(122 days)
Axoguard HA+ Nerve Protector is indicated for the management and peripheral nerve injuries where there is no gap, or following closure of the gap.
Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. 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 joint 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 the surgeon's needs.
The provided text describes a 510(k) premarket notification for a medical device called "Axoguard HA+ Nerve Protector." This submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device's efficacy through a clinical study in the same way an AI/ML device would be.
Therefore, the requested information elements related to AI/ML device studies (e.g., sample sizes for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. This document focuses on demonstrating the safety and performance of a physical surgical implant through bench testing, biocompatibility studies, and non-clinical (animal) studies, primarily by showing it meets predetermined acceptance criteria and is comparable to an existing device.
However, I can provide the acceptance criteria and performance results that are present in the document.
Acceptance Criteria and Reported Device Performance
For this medical device (Axoguard HA+ Nerve Protector), the acceptance criteria are met when the results of various bench tests and biocompatibility assessments demonstrate that the device performs as intended and is safe for its indicated use, showing substantial equivalence to the predicate device. The performance data presented are primarily from bench testing and biocompatibility studies, along with a non-clinical GLP (Good Laboratory Practice) study in rats.
Here's a table summarizing the acceptance criteria (implied by the "Test Method Summary" and the general expectation for medical devices) and the reported device performance:
| Test | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance/Result |
|---|---|---|---|
| Bench Testing | |||
| Coefficient of Friction | Aged and unaged devices evaluated for static coefficient of friction (lubricity) based on ASTM D1894-14. | Must meet pre-defined lubricity specifications for intended use. | "Test articles met the acceptance criteria." |
| Suture Retention Strength | Aged and unaged devices evaluated for suture retention strength by measuring the force required to pull a suture free, based on ANSI/AAMI/ISO 7198. | Must demonstrate sufficient strength to securely hold sutures without pull-through at specified forces. | "Test articles met the acceptance criteria." |
| Ultimate Tensile Strength | Aged and unaged devices evaluated for ultimate tensile strength by measuring the separation force required for device failure, based on ASTM D882-18. | Must exhibit adequate tensile strength to withstand surgical handling and in-vivo stresses. | "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, evaluated per ASTM F2096-11(2019). | Packaging must maintain integrity to ensure sterility and product protection. | "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, subjected to testing per ASTM F88/F88-21. | Packaging seals must meet specified strength requirements to prevent bacterial ingress. | "Test articles met the acceptance criteria." |
| Biocompatibility | (All based on ISO 10993-1 and relevant sub-parts) | Must demonstrate no adverse biological reactions. | All endpoints met. |
| Sensitization | Test article extracts evaluated for potential to cause delayed dermal contact sensitization in a guinea pig maximization test based on ISO 10993-10. | Must show no evidence of causing sensitization. | "Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig." |
| Irritation | Test article extracts evaluated for potential to cause irritation following intracutaneous injection in rabbits based on ISO 10993-23. | Must be non-irritating. | "Test article extracts met the requirements of the test and were considered non-irritants." |
| Acute Systemic Toxicity | Test article extracts evaluated for acute systemic toxicity in mice based on ISO 10993-11. | Must show no mortality or evidence of systemic toxicity. | "There was no mortality or evidence of systemic toxicity from the test article extracts. Each test article extract met the requirements of the study." |
| Pyrogenicity | Test article extracts evaluated for potential to induce a pyrogenic response following intravenous injection in rabbits based on USP 43- NF38, General Chapter <151>, ISO 10993-11. | Must meet requirements for the absence of pyrogens. | "The test article met the requirements for the absence of pyrogens." |
| Genotoxicity (Ames) | Test article extracts evaluated for mutagenic potential in Escherichia coli or Salmonella typhimurium strains (with/without S9 metabolic activation) based on ISO 10993-3. | Must be non-mutagenic. | "Test article extracts met the requirements of the test and were considered non-mutagenic." |
| Genotoxicity (Mouse Lymphoma Assay) | Test article extracts evaluated for mutagenic potential using the mouse lymphoma forward gene mutation assay based on ISO 10993-3. | Must be non-mutagenic. | "Test article extracts met the requirements of the test and were considered non-mutagenic." |
