(137 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interaction of a collagen matrix for nerve repair. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
Yes
Explanation: The device is indicated for "repair of peripheral nerve injuries" and "provides a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue," and "provides protection of the damaged nerve while the nerve heals," all of which describes therapeutic action.
No
The device description indicates it is a bioabsorbable scaffold for nerve repair and protection, not a tool for diagnosis.
No
The device description clearly states the device is a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and is provided sterile and intended for one-time use. This describes a physical, implantable medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of peripheral nerve injuries by providing a scaffold and protection during healing. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable bioabsorbable material used to physically support and protect damaged nerves.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples taken from the human body. This device is used in vivo for treatment and repair.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing:
Test: Ultimate tensile strength
Results: The tensile strength was comparable to Surgisis Nerve Cuff predicate
Conclusions: Substantially equivalent
Test: Suture retention strength
Results: The suture retention strength was comparable to the Surgisis Nerve Cuff
Conclusions: Substantially equivalent
Test: Compression and rebound testing
Results: 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.
Conclusions: Substantially equivalent
Test: Hydration testing
Results: Re-hydrated devices were compared to non-hydrated controls.
Conclusions: Devices were within the specified thickness range upon hydration
The results of these tests showed that the Nerve Cuff has sufficient tensile and suture retention strength for its application.
Biocompatibility testing:
Test: Genotoxicity
Results: Mouse micronucleus assay - results indicate that the test article is non-mutagenic in this system. Mouse lymphoma assay - 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.
Conclusions: Non-mutagenic
Test: Direct contact in vitro hemolysis
Results: Under conditions of the study, the mean hemolytic index of the test article was 2%.
Conclusions: Non-hemolytic
Test: Cytotoxicity
Results: Under the conditions of the study, the test extract showed no evidence of causing cell lysis or toxicity (less than Grade 2 – mild reactivity.
Conclusions: Non-cytotoxic
Test: Muscle implantation
Results: At 4, 12, and 24 weeks after implantation, the macroscopic reaction was not significant compared to control. At 4 and 12 weeks the test article was classified as a moderate irritant compared to the negative control (polyethylene). As compared to sponsor provided control 1 (Dexon Mesh), the test article was classified as a slight irritant. As compared to sponsor provided control 2 (Supple Periguard), there was little or no difference. 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.
Conclusions: Non-irritant at 24 weeks after implantation
Test: Acute intracutaneous reactivity
Results: Under the conditions of the study, there was no evidence of significant irritation from the extracts injected intracutaneously into rabbits.
Conclusions: Non-irritant
Test: Sensitization
Results: Under the conditions of the study, the test article showed no evidence of causing delayed contact sensitization in the guinea pig.
Conclusions: Non-irritant
Test: Acute systemic toxicity
Results: Under the conditions of the study, there was no mortality or evidence of systemic toxicity from the extracts.
Conclusions: No systemic toxicity
Test: Pyrogenicity
Results: Under the conditions of the study, the total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits.
Conclusions: Non-pyrogenic
Test: LAL endotoxins
Results: 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.
Conclusions: Non-pyrogenic
Test: Subchronic systemic toxicity
Results: 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.
Conclusions: No systemic toxicity
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
510(k) Premarket Notification: Nerve Cuff
:
| Bench testing: | ||
|---|---|---|
| Test | Results | Conclusions |
| Ultimate tensile strength | The tensile strength was | |
| comparable to Surgisis | ||
| Nerve Cuff predicate | Substantially equivalent | |
| Suture retention strength | The suture retention | |
| strength was comparable | ||
| to the Surgisis Nerve Cuff | Substantially equivalent | |
| Compression and rebound | ||
| testing | 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. | Substantially equivalent | |
| Hydration testing | Re-hydrated devices were | |
| compared to non-hydrated | ||
| controls. | Devices were within the | |
| specified thickness range | ||
| upon 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 that | |
| the test article is non-mutagenic in this system. | ||
| Mouse lymphoma assay - 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. | Non-mutagenic | |
| Direct contact | ||
| in vitro | ||
| hemolysis | Under conditions of the study, the mean | |
| hemolytic index of the test article was 2%. | Non-hemolytic | |
| Cytotoxicity | Under the conditions of the study, the test | |
| extract showed no evidence of causing cell lysis | ||
| or toxicity (less than Grade 2 – mild reactivity. | Non-cytotoxic | |
| Muscle | ||
| implantation | At 4, 12, and 24 weeks after implantation, the | |
| macroscopic reaction was not significant | ||
| compared to control. | ||
| At 4 and 12 weeks the test article was classified | ||
| as a moderate irritant compared to the negative | Non-irritant at | |
| 24 weeks after | ||
| implantation |
2
| Test | Results | Conclusions |
|---|---|---|
| control (polyethylene). As compared to sponsor | ||
| provided control 1(Dexon Mesh), the test article | ||
| was classified as a slight irritant. As compared | ||
| to sponsor provided control 2 (Supple | ||
| Periguard), there was little or no difference. 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. | ||
| Acute | ||
| intracutaneous | ||
| reactivity | Under the conditions of the study, there was no | |
| evidence of significant irritation from the | ||
| extracts injected intracutaneously into rabbits. | Non-irritant | |
| Sensitization | Under the conditions of the study, the test article | |
| showed no evidence of causing delayed contact | ||
| sensitization in the guinea pig. | Non-irritant | |
| Acute systemic | ||
| toxicity | Under the conditions of the study, there was no | |
| mortality or evidence of systemic toxicity from | ||
| the extracts. | No systemic | |
| toxicity | ||
| Pyrogenicity | Under the conditions of the study, the total rise | |
| of rabbit temperatures during the 3 hour | ||
| observation period was within acceptable USP | ||
| limits. | Non-pyrogenic | |
| LAL endotoxins | 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. | Non-pyrogenic | |
| Subchronic | ||
| 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. | No systemic | |
| toxicity |
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
3
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
4
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
5
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
6
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
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