(137 days)
The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and 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 Nerve Cuff (K031069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in clamshell container inside a sealed double pouch system.
The document describes the acceptance criteria and study results for the Cook Biotech Incorporated Nerve Cuff (K132660). The submission focuses on demonstrating substantial equivalence to a predicate device (Surgisis Nerve Cuff, K031069) through bench, biocompatibility, and animal studies.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative "acceptance criteria" for each test in the way you might find in an AI/software device submission. Instead, it demonstrates performance by showing that the Nerve Cuff is "substantially equivalent" to its predicate device or meets specific qualitative standards.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Ultimate tensile strength | Comparable to predicate (Surgisis Nerve Cuff) | "The tensile strength was comparable to Surgisis Nerve Cuff predicate." "the Nerve Cuff has sufficient tensile... strength for its application." |
| Suture retention strength | Comparable to predicate (Surgisis Nerve Cuff) | "The suture retention strength was comparable to the Surgisis Nerve Cuff." "the Nerve Cuff has sufficient... suture retention strength for its application." | |
| Compression and rebound testing | Applicable results from predicate (as material/configuration are identical) | "Compression and rebound testing was performed on the predicate Surgisis Nerve Cuff. Since the Nerve Cuff is identical in material and configuration to the Surgisis Nerve Cuff, the results are applicable to the subject device's intended use." | |
| Hydration testing | Devices within specified thickness range upon hydration | "Re-hydrated devices were compared to non-hydrated controls. Devices were within the specified thickness range upon hydration." | |
| Biocompatibility | Genotoxicity (Mouse micronucleus assay) | Non-mutagenic | "results indicate that the test article is non-mutagenic in this system." |
| Genotoxicity (Mouse lymphoma assay) | Non-mutagenic | "results show that the test article extracts were well within the limits defined for a negative response and the test article is considered non-mutagenic in this assay." | |
| Direct contact in vitro hemolysis | Non-hemolytic (Hemolytic index ≤ 5%) | "Under conditions of the study, the mean hemolytic index of the test article was 2%." | |
| Cytotoxicity | Non-cytotoxic (no evidence of cell lysis/toxicity, < Grade 2 reactivity) | "Under the conditions of the study, the test extract showed no evidence of causing cell lysis or toxicity (less than Grade 2 – mild reactivity." | |
| Muscle Implantation (irritation) | Non-irritant at 24 weeks after implantation (compared to control) | "At 4, 12, and 24 weeks after implantation, the macroscopic reaction was not significant compared to control... At 24 weeks after implantation, microscopy examination of implants sites revealed that the test article was similar to or less irritating than all the control materials." (Note: It was classified as a moderate irritant at 4 and 12 weeks, but concluded non-irritant at 24 weeks within the context of the study vs. controls). | |
| Acute Intracutaneous Reactivity | Non-irritant | "Under the conditions of the study, there was no evidence of significant irritation from the extracts injected intracutaneously into rabbits." | |
| Sensitization | Non-irritant | "Under the conditions of the study, the test article showed no evidence of causing delayed contact sensitization in the guinea pig." | |
| Acute Systemic Toxicity | No systemic toxicity | "Under the conditions of the study, there was no mortality or evidence of systemic toxicity from the extracts." | |
| Pyrogenicity | Non-pyrogenic (total rise of rabbit temps within USP limits) | "Under the conditions of the study, the total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits." | |
| LAL endotoxins | Non-pyrogenic (<20 EU per device for blood contact) | "Under the conditions of the study, the endotoxin concentration for each article was less than 20 EU per device as required by FDA for devices in blood contact." | |
| Subchronic Systemic Toxicity | No systemic toxicity | "Data and observations revealed no significant evidence of systemic toxicity from the test article following subcutaneous implantation in the rat. There were no changes in histopathology, hematology values or clinical chemistry values in either male or female rats that would be considered indicative of systemic changes related to treatment with the test article." | |
| Animal Studies | Nerve wrap effectiveness and biocompatibility | Healthy nerve regeneration (myelination, density, vascularization) compared to sham controls; safe and effective. | "The Nerve Cuff was implanted in rabbits as a nerve wrap. The wrapped nerves were healthy in terms of myelination, density and vascularization compared to sham controls. All assessments showed that the device is safe and effective as a nerve wrap." "Therefore, results showed that the Nerve Cuff is biocompatible and safe in its application." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The sample sizes for each specific bench test (tensile strength, suture retention, hydration) are not explicitly stated in the provided text. Compression and rebound testing was done on the predicate, not the new device.
