A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT Plus is composed of a single or multiple filesned knitted nylon fabric, bonded to a thin porous silicone membrane (enproximately 0.01 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen. peptides, chondroitin-4-sulfate, chondroitin-6-sulfate, Immuno-10 (Aloe polysiaconarides), vitamin C, vitamin E, and polysorbate 20.

AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly.

AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each.

AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each.

AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.

AI/ML Overview

The provided text is a 510(k) summary for the AWBAT Plus Wound Dressings. It describes the device, its intended use, and its substantial equivalence to a predicate device (AWBAT).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices. This is a traditional wound dressing, and the assessment here focuses on biocompatibility and comparison to a predicate device, rather than performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI system.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is an attempt to answer based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Compliant with ISO 10993-1:2003 for:	Biocompatibility: Testing "is being conducted" and Aubrey Inc. certifies it will not distribute until testing demonstrates compliance with ISO 10993-1:2003. This implies performance will meet these criteria, but specific results are not reported in this summary.
- Cytotoxicity	(Results not reported in this summary, but expected to be compliant)
- Sensitization	(Results not reported in this summary, but expected to be compliant)
- Irritation or intracutaneous reactivity	(Results not reported in this summary, but expected to be compliant)
Substantial Equivalence: To predicate device AWBAT (K082869) in terms of intended use, materials, design, function, and operating characteristics.	Substantially Equivalent: The submission "demonstrates that AWBAT Plus... is substantially equivalent to the AWBAT wound dressing (K082869) in terms of intended use, materials, design, function and operating characteristics."
Manufacturing Process: Compliance with US FDA and European Standards for medical device manufacturing.	Manufacturing Process: The manufacturing process "complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices."

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

This information is not available in the provided 510(k) summary. The submission focuses on biocompatibility testing (which is not typically "test set" based in the AI/ML sense) and demonstrating substantial equivalence to a predicate device, rather than a clinical performance study with a test set of cases.

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

This information is not available. The device is a wound dressing, not an AI/ML diagnostic tool, so the concept of "ground truth" and expert adjudication in this context does not apply. The assessment is based on material properties, biocompatibility, and intended use comparison.

4. Adjudication Method for the Test Set

This information is not available. Not applicable for this type of device and submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted image analysis or diagnostic tools and is not applicable to a wound dressing. The device does not use software (as stated in Table 1, "Does the device use software? No").

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This device is a physical wound dressing and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML devices (e.g., pathology, outcomes data) is not applicable here. The assessment for this device relies on:

Biocompatibility testing against a recognized standard (ISO 10993-1:2003). The 'truth' here is compliance with the assays defined by the standard (cytotoxicity, sensitization, irritation).
Comparison of device characteristics to a legally marketed predicate device. The 'truth' of substantial equivalence is established by comparing features like intended use, materials, design, function, and operating characteristics.

8. The Sample Size for the Training Set

This information is not available. Not applicable as this is not an AI/ML device requiring a training set.

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

This information is not available. Not applicable as this is not an AI/ML device requiring a training set.

Summary

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K091863
page 1 of 6

AWBAT Plus Wound Dressings Traditional 510(k)

SECTION 5: 510(k) Summary

JAN 9 1 2010

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 5807.92.

5.1 Name, Address, Phone and Fax Number of the Applicant

Aubrey Inc.

5930 Sea Lion Place, Suite 100

Carlsbad, CA 92010

Phone: (760) 602-8303

Fax: (760) 602-8304

Contact Person 5.2

Aubrey Woodroof, PhD, MBA Chairman and CEO Aubrey Inc. 5930 Sea Lion Place, Suite 100 Carlsbad, CA 92010 Phone: (760) 602-8303 Fax: (760) 602-8304

5.3 Date Prepared

22 June 2009

5.4 Device

Name: AWBAT Plus

Trade Names: AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus Common Name: Wound Dressing Collagen Classification Name: Unclassified Product Code: FRO

CONFIDENTIAL

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K091863
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A WBAT Plus Wound Dressing Traditional 510(k)

5.5 Predicate Device

Name: AWBAT

Trade Names: AWBAT-S, AWBAT-D, AWBAT-M

Common Name: Wound Dressing, Collagen

Classification Name: Unclassified

Product Code: KGN

5.6 Device Description

AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly.

AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each.

AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each.

AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.

The following table addresses the Design and Use of the Device:

Question	Yes	No
Is the intended device for prescription use?	Yes*
Is the intended device for over-the-counter use?		No
Does the device contain components derived from a tissue or otherbiological source?	Yes**
Is the device provided sterile?	Yes
Is the device intended for single use?	Yes
Is the device a reprocessed single use device?		No
If yes, does this device type require reprocessed validation data?		N/A
Does the device contain a drug?		No
Does the device contain a biologic?	Yes**
Does the device use software?		No

Table 1: Design and Use of the Device

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K091863
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AWBAT Plus Wound Dressing Traditional 510(k)

Question	Yes	No
Does the submission include clinical information?		No
Is the device implanted?		No

*AWBAT is intended for application by a physician.

** AWBAT contains biological components: porcine type 1 collagen (gelatin), chondroitin sulfate, Immuno-10 (Aloe polysaccharides), vitamin C and vitamin E.

AWBAT S Plus is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous sillcone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides, chondroitin-4-sulfate, chondroitin-sulfate, lmmuno-10 (Aloe polysaccharides), vitamin C, vitamin E, and polysorbate 20.

AWBAT-D Plus has the same composition as AWBAT-S Pius, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outler sterior wasn

for is is m . . Si fabric is monofilament (thinner & less adherent).

AWBAT Plus, like AWBAT, can be manufactured in flat sheets or shaped into gloves, socks or masks.

5.7 Device Intended Use

Temporary wound dressing for coverage of Superficial burns, Donor sites and Meshed autografts.

AWBAT-S Plus: is intended for clean Superficial burn wounds.

AWBAT-D Plus: is intended for Donor sites after hemostasis has been established.

AWBAT-M Plus: is intended to be used as a protective covering for Meshed autografts.

5.8 Technological Characteristics of Device Compared to Predicate Device

The following Table describes the comparative characteristics of AVBAT Plus and AVBAT.

Characteristic	AWBAT Plus	Predicate(s)
Intended Use/Indications forUse	AWBAT-S Plus is intended forclean, Superficial burn wounds.	Same intended use as AWBAT-S standard (K082869).
	AWBAT-D Plus is intended forDonor sites after hemostasishas been established.	Same intended use as AWBAT-D standard (K082869).
Characteristic	AWBAT Plus	Predicate(s)
	AWBAT-M Plus is intended foruse as a protective covering for	Same intended use as AWBAT-M standard (K082869).
	Meshed autografts.
Target Population	Burn Victims (AWBAT-S Plus).Patients who have had skinremoved (donor site) to apply toanother body site (AWBAT-DPlus).	Same as AWBAT-S standard(K082869).Same as AWBAT-D standard(K082869).
	Patients who have had skingrafts (AWBAT-M Plus)	Same as AWBAT-M standard(K082869).
Where Used	Hospital	Same as AWBAT standard(K082869).
Design	Thin porous silicone membrane,mechanically bonded to aknitted bifilament nylon fabric,coated with a non-toxic mixtureof porcine collagen peptide, andhydrophilic components (seematerials, below) (AWBAT-SPlus and AWBAT-D Plus)	Similar to AWBAT-S andAWBAT-D standard (K082869):Thin porous silicone membranemechanically bonded to aknitted bifilament nylon fabric,coated with a non-toxic mixtureof porcine collagen peptide.
	Thin porous silicone membrane,mechanically bonded to aknitted monofilament nylonfabric, coated with a non-toxicmixture of porcine collagenpeptide, and hydrophiliccomponents (see materials,below) (AWBAT-M Plus)	Similar to AWBAT-M standard(K082869): Thin porous siliconemembrane, mechanicallybonded to a knittedmonofilament nylon fabric,coated with a non-toxic mixtureof porcine collagen peptide.
Materials:
Nylon	Nylon fabric made from 15/2denier yarn (AWBAT-S Plusand AWBAT-D Plus)	Same as AWBAT-S andAWBAT-D standard (K082869)
	Nylon fabric made from 12/1denier yarn (AWBAT-M Plus)	Same as AWBAT-M standard(K082869)
Silicone	Silicone (approx 0.001 inch)	Same as AWBAT standard(K082869)
Collagen	Porcine gelatin	Same as AWBAT standard(K082869)
Chondroitin sulfate	Chondroiting-4-sulfate andchondoitin-6-sulfate	Chondroitin-6-sulfate same asIntegra (P900033)
Immuno-10, Vitamin C,vitamin E and Polysorbate 20	Immuno-10, Vitamin C,vitamin E and Polysorbate 20	None
Porosity	6.0% (AWBAT-S Plus)12.0% (AWBAT-D Plus)	Same as AWBAT-S standard(K082869)Same as AWBAT-D standard(K082869)
	11.0% (AWBAT-M Plus)	Same as AWBAT-M standard(K082869)
Occlusiveness	94.0% (AWBAT-S Plus)	Same as AWBAT-S standard(K082869)
Characteristic	AWBAT Plus	Predicate(s)
	88.0% (AWBAT-D Plus)	Same as AWBAT-S standard(K082869)
	89.0% (AWBAT-M Plus)	Same as AWBAT-S standard(K082869)
Sterilization Method	Electron Beam Radiation	Same as AWBAT standard(K082869).
Shelf Life.	3 years	Same as AWBAT standard(K082869).
Sizes	6"x6", 6"x12", 12"x12"	Same as AWBAT standard(K082869).

