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 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.

AI/ML Overview

Please note that the provided text describes a medical device called "Unite™ Biomatrix," which is a collagen-based wound dressing. It is not an AI/ML device, and therefore, many of the typical acceptance criteria and study details relevant to AI/ML device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable or present in this type of submission.

The document primarily focuses on establishing substantial equivalence to a predicate device for a wound dressing,
not on evaluating the performance of an algorithm.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

Device Name: Unite™ Biomatrix

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a wound dressing that establishes substantial equivalence to a predicate device, the "acceptance criteria" are not reported in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm. Instead, the acceptance criteria are implicitly met by demonstrating equivalence in design, materials, manufacturing controls, and intended use. The "device performance" in this context refers to its
similarity to the predicate device.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated for "Unite™ Biomatrix")
Material Composition: Equivalence in base material and processing.	Decellularized, equine pericardium; crosslinked and exposed to liquid chemical sterilant.
Sterility: Meets standards for sterility.	Passed the USP sterility test.
Endotoxin Limit: Satisfies endotoxin limits for a medical device.	Satisfies FDA requirements for LAL endotoxin limit for a medical device.
Intended Use/Indications for Use: Equivalent to the predicate device.	"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)" (Identical to predicate's indications).
Manufacturing Processes/Controls: Supplier qualification, receiving controls, and design verification demonstrate equivalence.	"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." (K071425)
Safety and Effectiveness: No new questions of safety or effectiveness.	Implied by substantial equivalence to a legally marketed predicate (DermADAPT™ Wound Dressing, K061494).

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided in the context of this 510(k) submission for a wound dressing. There is no "test set" in the sense of a dataset for an AI/ML algorithm. The equivalence is based on physical and chemical characterization, and comparison of design, materials, and intended use to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable/not provided as there is no "test set" or "ground truth" establishment in the context of an AI/ML algorithm. The evaluation is chemical and physical testing, and comparison to regulatory standards and a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks, which is not the nature of this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This concept is only applicable to AI/ML algorithms, which the Unite™ Biomatrix is not.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance would be defined by:

Standardized chemical and physical testing results (e.g., USP sterility test, LAL endotoxin limit).
Demonstration of material properties and design characteristics matching the predicate device.
Compliance with general controls for medical devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided as the device is not an AI/ML algorithm and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as above.

Summary of the Study:

The "study" described in the 510(k) submission for the Unite™ Biomatrix is not a clinical trial or an AI/ML performance study. Instead, it is a design verification and substantial equivalence demonstration study.

Objective: To demonstrate that the Unite™ Biomatrix is substantially equivalent to the predicate device, DermADAPT™ Wound Dressing (K061494).
Methodology: The submission focuses on comparing the new device to the predicate in terms of:
- Device Description: Both are decellularized equatorial pericardium, crosslinked, and liquid chemical sterilized.
- Material Composition: Equine pericardium.
- Performance Characteristics: Meeting USP sterility, satisfying FDA LAL endotoxin limits. The document states, "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."
- Intended Use/Indications for Use: The indications for use listed are identical to those of the predicate device.
Conclusion: The FDA reviewed the submission and determined the device to be substantially equivalent to the legally marketed predicate device for the stated indications for use. This determination allows the device to be marketed.

Summary

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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 150Irvine, CA 92618
C.	Company Phone:	(949) 502-3240
D.	Company Facsimile:	(949) 502-3241
E.	Contact Person:	Pamela MisajonVice President, RA/CApmisajon@pegasusbio.com

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

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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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Image /page/2/Picture/1 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.

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

N/A