ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL

K092826 · American Biotech Labs · FRO · Nov 12, 2009 · SU

Device Facts

• Record ID: K092826
• Device Name: ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
• Applicant: American Biotech Labs
• Product Code: FRO · SU
• Decision Date: Nov 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

ASAP® Silver Antibacterial Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.

Device Story

Water-based gel wound dressing containing proprietary silver hydrosol suspension; hydrophilic/buffering base matrix. Inhibits growth of microorganisms (Staphylococcus aureus, Pseudomonas aeruginosa, E. coli, MRSA, VRE, Candida albicans) within dressing. Supplied in multi-dose pump or low-density polyethylene-lined metal tube. Applied topically to wound sites to manage moisture and provide antibacterial environment. Used in clinical or home settings; applied by healthcare providers or patients. Benefits include wound protection and microbial inhibition.

Clinical Evidence

Bench testing only. Antibacterial effectiveness established via laboratory testing against specified microorganisms. Biocompatibility evaluated per ISO 10993 standards.

Technological Characteristics

Water-based gel; hydrophilic/buffering compounds; silver hydrosol suspension. Packaging: multi-dose pump or LDPE-lined metal tube. Biocompatibility: ISO 10993. No software or electronic components.

Indications for Use

Indicated for management of 1st/2nd degree burns, stasis/pressure/diabetic ulcers, lacerations, abrasions, skin tears, surgical incisions, device insertion sites, graft/donor sites.

Predicate Devices

• ASAP® Wound Dressing Gel (K082333)
• AcryDerm Antimicrobial Silver Wound Gel Dressing Model #B (K083103)

Submission Summary (Full Text)

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#### NOV 12 2009 K092826

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# 5.0510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ASAP® Antibacterial Silver Wound Dressing Gel is provided below.

| Device Common Name: | Antibacterial Wound Gel |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | ASAP® Antibacterial Silver Wound Dressing Gel |
| Submitter: | American Biotech Labs, LLC<br>80 West Canyon Crest Road<br>Alpine, UT 84004 |
| Contact: | Miriam Provost, Ph.D.<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Calley Herzog<br>Consultant, Medical Devices<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Classification<br>Regulation: | Unclassified, pre-amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Devices: | K082333 - ASAP® Wound Dressing Gel<br>K083103 -AcryDerm Antimicrobial Silver Wound Gel<br>Dressing Model #B |

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### Indication for Use:

ASAP® Silver Antibacterial Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.

### Device Description:

ASAP® Silver Antibacterial Wound Dressing Gel is a water based gel wound dressing that contains silver that in laboratory tests has been shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains, MRSA and VRE as well as fungi such as Candida albicans.

The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP® Antibacterial Silver Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a pop-open screw cap on the other end).

### Technological Characteristics:

The composition of ASAP® Antibacterial Silver Wound Dressing Gel is identical to that for ASAP® Wound Dressing Gel cleared in K082333. No changes have been made the product since previous clearance. Furthermore, the ASAP® Antibacterial Silver Wound Dressing Gel is substantially equivalent to the predicate devices listed above in that silver is the antibacterial ingredient and moisture is managed using an aqueous base combined with a proper blend of hydrophilic substances. ASAP® Antibacterial Silver Wound Dressing Gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The product was evaluated through standard biocompatibility tests (ISO 10993) and found to be acceptable. Antibacterial effectiveness was established through testing with appropriate organisms.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

NOV 12 2009.

American Biotech Labs, LLC % Biologics Consulting Group, Inc. Ms. Miriam Provost Senior Consultant 1317 King Street Alexandria, Virginia 22314

Rc: K092826

Trade/Device Name: ASAP® Antibacterial Silver Wound Dressing Gel Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: FRO Dated: September 10, 2009 Received: September 14, 2009

Dear Ms. Provost:

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. Iisting 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

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Page 2 - Ms. Miriam Provost

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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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ely yours,

Frell

N. Melkerson

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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## Indications for Use

510(k) Number (if known): K092826

The ASAP® Antibacterial Silver Wound Dressing Gel Device Name:

ASAP® Antibacterial Silver Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Daniel Krone for MXM
(Division Sign-Off)

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

510(k) Number KD92826.