BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS

K072068 · Bioartificial Gel Technologies (Bagtech), Inc. · FRO · Dec 21, 2007 · SU

Device Facts

• Record ID: K072068
• Device Name: BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS
• Applicant: Bioartificial Gel Technologies (Bagtech), Inc.
• Product Code: FRO · SU
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain. Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites. BioAquaCare™ is intended for single use only. BioAquaCare™ is not intended for treatment of third degree burns.

Device Story

Hydrogel wound dressing; provides moist environment for autolytic debridement; acts as microbial barrier. Composed of PEG-Soy protein, EDTA, sodium phosphate, sodium chloride, water, and preservative. Applied topically to wound bed; protects against abrasion, desiccation, and contamination; cooling effect reduces pain. Single-use; supplied with or without medical grade gauze for support; includes backing to control evaporation. Used in clinical or home settings under professional direction for chronic and acute wounds. Benefits patient by maintaining moisture, supporting healing, and preventing infection.

Clinical Evidence

Bench testing only. In vitro and animal studies conducted to characterize biocompatibility, preservative system effectiveness, and performance in managing various wound types (partial/full thickness, incisions, thermal/chemical burns, scarification). All studies demonstrated performance as expected.

Technological Characteristics

Hydrogel dressing containing PEG-Soy protein, EDTA, sodium phosphate, sodium chloride, water, and Liquid Germall Plus® preservative. Up to 95% water content. Supplied with/without medical grade gauze and evaporation-control backing. Manufactured in class 100 clean room. Non-biologic, non-medicinal.

Indications for Use

Indicated for local management of dry, light, or moderately exuding partial and full-thickness wounds, including minor burns, superficial injuries, lacerations, cuts, abrasions, incisions, surgical wounds, skin tears, chronic wounds (pressure, venous, arterial, diabetic ulcers), 2nd degree burns, and donor sites. Contraindicated for 3rd degree burns.

Predicate Devices

• Xylos Corporation's XCell® Antimicrobial Wound Dressing
• AcryMed Inc.'s AcryDerm Gel Wound Dressing

Submission Summary (Full Text)

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K072068

# 510(k) SUMMARY BAGTech's BioAquaCare™

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

#### Hogan & Hartson L.L.P.

555 Thirteen Street Washington D.C.

Phone: [phone] Facsimile: [phone]

DEC 2 1 2007

Contact Person: Jonathan S. Kahan, Partner

Date Prepared: July 26, 2007

#### Name of Device and Name/Address of Sponsor

Name of Device : BioAquaCare™

- BioArtificial Gel Technologies (BAGTech) Inc Sponsor : 400 de Maisonneuve West, Suite 1156 Montreal (Quebec) H3A 1L4 Canada
Common or Usual Name Hydrogel Wound Dressing

Classification Name Dressing, wound, drug

Classification: Unclassified

Product Code: FRO

### Predicate Devices

Xylos Corporation's XCell® Antimicrobial Wound Dressing

AcryMed Inc.'s AcryDerm Gel Wound Dressing

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### Intended Use / Indications for Use

BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and fullthickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: {1} chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and, diabetic ulcers; and (2) 2nd degree burns and donor

BioXquaCare™ is intended for single use only.

BioAquaCare™ is not intended for treatment of third degree burns.

# Technological Characteristics

BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.

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BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.

### Performance Data

Various in vitro and animal studies were conducted to characterize BioAquaCare's biocompatibility, preservative system's effectiveness and, effectiveness in the management of different types of wounds including partial thickness wounds , full thickness wounds, incision wounds, thermal burns, chemical burns and scarification.

In all instances, BioAquaCare™ functioned as intended and the performance observed was as expected.

### Substantial Equivalence

BioAquaCare™ is as safe and effective as the predicate devices. BioAquaCare™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between BioAquaCare™ and its predicate devices raise no new issues of safety or effectiveness. Thus, BioAquaCare™ is substantially equivalent.

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEC 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioArtificial Gel Technology % Hogan & Hartson, LLP Mr. Johnathan S. Kahan Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K072068 Trade/Device Name: BioAquaCare™ Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2007 Received: December 13, 2007

Dear Mr. Kahan:

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.

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Page 2 – Mr. Johnathan S. Kahan

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N. Wilkinson

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 Statement

510(k) Number (if known): K072068

Device Name: BioAquaCare™

Indications for Use:

BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.

BioAquaCare™ is intended for single use only.

BioAquaCare™ is not intended for treatment of third degree burns.

Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Millerson

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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

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