(266 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interaction of a physical nerve cuff, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed to "repair peripheral nerve function" and is "indicated for the repair of peripheral nerve discontinuities," directly addressing a health condition.
No
The device is described as being indicated for the repair and management of peripheral nerve injuries, indicating a therapeutic or treatment function rather than a diagnostic one.
No
The device description clearly states it is a physical implant made from polyglycolic acid and alginate gel, designed to be cut and implanted. It is a hardware 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 and management of peripheral nerve injuries by providing a scaffold for nerve regeneration. This is a therapeutic and surgical intervention performed in vivo (within the body).
- Device Description: The device is an implantable material designed to be surgically placed to cover damaged nerve sections.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is clearly intended for direct surgical implantation to aid in nerve repair, which falls under the category of medical devices used for treatment or restoration of function, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device Description
The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets.
The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons.
When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.
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: Comparative bench testing of Mochida Nerve Cuff and the predicate devices, including tensile strength, suture retention strength, pH, stiffness, degradation, swelling rate, and porosity testing, was conducted. Results for Tensile strength, Suture retention strength, and Stiffness were "Pass". pH, Degradation, and Swelling rate were "N/A (For reference)". Porosity was "N/A (For reference)".
Animal study: The subject device has also been tested in two animal studies using the rat sciatic nerve model.
- The first study evaluated the nerve repair process, article degradation and local tissue response to Mochida Nerve Cuff when applied to a sciatic nerve transection (nerve gap) in the rat for 1, 8, and 26 weeks, as compared to the Collagen Nerve Cuff predicate.
- The second study evaluated the article degradation and local tissue response to Mochida Nerve Cuff when applied to a sciatic nerve without transection (no substantial loss of nerve tissue) in the rat for 1, 8, and 13 weeks, as compared to the Collagen Nerve Wrap predicate.
In addition to the test article and control article (predicate device), the studies also included a sham arm to evaluate the response that could be elicited from the surgical procedures.
Key results: For all evaluated endpoints in both studies, including neurological findings and histology findings, the results demonstrated that the Mochida Nerve Cuff has the similar safety profile and performance as the predicate devices. Therefore, the results of the in vivo animal study support the substantial equivalence.
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
Image /page/0/Picture/0 description: The image shows the date June 21, 2024. The month is June, the day is the 21st, and the year is 2024. The date is written in a clear, legible font. The text is black on a white background.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mochida Pharmaceutical Co., Ltd. % Kelliann Payne Partner Hogan Lovells U.S. LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K233322
Trade/Device Name: Mochida Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: May 24, 2024 Received: May 24, 2024
Dear Kelliann Payne:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/8 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2024.06.21. The time of the signature is 17:44:13 -04'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/20/2023 See PRA Statement on last page
510(k) Number (if known)
Device Name
Mochida Nerve Cuff
Indications for Use (Describe)
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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4
510(k) SUMMARY Mochida's Nerve Cuff
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mochida Pharmaceutical Co., Ltd. 1-7 Yotsuva. Shiniuku-ku Tokyo, Japan Phone: +81-3-3225-6306 Fax: +81-3-3225-5886
Contact: Akiko Koarai, Head of Medical Device Quality Management and Regulatory Affairs Department
Date Prepared: June 20, 2024
Name of Device
Trade name: Mochida Nerve Cuff Common name: Cuff. Nerve Classification name: Nerve cuff (21 CFR 882.5275) Regulatory class: II Product code: JXI
Predicate Devices
Collagen Matrix, Inc.'s Collagen Nerve Wrap (K060952) (Predicate device) Collagen Matrix, Inc.'s Collagen Nerve Cuff (K012814) (Predicate device)
Device Description
The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets.
The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons.
When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.
Indications for Use
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
5
Comparison of Technological Characteristics with the Predicate Device
The subject device has similar technological characteristics as the predicate devices. Both are smooth, flexible products that are made of biodegradable materials, and are supplied in sterilized packages and for single use. Both devices aim to achieve the function of nerve repair through supporting nerve axon regeneration by providing a scaffold for growth of axons following the degradation/absorption process after nerve injury.
Both the subject and the predicate devices are made of biodegradable material. Specifically, the subject device consists of covalently cross-linked alginate gel, which is biodegradable, similar to the collagen material used in the predicate device.
Both the subject and the predicate devices are supplied in sheet/wrap forms. Both devices have the same fundamental science, which is to serve as scaffolds for Schwann and nerve cells to grow and to protect the regrowth site from the environment, such as ingrowth of scar tissue.
