Under the supervision of a healthcare professional, Silver Bandages are indicated for the management of pressure ulcers diabetic foot ulcers, as well as minor cuts, scrapes, abrasions, lacerations, and burns.

The Bandages are indicated for first aid to cover minor cuts, scrapes, abrasions, lacerations and burns.

Device Description

There will be two primary models covered under this submission, the Silver Bandage which will be available by prescription only and the Bandage which will be available for over-the-counter use.

Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound area. The Silver Bandage may be used under supervision of a healthcare professional. In Vitro testing showed that silver in the pad reduced bacterial growth by over 99% (S. aureus. S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time.

The Bandage is an adhesive bandage which may be purchased for over-the-counter use as a first aid. The device consists of a hydrophyillic pad stock with sufficient absorbency to absorb normal quantities of blood or other wound exudates typical of minor abrasions or lacerations, supplied on a flexible, non-absorbent backing coated with a pressure sensitive adhesive capable of adhering the device to human skin

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Silver Bandage and Bandage). It is not for a software or AI-based device, so most of the requested information (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable.

However, I can extract the acceptance criteria related to its design and performance, and how the study proves it meets those criteria based on the information provided.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance / Study Results
Bacterial Growth Reduction (Silver Bandage)	"In Vitro testing showed that silver in the pad reduced bacterial growth by over 99% (S. aureus, S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time." (This applies to both prescription and OTC Silver Bandages, though for OTC it's noted for the prescription-use case).
Absorbency (Bandage)	"The device consists of a hydrophyillic pad stock with sufficient absorbency to absorb normal quantities of blood or other wound exudates typical of minor abrasions or lacerations..." (This is a descriptive statement of its design and intended function).
Adhesion (Bandage)	"...flexible, non-absorbent backing coated with a pressure sensitive adhesive capable of adhering the device to human skin." (Descriptive statement of design and intended function).
Biocompatibility	"Biocompatibility assessment was performed on the bandage to include patient skin contact surface (tape) and the fluid path contacting surface (the silver pad) with satisfactory results."
Substantial Equivalence	"Both bandage products (Prescription and OTC) products are substantially equivalent in design and function to the Curad® Silver Bandage manufactured by Beiersdorf, Inc. The Curad® Silver Bandage was cleared by FDA under K032463."

Study Details (Not Applicable for most AI/Software specific questions)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the in-vitro bacterial reduction test or biocompatibility, but the bacterial testing involved specific bacterial strains.
- Data Provenance: The bacterial reduction and biocompatibility tests are described as "In Vitro testing" and "Biocompatibility assessment," implying laboratory-based studies. No country of origin is specified for these tests. They are not described as retrospective or prospective human subject studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a wound dressing, not a diagnostic AI system requiring expert consensus for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a study requiring adjudication of expert interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bacterial Reduction: The "ground truth" would be the direct measurement of bacterial growth reduction in laboratory conditions, likely compared to untreated controls or growth media.
- Biocompatibility: Conformance to established biocompatibility standards.
- Substantial Equivalence: Comparison to a predicate device (Curad® Silver Bandage) based on design, materials, and intended use.
The sample size for the training set:
- Not Applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable.

Summary

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K082910
page 1 of 2

510(k) SUMMARY (as required by 807.92(c))

Submitter of 510(k): Contact Person: Date of Summary: Classification Name: Product Code:

Regulatory Correspondent:

Trade/Proprietary Name:

Device Description:

Jon Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572 Phone: 813-645-2855 Fax: 813-645-2856 Email: wardjp@ajwtech.com

ASO LLC 300 Sarasota Blvd. Sarasota, FL 34240 Phone: 941-378-6656 Fax: 941-378-6688

Joan Rubendall

6/1/09

Dressing, Wound, Drug

FRO

Multiple -Bandages shall be marketed as private label brands identified with the customer's name or trade name.

There will be two primary models covered under this submission, the Silver Bandage which will be available by prescription only and the Bandage which will be available for over-the-counter use.

JUN 17 2009

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K082910
Page 2 of 2

Prescription Use - Under the supervision of a healthcare professional, Silver Bandages are indicated for the management of pressure ulcers diabetic foot ulcers, as well as minor cuts, scrapes, abrasions, lacerations, and burns.

Over-the-counter Use - The Bandages are indicated for first aid to cover minor cuts, scrapes, abrasions, lacerations and burns.

The both bandages have a traditional bandage design consisting of an adhesive coated backing, wound pad that contains silver, paper release tabs and protected by a cohesive coated paper wrapper that serves as the sterile barrier. The types of materials are similar to the Curad @ Silver Bandage with silver. Equivalent concentrations of silver are released in the predicate device and new device. Biocompatibility assessment was performed on the bandage to include patient skin contact surface (tape) and the fluid path contacting surface (the silver pad) with satisfactory results.

In Vitro testing showed that silver in the pad, of the prescription use Silver Bandages, reduced bacterial growth by over 99% (S. aureus, S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time.

Both bandage products (Prescription and OTC) products are substantially equivalent in design and function to the Curad® Silver Bandage manufactured by Beiersdorf, Inc. The Curad® Silver Bandage was cleared by FDA under K032463.

Intended Use:

Technological Characteristics:

Performance Testing:

Substantial Equivalence:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

JUN 17 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ASO LLC

% AJW Technology Consultants, Incorporated Mr. Jonathan Ward 962 Allegro Lane Apollo Beach, Florida 33572

Re: K082910

Trade/Device Name: Silver Bandage Regulation Number: Unclassified Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2009 Received: June 3, 2009

Dear Mr. Ward:

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

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Page 2-Mr. Jonathan Ward

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.

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/CDRH/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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K082910

Device Name: Silver Bandage

Indications for Use:

Under the supervision of a healthcare professional, Silver Bandages are indicated for the management of pressure ulcers diabetic foot ulcers, minor cuts, scrapes, abrasions, lacerations, and burns.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Keane bankin

Page 1 of 2

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KD82910

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510(k) Number (if known): K082910

Device Name: Bandages

Indications for Use:

The Bandages are indicated for first aid to cover minor cuts, scrapes, abrasions, lacerations and burns.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 2 of 2

510(k) Number K062910

Regulation Number and Section

N/A