(85 days)
Not Found
No
The device description and intended use focus on the material composition and application of a wound dressing. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for the management of various types of wounds, including diabetic ulcers, venous ulcers, and surgical wounds, which are conditions that require therapeutic intervention to heal or manage.
No
TALIDERM™ is a wound dressing used for the management of wounds. It does not perform any diagnostic function.
No
The device description explicitly states that TALIDERM™ is a sterile primary wound dressing comprised of physical materials (shortened fibers of poly-N-acetyl glucosamine), indicating it is a physical medical device, not software-only.
Based on the provided information, TALIDERM™ is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that TALIDERM™ is a wound dressing for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: It is described as a sterile primary wound dressing comprised of fibers. This aligns with a topical wound care product.
- Lack of Diagnostic Function: There is no mention of TALIDERM™ being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are designed for this purpose.
- Performance Studies: The performance studies focus on biocompatibility, physical properties, and clinical evidence related to wound healing and safety, not diagnostic accuracy.
In summary, TALIDERM™ is a medical device used for wound management, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
TALIDERM™ is intended for use under the direction of a healthcare professional.
TALIDERM™ 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, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, 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
healthcare professional
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)
Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of TALIDERM™
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Marine Polymer Technologies, Inc .- SyvekPatch (K984177), SyvekNT(K022673), Marine Polymer Technologies, Inc. - RDH Bandage (K002550), Tissue Technologies Holdings LLC - TT101 Wound Care Dressing (K061060), TEI Biosciences Inc. Dress Skin (K023778), J&J Medical Ltd .- PROMOGRAN Matrix Wound Dressing (K014129)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
KO70557
Marine Polymer Technologies, Inc. TALIDERM Confidential
VIII. 510(k) Summary
MAY 2 3 2007
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 Phone: 781-270-3200 x 13
C. Date of Submission:
February 15, 2007
TALIDERM™
D. Trade (Brand) Name:
E. Common Name:
Dressing, Wound Hydrophilic
F. Classification Number/ Name:
Unclassified
G. Regulatory Class:
H. Product Code:
I. Predicate Devices:
Marine Polymer Technologies, Inc .- SyvekPatch (K984177) and SyvekNT(K022673) Marine Polymer Technologies, Inc. - RDH Bandage (K002550) Tissue Technologies Holdings LLC - TT101 Wound Care Dressing (K061060) TEI Biosciences Inc. Dress Skin (K023778) J&J Medical Ltd .- PROMOGRAN Matrix Wound Dressing (K014129)
FRO
0
1
J. Intended Use:
TALIDERM™ is intended for use under the direction of a healthcare professional.
TALIDERM™ 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, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.
K. Device Description:
TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.
L. Summary of Substantial Equivalence:
Marine Polymer Technologies has submitted information on indication for use, biocompatibility and performance characteristics to establish that TALIDERMM is substantially equivalent to currently marketed predicate devices. TALIDERMIM has essentially the same intended use as the predicate devices. Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of TALIDERM™
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 stylized eagle with three overlapping wing segments. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marine Polymer Technologies % Mr. Sergio Finkielsztein President 107 Water Street Danvers, Massachusetts 01923
MAY 2 3 2007
Re: K070557
Trade/Device Name: Taliderm™ Regulatory Class: Unclassified Product Code: FRO Dated: April 12, 2007 Received: April 13, 2007
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
3
Page 2 - Mr. Sergio Finkielsztein
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 2:
Indications for Use Statement
INDICATIONS FOR USE
510(k) Number (if known) K 070557
Device Name TALIDERM™M
TALIDERMIM 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-molu's surgery, and other bleeding surface wounds Abrasions
Traumatic wounds healing by secondary intention
Dehisced surgical wounds.
TALIDERM™ is intended for use under the direction of a healthcare professional.
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Bevice Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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510(k) Number 10
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