(13 days)
Not Found
No
The summary describes a sterile wound matrix made of poly-N-acetylglucosamine fibers and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for the management of various wounds, which is a therapeutic purpose.
No
Explanation: The information provided indicates that Talymed™ is a sterile wound matrix used for the management of wounds, not for diagnosis. Its description and intended use focus on treatment and healing, not on identifying a disease or condition.
No
The device description explicitly states that Talymed™ is a "sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Talymed™ is for the "management of wounds." This involves direct application to the body for therapeutic purposes.
- Device Description: The description details a "sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae." This is a material designed to interact with the wound itself, not with a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment. IVDs are typically used in vitro (outside the body) to analyze biological samples.
Therefore, Talymed™ is a therapeutic device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
FRO
Device Description
Talymed" is a sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Marine Polymer Technologies, Taliderm K070557, Cook Biotech Int. Oasis Wound Matrix K061711
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 10 2002 4
Page 1 of 2
VII. 510(k) Summary
| A. Sponsor/Submitter: | Marine Polymer Technologies, Inc.
107 Water Street
Danvers, MA 01923
Phone: 781-270-3200
Fax: 781-270-1133 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|
| B. Contact Person | Sergio Finkielsztein
President
781-270-3200 x 13
JUL 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 K070557
Cook 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.
1
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.
2
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
3
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
4
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