(84 days)
Not Found
Not Found.
No
The device description and performance studies focus on the material properties and equivalence to a predicate device, with no mention of AI/ML or related concepts.
No.
Explanation: The device is a wound dressing intended for management of minor wounds, which is not typically classified as a therapeutic device in the context of advanced medical interventions.
No
The device is described as a wound dressing intended for the management of minor scrapes, bruises, abrasions, lacerations, and burns, not for diagnosing conditions.
No
The device description explicitly states it is a physical wound dressing in powder or pad form, made of collagen. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a collagen wound dressing that absorbs wound fluid and maintains a moist wound environment. This is a physical dressing applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device falls under the category of a wound dressing, which is a medical device used for the physical treatment and management of wounds.
N/A
Not Found. This document is a 510(k) Premarket Notification. The document is a clearance letter, and not an FDA summary document containing the requested information.
N/A
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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Strukmyer Medical, LLC. % Richard Hamer Consultant Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton, Florida 34210
Re: K232758
Trade/Device Name: Comatryx OTC Collagen Wound Dressing Regulatory Class: Unclassifed Product Code: KGN Dated: October 2, 2023 Received: October 3, 2023
Dear Richard Hamer:
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" (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).
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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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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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Indications for Use
510(k) Number (if known) K232758
Device Name
CoMatryx OTC Collagen Wound Dressings
Indications for Use (Describe)
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns
| Type of Use (Select one or both, as applicable) | Production Use (Part 21 CFR 601 Subpart E) Same as Contract Use (21 CFR 601 Subpart C) | Production Use (Part 21 CFR 601 Subpart E) | Same as Contract Use (21 CFR 601 Subpart C) |
|---|---|---|---|
| Production Use (Part 21 CFR 601 Subpart E) | Same as Contract Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K232758
510(k) SUMMARY
I. ADMINISTRATIVE
Submitter:
Strukmyer Medical LLC 1801 Big Town Blvd, Suite 100 Mesquite, Texas 75149 Telephone: 214-275-9595
Contact Person: Christian Quinto E-Mail: cquinto@strukmyer.com
Date Prepared: December 1, 2023
II. DEVICE NAME
Proprietary Name: CoMatryx OTC Collagen Wound Dressing
Common or Usual Name: Collagen Wound Dressing
Regulatory Class: Unclassified
Product Code: KGN
III. PREDICATE DEVICES
Cellusheet Dressing and Cellufil Particles, K213092, Human Biosciences, Inc. Comatryx Collagen Wound Dressing, K171645, Strukmyer Medical, LLC (reference device)
IV. DEVICE DESCRIPTION
CoMatryx OTC Collagen Wound Dressing is a native bovine Type I Collagen which, when applied to a wound surface in powder or pad form, absorbs wound fluid and maintains a moist wound environment. The CoMatryx OTC powder and pads are provided sterile in the following configurations:
4
- . 1 gram powder in 1 pouch
- 2"x2," 3"x4," and 8"x12" pad in pouch ●
INDICATIONS FOR USE V.
CoMatryx OTC Collagen Wound Dressings are indicated for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor bums.
COMPARISON TO PREDICATE DEVICE VI.
CoMatryx OTC Collagen Wound Dressings are composed of Type 1 bovine collagen which absorbs wound fluid, maintains a moist wound environment and are equivalent to predicate products currently in commercial distribution.
Both the predicate device and CoMatryx OTC Collagen Wound Dressings are derived from Type 1 bovine collagen dressings and supplied in powder form or as pads of various sizes.
The CoMatryx OTC Collagen Wound Dressings have the same intended uses, technological characteristics, and basic principles of operation as the predicate device and raise no new issues of safety or effectiveness. See below for a comparison table:
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| Parameters | Subject Device
CoMatryx OTC Collagen Wound
Dressings | Predicate Device
Cellufil and Cellusheet Wound
Dressings
K213092 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Strukmyer Medical LLC | Human Biosciences Inc. |
| Intended Use | Management of wounds | Management of wounds |
| Indications for Use | Management of minor cuts, minor
scrapes, minor bruises, minor
abrasions, minor lacerations, and minor
burns | Management of minor cuts, minor
scrapes, minor bruises, minor abrasions,
minor lacerations, and minor burns. |
| Product Code | KGN | KGN |
| Device Class | Unclassified | Unclassified |
| Rx or OTC | OTC | OTC |
| Physical Shape | Powder and Pads | Powder and Pads |
| Usage | Single patient use only | Single patient use only |
| Package Sizes | 1 gram in 1 pouch
2"x2", 3"x4", 8"x12" pads | 1 gram in 1 pouch
2"x2", 3"x4", 8"x12" pads |
| Product Description | Type I Bovine Collagen | Type I Bovine Collagen |
| Animal Tissue | Dermis | Dermis |
| Sterilization Method | E-Beam. Product supplied sterile. | E-Beam. Product supplied sterile. |
| Storage Condition | Store in a cool and dry space | Store in a cool and dry space |
| Shelf Life | Powder - 36 months
Pads - 48 months | 60 months |
VII. PERFORMANCE DATA
Comatryx OTC Collagen Wound Dressings are identical to the predicate device except for the indications for use; therefore, testing from K171645 applies to this device.
VIII. CONCLUSION
Based on a comparison of the composition, technological characteristics, intended use and biocompatibility test results, we conclude that the CoMatryx OTC Collagen Wound Dressings perform at least as well as the predicate device. The CoMatryx OTC Collagen Wound Dressings are therefore considered to be substantially equivalent to the above-mentioned predicate device