| Endotoxin | Test article extracts evaluated for bacterial endotoxins using the Kinetic-Turbidimetric test method per USP 43-NF38, General Chapter <85>, USP43-NF38, General Chapter <161>, and ANSI/AAMI ST72. | Must meet USP requirements for endotoxin levels. | "Test article extracts met USP requirement." |
| Cytotoxicity | Test article extracts evaluated for potential to cause cytotoxic effects using an in vitro mammalian cell culture test based on ISO 10993-5. | Must show no evidence of cell lysis or toxicity. | "Test article extracts showed no evidence of causing cell lysis or toxicity and each had a grade of 0 (no reactivity)." |
| Non-Clinical GLP Study (Animal) | Evaluated effects of Axoguard HA+ Nerve Protector on nerve regeneration after implantation in a rat sciatic nerve transection injury model. 60 Lewis Rats (10 males, 10 females per group) divided into Sham, Test, and Control groups. Endpoint at 6 or 12 weeks. | Must demonstrate safety and efficacy comparable to control/sham for nerve regeneration and related outcomes. | "The study met set acceptance criteria regarding safety and local effects related to nerve regeneration following implantation... The nerve regeneration-related outcomes in the Test device... were not statistically significantly different when compared to the Control device." |
Regarding the AI/ML specific questions:
- Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML diagnostic or therapeutic. The "test set" here refers to physical samples used in bench tests and animals in a non-clinical study. The non-clinical study used 60 Lewis Rats. The provenance is a laboratory study, not human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this comes from standardized material testing, chemical analyses, and biological observations in animal models, not human expert consensus on images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For bench testing, the ground truth is defined by the physical or chemical properties measured against established standards (e.g., ASTM, ISO). For biocompatibility, it's the biological response in standardized in-vitro and in-vivo tests. For the non-clinical study, the ground truth was established by histology endpoints for axonal outgrowth, axonal myelination, and gastrocnemius muscle weight in the rat model. This is essentially biological/pathological assessment in an animal model.
- The sample size for the training set: Not applicable, as there is no AI/ML algorithm involved.
- How the ground truth for the training set was established: Not applicable.
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October 12, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized image of a human figure. To the right of the seal, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font and is placed inside a blue square.
AxoGen Corporation Shravani Shastry Senior Regulatory Affairs Specialist 13631 Progress Blvd. Suite 400 Alachua. FL 32615-9409
Re: K231708
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: September 11, 2023 Received: September 11, 2023
Dear Shravani Shastry:
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"
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(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/7 description: The image shows the name "Adam D. Pierce -S" in large, bold font on the left side. On the right side, it says "Digitally signed by Adam D. Pierce -S" in a smaller font. Below that, it says "Date: 2023.10.12 09:41:27 -04'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices
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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) K231708
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 and peripheral nerve injuries where there is no gap, or following closure of the gap.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K231708
1. Submitter
| Name: | Axogen Corporation | ||
|---|---|---|---|
| 13631 Progress Blvd, Ste 400 | |||
| Alachua, FL, 32615 | |||
| Contact Person: | Shravani Shastry | ||
| Contact Title: | Senior Regulatory Affairs Specialist | ||
| Phone (office): | 888-296-4361 | ||
| Email: | ra@axogeninc.com | ||
| Date Prepared: | October 12th, 2023 | ||
| 2. Device Information | Axoguard HA+ Nerve Protector | ||
| Trade/Device Name: | Nerve Cuff | ||
| Common/Usual Name: | Nerve Cuff | ||
| Classification Name: | Class II | ||
| Regulatory Class: | JXI | ||
| Product Code: | 21 CFR 882.5275 | ||
| Regulation Number: |
3. Predicate Device
| Device | Company | Predicate 510(k) | Clearance date |
|---|---|---|---|
| Axoguard HA+Nerve Protector | Axogen | K223640 | April 7, 2023 |
4. Device Description
Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. 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 joint 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 the surgeon's needs.
5. Indications for Use
Axoguard HA+ Nerve Protector is indicated for the management and protection of peripheral nerve injuries where there is no gap, or following closure of the gap.
