The Pegasus Biologics DermADAPT™ Wound Dressing 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 Description

The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DermADAPT™ Wound Dressing, a collagen-based wound dressing. However, it does not contain the specific information requested about acceptance criteria, performance data from a study, sample sizes, expert qualifications, or detailed study methodologies that would typically be found in a clinical trial report or a performance validation study for a device of this nature.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the DermADAPT™ Wound Dressing as would be seen in a clinical study comparing its efficacy to a gold standard or a defined benchmark.

Instead, the document highlights:

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Biocompatibility	"Biocompatibility test results indicate that the device satisfies all biocompatibility requirements."
Biomechanical Performance	"Biomechanical test results indicate that the dressing satisfies performance requirements for a wound dressing."
Sterility	"DermADAPT™ is subjected to 14 day USP sterility testing and USP endotoxin testing prior to release." (Implies meeting USP standards for sterility and endotoxin levels are the acceptance criteria, and these tests are passed.)
Substantial Equivalence	"The results of testing demonstrate that DermADAPT™ Wound Dressing is substantially equivalent to the predicate devices in design, function, source of substrate materials and indications for use." This is the overarching "acceptance" for 510(k) clearance, rather than a clinical performance metric. The predicate devices are BIOPAD® (K040283) and Stimulen™ Collagen (K030774).
Material Composition	"The components of the DermADAPT™ Wound Dressing are similar in basic materials, design, construction and performance to the predicate devices. The device consists primarily of Type 1 collagen that has been decellularized, crosslinked, and passes USP sterility testing, and is provided in dimensions appropriate for covering and protecting surface wounds." (Implies acceptance criteria related to material composition and manufacturing steps are met.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document only mentions "Biocompatibility testing and in vitro bench testing has been conducted," without any details on the number of samples or specimens tested.
Data Provenance: Not specified. It's implied the testing was conducted by Pegasus Biologics, Inc., but no information on the country of origin of the data or whether it was retrospective or prospective is given. For biocompatibility and bench testing, this level of detail is often not included in a 510(k) summary unless a specific clinical study involving human subjects was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This information is typically relevant for studies involving subjective interpretation (e.g., image analysis, diagnostic performance). The tests mentioned (biocompatibility, biomechanical, sterility, endotoxin) are objective laboratory tests.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods are relevant for studies where subjective interpretations are made and need to be reconciled.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used

The "ground truth" for the tests mentioned are:

Biocompatibility: Likely established through standardized tests (e.g., ISO 10993 series) with pre-defined pass/fail criteria.
Biomechanical Performance: Established through "in vitro bench testing" likely against specified physical properties (e.g., tensile strength, absorption capacity, degradation rate) with pre-defined performance requirements for a wound dressing.
Sterility and Endotoxin: Established by meeting USP (United States Pharmacopeia) standards for sterility and endotoxin levels.

8. The sample size for the training set

Not applicable. This device is a physical wound dressing, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

{0}------------------------------------------------

K061494
page 1 of 2

510(K) SUMMARY

SUBMITTER INFORMATION

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

A.	Device Trade Name:	DermADAPT™ Wound Dressing
B.	Common Name:	Dressing, Wound, Collagen
C.	Classification Name(s):	Unclassified
D.	Device Code:	KGN

IDENTIFICATION OF PREDICATE DEVICES

The DermADAPTTM Wound Dressing is substantially equivalent to many commercially available collagen-based wound dressings. Two specific predicate devices are BIOPAD® (Euroresearch S.R.L.) cleared under Premarket Notification Number K040283 and Stimulen™ Collagen (Southwest Technologies, Inc.) cleared under Premarket Notification Number K030774.

DEVICE DESCRIPTION

{1}------------------------------------------------

K061494
page 2 of a

INDICATIONS FOR USE

The Pegasus Biologics DermADAPT™ Wound Dressing 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)

TECHNOLOGICAL CHARACTERISTICS

The components of the DermADAPT™ Wound Dressing are similar in basic materials. design, construction and performance to the predicate devices. The device consists primarily of Type 1 collagen that has been decellularized, crosslinked, and passes USP sterility testing, and is provided in dimensions appropriate for covering and protecting surface wounds.

BIOCOMPATIBILITY AND PERFORMANCE TESTING

Biocompatibility testing and in vitro bench testing has been conducted to evaluate the biological safety and biomechanical performance characteristics of the DermADAPT™ Wound Dressing. Biocompatibility test results indicate that the device satisfies all biocompatibility requirements. Biomechanical test results indicate that the dressing satisfies performance requirements for a wound dressing.

STERILITY

DermADAPT™ is subjected to 14 day USP sterility testing and USP endotoxin testing prior to release.

CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that DermADAPT™ Wound Dressing is substantially equivalent to the predicate devices in design, function, source of substrate materials and indications for use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2006

Pegasus Biologics, Inc. % Ms. Pamela Misajon Vice President, RA/CA 6 Jenner, Suite 150 Irvine, California 92618

Re: K061494

Trade/Device Name: DermADAPT™ Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: September 11, 2006 Received: September 13, 2006

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 (OS) 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

{3}------------------------------------------------

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/cdrl/industry/support/index.html.

Sincerely yours,
Mark A. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

K061494 510(k) Number:

Device Name: DermADAPTTM Wound Dressing

Indications for Use ......

The Pegasus Biologics DermADAPT™ Wound Dressing 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

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
Page ______ of ______510(k) Number K061491

Confidential

Regulation Number and Section

N/A