Both the subject and predicate devices remain in the body for a period of time until the injured nerves are repaired. The comparative animal studies showed similar host reaction and nerve regeneration between the subject device and Collagen Nerve Cuff predicate. Both the subject and predicate devices are provided sterile and are intended for single use. Sterilization validation testing demonstrated that the sterilization method used for the subject device is adequate to achieve sterility of the device. In addition, biocompatibility testing showed the biological safety of the device, further supporting the adequacy of the sterilization.
| | Mochida Nerve Cuff
(Subject device) | Collagen Matrix, Inc.'s
Collagen Nerve Wrap
(K060952)
(Predicate device) | Collagen Matrix, Inc.'s
Collagen Nerve Cuff
(K012814)
(Predicate device) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 882.5275 | 21 CFR 882.5275 | 21 CFR 882.5275 |
| Product Code | JXI | JXI | JXI |
| Resorbable | Yes | Yes | Yes |
| Suturable | Yes | Yes | Yes |
| Material | Sodium Alginate
Polyglycolic acid | Collagen | Type I Collagen |
| Indications
For Use | Mochida Nerve Cuff is
indicated for the repair
of peripheral nerve
discontinuities where
gap closure can be
achieved by flexion of
the extremity, or the
management of
peripheral nerve injuries
in which there has been
no substantial loss of
nerve tissue. | Collagen Nerve Wrap is
indicated for the
management of peripheral
nerve injuries in which
there has been no
substantial loss of nerve
tissue and where gap
closure can be achieved
by flexion of the extremity. | Collagen Nerve Cuff is
intended for use in
repair of peripheral
nerve discontinuities
where gap closure can
be achieved by flexion
of the extremity. |
6
| | Mochida Nerve Cuff
(Subject device) | Collagen Matrix, Inc.'s
Collagen Nerve Wrap
(K060952)
(Predicate device) | Collagen Matrix, Inc.'s
Collagen Nerve Cuff
(K012814)
(Predicate device) |
|-------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Physical
structure | Sheet | Wraps (Pre-rolled membrane) | Tubular matrix |
| Size | 5.5 cm × 5.5 cm
(Long ×Wide)
Can be cut to
appropriate size | 4 x 25 mm | Diameter: 1.0, 1.5, 2.0,
2.5, 3.0, 3.5, 4.0, 5.0,
6.0, 10.0 mm;
Lengths of 1, 2 and 3
cm. |
| | | 4 x 50 mm | |
| | | 6 x 25 mm | |
| | | 6 x 50 mm | |
| | | 12 x 25 mm | |
| | | 12 x 50 mm | |
| | | Can be trimmed or
shaped to appropriate
size | |
| | | Biocompatibility | |
| Preparation for
use | Use dry or minimally
hydrated | Hydrated for 5 minutes in
saline | Hydrated for 5 minutes
in saline |
| Reusable | Single-use | Single-use | Single-use |
| Sterilization
Method | eBeam | Gamma irradiation | Gamma irradiation |
| Packaging | Double Pouch | Double blister | not publicly available |
| Shelf life | 4 months | 3 years | 3 years |
Performance Data
The technical characteristics of the subject and predicate devices have been tested using comparative bench tests, which showed very similar results. In addition, performance testing, including biocompatibility testing and animal testing, demonstrates similar safety and performance of the subject device and its predicates. The following performance testing has been conducted:
Stability testing of the product and the packaging
Stability of the Mochida Nerve Cuff was demonstrated by the real-time and accelerated aging methodologies for the product and the packaging materials.
Transportation testing
The transportation testing was conducted to demonstrate the ability of the Mochida Nerve Cuff and its packaging to withstand the distribution environment. The testing was conducted according to ASTM D4169-22.
Pyrogenicity testing
Mochida Nerve Cuff is labeled as non-pyrogenic. Endotoxin testing was conducted to demonstrate that the product is non-pyrogenic.
