute systemic toxicity. | Pass; No mortality or evidence of acute systemic toxicity. | |
| Subchronic and chronic toxicity | Non-irritating to subcutaneous tissue; No evidence of subchronic or chronic toxicity. | Pass; Non-irritating to subcutaneous tissue; No evidence of subchronic or chronic toxicity. | |
| Genotoxicity | Device extracts are non-mutagenic. | Pass; Device extracts are non-mutagenic. | |
| Implantation | Irritation not greater than control materials at 24 weeks. | Pass; Irritation not greater than control materials at 24 weeks. | |
| Sterilization | Sterilization validation | Devices have a sterility assurance level (SAL) of 10-6. | Pass; Devices have a sterility assurance level (SAL) of 10-6. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state distinct "test sets" with specific sample sizes for this submission (K162741) in the context of evaluating algorithm performance or clinical outcomes. Instead, it leverages data from the predicate device (K031069) and reference device (K132660) due to identical material and manufacturing processes.
- User handling validation: "representative final product" was used. Specific sample size not given.
- Pre-clinical study discussion/evaluation: "representative final product" was used. Specific sample size not given.
- Bench Testing:
- Ultimate tensile strength: Not specified.
- Suture retention strength: "All samples met acceptance criteria." Specific sample size not given.
- Compression and rebound: "All samples met acceptance criteria." Specific sample size not given.
- Biocompatibility Testing:
- Cytotoxicity: Not specified.
- Sensitization: Guinea pigs (sample size not given).
- Intracutaneous reactivity: Rabbits (sample size not given).
- Acute systemic toxicity: Mice (sample size not given).
- Subchronic and chronic toxicity: Rats for 4 weeks (subchronic) and 18 weeks (chronic) (sample size not given).
- Genotoxicity: Not specified.
- Implantation: Rabbits for 4, 12, and 24 weeks (sample size not given).
- Sterilization validation: Not specified.
Data Provenance: The studies cited (bench, biocompatibility, sterilization) relate to the material and manufacturing process, which are stated to be identical to the predicate device (Surgisis Nerve Cuff, K031069). Therefore, the data provenance is indirectly tied to the studies performed for that predicate, which would have been conducted to support its clearance. There is no information regarding country of origin or whether these original studies were retrospective or prospective in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Key Opinion Leaders / Surgeons: For the "User handling validation" and "Pre-clinical study discussion/evaluation," surgeons and "key opinion leaders" were involved. The exact number of experts and their specific qualifications (e.g., years of experience or specialty beyond "surgeon") are not detailed. Their role was to assess handling characteristics and provide feedback on pre-clinical data.
- For other tests (bench, biocompatibility, sterilization), the "ground truth" is established by adherence to recognized standards (e.g., ISO, EN ISO) and objective measurements, not by expert consensus in the same way clinical ground truth is established.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for a "test set" in the context of clinical outcomes or diagnostic accuracy. For the "User handling validation" and "Pre-clinical study discussion/evaluation," it states "acceptability to the end user" and "No concerns regarding pre-clinical data," implying a consensus or agreement among the participating experts/surgeons, but no specific adjudication method (e.g., 2+1, 3+1) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a medical device (nerve cuff), not an AI or imaging diagnostic algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable. The device's performance is assessed through material properties, biocompatibility, and handling, mainly by comparison to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm has not been done. This is a hardware medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for various tests is primarily objective measurements and established scientific/biological standards:
- Functional Performance (User handling, Pre-clinical discussion): Subjective assessment by surgeons/key opinion leaders (qualitative "ground truth" on handling and acceptability).
- Bench Testing (Tensile strength, Suture retention, Compression/rebound): Direct physical measurements and comparison to performance of the predicate device, against engineering specifications and the device's intended function.
- Biocompatibility Testing: Biological responses observed in animal models (mice, guinea pigs, rabbits) and in vitro tests, evaluated against established safety profiles and ISO standards. This is akin to pathology/biological response data.
- Sterilization Validation: Microbiological testing to achieve a specific Sterility Assurance Level (SAL), based on established sterilization protocols (EN ISO 11135).
