(83 days)
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 indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations, which are conditions that require a therapeutic intervention. Additionally, it contains silver hydrosol which "may inhibit the growth of microorganisms," suggesting a therapeutic action.
No
The device is a wound dressing gel intended for topical management of minor cuts, burns, and skin irritations. It does not perform any diagnostic function.
No
The device description clearly states it is a water-based gel wound dressing 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 minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations." This describes a treatment or management of external wounds, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "water based gel wound dressing." This is a topical application, not a device used to analyze biological samples.
- Lack of Diagnostic Activity: The description mentions that the gel "may inhibit the growth of microorganisms within the dressing" and that antimicrobial effectiveness was established. While this relates to microorganisms, it's about preventing their growth in the dressing and potentially on the wound surface, not about diagnosing an infection or analyzing a sample for the presence of microorganisms.
- No Mention of In Vitro Testing: There is no indication that this device is used to test samples (like blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Product codes
FRO
Device Description
ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing 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 OTC™ 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 popopen 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 device was evaluated with biocompatibility testing (ISO 10993) and was found to be acceptable. The gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. Antimicrobial effectiveness was established through testing in accordance with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, MRSA and VRE, as well as fungi such as Candida albicans and aspergillus niger.
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
MAY 2 0 2014
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ASAP OTCTM Wound Dressing Gel is provided below.
| Device Common Name: | Wound Dressing | |
|---|---|---|
| Device Proprietary Name: | ASAP OTC™ Wound Dressing Gel | |
| Submitter: | ABL Medical, LLC | |
| 705 E 50 S | ||
| American Fork, UT 84003 | ||
| Contact: | Calley Herzog | |
| Consultant | ||
| Biologics Consulting Group, Inc. | ||
| 400 N. Washington St., Suite 100 | ||
| Email: cherzog@bcg-usa.com | ||
| Phone: 720-883-3633 | ||
| Fax: 703-548-7457 | ||
| Date Prepared: | May 16, 2014 | |
| Classification Regulation: | Unclassified | |
| Panel: | General & Plastic Surgery | |
| Product Code: | FRO | |
| Predicate Device: | K082333. ASAP Wound Dressing Gel |
Indication for Use:
ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 15t and 2nd degree burns, and skin irritations.
Device Description:
ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing 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 OTC™ 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 popopen screw cap on the other end).
Performance Data:
The device was evaluated with biocompatibility testing (ISO 10993) and was found to be acceptable. The gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. Antimicrobial effectiveness was established through testing in accordance
1
with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, MRSA and VRE, as well as fungi such as Candida albicans and aspergillus niger.
Substantial Equivalence Summary:
The composition of ASAP OTC™ Wound Dressing Gel is similar to that of the ASAP, Wound Dressing Gel cleared in K082333. The only differences between the subject device and the predicate device are that 1) the subject device contains 24ppm silver hydrosol and the predicate device contains 32ppm silver hydrosol and 2) the subject device does not contain propylene glycol.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K082333 |
| Submitter | ABL Medical, LLC | American Biotech Labs |
| (Note: 510(k) ownership has been | ||
| transferred to ABL Medical LLC) | ||
| Classification Regulation | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Indication | ASAP OTCTM Wound Dressing | |
| Gel is indicated for the topical | ||
| management of minor cuts, | ||
| lacerations, abrasions, 1st and 2nd | ||
| degree burns, and skin irritations. | For the topical management of | |
| minor cuts, lacerations, abrasions, | ||
| 1st and 2nd degree burns, and skin | ||
| irritations. (Over-the-Counter) | ||
| Packaging | Multi-dose gel pump or 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) | Multi-dose gel pump or 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) | ||
| Sterilized | Not provided sterile | Not provided sterile |
| Shelf Life | No shelf life claimed | No shelf life claimed |
| Ingredients | ||
| Active & Diluent | 24 ppm ASAP Solution - 98.42% | 32 ppm ASAP Solution - 91% |
| Thickening Agent | Carbopol ETD 2020 - 0.58% | Carbopol ETD 2020 - 0.58% |
| Buffering Agent, Penetrating | ||
| Agent | Triethanolamine (TEA) - 1% | Triethanolamine (TEA) - 1% |
| Humectant | Propylene Glycol - 7% |
Table 1: Device Comparison Table
2
.
| Proposed Device | Predicate Device | |
|---|---|---|
| Specifications | ||
| Appearance | Clear to golden yellow translucent | |
| gel | Clear to golden yellow translucent | |
| gel | ||
| Odor | Odorless | Odorless |
| Specific Gravity | 1.01 | 1.02 |
| Flowability | At 45° & 90° - more than 5 min. to | |
| travel 1 inch from the origin | At 45° & 90° - more than 5 min. | |
| to travel 1 inch from the origin | ||
| Feel/Tackiness | 1 - smooth | 1 - smooth |
| Viscosity RT 30° | 25,000 - 60,000 | 25,000 - 60,000 |
| PH | 6.5 to 8.0 | 6.5 to 8.0 |
| Light Exposure | No further discoloration | No further discoloration |
| Compatibility | No discoloration of product / | |
| reaction with containers | No discoloration of product / | |
| reaction with containers | ||
| Moisture Donation | Greater than 5% | Greater than 5% |
| Moisture Uptake | Greater than 5% | Greater than 5% |
.
:
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
ABL Medical, LLC % Ms. Calley Herzog Biologics Consulting Group Incorporated 400 North Washington Street, Suite 100 Alexandria, Virginia 22314
Re: K140483
Trade/Device Name: ASAP OTC™ Wound Dressing Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2014 Received: April 24, 2014
Dear Ms. Herzog:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 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.
4
Page 2 - Ms. Calley Herzog
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices . . Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K140483
Device Name
ASAP OTCTM Wound Dressing Gel
Indications for Use (Describe)
ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, Ist and 2nd degree burns, and skin irritations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jiyoung Dar
FORM FDA 3881 (1/14)