7
Biocompatibility testing
Biocompatibility testing was conducted according to FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
| Test | Test Summary | Conclusions |
|---|---|---|
| Chemical | ||
| characterization | The chemical characterization was | |
| implemented based on ISO 10993-18. The | ||
| extractable and leachable that could be | ||
| released from the test article were identified and | ||
| quantified. | The study did not identify | |
| any analytes that represent | ||
| a significant toxicological | ||
| risk. | ||
| Cytotoxicity | The device was evaluated for potential cytotoxic | |
| effects following ISO 10993-5 guidelines. | The cytotoxicity test results | |
| do not raise any safety | ||
| concerns. | ||
| Sensitization | The device was evaluated for the potential to | |
| cause sensitization in guinea pigs based on ISO | ||
| 10993-10. The test animals showed no | ||
| evidence of inducting sensitization. | Non-sensitizing | |
| Irritation | The device was evaluated for the potential to | |
| cause irritation following intracutaneous | ||
| injection in rabbits based on ISO 10993-23. The | ||
| extracts of the test article show no evidence of | ||
| irritation. | Non-irritant | |
| Acute systemic | ||
| toxicity | The device was evaluated for acute systemic | |
| toxicity in mice based on ISO 10993-11. No | ||
| change was observed in general conditions or | ||
| in necropsy. | No acute systemic toxicity | |
| Subacute | ||
| toxicity | The device was evaluated for acute systemic | |
| toxicity in rats based on ISO 10993-6 and ISO | ||
| 10993-11. No abnormality occurred in general | ||
| conditions or surgical sites after implantation. | No subacute systemic | |
| toxicity | ||
| Pyrogenicity | The device was evaluated for the potential to | |
| induce a pyrogenic response following | ||
| intravenous injection in rabbits based on ISO | ||
| 10993-11. The total rise of temperature was | ||
| within acceptable range. | Non-pyrogenic | |
| Genotoxicity - | ||
| Bacterial | ||
| Reverse | ||
| Mutation | The device was evaluated for the potential to | |
| induce reverse mutations in bacteria per ISO | ||
| 10993-3. | ||
| The result indicated that the extracts of the | ||
| device were not genotoxic. | Non-genotoxic | |
| Genotoxicity - | ||
| Chromosomal | ||
| Abnormality | The device was evaluated for the potential of | |
| clastogenicity per ISO 10993-3. It showed that | ||
| this device is clastogenicity negative in cultured | ||
| mammalian cells. | Non-genotoxic | |
| Test | Test Summary | Conclusions |
| Hemolysis | ||
| testing | The device was evaluated for hemolytic | |
| potential when in contact with blood based on | ||
| ISO 10993-4 and ASTM F756 standard. Under | ||
| the conditions of this study, data obtained were | ||
| considered not analyzable. | No conclusion was drawn | |
| for hemolytic potential of the | ||
| treated test article extract. | ||
| Subchronic | ||
| toxicity, Chronic | ||
| toxicity, and | ||
| Carcinogenicity | These endpoints were addressed with a | |
| chemical characterization/toxicological risk | ||
| assessment approach. | Justified by chemical | |
| characterization/toxicological | ||
| risk assessment |
8
Bench testing
Comparative bench testing of Mochida Nerve Cuff and the predicate devices, including tensile strength, suture retention strength, pH, stiffness, degradation, swelling rate, and porosity testing, was conducted.
| Test | Test Method Summary | Results |
|---|---|---|
| Tensile strength | The device is cut into a piece, and then pull both ends of | |
| the test piece and measure the strength when it breaks. | Pass | |
| Suture retention | ||
| strength | After passing a suture with a needle though the wetted | |
| specimen, fix the suture to blocks. Pull the specimen, | ||
| and measure the strength at which the device breaks. | Pass | |
| pH | Measure the pH of the sample extract of the device. | N/A |
| (For | ||
| reference) | ||
| Stiffness | Wrap sample around the smooth shaft and record any | |
| observation of cracking or breaking. | Pass | |
| Degradation | Immerse the devise in a solution and measure the | |
| weight of the devise after picking up from the solution | ||
| after a period of time. | N/A | |
| (For | ||
| reference) | ||
| Swelling rate | Measure the absorbed amount of water per device | |
| weight. | N/A | |
| (For | ||
| reference) | ||
| Porosity | Porosimetry | N/A |
| (For | ||
| reference) |
Animal study
In addition to the bench testing, the subject device has also been tested in two animal studies using the rat sciatic nerve model. The first study evaluated the nerve repair process, article degradation and local tissue response to Mochida Nerve Cuff when applied to a sciatic nerve transection (nerve gap) in the rat for 1, 8, and 26 weeks, as compared to the Collagen Nerve Cuff predicate. The second study evaluated the article degradation and local tissue response to Mochida Nerve Cuff when applied to a sciatic nerve without transection (no substantial loss of nerve tissue) in the rat for 1, 8, and 13 weeks, as compared to the Collagen Nerve Wrap predicate. In addition to the test article and control article (predicate device), the studies also
9
included a sham arm to evaluate the response that could be elicited from the surgical procedures.
For all evaluated endpoints in both studies, including neurological findings and histology findings, the results demonstrated that the Mochida Nerve Cuff has the similar safety profile and performance as the predicate devices. Therefore, the results of the in vivo animal study support the substantial equivalence.
Conclusions
The Mochida Nerve Cuff and its predicate devices have intended use and similar indications, technological characteristics and principles of operation. The minor technological differences do not present any new issues of safety or effectiveness. Performance testing demonstrated that the subject device performs similarly as the predicate devices. Thus, the Mochida Nerve Cuff is substantially equivalent to the predicate devices.