UNITE BIOMATRIX

K071425 · Pegasus Biologics, Inc. · KGN · Jun 20, 2007 · SU

Device Facts

• Record ID: K071425
• Device Name: UNITE BIOMATRIX
• Applicant: Pegasus Biologics, Inc.
• Product Code: KGN · SU
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: Partial and full thickness wounds, . Draining wounds, . Pressure sores/ulcers, ◆ Venous ulcers, . . Chronic vascular ulcers, Diabetic ulcers, . Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ● Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)

Device Story

Unite™ Biomatrix is a decellularized, crosslinked equine pericardium wound dressing. It functions as a collagen-based scaffold for local management of moderately to heavily exuding wounds. The device is applied topically by a clinician to the wound site. It requires rinsing prior to use. The dressing provides a matrix to support wound healing. It is intended for use in clinical settings for various wound types including surgical, trauma, and chronic ulcers.

Clinical Evidence

Bench testing only. The device passed USP sterility testing and met FDA requirements for LAL endotoxin limits.

Technological Characteristics

Decellularized, crosslinked equine pericardium. Supplied as a collagen-based dressing. Requires rinsing before application. Sterilized via liquid chemical sterilant.

Indications for Use

Indicated for local management of moderately to heavy exuding wounds in patients with partial/full thickness wounds, draining wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, burns, skin tears), and surgical wounds (donor sites, post-laser/Mohs, podiatric, dehisced incisions).

Predicate Devices

• DermADAPT™ Wound Dressing (K061494)

Submission Summary (Full Text)

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# JUN 2 0 2007

### 510(K) SUMMARY

#### SUBMITTER INFORMATION 11.1

| A. | Company Name: | Pegasus Biologics, Inc. |
|----|--------------------|--------------------------------------------------------------------|
| B. | Company Address: | 6 Jenner, Suite 150<br>Irvine, CA 92618 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Pamela Misajon<br>Vice President, RA/CA<br>[e-mail] |

#### DEVICE IDENTIFICATION 11.2

| A. | Device Trade Name: | Unite™ Biomatrix |
|----|----------------------------|-----------------------------|
| B. | Common Name: | Dressing, Wound, Collagen |
| C. | Classification Name(s): | Unclassified |
| D. | Classification Regulation: | Unclassified |
| E. | Regulatory Class: | Unclassified |
| F. | Product Code: | KGN |
| G. | Advisory Panel: | General and Plastic Surgery |

## 11.3 IDENTIFICATION OF PREDICATE DEVICE

The Unite™ Biomatrix is substantially equivalent to the DermADAPT™ Wound Dressing manufactured by Pegasus Biologics, Inc. and cleared for commercial distribution under 510(k) K061494.

### 11.4 DEVICE DESCRIPTION

The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

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#### INDICATIONS FOR USE 11.5

The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:

- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers, ◆
- Venous ulcers, .
- . Chronic vascular ulcers,
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ●
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)

#### SUBSTANTIAL EQUIVALENCE 11.6

Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pegasus Biologics, Inc. % Ms. Pamela Misajon Vice President, RA/CA 6 Jenner, Suite 105 Irvine, California 92618

JUN 2 0 2007

Re: K071425

Trade/Device Name: Unite™ Biomatrix Regulatory Class: Unclassified Product Code: KGN Dated: May 15, 2007 Received: May 23, 2007

Dear Ms. Misajon:

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 - Ms. Pamela Misajon

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. Molkerson

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):

Unite™ Biomatrix Device Name:

Indications for Use:

The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:

- Partial and full thickness wounds, .
- Draining wounds, ●
- . Pressure sores/ulcers,
- . Venous ulcers,
- Chronic vascular ulcers, .
- . Diabetic ulcers,
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin ● tears),
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' . surgery, podiatric wounds, dehisced surgical incisions)

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) | |

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | L071428 |
|---------------|---------|
|---------------|---------|

Pegasus Biologics, Inc. Confidential