(31 days)
No
The summary describes a passive, bioabsorbable material used as a scaffold for nerve repair. There is no mention of any computational or analytical functions that would involve AI or ML.
Yes
The device is intended for the repair of peripheral nerve discontinuities to provide a scaffold for healing and protect the damaged nerve, which classifies it as a therapeutic device.
No
Explanation: The device description states that the Nerve Cuff is implanted around an injured nerve to provide a scaffold for repair and protection, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it is composed of a bioabsorbable, extracellular collagen matrix (SIS) and is implanted around an injured nerve, indicating it is a physical, implantable medical device, not software.
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 discontinuities by providing a scaffold and protection during healing. This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is an implantable bioabsorbable collagen matrix intended to be placed around an injured nerve. This is a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro to examine specimens from the human body. This device is designed for direct surgical implantation in vivo.
N/A
Intended Use / Indications for 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.
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 (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.
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)
Non-Clinical Tests:
- User handling validation:
- Test Method Summary: Surgeon handling of representative final product. Acceptance criteria: product possesses acceptable characteristics for handling, trimming and suturing.
- Results: 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:
- Test Method Summary: Discussion of product line and surgeon handling of representative final product. Acceptance criteria: No concerns regarding pre-clinical data and acceptable device handling characteristics.
- Results: 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 Information:
- Ultimate tensile strength:
- Test Method Summary: Testing according to ISO 7198:1990 and ISO 5081.
- Results: The ultimate tensile strength of the material composing the subject device is greater than the predicate device.
- Suture retention strength:
- Test Method Summary: Testing according to ISO 7198:1998.
- Results: 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:
- Test Method Summary: Devices were tested for maximum force required to collapse the tube and ability to rebound to original diameter.
- Results: All samples met acceptance criteria with performance comparable to that of the predicate device.
Biocompatibility Testing:
- Cytotoxicity:
- Test Method Summary: ISO 10993-5: Direct contact cytotoxicity following ISO elution.
- Results: Pass. Non-cytotoxic.
- Sensitization:
- Test Method Summary: ISO 10993-10: Maximization test in guinea pigs (sodium chloride and sesame oil extraction vehicles).
- Results: Pass. No evidence of sensitization.
- Intracutaneous reactivity:
- Test Method Summary: ISO 10993-10: Intracutaneous reactivity test in rabbits (sodium chloride and sesame oil extraction vehicles).
- Results: Pass. No evidence of intracutaneous reactivity.
- Acute systemic toxicity:
- Test Method Summary: ISO 10993-11: Acute systemic toxicity test in mice (sodium chloride and cottonseed oil extraction vehicles).
- Results: Pass. No mortality or evidence of acute systemic toxicity.
- Subchronic and chronic toxicity:
- Test Method Summary: ISO 10993-11: Direct subcutaneous implant in rats for 4 weeks (subchronic) and 18 weeks (chronic).
- Results: Pass. Non-irritating to subcutaneous tissue. No evidence of subchronic or chronic toxicity.
- Genotoxicity:
- Test Method Summary: ISO 10993-3: Bacterial reverse mutation study.
- Results: Pass. Device extracts are non-mutagenic.
- Implantation:
- Test Method Summary: ISO 10993-6: Muscle implantation in rabbits for 4, 12, and 24 weeks.
- Results: Pass. Irritation not greater than control materials at 24 weeks.
Sterilization:
- Sterilization validation:
- Test Method Summary: Validation method in conformance with EN ISO 11135-2007. The validation of sterilization was performed using the over-kill method per guidelines outlined in sections 9.3.2 and 9.3.3 of the EN ISO 11135 standard.
- Results: Pass. Devices have a sterility assurance level (SAL) of 10-6.
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.
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
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.
1
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
2
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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3
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.
4
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 final | |
| product |
Acceptance criteria: 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 | Discussion of product line and surgeon
handling of representative final product
Acceptance criteria: 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. |
Table 5-1. Functional Performance Information
5
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 to | |
| ISO 7198:1990 and | ||
| ISO 5081 | The ultimate tensile strength of | |
| the material composing the | ||
| subject device is greater than the | ||
| predicate device. | ||
| Suture retention strength | Testing according to | |
| ISO 7198:1998 | 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 | Devices were tested for maximum force | |
| required to collapse the tube and ability | ||
| to rebound to original diameter | All samples met acceptance | |
| criteria with performance | ||
| comparable to that of the | ||
| predicate device. |
Table 5-2. Bench Testing Information
6
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 contact | |
| cytotoxicity following ISO elution | Pass | |
| Non-cytotoxic | ||
| Sensitization | ISO 10993-10: Maximization test in | |
| guinea pigs (sodium chloride and | ||
| sesame oil extraction vehicles) | Pass | |
| No evidence of sensitization | ||
| Intracutaneous reactivity | ISO 10993-10: Intracutaneous | |
| reactivity test in rabbits (sodium | ||
| chloride and sesame oil extraction | ||
| vehicles) | Pass | |
| No evidence of intracutaneous | ||
| reactivity | ||
| Acute systemic toxicity | ISO 10993-11: Acute systemic toxicity | |
| test in mice (sodium chloride and | ||
| cottonseed oil extraction vehicles) | Pass | |
| No mortality or evidence of acute | ||
| systemic toxicity | ||
| Subchronic and chronic | ||
| toxicity | ISO 10993-11: Direct subcutaneous | |
| implant in rats for 4 weeks(subchronic) | ||
| and 18 weeks (chronic) | Pass | |
| Non-irritating to subcutaneous | ||
| tissue | ||
| No evidence of subchronic or | ||
| chronic toxicity | ||
| Genotoxicity | ISO 10993-3: Bacterial reverse | |
| mutation study | Pass | |
| Device extracts are non-mutagenic | ||
| Implantation | ISO 10993-6: Muscle implantation in | |
| rabbits for 4, 12, and 24 weeks | Pass | |
| Irritation not greater than control | ||
| materials 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 with | |
| EN ISO 11135-2007 | ||
| The validation of sterilization was | ||
| performed using the over-kill method | ||
| per guidelines outlined in sections 9.3.2 | ||
| and 9.3.3 of the EN ISO 11135 | ||
| standard. | Pass | |
| Devices have a sterility assurance | ||
| level (SAL) of 10-6 |
7
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 intestinal
submucosa; primarily
collagen types, III, IV,
and VI | Porcine small intestinal
submucosa; primarily
collagen types, III, IV,
and VI | Porcine small intestinal
submucosa; primarily
collagen 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 single
use? | Yes | Yes | Yes |
| Packaging
configuration | Clamshell tray in Tyvek
pouch with an outer box | Clamshell tray in a
double Tyvek pouch | Clamshell tray in Tyvek
pouch with an outer box |
| Shelf Life | 18 months | 18 months | 18 months |
| Intended Use | Intended for the repair of
peripheral nerve
discontinuities where gap
closure can be achieved
by flexion of the
extremity. | Intended for the repair of
peripheral nerve
discontinuities where gap
closure can be achieved
by flexion of the
extremity | Intended 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. |
| Dimensions | 1.5-10 mm diameter x 1-
5 cm length | Diameter (mm)
Length (cm)
2
5
7 | 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
8
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.