COLLATEK HYDROGEL

K022995 · Biocore Medical Technologies, Inc. · MGQ · Dec 2, 2002 · SU

Device Facts

• Record ID: K022995
• Device Name: COLLATEK HYDROGEL
• Applicant: Biocore Medical Technologies, Inc.
• Product Code: MGQ · SU
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as: - First and second degree burns - Severe sunburns - Superficial injuries, cuts, abrasions and surgical wounds Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds: - Pressure (stage I-IV) and venous stasis ulcers - Ulcers caused by mixed vascular etiologies - Diabetic ulcers - Donor sites and grafts

Device Story

Collatek Hydrogel is a sterile wound dressing composed of polyacrylic acid and collagen. It functions by maintaining a moist wound environment to facilitate healing in dry to moderately exudating wounds. The device is applied topically to the wound site. It is intended for use in clinical settings under professional guidance. By providing a moist environment, the dressing protects the wound bed, potentially accelerating healing and managing exudate. The collagen component is derived from bovine sources.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically biocompatibility testing conducted in accordance with GLP and FDA Blue Book Memorandum G95-1.

Technological Characteristics

Hydrogel wound dressing composed of polyacrylic acid (Carbomer) and bovine-derived collagen. Designed to maintain a moist wound environment. Sterile packaging. Biocompatibility verified per FDA Blue Book Memorandum G95-1.

Indications for Use

Indicated for patients with dry, light, or moderately exudating partial and full thickness wounds, including 1st/2nd degree burns, severe sunburns, superficial injuries, cuts, abrasions, surgical wounds, pressure ulcers (stage I-IV), venous stasis ulcers, mixed etiology ulcers, diabetic ulcers, donor sites, and grafts. Contraindicated for 3rd degree burns and patients sensitive to bovine products.

Predicate Devices

• Woun'Dres Collagen Hydrogel Wound Dressing (K991202)
• Nu-Gel Wound Dressing (K983362)

Submission Summary (Full Text)

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# 510(k) Summary

#### Submitter's Name and Address:

BioCore Medical Technologies, Inc. 11800 Tech Rd. Suite 240 Silver Spring, MD 20904

#### Contact Person, Telephone and Fax Number:

Ajay Kumar Phone: [phone] Fax: [phone]

### Date Summary was Prepared:

September 6, 2002

#### Device Names:

| Proprietary Name: | Collatek Hydrogel |
|----------------------|-------------------------|
| Common Name: | Wound dressing |
| Classification Name: | Wound and burn dressing |

### Predicate Device:

| Trade name: | Woun'Dres Collagen Hydrogel Wound Dressing |
|----------------|--------------------------------------------|
| Company: | Coloplast Corporation |
| 510(k) number: | K991202 |
| Date Approved: | June 4, 1999 |

| Trade name: | Nu-Gel Wound Dressing |
|----------------|----------------------------------|
| Company: | Johnson and Johnson Medical Inc. |
| 510(k) number: | K983362 |
| Date Approved: | December 16, 1998 |

### Device Description:

Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.

### Basis for Substantial Equivalence:

#### 1. Indications for Use

Collatek Hydrogel will be used to manage full thickness wounds with moderate to heavy exudate. Collatek Hydrogel is intended for use on dry, light and moderately exudating of the following types: first and second degree burns, severe sunburns, superficial injuries, abrasions, cuts, surgical wounds, pressure ulcers, venous stasis ulcers, ulcers caused by mixed etiologies, diabetic ulcers, donor sites and grafts.

Woun'Dres is indicated for partial and full thickness wounds including pressure ulcers, dower extremity ulcers including venous arterial and mixed etiology, surgical wounds, first and second degree burns and abrasions. Nu-Gel is indicated for first and second degree burns, superficial injuries, radiation

DEC 0 2 2002

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burns, pressure ulcers stage I-IV, lower extremity ulcers, arterial ulcers, ulcers of mixed etiology, diabetic ulcers, donor sites and grafts. Therefore, Collatek Hydrogel 's indications for use are comparable to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing).

#### 2. Technological Characteristics

Collatek Hydrogel is designed to create a favorable environment at the wound site by providing a moist environment in the case of dry or light to moderately exudating wounds. Nu-Gel provides a moist environment by protecting against dehydration and absorbing excess exudates. Woun'Dres is a hydrogel dressing for providing a moist environment. Therefore, Collatek Hydrogel is similar in technological characteristics to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing).

#### 3. Materials

Collatek Hydrogel contains polyacrylic acid (Trade name: Carbomer) and collagen as primary components. Woun'Dres is made from collagen and Allantoin. Nu-Gel consists of polyvinyl pyrrolidone. The polymers in these dressings are to provide a hydrogel for maintaining a moist environment. Therefore, Collatek Hydrogel is similar to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing) with respect to materials of construction.

#### 4. Safety

Biocompatibility testing has confirmed that Collatek Hydrogel meets requirements as stated by the FDA regulations in Blue Book Memorandum G95-1. Biocompatibility tests were in accordance with GLP. Woun'Dres and Nu-Gel Wound Dressing both passed biocompatibility tests.

#### 5. Sterility and Packaging

Collatek will be packaged as a sterile dressing.

### Conclusion

Collatek Hydrogel is similar in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: Woun'Dres and Nu-Gel Wound Dressing

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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 lines forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioCore Medical Technologies, Inc. Ajav Kumar VP of Operations 11800 Tech Road, Suite 240 Silver Spring, Maryland 20904

Re: K022995

Trade/Device Name: Collatek Hydrogel Regulation Name: Wound and burn dressing, hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: September 6, 2002 Received: September 9, 2002

Dear Mr. Kumar:

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

# DFC 0 2 2002

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Page 2 - Mr. Ajay Kumar

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 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]. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

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

Enclosure

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#### 11022995 510(k) Number (if known):

Device Name: Collatek Hydrogel

#### Indications for Use:

Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:

- First and second degree burns
- · Severe sunburns ■
- · Superficial injuries, cuts, abrasions and surgical wounds

Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

- 1 Pressure (stage I-IV) and venous stasis ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Donor sites and grafts lik

Precautions:

- Collatek Hydrogel is not recommended for persons sensitive to bovine products I
- Collatek is not recommended for third degree burns

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

Division Sign~Off) Division of General, Restorative and Neurological Devices

10(k) N K022995
OR Over-The-Counter-Use
(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)