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6. Comparison of Technological Characteristics with the Predicate Device
Axoguard HA+ Nerve Protector is similar in intended use, design, principle of operation, and material (ECM base membrane) as Axoguard HA+ Nerve Protector. Table 7-1 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(This submission) | Axoguard HA+ Nerve Protector(Predicate) | ||||||||||||||||||||||||||||||||||||
| 510(k)# | K231708 | K223640 | ||||||||||||||||||||||||||||||||||||
| 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/Overthe Counter Use | Rx only | Rx only | ||||||||||||||||||||||||||||||||||||
| Intended Use | Designed to be an interfacebetween the peripheral nerveand the surrounding tissue. | Designed to be an interface between theperipheral nerve and the surrounding tissue. | ||||||||||||||||||||||||||||||||||||
| Indications for Use | Axoguard HA+ NerveProtector is indicated for themanagement and protection ofperipheral nerve injuries wherethere is no gap, or followingclosure of the gap. | Axoguard HA+ Nerve Protector is indicatedfor the management of peripheral nerveinjuries where there is no gap | ||||||||||||||||||||||||||||||||||||
| Dimensions | Width(cm) Length(cm) Area(cm2) 1 2 2 2 2 4 2 4 8 3 6 18 4 8 32 | Width(cm) Length(cm) Area(cm2) 1 2 2 2 2 4 2 4 8 3 6 18 4 8 32 |
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| Thickness: 100µm to 1000µmSIS thickness range(manufacturing specification). | Thickness: 100µm to 1000µm SIS thicknessrange (manufacturing specification). | |
|---|---|---|
| Material | Porcine SIS 2.0 decellularizedextracellular matrix suppliedby Cook Biotech, Inc., with a2.2mg/cm² dry coating ofsodium hyaluronate andsodium alginate applied to bothsides of the device in a 1:1ratio. | Porcine SIS 2.0 decellularized extracellularmatrix supplied by Cook Biotech, Inc., witha 2.2mg/cm² dry coating of sodiumhyaluronate and sodium alginate applied toboth sides of the device in a 1:1 ratio. |
| Configuration | Flat Sheet | Flat Sheet |
| Sterile/SingleUse | Single use only | Single use only |
| Sterility /SterilizationMethod | SAL 10-6 / Ethylene Oxide | SAL 10-6 / Ethylene Oxide |
7. Performance Data
7.1 Bench testing
The following performance data are provided in support of the substantial equivalence determination: biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (FDA Recognized Consensus Standard 2-258), and bench testing including coefficient of friction, suture retention, ultimate tensile strength, bubble emission (packaging), seal strength (packaging). Table 7.1-1 summarizes the testing performed for the Axoguard HA+ Nerve Protector.
| Table 7.1-1: Axoguard HA+ Nerve Protector Testing Summary | ||||
|---|---|---|---|---|
| Test | Test Method Summary | Summary Result | ||
| Coefficient of Friction | Aged and unaged devices were evaluated fortheir static coefficient of friction (lubricity)based on ASTM D1894-14. | Test articles met theacceptance criteria. | ||
| Suture Retention Strength | Aged and unaged devices were evaluated fortheir suture retention strength by placing asuture through the devices and the force requiredto pull free was measured, based onANSI/AAMI/ISO 7198. | Test articles met theacceptance criteria. | ||
| Ultimate Tensile Strength | Aged and unaged devices were evaluated fortheir ultimate tensile strength by placing thedevices between two grips. The separation forcerequired resulting in device failure wasmeasured, based on ASTM D882-18. | Test articles met theacceptance criteria. |
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| Bubble Emission(Packaging) | Aged and unaged devices underwent ethyleneoxide sterilization, and visual inspection prior tobubble leak testing. The test articles underwentevaluation in accordance with ASTM F2096-11(2019). | Test articles met theacceptance criteria. |
|---|---|---|
| Seal Strength (Packaging) | Aged and unaged devices underwent ethyleneoxide sterilization, and visual inspection prior toseal strength testing. The test article sample setswere subjected to seal strength testing inaccordance with ASTM F88/F88-21. | Test articles met theacceptance criteria. |
7.2 Biocompatibility
Biocompatibility endpoints for the subject device are in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within risk management process (FDA Recognized Consensus Standard 2-258) was assessed. All necessary endpoints according to the standard were met (Table 8.2-1).
