(130 days)
AWBAT-S is intended for clean Superfical burn wounds.
AWBAT-D is intended for Donor sites after hemostasis has been established.
AWBAT-M is to be used as protective covering for Meshed autografts.
A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides.
AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly.
AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each.
AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each.
AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M pore is 0.0070 square inch each.
AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component).
AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap.
AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent).
This document is a 510(k) Summary for a medical device called AWBAT (AWBAT-S, AWBAT-D, AWBAT-M), which is a temporary wound dressing. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Biobrane®).
The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text explicitly states "Does the submission include clinical information? No". This confirms that no clinical studies, and thus no stated acceptance criteria or performance data, are present in this 510(k) summary.
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Page ① of ② / K082869
AUBREY INC.
5390 Sea Lion Place, Suite 100 Carlsbad, California 92010 (760) 602-8303 P (760) 602-8304 F
510(k) SUMMARY
ER - 6 2009
Submitted by:
Stephen W. Moss President AUBREY INC. 5930 Sea Lion Place, Suite 100 Carlsbad, California 92009 (760) 602-8303 Phone (760) 602-8304 Fax
September 23, 2008
Device
Name: AWBAT Trade Names: AWBAT-S. AWBAT-D. AWBAT-M Common Name: Wound Dressing, Collagen Classification Name: Unclassified Product Code: KGN
Predicate Device
Name: Biobrane® Trade Names: Biobrane®, Biobrane®-L Common Name: Wound Dressing, Collagen Classification Name: Unclassified Product Code. KGN
Description of Device
A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides.
AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly.
AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each.
AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each.
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AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M 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 other | Yes* | |
| biological source? | * | |
| 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 | |
| Does the submission include clinical information? | No | |
| Is the device implanted? | No |
*AWBAT is intended for application by a physician.
** AWBAT contains a xenogenic component: porcine type 1 collagen (gelatin).
AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component).
AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap.
AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent):
Intended Use of the Device
Temporary wound dressing for coverage of Superficial burns, Donor sites and Meshed autographs.
AWBAT-S: is intended for clean Superficial burn wounds.
AWBAT-D: is intended for Donor sites after hemostasis has been established.
AWBAT-M: is intended to be used as a protective covering for Meshed autografts.
S-2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three branches extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aubrey Inc. % E. Aurbrey Woodproof, PhD, MBA Chairman and CEO 5390 Sea Lion Place, Suite 100 Carlsbad, California 92010
FEB - 6 2009
Re: K082869
Trade/Device Name: AWBAT™ (AWBAT-S, AWBAT-M and AWBAT-D) Regulatory Class: Unclassified Product Code: KGN Dated: January 30, 2009 Received: February 2, 2008
Dear Dr. Woodproof:
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. Drue, 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.
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Page 2 - E. Aurbrey Woodproof, PhD, MBA
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Wilkinson
- 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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510(k) Premarket Notification for AWBAT
Indications for Use
510(k) Number: K082869
Device Name: AWBAT™ (AWBAT-S, AWBAT-M and AWBAT-D)
Indications for Use: AWBAT-S is intended for clean Superfical burn wounds.
AWBAT-D is intended for Donor sites after hemostasis has been established.
AWBAT-M is to be used as protective covering for Meshed autografts.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Devices
Division of General, Restorative, 1 of 1 and Neurological Devices
510(k) Num
N/A