WoundPal is intended to be used as a primary dressing in the management of partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations.

Device Description

The proposed WoundPal is a single use wound dressing consisting of a woven cotton gauze treated with an OTC antibiotic mixture composed of Polymyxin B Sulfate USP (10,000 units/gram) and Bacitracin Zinc USP (500 units/gram) in a hydrogel with 2% w/w lidocaine hydrochloride. Normal saline 0.9% is also added to maintain a moist dressing. A trace amount of oil of wintergreen is added as a fragrance. The product is intended as a primary dressing for use in the local management of painful skin wounds. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. The dressing may be held in place with a variety of secondary dressings, including an additional bandage or with the addition of an outer layer comprised of a polymeric film that may be secured by applying zinc oxide ointment USP between the film and intact skin surrounding the wound.

AI/ML Overview

The provided text is a 510(k) summary for the WoundPal Medicated Wound Dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided document.

The document primarily states:

Device Description: A single-use wound dressing with an OTC antibiotic mixture (Polymyxin B Sulfate USP and Bacitracin Zinc USP), hydrogel with 2% w/w lidocaine hydrochloride, normal saline, and a trace of oil of wintergreen.
Intended Use/Indications for Use: Primary dressing for partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations. It absorbs wound exudates and maintains a moist environment.
Technological Characteristics: The device is considered equivalent to predicate devices as wound coverings/dressings, containing ingredients to prevent bacterial contamination, lidocaine for pain relief, and saline for moistening.
Safety and Efficacy: The document explicitly states, "Because of the long history of safe use of the components of WoundPal independently, and in combination, the device does not raise any new safety issues and biocompatibility testing was not necessary." This indicates that a new performance study with specific acceptance criteria, as one might find for a novel device or software, was not deemed necessary for this 510(k) clearance based on the substantial equivalence pathway for a combination product of well-established components.

In summary, the provided text does not contain the information required to populate the requested table and answer the study-related questions. The 510(k) submission for WoundPal relied on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a new clinical performance study with acceptance criteria.

Summary

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K053476
510(k) Summary

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Sponsor Information:

AT Squared, LLC 10274 Alliance Road Cincinnati, Ohio 45242 Phone (513) 891-9991 Fax (513) 891-9947 Contact Person: Aletha W. Tippett, M.D. Date Prepared: November 23, 2005

JUN 2 6 2006

Device Name:

Proprietary Name: WoundPal Common/Usual Name: Medicated Hydrogel Wound Dressing Classification Name: Dressing, Wound and Burn, Hydrogel with Drug and/or Biologic (Unclassified, Product Code MGQ)

Predicate Devices:

WoundPal is substantially equivalent to the following cleared devices:

. Regenecare Wound Gel (MPM Medical, Inc., K02050540)
Cardiotech Antibiotic Hydrogel Wound Dressing (Cardiotech Intl., K022584) ●
Kendall Kerlix MD Antimicrobial Gauze Dressing (The Kendall Company LP, ● K990530)
20mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride (Steripak, ● K972195)

Device Description:

Intended Use:

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K053476

Technological Characteristics:

WoundPal is equivalent to the referenced predicate devices in that they are intended to be used as wound coverings and/or wound dressings. It is equivalent to the Cardiotech's Antibiotic Hydrogel Wound Dressing and Kendall Kerlix MD Antimicrobial Gauze Dressing because they all contain ingredients that help to prevent bacterial contamination of the dressing and have a broad spectrum of antimicrobial activity. WoundPal is similar to Regenecare Wound Gel because they both contain lidocaine and provide relief for painful wounds. It is similar to Steripak's Normal Saline Topical Solution because the saline present in WoundPal moistens and lubricates the wound dressing.

Although there are minor technical differences between the subject device and its predicate devices, these differences to not raise new questions of safety or efficacy. Because of the long history of safe use of the components of WoundPal independently, and in combination, the device does not raise any new safety issues and biocompatibility testing was not necessary.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected at the shoulders, representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2006

AT Squared, LLC c/o Aletha W. Tippett, M.D. 10274 Alliance Road Cincinnati, Ohio 45242

Re: K053476

Trade/Device Name: WoundPal Medicated Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 16, 2006 Received: May 18, 2006

Dear Dr. Tippett:

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 Noesmanic Act (Act) that do not require approval of a premarket approval application (PMA). You max. 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 advation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050,

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Page 2 - Aletha W. Tippett, M.D.

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 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 vours.

Barbara Buchner
for

Mark 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): K053476

Device Name: WoundPal Medicated Wound Dressing

Indications For Use:

WoundPal is indicated for use as a primary dressing in the management of partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations. Absorbs wound exudates and maintains a moist environment.

Prescription Usc X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use_______

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K053476
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Regulation Number and Section

N/A