(106 days)
Not Found
No
The document describes a passive wound matrix made of polymers and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for the management of various wound types (e.g., pressure ulcers, diabetic ulcers), which aligns with the definition of a therapeutic device as it treats or manages a condition.
No
The device is a wound matrix intended for the management and healing of wounds, not for diagnosing them. Its description focuses on handling and supporting wound healing rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a sterile, single-use, conformable, non-woven, fibrous, three-dimensional matrix made from polymer fibers, indicating it is a physical medical device, not software.
Based on the provided information, the Phoenix Wound Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the management of wounds. This involves applying a material to the wound itself to aid in healing.
- Device Description: The device is a sterile, single-use matrix made of polymers. It is applied directly to the wound.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVD devices are specifically designed for these types of in vitro (outside the body) tests.
The Phoenix Wound Matrix is a therapeutic device intended to support wound healing, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
QSZ, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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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Image /page/1/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 and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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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Image /page/4/Picture/2 description: The image shows the logo for Nanofiber Solutions. The logo consists of a purple square with white curved lines inside, followed by the word "Nanofiber" in purple, and the word "SOLUTIONS" in smaller purple letters below it. The logo is simple and modern, and the use of purple gives it a sense of sophistication.
SUBMITTER'S INFORMATION
| Owner: | Nanofiber Solutions, Inc |
|---|---|
| Address: | 4389 Weaver Court North |
| Hilliard, OH 43026 | |
| Official Correspondent: | Ronald L. Bracken |
| 770-597-7656 | |
| ronny.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.