MODIFICATION TO SKVEKPATCH

K984177 · Marine Polymer Technologies, Inc. · KMF · Dec 18, 1998 · General Hospital

Device Facts

• Record ID: K984177
• Device Name: MODIFICATION TO SKVEKPATCH
• Applicant: Marine Polymer Technologies, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Dec 18, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement. ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

Device Story

SyvekPatch/ProDeinPatch are topical hemostatic dressings. Used for local management of bleeding wounds and rapid control of bleeding in hemodialysis or anticoagulated patients. Applied by healthcare professionals (SyvekPatch) or patients (ProDeinPatch). Device acts as a physical barrier/hemostatic agent to manage bleeding at wound sites. Benefits include rapid bleeding control in clinical or home settings. Does not accelerate wound healing or epithelization; not for third-degree burns or long-term use.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.

Indications for Use

Indicated for local management of bleeding wounds (lacerations, abrasions, nose bleeds, vascular access sites, percutaneous catheters/tubes, surgical debridement) and rapid control of bleeding in hemodialysis patients or patients on anticoagulation therapy.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

DEC 18 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sergio Finkielsztein, President Marine Polymer Technologies, Inc. 107 Water Street Danvers, Massachusetts 01923

Re: K984177 Trade Name: Syvekpatch (prescription) Prodein (over-the-counter) Regulatory Class: Unclassifed Product Code: KMF Dated: November 19,1998 Received: November 20,1998

Dear Mr. Finkielsztein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of wound healing or 2. epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an 3. artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

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Page 2 - Sergio Finkielsztein

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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## Indications for Use Statement

Page 1 of 1

510(k) Number : K984177

ProDein™Patch Device Name:

Indications for use:

ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K984177 |

| Prescription Use<br>(Per 21 C.F.R. 801.109) | OR | Over-The-Counter Use X<br>(Optional Format 1-2-96) |
|---------------------------------------------|----|----------------------------------------------------|
|---------------------------------------------|----|----------------------------------------------------|

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## Indications for Use Statement

Page 1 of 1

510(k) Number : K984177

SyvekPatch™ Device Name:

Indications for use:

SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications:

SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| <img alt="signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of General Restorative Devices, | |
| 510(k) Number | K984177 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------------------------------------------------------------|----|------------------------------------------------------------------------------------|
| (Per 21 C.F.R. 801.109) | | (Optional Format 1-2-96) |
| <img alt="prescription use checkbox" src="prescription_use_checkbox.png"/> | | <img alt="over the counter use checkbox" src="over_the_counter_use_checkbox.png"/> |