(106 days)
The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
The Phoenix Wound Matrix is a sterile, single use device intended for the management of wounds. The Phoenix Wound Matrix is a conformable, non-woven, fibrous, three-dimensional matrix. The Phoenix Wound Matrix is made from two types of polymer fibers: Poly(lactide-co-caprolactone) and Polyglycolic acid, which are bioabsorbed after degrading via hydrolysis.
This response is based on the provided text, which is a 510(k) submission summary for the Phoenix Wound Matrix. It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of new technology through a comprehensive clinical study with acceptance criteria and a detailed study design. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC), and ground truth establishment for AI/algorithm performance cannot be extracted from this document, as it pertains to a different type of regulatory submission (most often for novel AI/ML medical devices).
The document is a declaration of substantial equivalence for a wound matrix, not an AI/ML device. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test and training sets, expert consensus, MRMC studies, and ground truth establishment are not applicable in this context.
However, I can extract information related to the device's performance testing from the "Performance Data" section.
Device: Phoenix Wound Matrix
Regulatory Pathway: 510(k) (seeking substantial equivalence to predicate devices)
1. Acceptance Criteria and Reported Device Performance
Since this is a traditional medical device (wound matrix) and not an AI/ML device, the "acceptance criteria" are not defined as statistical metrics for an algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, they relate to biocompatibility, mechanical properties, and non-inferiority in wound healing.
| Acceptance Criteria Category | Specific Tests/Assessments | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993, Biological Evaluation of Medical Devices testing: | "ISO 10993, Biological Evaluation of Medical Devices testing has demonstrated that the device is safe."Specific tests conducted: |
| - Cytotoxicity | Passed | |
| - Dermal irritation | Passed | |
| - Sensitization | Passed | |
| - Acute systemic toxicity | Passed | |
| - Genotoxicity | Passed | |
| - 6-week muscle implantation | Passed (device found to be safe through this evaluation) | |
| - 6-week sub-acute/sub-chronic toxicity | Passed (device found to be safe through this evaluation) | |
| Mechanical Properties | Functional testing for sufficient mechanical properties | "Functional testing demonstrates that the device has sufficient mechanical properties (strength and flexibility) for unaged and aged devices." |
| Wound Healing Response | Animal wound healing study in a porcine model (demonstrating no delay in wound healing response) | "An animal wound healing study in a porcine model has demonstrated that there was no delay in the wound healing response due to the subject device." (This implies a comparison to a control or standard treatment, showing non-inferiority in healing time/pattern, though specific metrics are not detailed in this summary). This is a demonstration that the device does not negatively impact the healing process, supporting its safety and effectiveness for its intended use. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: Not explicitly stated in terms of number of wounds or animals. The text only mentions "an animal wound healing study in a porcine model."
- Data Provenance: The study was an "animal wound healing study in a porcine model." This implies a controlled laboratory setting, likely in the US given the FDA submission. It is by nature a prospective experiment in an animal model, not retrospective human data.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This device is a wound dressing, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The performance data is based on direct biological and mechanical testing.
4. Adjudication Method for the Test Set
- Not applicable. As above, no human expert adjudication is described for the performance testing of this physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI/ML diagnostic or image-based device. An MRMC study is not relevant for evaluating the performance of a wound matrix.
6. Standalone (Algorithm Only) Performance
- Not applicable. There is no algorithm associated with this physical wound matrix device for standalone performance evaluation.
7. Type of Ground Truth Used
- Biological and Physical Measurements: For biocompatibility, the ground truth is established by standard ISO 10993 biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization, histological examination for implantation studies). For mechanical properties, it's defined by laboratory stress/strain measurements. For wound healing, it's based on observed healing progression in the animal model.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."
9. How Ground Truth for Training Set was Established
- Not applicable. As there is no training set, this question is irrelevant.
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December 15, 2022
Nanofiber Solutions, Inc. Ronald Bracken President and COO 4389 Weaver Court North Hilliard, Ohio 43026
Re: K173544
Trade/Device Name: Phoenix Wound Matrix Regulatory Class: Unclassified Product Code: QSZ
Dear Ronald Bracken:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 2, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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March 2, 2018
Nanofiber Solutions, Inc. Ronald Bracken President and COO 4389 Weaver Court North Hilliard, Ohio 43026
Re: K173544
Trade/Device Name: Phoenix Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: November 15, 2017 Received: November 16, 2017
Dear Ronald Bracken:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173544
Device Name Phoenix Wound Matrix
Indications for Use (Describe)
The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
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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SUBMITTER'S INFORMATION
| Owner: | Nanofiber Solutions, Inc |
|---|---|
| Address: | 4389 Weaver Court NorthHilliard, OH 43026 |
| Official Correspondent: | Ronald L. Bracken770-597-7656ronny.bracken@nanofibersolutions.com |
| Date Summary Prepared: | March 1, 2018 |
DEVICE INFORMATION
| Name of Device: Phoenix Wound Matrix | |
|---|---|
| -- | -------------------------------------- |
- Common/Usual Name: Wound Dressing
- Unclassified, FRO (Dressing, wound, drug) Classification Name:
- K132397 GORE BIO-A Wound Matrix (FRO) Predicate Device(s): K090160 SUPRATHEL Wound & Burn Dressing (FRO)
- Device Description: The Phoenix Wound Matrix is a sterile, single use device intended for the management of wounds. The Phoenix Wound Matrix is a conformable, non-woven, fibrous, three-dimensional matrix. The Phoenix Wound Matrix is made from two types of polymer fibers: Poly(lactide-co-caprolactone) and Polyglycolic acid, which are bioabsorbed after degrading via hydrolysis.
- Indication for Use: The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
- Technological The nonwoven fibrous three-dimensional matrix comprised of Poly(lactide-co-caprolactone) and Polyglycolic acid fibers is Characteristics: designed to conform to the wound bed.
- Indication for Use: The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
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- Comparison to Predicate The Phoenix Wound Matrix is substantially equivalent to the Devices: GORE® BIO-A® Wound Matrix (K132397) and SUPRATHEL® Wound & Burn Dressing (K090160). The Phoenix Wound Matrix raises no different questions of safety or effectiveness as compared to the predicate devices. The Phoenix Wound Matrix has the same intended use and indications for use, technological characteristics, and principles of operation as the predicate devices. There are no new novel features as compared to the Gore Bio-A and Suprathel predicate device. The minor differences between the Phoenix Wound Matrix and its predicate devices raise no different issues of safety or effectiveness.
- Performance Data: The Nanofiber Solutions wound matrix has been tested for safety and performance. ISO 10993, Biological Evaluation of Medical Devices testing has demonstrated that the device is safe. The following testing was conducted: cytotoxicity, dermal irritation, sensitization, acute systemic toxicity, genotoxicity, 6 week muscle implantation and 6 week sub-acute/sub-chronic toxicity. Functional testing demonstrates that the device has sufficient mechanical properties (strength and flexibility) for unaged and aged devices. An animal wound healing study in a porcine model has demonstrated that there was no delay in the wound healing response due to the subject device.
N/A