(277 days)
No
The device is a cleansing solution with a mechanical action and a preservative. There is no mention of any computational or analytical capabilities that would involve AI or ML.
Yes
The device is indicated for cleansing and moistening various skin and dermal lesions, including different stages of ulcers, burns, and surgical wounds, which are all conditions that benefit from therapeutic intervention.
No
The device is a cleanser intended for external cleansing of skin and wounds, aiding in the removal of debris. It does not perform any diagnostic function.
No
The device is a liquid cleansing solution, which is a physical substance, 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 cleansing, moistening, and irrigating skin and wounds. This is a topical application for external use on the body.
- Mechanism of Action: The mechanism of action is described as the mechanical action of the fluid moving across the skin or wound surface to aid in the removal of foreign objects.
- Device Description: The device is a cleansing solution applied externally.
- Anatomical Site: The anatomical site is the skin and various types of wounds.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, tissue, etc., in a laboratory setting to gain information about a patient's health status. This device is applied directly to the body for cleansing purposes.
N/A
Intended Use / Indications for Use
The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are cleansing solutions intended for the external cleansing of skin and wounds. The mechanical action of the fluid moving across the skin or wound surface provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are identical devices. The only difference is that the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is for prescription use and the AGX Wound Wash Skin and Wound Cleanser is for Over-the-Counter Use.
The solution consists of deionized water containing 10ppm silver. The silver is from American Biotech Labs and is the same silver used in ABL Medical's Wound Dressing hydrogel devices cleared in K140483, K092826 and K082333. The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which 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, Klebsiella pneumoniae. MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations
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)
Performance Testing:
Verification Testing: The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser has been tested to verify that it meets its device specifications.
Comparative Testing: The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser specifications were compared to the Silvaklenz Antibacterial Silver Skin & Wound Cleanser cleared in K063069. The specifications were shown to be substantially equivalent.
Biocompatibility Testing: The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser is a patient contacting device, with limited exposure ( and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.
Stability Testing: Stability testing was performed on real time aged samples to establish a shelf life of 3 years. The testing demonstrated that the wound wash maintains its specifications over the three year shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of three human profiles facing right, arranged in a way that they appear interconnected. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
ABL Medical, LLC % Ms. Calley Herzog Biologics Consulting Group Incorporated 400 North Washington Street, Suite 100 Alexandria, Virginia 22314
Re: K151185
Trade/Device Name: AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Prescription), and AGX Wound Wash Antibacterial Skin and Wound Cleanser (Over-the-Counter)
Regulatory Class: Unclassified Product Code: FRO Dated: December 22, 2015 Received: December 28, 2015
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
1
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 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/Resourcesfor You/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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151185
Device Name
AGX Wound Wash Skin and Wound Cleanser and AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser
Indications for Use (Describe)
The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
| 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) |
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3
K151185 - 510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser is provided below.
| Device Common Name: | Wound Cleanser |
|---|---|
| Device Proprietary Name: | AGRX Wound Wash Antibacterial Silver Skin and Wound |
| Cleanser (Prescription) | |
| AGX Wound Wash Skin and Wound Cleanser (Over-the- | |
| Counter) | |
| Applicant: | ABL Medical, LLC |
| 705 E 50 S | |
| American Fork, UT 84003 | |
| Contact: | Robert Holladay |
| ABL Medical, LLC | |
| Phone: 801-763-8000 | |
| Email: bob@ablmedical.com | |
| Prepared By: | Calley Herzog |
| Senior Consultant | |
| Biologics Consulting Group, Inc. | |
| 400 N. Washington St., Suite 100 | |
| Alexandria, VA 22314 | |
| Email: cherzog@bcg-usa.com | |
| Phone: 720-883-3633 | |
| Fax: 703-548-7457 | |
| Date Prepared: | April 30, 2015 |
| Classification Regulation: | Unclassified |
| Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Device: | K063069, Silvaklenz Antibacterial Silver Skin & Wound |
| Cleanser |
Indication for Use:
The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -
For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
4
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -
To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
Device Description:
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are cleansing solutions intended for the external cleansing of skin and wounds. The mechanical action of the fluid moving across the skin or wound surface provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are identical devices. The only difference is that the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is for prescription use and the AGX Wound Wash Skin and Wound Cleanser is for Over-the-Counter Use.
