(13 days)
Talymed™ is indicated for the management of wounds including:
Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations Traumatic wounds healing by secondary intention Chronic vascular ulcers Dehisced surgical wounds.
Talymed" is a sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae.
This document is a 510(k) summary for Talymed™, a hydrophilic wound dressing. It is important to note that a 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study in the way a novel AI algorithm might. Therefore, the information provided will reflect this regulatory context.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" and "device performance" are typically framed around demonstrating equivalence to a predicate device. The primary "performance characteristic" is its intended use and physical properties being comparable and safe.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Intended Use Equivalence: Talymed™ has essentially the same intended use as predicate devices. | Talymed™ is indicated for the management of wounds including: Diabetic ulcers, Venous ulcers, Pressure wounds, Ulcers caused by mixed vascular etiologies, Full thickness and partial thickness wounds, Second degree burns, Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations, Traumatic wounds healing by secondary intention, Chronic vascular ulcers, Dehisced surgical wounds. This matches the broad indications of wound dressings. |
| Biocompatibility: All materials are biocompatible, and no new adverse effects were introduced. | Results of scientific testing ensured that all materials are biocompatible and no new adverse effects were introduced. (Specific test results are not detailed in this summary, but are implied to be part of the full 510(k) submission). |
| Physical Properties: Physical properties are appropriate for the intended use. | Results of scientific testing ensured that physical properties are appropriate for the intended use. (Specific property measurements and comparative data are not detailed here, but implied to be part of the full submission). |
| Safety: The device is safe and effective when used as intended. | The FDA’s substantial equivalence determination implies that the device is considered safe and effective for its stated indications, based on the comparison to predicate devices and submitted data. |
2. Sample size used for the test set and the data provenance
The document does not specify a test set sample size or data provenance in the way one would for a clinical trial validating a novel AI device. The 510(k) process relies on:
- Comparison to predicate devices: The "test set" here is primarily the characteristics of the new device and how they compare to legally marketed predicate devices (Marine Polymer Technologies, Taliderm K070557 and Cook Biotech Int. Oasis Wound Matrix K061711).
- Scientific testing: The summary states "Results of scientific testing have ensured that all materials are biocompatible... and physical properties are appropriate." This refers to laboratory-based tests (e.g., cytotoxicity, irritation, sensitization for biocompatibility; tensile strength, absorbency for physical properties) rather than a clinical "test set" on patients. The sample sizes for these lab tests would be determined by relevant ISO standards or internal protocols, but are not disclosed in this summary.
- Data Provenance: Not applicable in the context of clinical data for a "test set" as described. The "data" are results from laboratory tests and a comparison of the device's design and intended use to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert annotation to establish ground truth for a diagnostic AI. The "ground truth" for a 510(k) for a wound dressing is:
- The known safety and performance of the predicate devices.
- The established scientific principles for biocompatibility and material properties.
4. Adjudication method for the test set
Not applicable. There is no "adjudication method" in the context of a 510(k) for physical device characteristics. The assessment is a regulatory review comparing the device to predicates and relevant standards.
5. 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. This is a wound dressing, not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader assistance, or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI.
7. The type of ground truth used
The "ground truth" in this 510(k) context consists of:
- Predicate Device Performance: The established safety and effectiveness profile of the predicate devices (Taliderm K070557 and Oasis Wound Matrix K061711) for their specified indications.
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological safety of medical devices.
- Material Science Principles: General scientific understanding and established test methods for evaluating the physical and chemical properties of materials used in medical devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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K 10 2002 4
Page 1 of 2
VII. 510(k) Summary
| A. Sponsor/Submitter: | Marine Polymer Technologies, Inc.107 Water StreetDanvers, MA 01923Phone: 781-270-3200Fax: 781-270-1133 |
|---|---|
| B. Contact Person | Sergio FinkielszteinPresident781-270-3200 x 13JUL 2 8 2010 |
| C. Date of Submission: | July 13, 2010 |
| D. Trade (Brand) Name: | Talymed™ |
| E. Common Name: | Dressing, wound hydrophylic |
| F. Classification Name/Number: | Unclassified |
| H. Product Code: | FRO |
| I. Predicate Devices: | Marine Polymer Technologies, Taliderm K070557Cook Biotech Int. Oasis Wound Matrix K061711 |
J. Intended Use:
Talymed™ is indicated for the management of wounds including:
Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations Traumatic wounds healing by secondary intention Chronic vascular ulcers Dehisced surgical wounds.
K. Device Description:
Talymed" is a sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae.
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102002
5
L. Summary of Substantial Equivalence:
Marine Polymer Technologies has submitted information on indication for use, biocompatibility and performance characteristics to establish that Talymed™ is substantially equivalent to currently marketed predicate device. Talymed™ has essentially the same intended use as the predicate devices. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Marine Polymer Technologies % Mr. Sergio Finkielsztein President 107 Water Street Danvers, Massachusetts 01923
Re: K102002
Trade/Device Name: Talymed™ Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2010 Received: July 15, 2010
Dear Mr. Finkielsztein:
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
JUL 2 8 2010
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Page 2 - Mr. Sergio Finkielsztein
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number
Talymed™ Device Name:
JUL 2 8 2010
Indications for use:
Talymed TM is indicated for the management of wounds including:
Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations Traumatic wounds healing by secondary intention Chronic vascular ulcers Dehisced surgical wounds.
× Prescription Use (Per 21 CFR. 801Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Ksan ofullxM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102002
N/A