Table 2: Comparative Characteristics

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A WBAT Plus Wound Dressing Traditional 510(k)

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AWBAT Plus Wound Dressing Traditional 510(k)

Device Testing 5.9

Biocompatibility testing is being conducted per FDA recognized consensus standard ise 10993-1:2003 for the materials used to manufacture the AVBAT product family to assure they are safe for its intended use. Aubrey Inc. certifies that it will not distribute AWBAT Plus until this testing is completed and demonstrates compliance with the requirements of FDA recognized consensus standard ISO 10993-1:2003.

Per ISO 10993-1:2003, AWBAT Plus is categorized as follows (from Table 1 of the standard):

. Contact Duration: (B), Prolonged
. Body Contact Category: Surface Device
. Body Contact Type: Breached or compromised surface

Per Table 1 of ISO 10993-1:2003, the following testing is indicated:

. Cytotoxicity
Sensitization .
Irritation or intracutaneous reactivity. .

The manufacturing process of the AWBAT product family complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

5.10 Substantial Equivalence Summary

The submitted material in this Premarket Notification demonstrates that AWBAT Plus wound dressing (AWBAT-S Plus, AWBAT-D Plus and AWBAT-M Plus) is substantially equivalent to the AWBAT wound dressing (K082869) in terms of intended use, materials, design, function

Confidential

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K091863
page 6 of 6

AWBAT Plus Wound Dressing Traditional 510(k)

Both AWBAT and AWBAT Plus are Temporary Wound and operating characteristics. Dressings for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. Both AWBAT and AWBAT Plus are composed of the same three base components in the same configurations: nylon, silicone, and collagen peptides. Additionally, AVØRT Plus contains hydrophilic components Immuno-10 (Aloe polysaccharides) and chondroitin-4sulfate/chondroitin-6-sulfate for enhancing the creation of a noist wound healing environment. In conjunction, small amounts of anti-oxidant components, vitamin E oil and vitamin C crystals, are added to protect the hydrophilic components during the manufacturing process, with a small amount polysorbate 20 included to emulsify the vitamin E oil.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of an eagle with its wings spread, symbolizing protection and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 1 2010

Aubrey, Inc. % Shepard G. Bentley 5930 Sea Lion Place, Suite 100 Carlsbad, California 92010

Re: K091863 Trade/Device Name: AWBAT Plus (AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus) Regulation Number: Unclassified Product Code: FRO Dated: December 17, 2009 Received: December 28, 2009

Dear Shepard G. Bentley:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Shepard G. Bentley

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm.for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807:97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Fid
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AWBAT Plus Wound Dressing Traditional 510(k)

SECTION 4: Indications for Use Statement INDICATIONS FOR USE STATEMENT

Kog1863 510(k) Number (if known): __ Device Name: AWBAT Plus (AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus)

Indications for Use:

AWBAT-S Plus: is intended for clean Superficial burn wounds.

AWBAT-D Plus: are intended for Donor sites after hemostasis has been established. AWBAT-M Plus: are intended to be used as a protective covering for Meshed autografts.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

Daniel Krause for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091863

CONFIDENTIAL

Regulation Number and Section

N/A