There is no mention of pathology, clinical outcomes data from human trials, or expert consensus on disease diagnosis as ground truth, as the submission focuses on safety and performance characteristics for a device that provides a physical structure for nerve repair, rather than a diagnostic tool.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The device's characteristics are established through various physical, chemical, and biological tests, not through training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device submission.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Cook Biotech Incorporated Katrina Molland, PhD Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K162741
Trade/Device Name: AxoGuard Nerve Connector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: September 29, 2016 Received: September 30, 2016
Dear Dr. Molland:
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 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.
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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,
Michael J. Hoffmann -A
Carlos L. Peña, PhD, MS for 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) K162741
Device Name AxoGuard Nerve Connector
Indications for Use (Describe)
The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
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
Submitted by: Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 29 September, 2016
Name of Device:
| Trade/Proprietary Names: | Nerve Cuff |
|---|---|
| AxoGuard Nerve Connector | |
| Common/Usual Names: | Cuff, Nerve |
| Product Code: | JXI |
| Device Class: | 21 CFR §882.5275, Class II |
| Classification Panel: | Neurology |
Predicate Device:
The predicate device is Surgisis Nerve Cuff (K031069), cleared May 15, 2003 and manufactured by Cook Biotech Incorporated.
Reference Device:
The reference device is the Nerve Cuff (K132660), cleared July 23, 2014 and manufactured by Cook Biotech Incorporated.
Intended Use:
The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
The device is supplied sterile and is intended for one-time use.
This intended use is identical to that of the predicate device cleared under K031069.
Device Description:
The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate (Surgisis Nerve Cuff, K031069), and reference device (Nerve Cuff, K132660). Both the predicate and reference devices are also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted around an injured nerve to provide a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. In addition, the Nerve Cuff protects the damaged or severed nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in a clamshell container inside a sealed pouch.
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Comparison to Predicate Device:
The Nerve Cuff is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate, Surgisis Nerve Cuff. This Special 510(k) describes a size change to supply the Nerve Cuff in shorter lengths and one narrower diameter. The subject device is identical to the predicate with regard to intended use, indications for use, target population, anatomical site, use setting, performance, materials, compatibility with the environment and other devices, chemical safety, design, standards met, biocompatibility, and sterility. The subject device differs from the predicate device solely in regard to its dimensions as detailed in the Substantial Equivalence Table (Table 5-5).
The introduction of new device sizes does not affect substantial equivalence to the predicate device.
Comparison to Reference Device:
The size range of the reference device is identical to the expanded size range that forms the basis for this submission. The subject and reference (K132660) devices have a common predicate, the Surgisis Nerve Cuff (K031069). They are identical in material composition, and differ in design only with respect to a slit in the reference device. Their intended uses are nearly the slit allows the reference device to be used where there is no gap in the injured nerve.
Summary of Non-Clinical Tests:
The functional performance verification and product characterization testing that was conducted on the subject device is provided in Table 5-1:
| Test | Test Method Summary | Results |
|---|---|---|
| User handling validation | Surgeon handling of representative finalproductAcceptance criteria: product possessesacceptable characteristics for handling,trimming and suturing | The handling characteristics ofthe subject device aresubstantially equivalent to thepredicate device based onacceptability to the end user. Allsamples met acceptance criteria. |
| Pre-clinical studydiscussion /evaluation ofproduct line by keyopinion leaders | Discussion of product line and surgeonhandling of representative final productAcceptance criteria: No concernsregarding pre-clinical data andacceptable device handlingcharacteristics | No concerns regarding pre-clinical data and the handlingcharacteristics of the subjectdevice are substantiallyequivalent to the predicate devicebased on acceptability to the enduser. All samples met acceptancecriteria. |
Table 5-1. Functional Performance Information
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Product characterization using known standards and/or clinically relevant acceptance criteria was performed on the predicate device. A summary of this testing is provided in Table 5-2. The predicate test data was leveraged to support the substantial equivalence of the subject device material and manufacturing process is identical for the subject and predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Ultimate tensile strength | Testing according toISO 7198:1990 andISO 5081 | The ultimate tensile strength ofthe material composing thesubject device is greater than thepredicate device. |