The solution consists of deionized water containing 10ppm silver. The silver is from American Biotech Labs and is the same silver used in ABL Medical's Wound Dressing hydrogel devices cleared in K140483, K092826 and K082333. The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which 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, Klebsiella pneumoniae. MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.
Performance Testing:
Verification Testing
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser has been tested to verify that it meets its device specifications.
Comparative Testing
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser specifications were compared to the Silvaklenz Antibacterial Silver Skin & Wound Cleanser cleared in K063069. The specifications were shown to be substantially equivalent.
Biocompatibility Testing
The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser is a patient contacting device, with limited exposure ( and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.
Stability Testing
Stability testing was performed on real time aged samples to establish a shelf life of 3 years. The testing demonstrated that the wound wash maintains its specifications over the three year shelf life.
Substantial Equivalence:
The predicate device for the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser is the Silvaklenz Antibacterial Silver Skin & Wound Cleanser cleared in K063069. A device comparison table is provided in the table below.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K151185 | K063069 |
| Submitter | ABL Medical, LLC | Medical Molecular Therapeutics, LLC |
| Device Name | AGRX Wound Wash Antibacterial | |
| Silver Skin and Wound Cleanser | ||
| AGX Wound Wash and Wound | ||
| Cleanser | Silvaklenz Antibacterial Silver Skin & | |
| Wound Cleanser | ||
| Classification | ||
| Regulation | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Indication | The AGX Wound Wash Skin and | |
| Wound Cleanser is indicated for | ||
| Over the Counter Use - | For Over the Counter Indications - | |
| Proposed Device | Predicate Device | |
| For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution. | For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action. | |
| The AGRX Wound Wash | ||
| Antibacterial Silver Skin and | ||
| Wound Cleanser is Indicated for | ||
| Prescription Use - | ||
| To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. | ||
| Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution. | For Professional Prescription | |
| Indications - | ||
| To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations. | ||
| Packaging | 2oz, 4 oz, 8 oz and 16 oz spray and squeeze bottles | 2oz, 4 oz, 8 oz and 16 oz spray and squeeze bottles |
| Ingredients | Silver solution: deionized water and silver (10 ppm) | Surfactant (soap), cocamidopropyl betaine, silver |
| Sterile when used? | No | No |
| Shelf Life | 3 years | None claimed |
| Biocompatibility Testing | Primary Skin Irritation / ISO | |
| 10993-10: Tests for Irritation and Sensitization | ||
| Repeated Patch Dermal | ||
| Sensitization Test / ISO 10992-10: | ||
| 2010 Tests for Irritation and Skin | ||
| Sensitization | ||
| Agar Overlay / ISO 10993-5: | ||
| Cytotoxicity | ISO Modified Intracutaneous Study | |
| ISO Modified Systemic Toxicity | ||
| Study | ||
| ISO Maximization Sensitization | ||
| Cytotoxicity | ||
| Antimicrobial | ||
| Effectiveness Testing | USP | USP |
6
Conclusion of Substantial Equivalence Evaluation
7
The subject device is similar in both indications for use and technological characteristics when compared to the predicate device. The subject device and the predicate device have similar labeling, instructions for use and packaging. The only difference between the subject device and the predicate is the ingredients. This difference does not affect the safety of the device as evidenced by the biocompatibility testing and antimicrobial effectiveness testing which is the same testing that was performed on the predicate device. This difference in ingredients does not affect the effectiveness of the subject device based on the fact that the mechanism of action for both the predicate device and the subject device is as a wound wash provided by the mechanical action of the fluid moving across the skin or wound as it is expelled out of the bottle. Furthermore, the performance testing and the comparative testing confirm that the difference in ingredients does not render the device NSE because this difference does not raise different questions of safety and effectiveness. Therefore the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser can be found substantially equivalent to the Silvaklenz Antibacterial Silver Skin & Wound Cleanser as cleared in K063069.