HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER

K061227 · The Hymed Group Corp. · FRO · Dec 20, 2006 · SU

Device Facts

• Record ID: K061227
• Device Name: HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
• Applicant: The Hymed Group Corp.
• Product Code: FRO · SU
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collagen/Ag Wound Gel is an absorbent wound dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites.

Device Story

Hydrolyzed Collagen/Ag Wound Gel is an aqueous hydrogel dressing containing 1.0% silver oxide. It is a line extension of the HyCure Hydrolyzed Collagen wound gel. The device is provided in a patient-ready dispensable tube for topical application to wounds. The hydrogel maintains a moist wound environment to facilitate healing, while the silver oxide acts to inhibit the growth of microbes absorbed into the gel. It is intended for use in clinical or home settings for the management of various wound types. The device does not require complex operation; it is applied directly to the wound site by a healthcare provider or patient. It provides a physical barrier and antimicrobial environment to support wound management.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993 (cytotoxicity grade 1). In-vitro evaluation confirmed the device controls bacterial growth within the hydrogel. No clinical studies were performed.

Technological Characteristics

Aqueous hydrogel containing 1.0% silver oxide. Identical base formulation to HyCure (K955506). Provided in a dispensable tube. Non-sterile/sterile status not explicitly detailed, but evaluated per ISO 10993 standards.

Indications for Use

Indicated for management of pressure ulcers (Stages I-IV), venous stasis ulcers, diabetic ulcers, ulcers from arterial insufficiency, surgical wounds, traumatic wounds, first and second degree burns, superficial wounds, and grafted wounds/donor sites.

Predicate Devices

• HyCure® Hydrolyzed Collagen (K955506)
• HeliDerm™ Collagen Wound Dressing (K990086)
• X-Static® Silverseal Hydrogel Wound Dressing (K040019)
• SilvaSorb Silver Antimicrobial Wound Gel (K011994)
• AcryDerm Silver Antimicrobial Wound Dressing (K011994)

Submission Summary (Full Text)

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The Hymed Group Phone: [phone]

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"510(k)" Premarket Notification Hydrolyzed Collagen/Ag Wound Gel

## 510(k) Summary

Summary Information: Amended November 14, 2006 as per FDA communications dated June 9, 2006 and November 7, 2006.

- . Submitters Name and Address:
The Hymed Group Corporation 1890 Bucknell Drive Bethlehem, PA 18015

DEC 20 2006

- Contact Person: Dr. George Petito President Phone: [phone] E-Mail: [e-mail]
- Establishment Number: 2530949 .
- . User Fee ID Number: MD6025566-956733
- Date of Amended Summary Preparation: . November 14 2006
- Name of Device:
- o Proprietary: Hydrolyzed Collagen/Ag Wound Gel
- Common: O Moist wound gel
- ಂ Classification Name: Hydrophilic Wound Dressing
- Medical Device Classification: � Unclassified, PMN Non-exempt

Prolode-FRO

- Identification of predicate devices to which substantial equivalence is being . claimed:
- HyCure® Hydrolyzed Collagen 0 K955506 O HeliDerm™ Collagen Wound Dressing K990086
- X-Static® Silverseal Hydrogel Wound Dressing O K040019
- SilvaSorb Silver Antimicrobial Wound Gel O K011994
- AcryDerm Silver Antimicrobial Wound Dressing 0 K011994
- Description of the Device: Hydrolyzed Collagen/Ag Wound Gel is a line . extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of

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The Hymed Group Phone: [phone]

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14061227

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### "510(k)" Premarket Notification Hydrolyzed Collagen/Ag Wound Gel

microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.

- Intended use of the Device: Collagen/Ag Wound Gel is an absorbent wound . dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites.
- Technology Characteristics: Collagen/Ag Wound Gel is an aqueous, hydrogel . identical in formulation to HyCure® Hydrolyzed Collagen Wound Gel (K955506). Collagen/Ag Wound Gel contains 1.0% silver oxide for the purpose of controlling bacterial bioburden within the gel as does silver containing hydrogels currently in commercial distribution and the particular change does not affect the intended use or alter the fundamental scientific technology of the device.
- Non-Clinical Performance Data: Hydrolyzed Collagen/Ag Wound Gel has been ● evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
- . cytotoxicity (Exhibit I) indicated a grade 1 cytotoxic grade.
- . Microbial control within the hydrogel claims are supported by invitro evaluation (Exhibit II). Collagen/Ag gel was found to control bacterial growth within the hydrogel.

Collagen/Ag gel has not been studied in a clinical setting.

End of Summary

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Hymed Group Corporation % George Petito, Ph.D. President 1890 Bucknell Drive Bethlehem, Pennsylvania 18015

DEC 2 0 2006

Re: K061227

Trade/Device Name: Hydrolyzed Collagen Gel with Siver Regulation Class: Unclassified Product Code: FRO Dated: November 14, 2006 Received: November 20, 2006

Dear Dr. Petito:

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, UDA 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.

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Page 2 - George Petito, Ph.D.

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 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.

[signature]

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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# Indications for Use

510(k) Number (if known):K061227

Device Name: Hydrolyzed Collagen Gel with Silver Indications For Use:

Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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, and Neurological Devices

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**510(k) Number** L061227