- Biocompatibility Testing: The specific sample sizes for tests like genotoxicity (number of animals or cells), hemolysis (number of samples), cytotoxicity (number of well plates/cells), muscle implantation (number of animals), intracutaneous reactivity (number of rabbits), sensitization (number of guinea pigs), acute systemic toxicity (number of animals), pyrogenicity (number of rabbits), LAL endotoxins (number of devices), and subchronic systemic toxicity (number of rats) are not explicitly detailed in the provided summary.
- Animal Studies: The Nerve Cuff was "implanted in rabbits as a nerve wrap." The number of rabbits is not specified.
- Data Provenance: The document does not specify the country of origin for any of the studies (bench, biocompatibility, or animal). All studies appear to be prospective, laboratory-based tests/experiments. This is not a clinical study involving human patients.
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 product is a medical implant (nerve cuff), not an AI/software device that requires human expert interpretation of imaging or other data for ground truth establishment. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications like radiologists is not applicable to this 510(k) submission. Ground truth for the studies (e.g., biocompatibility endpoints, nerve health in animals) would be established through laboratory analyses, histological examination, and macroscopic observations by scientific and veterinary professionals, respectively, but their specific number and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable as it pertains to human interpretation of data, typically in clinical studies or AI evaluations where a consensus among experts is needed. The studies conducted for this device (bench, biocompatibility, animal) rely on objective measurements and established scientific methodologies, not subjective expert adjudication of a "test set."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. The Nerve Cuff is a physical implant, not an AI or diagnostic software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Nerve Cuff 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 studies was based on:
- Bench Testing: Objective physical measurements (tensile strength, suture retention, thickness).
- Biocompatibility Testing: Standardized laboratory assays and animal models for genotoxicity, hemolysis, cytotoxicity, irritation, sensitization, systemic toxicity, and pyrogenicity, with results typically assessed against established scientific criteria and ISO standards. Histopathology was used for muscle implantation and subchronic systemic toxicity assessments.
- Animal Studies: Macroscopic and microscopic histological assessments of nerve health (myelination, density, vascularization) compared to sham controls.
8. The sample size for the training set
This is not applicable. The Nerve Cuff is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reason stated in point 8.
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510(k) Premarket Notification: Nerve Cuff
JAN 10 2014
510(k) Summary
January 10, 2014
Cook Biotech Incorporated
Nerve Cuff
Manufacturer Name:
Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709
Official Contact:
Perry W. Guinn
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Nerve Cuff Nerve Cuff Class II, 21 CFR §882.5275 (JXI)
INDICATIONS FOR USE:
The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.
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 Nerve Cuff (K031069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in clamshell container inside a sealed double pouch system.
EQUIVALENCE TO MARKETED DEVICES
The Nerve Cuff is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate Surgisis Nerve Cuff as shown through bench. biocompatibility and animal studies.
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510(k) Premarket Notification: Nerve Cuff
:
| Bench testing: | ||
|---|---|---|
| Test | Results | Conclusions |
| Ultimate tensile strength | The tensile strength wascomparable to SurgisisNerve Cuff predicate | Substantially equivalent |
| Suture retention strength | The suture retentionstrength was comparableto the Surgisis Nerve Cuff | Substantially equivalent |
| Compression and reboundtesting | Compression and reboundtesting was performed onthe predicate SurgisisNerve Cuff. Since theNerve Cuff is identical inmaterial and configurationto the Surgisis Nerve Cuff,the results are applicableto the subject device'sintended use. | Substantially equivalent |
| Hydration testing | Re-hydrated devices werecompared to non-hydratedcontrols. | Devices were within thespecified thickness rangeupon hydration |
Bench testing:
The results of these tests showed that the Nerve Cuff has sufficient tensile and suture retention strength for its application.
