(123 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical implant, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes.
The device is intended for the management of peripheral nerve injuries by providing non-constricting protection and remodeling during the healing process, which aligns with the definition of a therapeutic device.
No
The device, Axoguard HA+ Nerve Protector, is described as a surgical implant that provides protection for peripheral nerves. Its function is to be an "interface between the nerve and the surrounding tissue" and to remodel during healing. It is not used to diagnose a medical condition, but rather to treat one (management of peripheral nerve injuries).
No
The device description clearly states it is a "surgical implant" comprised of an "extracellular matrix (ECM)" and a "lubricant coating." This indicates a physical, hardware-based medical device, not a software-only one.
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 "management of peripheral nerve injuries where is no gap." This describes a surgical implant used directly on the body to protect a nerve.
- Device Description: The description clearly states it is a "surgical implant" that provides "non-constricting protection for peripheral nerves." It is comprised of an extracellular matrix and is designed to be an "interface between the nerve and the surrounding tissue."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant used in vivo (within the body), not in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device Description
The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the ioint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet surgeons' needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Performance testing included coefficient of friction, suture retention, ultimate tensile strength, bubble emission (packaging), seal strength (packaging) and end-user validation. These evaluations demonstrate that the device meets the requirements for its intended use. All test articles met the acceptance criteria for each test. Biocompatibility endpoints for cytotoxicity, irritation, sensitization, material mediated pyrogenicity, acute systemic toxicity, and genotoxicity were assessed and all necessary endpoints were met. Additionally, two non-clinical GLP studies evaluating the effects and biocompatibility of the device on the nerve and the surrounding muscle tissue were performed.
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 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 7, 2023
AxoGen Corporation Jonathan White Senior Regulatory Affairs Specialist 13631 Progress Blvd. Ste 400 Alachua, Florida 32615-9409
Re: K223640
Trade/Device Name: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 5, 2022 Received: December 5, 2022
Dear Jonathan White:
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. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Yen-chih Lin Digitally signed by Yenchih Lin chih Lin -S Date: 2023.04.07 -2 14:28:21 -04'00'
for Adam Pierce Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223640
Device Name
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Indications for Use (Describe)
Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K223640
1. Submitter
| Name: | Axogen Corporation
13631 Progress Blvd, Ste 400
Alachua, FL 32615 | |
|-----------------------|-------------------------------------------------------------------------|--|
| Contact Person: | Jonathan White | |
| Contact Title: | Senior Regulatory Affairs Specialist | |
| Phone (office): | 386-462-6800 | |
| Email: | ra@axogeninc.com | |
| Date Prepared: | December 5, 2022 | |
| 2. Device Information | | |
| Trade Name: | Axoguard HA+ Nerve Protector | |
| Common Name: | Nerve Cuff | |
| Classification Name: | Nerve Cuff | |
| Regulatory Class: | Class II | |
3. Predicate Device
Regulation Number:
Product Code:
Axoguard HA+ Nerve Protector is substantially equivalent to the following device:
21 CFR 882.5275
JXI
- Axoguard Nerve Protector K132660 ●
4. Device Description
The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the ioint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet surgeons' needs.
5. Indications for Use
Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where there is no gap.
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6. Comparison of Technological Characteristics with the Predicate Device
Axoguard HA+ Nerve Protector is similar in intended use and indications for use, design, principle of operation, and material (ECM base membrane) as Axoguard Nerve Protector. Table 6-1 below summarizes the comparison between Axoguard HA+ Nerve Protector and its predicate.