| Suture retention strength | Testing according toISO 7198:1998 | The suture retention strength ofthe material composing thesubject device is sufficient toperform the intended use. Allsamples met acceptance criteria. |
| Compression and rebound | Devices were tested for maximum forcerequired to collapse the tube and abilityto rebound to original diameter | All samples met acceptancecriteria with performancecomparable to that of thepredicate device. |
Table 5-2. Bench Testing Information
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Biocompatibility Testing:
Biocompatibility of the predicate device has been established in accordance with ISO 10993-1:2009 -Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process to demonstrate that the device is safe for permanent contact (>30 days) implantation as detailed in Table 5-3. The predicate test data was leveraged to support the substantial equivalence of the subject device as the device material and manufacturing process is identical for the subject and predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5: Direct contactcytotoxicity following ISO elution | PassNon-cytotoxic |
| Sensitization | ISO 10993-10: Maximization test inguinea pigs (sodium chloride andsesame oil extraction vehicles) | PassNo evidence of sensitization |
| Intracutaneous reactivity | ISO 10993-10: Intracutaneousreactivity test in rabbits (sodiumchloride and sesame oil extractionvehicles) | PassNo evidence of intracutaneousreactivity |
| Acute systemic toxicity | ISO 10993-11: Acute systemic toxicitytest in mice (sodium chloride andcottonseed oil extraction vehicles) | PassNo mortality or evidence of acutesystemic toxicity |
| Subchronic and chronictoxicity | ISO 10993-11: Direct subcutaneousimplant in rats for 4 weeks(subchronic)and 18 weeks (chronic) | PassNon-irritating to subcutaneoustissueNo evidence of subchronic orchronic toxicity |
| Genotoxicity | ISO 10993-3: Bacterial reversemutation study | PassDevice extracts are non-mutagenic |
| Implantation | ISO 10993-6: Muscle implantation inrabbits for 4, 12, and 24 weeks | PassIrritation not greater than controlmaterials at 24 weeks |
Table 5-3. Biocompatibility Information
Sterilization:
The method employed to ensure sterility of the predicate device is provided in Table 5-4. The predicate test data was leveraged to support the substantial equivalence of the subject device material and manufacturing process is identical for the subject and predicate device.
| Table 5-4. Sterilization Information | |
|---|---|
| -------------------------------------- | -- |
| Test | Test Method Summary | Results |
|---|---|---|
| Sterilization validation | Validation method in conformance withEN ISO 11135-2007The validation of sterilization wasperformed using the over-kill methodper guidelines outlined in sections 9.3.2and 9.3.3 of the EN ISO 11135standard. | PassDevices have a sterility assurancelevel (SAL) of 10-6 |
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Substantial Equivalence:
Table 5-5 below provides a comparison of the subject device, its predicate and the reference device.
| Device | Nerve Cuff(Subject Device) | Surgisis Nerve Cuff(Predicate Device) | Nerve Cuff(Reference Device) |
|---|---|---|---|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc | Cook Biotech Inc |
| 510(k) number | unassigned | K031069 | K132660 |
| Product Code | JXI | JXI | JXI |
| Material | Porcine small intestinalsubmucosa; primarilycollagen types, III, IV,and VI | Porcine small intestinalsubmucosa; primarilycollagen types, III, IV,and VI | Porcine small intestinalsubmucosa; primarilycollagen types, III, IV,and VI |
| Shape | Hollow tube | Hollow tube | Hollow tube with a slit |
| Supplied sterile? | Yes | Yes | Yes |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Intended for singleuse? | Yes | Yes | Yes |
| Packagingconfiguration | Clamshell tray in Tyvekpouch with an outer box | Clamshell tray in adouble Tyvek pouch | Clamshell tray in Tyvekpouch with an outer box |
| Shelf Life | 18 months | 18 months | 18 months |
| Intended Use | Intended for the repair ofperipheral nervediscontinuities where gapclosure can be achievedby flexion of theextremity. | Intended for the repair ofperipheral nervediscontinuities where gapclosure can be achievedby flexion of theextremity | Intended for the repair ofperipheral nerve injuriesin which there is no gapor where a gap closure isachieved by flexion ofthe extremity. |
| Dimensions | 1.5-10 mm diameter x 1-5 cm length | Diameter (mm)Length (cm)257 | 1.5-10 mm diameter x 1-5 cm length |
| Thickness | 100-1000 μm | 100-1000 μm | 100-1000 μm |
Table 5-5. Substantial Equivalence Information
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Conclusion:
The Nerve cuff is substantially equivalent to its predicate device in terms of indications for use, methods of operation, and fundamental technological characteristics. Successful risk analysis and completion of verification and validation activities provides evidence to support the conclusion that the size modification does not introduce new risks and that the subject device performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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).