MP 719

K070557 · Marine Polymer Technologies, Inc. · FRO · May 23, 2007 · SU

Device Facts

• Record ID: K070557
• Device Name: MP 719
• Applicant: Marine Polymer Technologies, Inc.
• Product Code: FRO · SU
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

TALIDERM is a sterile primary wound dressing composed of shortened poly-N-acetyl glucosamine fibers derived from microalgae. Used by healthcare professionals in clinical settings for managing various wound types, including ulcers, burns, and surgical sites. The dressing is applied directly to the wound surface to facilitate management. It functions as a hydrophilic barrier to support healing. Clinical benefit is derived from its biocompatible material properties, which assist in wound management and hemostasis for bleeding surfaces. No complex electronic or software components are involved.

Clinical Evidence

Clinical evidence supported the safety and performance of the device. Animal testing was conducted to simulate clinical conditions, demonstrating no adverse effects. No specific clinical trial metrics (e.g., sensitivity, specificity) are provided in the summary.

Technological Characteristics

Sterile primary wound dressing; material: shortened fibers of poly-N-acetyl glucosamine isolated from microalgae. Hydrophilic properties. No electronic components, software, or energy sources.

Indications for Use

Indicated for management of diabetic ulcers, venous ulcers, pressure wounds, mixed vascular etiology ulcers, full/partial thickness wounds, second degree burns, surgical wounds (donor sites/grafts, post-Mohs, bleeding surfaces), abrasions, traumatic wounds healing by secondary intention, and dehisced surgical wounds. Intended for use under healthcare professional direction.

Predicate Devices

• SyvekPatch (K984177)
• SyvekNT (K022673)
• RDH Bandage (K002550)
• TT101 Wound Care Dressing (K061060)
• Dress Skin (K023778)
• PROMOGRAN Matrix Wound Dressing (K014129)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

B. Contact Person

Sergio Finkielsztein President Phone: [phone] 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

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#### 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™

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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 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

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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 [phone] 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 [phone] or [phone] 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

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#### 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)

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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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