Biocompatibility testing:
| Test | Results | Conclusions |
|---|---|---|
| Genotoxicity | Mouse micronucleus assay - results indicate thatthe test article is non-mutagenic in this system.Mouse lymphoma assay - results show that thetest article extracts were well within the limitsdefined for a negative response and the testarticle is considered non-mutagenic in this assay. | Non-mutagenic |
| Direct contactin vitrohemolysis | Under conditions of the study, the meanhemolytic index of the test article was 2%. | Non-hemolytic |
| Cytotoxicity | Under the conditions of the study, the testextract showed no evidence of causing cell lysisor toxicity (less than Grade 2 – mild reactivity. | Non-cytotoxic |
| Muscleimplantation | At 4, 12, and 24 weeks after implantation, themacroscopic reaction was not significantcompared to control.At 4 and 12 weeks the test article was classifiedas a moderate irritant compared to the negative | Non-irritant at24 weeks afterimplantation |
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| Test | Results | Conclusions |
|---|---|---|
| control (polyethylene). As compared to sponsorprovided control 1(Dexon Mesh), the test articlewas classified as a slight irritant. As comparedto sponsor provided control 2 (SupplePeriguard), there was little or no difference. At24 weeks after implantation, microscopyexamination of implants sites revealed that thetest article was similar to or less irritating thanall the control materials. | ||
| Acuteintracutaneousreactivity | Under the conditions of the study, there was noevidence of significant irritation from theextracts injected intracutaneously into rabbits. | Non-irritant |
| Sensitization | Under the conditions of the study, the test articleshowed no evidence of causing delayed contactsensitization in the guinea pig. | Non-irritant |
| Acute systemictoxicity | Under the conditions of the study, there was nomortality or evidence of systemic toxicity fromthe extracts. | No systemictoxicity |
| Pyrogenicity | Under the conditions of the study, the total riseof rabbit temperatures during the 3 hourobservation period was within acceptable USPlimits. | Non-pyrogenic |
| LAL endotoxins | Under the conditions of the study, the endotoxinconcentration for each article was less than 20EU per device as required by FDA for devices inblood contact. | Non-pyrogenic |
| Subchronicsystemictoxicity | Data and observations revealed no significantevidence of systemic toxicity from the testarticle following subcutaneous implantation inthe rat. There were no changes inhistopathology, hematology values or clinicalchemistry values in either male or female ratsthat would be considered indicative of systemicchanges related to treatment with the test article. | No systemictoxicity |
The biocompatibility test results showed that the Nerve Cuff is safe and biocompatible and fulfills the ISO standard for a permanent, tissue contacting implant.
Animal studies
.
. The Nerve Cuff was implanted in rabbits as a nerve wrap. The wrapped nerves were . healthy in terms of myelination, density and vascularization compared to sham
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510(k) Premarket Notification: Nerve Cuff
controls. All assessments showed that the device is safe and effective as a nerve wrap. Therefore, results showed that the Nerve Cuff is biocompatible and safe in its application.
CONCLUSION: The Nerve Cuff is substantially equivalent to its predicate device in terms of safety and effectiveness as shown in bench and animal studies.
| Device | Nerve Cuff | Surgisis Nerve Cuff |
|---|---|---|
| Manufacturer | Cook Biotech Incorporated | Cook Biotech |
| Incorporated | ||
| 510(k) | K132660 | K031069 |
| Number | ||
| Intended Use | Indicated for peripheral | Intended for repair of |
| nerve injuries where there | peripheral nerve | |
| is no gap or where a gap | discontinuities where gap | |
| closure is achieved by | closure is achieved by | |
| flexion of the extremity. | flexion of the extremity. | |
| Material | Porcine small intestinal | Porcine small intestinal |
| submucosa | submucosa | |
| Primarily Types I, III, IV | Primarily Types I, III, IV | |
| and VI collagen | and VI collagen | |
| Dimensions | 1.5 - 10 mm (diameter) x | 2, 5, 7 mm (diameter) x 5 |
| 1- 5 cm length | cm length (nominal) | |
| (tubes) | ||
| Thickness | 100 um to 1000 um | 100 um to 1000 um |
| Sterilization | Ethylene oxide | Ethylene Oxide |
| Pliable | Yes | Yes |
| Wettable | Yes | Yes |
| Resorbable | Yes | Yes |
| Shelf-life | 18 months | 18 months |
| Packaging | Tray/Pouch or double | Tray/Double-peel pouch |
| pouch |
Table of Substantial Equivalence
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President, Regulatory Affairs & Quality Assurance 1425 Innovation Place West Lafayette, IN 47906-1000
Re: K132660
Trade/Device Name: Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 5, 2013 Received: December 9, 2013
Dear Mr. Guinn:
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Perry W. Guinn
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours.
Joyce M. Whang -S
Carlos L. Peña, Ph.D., M.S. 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): K132660
Device Name: Nerve Cuff
Indications For Use:
The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.
Prescription Use (Part 21 CFR 801 Subpart D)
र ।
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of 1
§ 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).