(59 days)
Not Found
No
The device description and intended use focus on the antibacterial properties of a silver-based gel wound dressing. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is indicated for use in the management of 1st and 2nd degree burns and various types of wounds, which are therapeutic applications. It is also shown to inhibit the growth of microorganisms, which aids in healing and treatment.
No
The device is a wound dressing gel intended for treatment and management of wounds and burns, not for diagnosing conditions.
No
The device description clearly states it is a water-based gel wound dressing containing silver, supplied in a multi-dose gel pump and a tube. This indicates 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 management of various types of wounds and burns. This is a topical application for treating external injuries.
- Device Description: The device is a wound dressing gel containing silver for antibacterial properties. It is applied directly to the wound.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological specimens outside the body.
The device is a wound care product intended for direct application to the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes
FRO
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).
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)
Antibacterial effectiveness was established through testing with appropriate organisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
NOV 12 2009 K092826
1 :
. 7
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 |
| 80 West Canyon Crest Road | |
| Alpine, UT 84004 | |
| Contact: | Miriam Provost, Ph.D. |
| Biologics Consulting Group, Inc. | |
| Phone: 703-242-0459 | |
| Fax: 720-293-0014 | |
| Email: mprovost@bcg-usa.com | |
| Alternate Contact: | Calley Herzog |
| Consultant, Medical Devices | |
| Biologics Consulting Group, Inc. | |
| Phone: 720-883-3633 | |
| Fax: 720-293-0014 | |
| Email: cherzog@bcg-usa.com | |
| Classification | |
| Regulation: | Unclassified, pre-amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Devices: | K082333 - ASAP® Wound Dressing Gel |
| K083103 -AcryDerm Antimicrobial Silver Wound Gel | |
| Dressing Model #B |
1
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.
2
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
3
Page 2 - Ms. Miriam Provost
ה
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 (800) 638-2041 or (301) 796-7100 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
4
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)
Page 1 of ી
Daniel Krone for MXM
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KD92826.