| Table 6-1: Device Technological Characteristics Comparison Summary | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | Axoguard HA+ Nerve Protector | Axoguard Nerve Protector (Predicate) | ||||||||||||||||||
| 510(k)# | K223640 | K132660 | ||||||||||||||||||
| Manufacturer | Axogen Corporation | Cook Biotech Inc. | ||||||||||||||||||
| Common Name | Nerve Cuff | Nerve Cuff | ||||||||||||||||||
| Device Class | Class II | Class II | ||||||||||||||||||
| Classification Name and Number | Nerve Cuff; 21 CFR 882.5275 | Nerve Cuff; 21 CFR 882.5275 | ||||||||||||||||||
| Classification Product Code | JXI | JXI | ||||||||||||||||||
| Prescription/Over the Counter Use | Rx only | Rx only | ||||||||||||||||||
| Intended Use | Designed to be an interface between the peripheral nerve and the surrounding tissue. | Designed to be an interface between the peripheral nerve and the surrounding tissue. | ||||||||||||||||||
| Indications for Use | Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where there is no gap. | Axoguard Nerve Protector 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. | ||||||||||||||||||
| Dimensions | Width (cm) Length (cm) Area (cm2) 1 2 2 2 2 4 2 4 8 3 6 18 4 8 32 | 1.5 - 10 mm (diameter) x 1- 5 cm length | ||||||||||||||||||
| Material | Porcine small intestinal submucosa (SIS) extracellular collagen matrix (ECM), sodium hyaluronate, and sodium alginate | Porcine small intestinal submucosa (SIS) extracellular collagen matrix (ECM) | ||||||||||||||||||
| Configuration | Flat sheet | Curled sheet | ||||||||||||||||||
| Sterile/Single Use | Sterile; single use | Sterile; single use | ||||||||||||||||||
| Sterility / Sterilization Method | SAL 10-6 / Ethylene Oxide | SAL 10-6 / Ethylene Oxide |
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7. Performance Data
The following performance data are provided in support of the substantial equivalence determination: performance testing including coefficient of friction, suture retention, ultimate tensile strength, bubble emission (packaging), seal strength (packaging) and end-user validation. These evaluations demonstrate that the device meets the requirements for its intended use. Table 7-1 summarizes the testing performed for the Axoguard HA+ Nerve Protector.
| Table 7-1: Axoguard HA+ Nerve Protector Testing Summary | ||||
|---|---|---|---|---|
| Test | Test Method Summary | Summary Result | ||
| Coefficient of Friction | Aged and unaged devices were evaluated for | |||
| their static coefficient of friction (lubricity) | ||||
| based on ASTM D1894-14. | Test articles met the | |||
| acceptance criteria. | ||||
| Suture Retention Strength | Aged and unaged devices were evaluated for | |||
| their suture retention strength by placing a | ||||
| suture through the devices and the force required | ||||
| to pull free was measured, based on | ||||
| ANSI/AAMI/ISO 7198. | Test articles met the | |||
| acceptance criteria. | ||||
| Ultimate Tensile Strength | Aged and unaged devices were evaluated for | |||
| their ultimate tensile strength by placing the | ||||
| devices between two grips. The separation force | ||||
| required resulting in device failure was | ||||
| measured, based on ASTM D882-18. | Test articles met the | |||
| acceptance criteria. | ||||
| Bubble Emission | ||||
| (Packaging) | Aged and unaged devices underwent ethylene | |||
| oxide sterilization, and visual inspection prior to | ||||
| bubble leak testing. The test articles underwent | ||||
| evaluation in accordance with ASTM F2096- | ||||
| 11(2019). | Test articles met the | |||
| acceptance criteria. | ||||
| Seal Strength (Packaging) | Aged and unaged devices underwent ethylene | |||
| oxide sterilization, and visual inspection prior to | ||||
| seal strength testing. The test article sample sets | ||||
| were subjected to seal strength testing in | ||||
| accordance with ASTM F88/F88-21. | Test articles met the | |||
| acceptance criteria. | ||||
| Endotoxin | Test article extracts were evaluated for bacterial | |||
| endotoxins using the Kinetic-Turbidimetric test | ||||
| method in accordance with USP 43- NF38, | ||||
| General Chapter , USP43-NF38, General | ||||
| Chapter and ANSI/AAMI ST72. | Test article extracts met USP | |||
| requirement. | ||||
| End-user Validation | Surgeon end-users implanted the subject device | |||
| in a simulated surgical environment to assess | ||||
| device ease of use, and its conformance to user | ||||
| needs and its intended use. | Test articles met the | |||
| acceptance criteria. |
Biocompatibility
Biocompatibility endpoints for cytotoxicity, irritation, sensitization, material mediated pyrogenicity, acute systemic toxicity, and genotoxicity for the subject device in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a
6
risk management process (FDA Recognized Consensus Standard 2-258) were assessed. Additionally, two non-clinical GLP studies evaluating the effects and biocompatibility of the device on the nerve and the surrounding muscle tissue were performed. All necessary endpoints according to the standard were met.
9. Substantial Equivalence
The non-clinical data support the safety of the device and demonstrate that the Axoguard HA+ Nerve Protector performs as intended in its specified use conditions, and is substantially equivalent to its predicate device and does not raise different questions of safety and effectiveness.