| Table 7.2-1: Axoguard HA+ Nerve Protector Testing Summary | ||||
|---|---|---|---|---|
| Test | Test Method Summary | Summary Result | ||
| Sensitization | Test article extracts of the device were evaluatedfor their potential to cause delayed dermalcontact sensitization in a guinea pigmaximization test based on ISO 10993-10. | Test article extracts showed noevidence of causing delayeddermal contact sensitization inthe guinea pig. | ||
| Irritation | Test article extracts of the device were evaluatedfor their potential to cause irritation followingintracutaneous injection in rabbits based on ISO10993-23. | Test article extracts met therequirements of the test andwere considered non-irritants. | ||
| Acute Systemic Toxicity | Test article extracts of the device were evaluatedfor acute systemic toxicity in mice based on ISO10993-11. | There was no mortality orevidence of systemic toxicityfrom the test article extracts.Each test article extract metthe requirements of the study. | ||
| Pyrogenicity | Test article extracts of the device were evaluatedfor their potential to induce a pyrogenicresponse following intravenous injection inrabbits based on USP 43- NF38, GeneralChapter <151>, ISO 10993-11. | The test article met therequirements for the absenceof pyrogens. | ||
| Genotoxicity (Ames) | Test article extracts of the device were evaluatedfor their mutagenic potential in a tryptophan-dependent strain of Escherichia coli or in one ormore strains of histidine-dependent Salmonellatyphimurium in the presence or absence of S9metabolic activation based on ISO 10993-3. | Test article extracts met therequirements of the test andwere considered non-mutagenic. |
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| Genotoxicity (MouseLymphoma Assay) | Test article extracts of the device were evaluatedfor their mutagenic potential using the mouselymphoma forward gene mutation assay basedon ISO 10993-3. | Test article extracts met therequirements of the test andwere considered non-mutagenic. |
|---|---|---|
| Endotoxin | Test article extracts were evaluated for bacterialendotoxins using the Kinetic-Turbidimetric testmethod in accordance with USP 43- NF38,General Chapter <85>, USP43-NF38, GeneralChapter <161> and ANSI/AAMI ST72. | Test article extracts met USPrequirement. |
| Cytotoxicity | Test article extracts of the device were evaluatedfor their potential to cause cytotoxic effectsusing an in vitro mammalian cell culture testbased on ISO 10993-5. | Test article extracts showed noevidence of causing cell lysisor toxicity and each had agrade of 0 (no reactivity). |
7.3 Non-Clinical GLP Studies
The objective of this GLP study was to evaluate the effects of the Axoguard HA+ Nerve Protector (Next Generation Protection device or NGP) device on nerve regeneration after implantation in a rat sciatic nerve transection injury model. A total of sixty (60) Lewis Rats, were enrolled and divided between three (3) groups of 20 (10 males and 10 females). The 3 groups were Sham device, Test device, and Control device, groups. Animals underwent a single surgical procedure on Day 0 in which the right sciatic nerve was exposed and transected. Following transection, the two nerve ends were loosely approximated using two non-resorbable 10-0 Nylon sutures approximately 180 degrees apart, creating a standard direct nerve repair (neurorrhaphy). Animals were allowed to heal for sixor twelve weeks post-implantation. All animals were successfully implanted and survived until appointed endpoints. Most animals maintained or gained body weight except three (3) that lost a small percentage (≤ 7%) of weight in Sham and Control device groups. There were no significant abnormal clinical observations for any animal in any group. There were no systemic effects to Axoguard HA+ Nerve Protector as indicated by animal health observations, body weight, hematology, serum chemistry or necropsy. Based on the histology endpoints for axonal outgrowth. axonal myelination and gastrocnemius muscle weight, the study met set acceptance criteria regarding safety and local effects related to nerve regeneration following implantation of Axoguard HA+ Nerve Protector in a rat sciatic nerve transection and repair model. The nerve regenerationrelated outcomes in the Test device, Axoguard HA+ Nerve Protector, the group were not statistically significantly different when compared to the Control device.
Conclusion:
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, is substantially equivalent to its predicate device, and does not raise different questions of safety and effectiveness.
§ 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).