(155 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for the "management of" various types of wounds, burns, and ulcers, which are all conditions that require therapeutic intervention.
No
The device is described as a "Biodegradable Matrix Wound Dressing" indicated for the management of various types of wounds and burns. Its function is to cover and protect wounds, not to diagnose a condition.
No
The device description clearly describes a physical, biodegradable matrix wound dressing, not a software product.
Based on the provided text, the SupraSDRM Biodegradable Matrix Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for managing various types of wounds and burns. This is a topical application for direct treatment of the wound.
- Device Description: The description details a physical matrix applied to the wound surface.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any testing of samples or diagnostic purposes.
- Performance Studies: The performance studies described focus on the physical properties, biocompatibility, sterilization, and stability of the dressing itself, not on its ability to diagnose or test biological samples.
Therefore, the SupraSDRM Biodegradable Matrix Wound Dressing is a wound care device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of:
- Partial and full thickness wounds
- Pressure (stage I and IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Partial thickness burns
- Cuts and abrasions
- Acute wounds
- Trauma wounds
- Surgical wounds
- Superficial wounds
- Grafted wounds and donor sites
Product codes
QSZ, FRO
Device Description
The SupraSDRM Biodegradable Matrix Wound Dressing is a tri-polymer, Biodegradable dermal covering that is provided in a flat sheet. The SupraSDRM Biodegradable Matrix Wound Dressing can be cut with scissors to the desired shape and size. The SupraSDRM Biodegradable Matrix Wound Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The SupraSDRM Biodegradable Matrix Wound Dressing can be used either alone or in conjunction with a petroleum jelly and/or gauze wound and burn dressing which can also serve to further secure the SupraSDRM Biodegradable Matrix Wound Dressing and prevent dislocation. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics (PMI) SupraSDRM Biodegradable Matrix Wound Dressing ranges from 1,500um to 2,100um according to the region to be treated. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in solid sheets that contain micropores that range in size from 13um to 300um.
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
In Vitro Testing. Mechanical tensile strength testing and inherent viscosity testing were performed on the PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and compared to the predicate device with samples exposed to in vitro saline conditions of 37℃ at various time periods.
Biocompatibility testing of the SupraSDRM Biodegradable Matrix Wound Dressing was performed according to ISO 10993-5 - Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro Cytotoxicity and ISO 10993-10 - Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Sterilization validations were performed against EN ISO 11137-1: Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
Package seals were evaluated for seal integrity and seal strength against ANSVAAMI/ISO Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for 11607-1 Materials, Sterile Barrier Systems and Packaging, and ANSVAAMI/ISO 11607-2 Packaging for Terminally Sterilized Medical Devices Part 2: Validation Requirements for Forming, Sealing and Assembly Process.
The following chemical and physical characteristics of the SupraSDRM Biodegradable Matrix Wound Dressing and the predicate device were compared: material composition, percentage of DL-lactide, percentage of caprolactone, percentage of trimethylene carbonate, inherent viscosity, glass transition temperature, porosity, product thickness, and manufacturing process.
Stability of the SupraSDRM Biodegradable Matrix Wound Dressing was evaluated against the following tests: inherent viscosity, product thickness, glass transition temperature, residual monomer, and residual excipients.
Key Metrics
Not Found
Predicate Device(s)
Suprathel Wound and Burn Dressing (K090160)
Reference Device(s)
Integra LifeSciences Bilayer Matrix Wound Dressing (K021792), Progressive Woundcare Technologies Iodophor Foam Dressing (K122634)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 15, 2022
PolyMedics Innovations GmbH Kenneth Kleinhenz Regulatory Affairs Consultant for Polymedics, Innovations, GmbH Heerweg 15D Denkendorf, 73770 Germany
Re: K170213
Trade/Device Name: SupraSDRM Biodegradable Matrix Wound Dressing Regulatory Class: Unclassified Product Code: QSZ
Dear Kenneth Kleinhenz:
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 June 28, 2017. 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
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2017
Polymedics Innovations Gmbh Mr. Kenneth Kleinhenz Regulatory Affairs Consultant for Polymedics, Innovations, Gmbh Heerweg 15d Denkendorf, 73770 DE
Re: K170213
Trade/Device Name: SupraSDRM Biodegradable Matrix Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 14, 2017 Received: June 16, 2017
Dear Mr. Kleinhenz:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
3
Indications for Use
510(k) Number (if known) K170213
Device Name
SurpaSDRM Biodegradable Matrix Wound Dressing
Indications for Use (Describe)
The SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of:
- · Partial and full thickness wounds
- Pressure (stage I and IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Venous stasis and diabetic ulcers
- · 1st and 2nd degree burns
- Partial thickness burns
- Cuts and abrasions
- Acute wounds
- Trauma wounds
- · Surgical wounds
- Superficial wounds
- Grafted wounds and donor sites
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Transaction Use (Part 21 CFR 301 Subpart E)
Own-Time Consumption (21 CFR 301 Subpart C)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Page 1 of 4
DATE OF PREPARATION: 26 June 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | PolyMedics Innovations, GmbH
Heerweg 15D
Denkendorf, Germany D-73770 |
| -------------------- | ---------------------------------------------------------------------------- |
|---|
Official Contact:
Kenneth K. Kleinhenz Regulatory Affairs Telephone (858) 344-7143 Fax (858) 458-0994
DEVICE NAME
| Classification Name: | Dressing, Wound and Drug |
|---|---|
| Trade/Proprietary Name: | SupraSDRM Biodegradable Matrix |
| Wound Dressing |
ESTABLISHMENT REGISTRATION NUMBER 3007710611
DEVICE CLASSIFICATION AND PRODUCT CODE
Wound and Drug Dressings are unclassified and have been assigned Product Code FRO.
