(231 days)
Not Found
No
The device description and performance studies focus on the chemical composition and antimicrobial properties of the gel, with no mention of AI or ML.
Yes
The device is described as a 'Wound Dressing Gel' and is used for the 'topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations,' which are therapeutic applications.
No
The device description and intended use indicate it is a wound dressing gel for topical management of skin injuries, not for diagnosing conditions.
No
The device description clearly states it is a gel containing silver hydrosol and is supplied in a multi-dose gel pump and a tube, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the topical management of wounds and skin irritations. This is a direct application to the body for therapeutic purposes.
- Device Description: The device is a gel applied topically.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health status, diagnose conditions, or monitor treatment. This device does not involve the analysis of specimens outside the body.
The device described is a wound dressing gel, which falls under the category of medical devices used for wound care.
N/A
Intended Use / Indications for Use
For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Product codes
FRO
Device Description
ASAP Wound Dressing Gel is an amorphous, water-based gel that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. 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 Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene tube, sealed on one end and fitted with a pop-open screw cap on the other end).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The product was evaluated through standard biological reactivity tests (ISO 10993) and found to be acceptable. Antimicrobial effectiveness was established through testing in accordance with USP .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071703, K011994, K070333, K062212, K023609, K022483
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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K0γ2333
Image /page/0/Picture/2 description: The image shows the logo for American Biotech Labs. The logo features a stylized atom symbol to the left of the company name. Below the company name is the tagline "A World Leader In Nano Silver Technology."
APR - 2 2009
510(k) Summary
Submitter's Name and Address:
Contact Person:
American Biotech Labs 780 West Canyon Crest Road Alpine, UT 84004
William D. Moeller A Managing Director Phone: 801-756-1000 Fax: 801-756-5454
ASAP Wound Dressing Gel
ASAP Wound Dressing Gel
Date of Preparation:
Professional Trade Name:
OTC Trade Name
Device Common-Usual Name:
Classification Number/Class
Unclassified
Wound Dressing Gel
March 20, 2009
This 510(k) Summary is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
The assigned 510(k) Number is: K082333
Predicate Devices:
Elta Silver Antimicrobial Wound Gel Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (K011994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Binding Dressing (K022483)
1
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Description of Device:
ASAP Wound Dressing Gel is an amorphous, water-based gel that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. 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 Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene tube, sealed on one end and fitted with a pop-open screw cap on the other end).
Indications for Use:
For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations
Technological Characteristics:
ASAP Wound Dressing Gel is an amorphous, water-based, gel that contains silver hydrosol. The composition of ASAP Wound Dressing Gel is substantially equivalent to the predicate devices listed above in that silver is the antimicrobial ingredient and moisture is managed using an aqueous base combined with a proper blend of hydrophilic substances. ASAP Wound Dressing Gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The product was evaluated through standard biological reactivity tests (ISO 10993) and found to be acceptable. Antimicrobial effectiveness was established through testing in accordance with USP .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2009
American Biotech Labs % Swankin & Turner Mr. James S. Turner 1400 16th Street, Northwest, Suite 101 Washington, District of Columbia 20036
Re: K082333
Trade/Device Name: ASAP Wound Dressing Gel Regulatory Class: Unclassified Product Code: FRO Dated: March 24, 2009 Received: March 25, 2009
Dear Mr. Turner:
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 Fed-ral 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 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.
3
Page 2 - Mr. James S. Turner
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,
for
Mark N. Melkerson
Director
Dep Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(K) Number (if known): K082333
Device Name: ASAP Wound Dressing Gel
Over-the-Counter Indications for Use:
For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use XX (Part 21 CFR 801 Subpart C)
0
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Keene fa mxm 4/1/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082333