INTENDED USE
The SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of:
- Partial and full thickness wounds
- Pressure (stage I and IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Partial thickness burns
- Cuts and abrasions
- Acute wounds
- Trauma wounds
- Surgical wounds
- Superficial wounds
- Grafted wounds and donor sites
5
DEVICE DESCRIPTION
The SupraSDRM Biodegradable Matrix Wound Dressing is a tri-polymer, Biodegradable dermal covering that is provided in a flat sheet. The SupraSDRM Biodegradable Matrix Wound Dressing can be cut with scissors to the desired shape and size. The SupraSDRM Biodegradable Matrix Wound Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The SupraSDRM Biodegradable Matrix Wound Dressing can be used either alone or in conjunction with a petroleum jelly and/or gauze wound and burn dressing which can also serve to further secure the SupraSDRM Biodegradable Matrix Wound Dressing and prevent dislocation. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics (PMI) SupraSDRM Biodegradable Matrix Wound Dressing ranges from 1,500um to 2,100um according to the region to be treated. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in solid sheets that contain micropores that range in size from 13um to 300um.
Material Composition
The SupraSDRM Biodegradable Matrix Wound Dressing is fabricated from a tri-polymer of polylactide, trimethylene carbonate, s-caprolactone and polyvinyl alcohol.
In Vitro Testing
Mechanical tensile strength testing and inherent viscosity testing were performed on the PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and compared to the predicate device with samples exposed to in vitro saline conditions of 37℃ at various time periods.
Biocompatibility testing of the SupraSDRM Biodegradable Matrix Wound Dressing was performed according to ISO 10993-5 - Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro Cytotoxicity and ISO 10993-10 - Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Sterilization validations were performed against EN ISO 11137-1: Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
Package seals were evaluated for seal integrity and seal strength against ANSVAAMI/ISO Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for 11607-1 Materials, Sterile Barrier Systems and Packaging, and ANSVAAMI/ISO 11607-2 Packaging for Terminally Sterilized Medical Devices Part 2: Validation Requirements for Forming, Sealing and Assembly Process.
6
The following chemical and physical characteristics of the SupraSDRM Biodegradable Matrix Wound Dressing and the predicate device were compared: material composition, percentage of DL-lactide, percentage of caprolactone, percentage of trimethylene carbonate, inherent viscosity, glass transition temperature, porosity, product thickness, and manufacturing process.
Stability of the SupraSDRM Biodegradable Matrix Wound Dressing was evaluated against the following tests: inherent viscosity, product thickness, glass transition temperature, residual monomer, and residual excipients.
EQUIVALENCE TO MARKETED PRODUCT
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing shares indications and design principles with the following predicate device and reference devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Suprathel Wound and Burn Dressing (K090160) predicate device and the Integra LifeSciences Bilayer Matrix Wound Dressing (K021792) reference device, and Progressive Woundcare Technologies Iodophor Foam Dressing (K122634) reference device; Unclassified medical devices that were cleared for marketing in the United States under K090160, K021792 and K122634 respectively.
Indications for Use
The SupraSDRM Biodegradable Matrix Wound Dressing and the Suprathel Wound and Burn Dressing (K090160), Integra LifeSciences Bilayer Matrix Wound Dressing (K021792), and the Progressive Woundcare Technologies Iodophor Foam Dressing (K122634) predicate and reference devices are substantially equivalent with respect to their indications for use as they are all indicated for the same uses as temporary dermal coverings of minor burns and various dermal wounds such as: diabetic ulcers, pressure ulcers, venous stasis ulcers, burns, traumatic wounds, surgical wounds, etc.
Design and Materials
The design and materials of the PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing, the predicate device |Suprathel Wound and Burn Dressing (K090160)] and the reference devices [Integra LifeSciences Bilayer Matrix Wound Dressing (K021792), and Progressive Woundcare Technologies Iodophor Foam Dressing (K122634)] are substantially equivalent as they are all sterile, single use, flat, thin, rectangular Biodegradable sheets with design characteristics of being flexible and semi-rigid devices that can be contoured in situ and cut to shape with surgical scissors.
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and the predicate devices [Suprathel Wound and Burn Dressing (K090160)] and reference devices [Integra LifeSciences Bilayer Matrix Wound Dressing (K021792), and Progressive Woundcare Technologies Iodophor Foam Dressing (K122634)] are substantially equivalent as they all have a thickness of 50um - 2100um and range in size from 50mm x 50mm to 180mm x 230mm.
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and the predicate device [Suprathel Wound and Burn Dressing (K090160)] and reference devices [Integra LifeSciences Bilayer Matrix Wound Dressing (K021792)] are substantially equivalent as they are all porous materials with pores that range in size from 5um - 300um and have a porosity that range from 85 - 98%.
7
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and the predicate device [Suprathel Wound and Burn Dressing (K090160)] and the reference device [Integra LifeSciences Bilayer Matrix Wound Dressing (K021792)] are substantially equivalent as they all have a mass per unit area of 45 - 150 g/m2.
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and the Suprathel Wound and Burn Dressing (K090160) predicate device are substantially equivalent as they are both fabricated from the same poly(DL-lactide-co-trimethylene carbonate-co-scaprolactone) in the same ratio.
The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing and the Woundcare Technologies Iodophor Foam Dressing (K122634) reference device are substantially equivalent as they are both fabricated from the same polyvinyl alcohol material.