(280 days)
Not Found
No
The device description focuses on the chemical composition and mechanical action of a wound cleansing solution. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
Explanation: The device is intended to cleanse, moisten, and irrigate skin and dermal lesions, including various types of ulcers and burns, which are conditions that require therapeutic intervention for wound healing and management.
No
The device is described as a "buffered skin and wound cleansing solution" intended for external cleansing and removal of foreign objects. Its function is therapeutic/cleansing, not diagnostic.
No
The device is described as a "buffered skin and wound cleansing solution" available in "spray bottles," indicating it is a physical product (liquid and container) and not solely 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 dermal lesions. This is a topical application for external use on the body.
- Device Description: The device is a buffered skin and wound cleansing solution applied externally. Its mechanism of action is mechanical (fluid movement) and chemical (surfactant) to remove foreign material.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not involve the examination of bodily specimens outside the body for diagnostic purposes.
The device is a topical wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the Over-The-Counter Indications:
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.
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.
Product codes
FRO
Device Description
A buffered skin and wound cleansing solution that is intended for the external cleansing of dermal wounds and skin. The mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The product contains a surfactant (soap), cocamidopropyl betaine, to assist with the removal foreign material such as dirt and debris. After application the wound is rinsed with water or normal saline. The Silvaklenz Antibacterial Silver Skin & Wound Cleanser is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.
Silvaklenz Antibacterial Silver Skin & Wound Cleanser is a combination product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, Silvaklenz Antibacterial Silver Skin & Wound Cleanser had three modes of action. One mode of action of the product is that of the device components (the pump-spray and the remaining ingredients of the aqueous solution) mechanically remove debris, necrotic tissue and foreign particles from the skin and wound surface. A second mode of action of the product is that of the cocamidopropyl betaine (drug component) reduces the surface tension and thereby assist with mechanical cleansing and debridement. A third mode of action is ionic silver (drug component) that functions as an antimicrobial agent.
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
OTC: 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.
Professional: To cleanse, moisten and irrigate 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.
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)
Silvaklenz Antibacterial Silver Skin & Wound Cleanser has been subject to in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization) and cytotoxicity testing (Agarose Overlay Method). These tests support the safe use of Silvaklenz Antimicrobial Silver Skin & Wound Cleansing Solution in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard the MIC and MBC Dilution Methods. Zone of Inhibition, USP Antimicrobial Effectiveness Test . USP Microbial Limit Test , Bioburden Aerobic Total Count and Microbial Challenge Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042729, K022670, K040019, K011994, K023612
Reference Device(s)
Not Found
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
Medical Molecular Therapeutics LLC 510(k) PreMarket Notificatione Silvaklenz ™ Antibacterial Silver Skin & Wound Cleanser Rev July 2007
JUL 1 3 2007
page 1 of 3
6
7. 510(k) Summary Information
7.1 Submitter's Name and Address
Medical Molecular Therapeutics LLC Arthur B. Flick MD 36 Lake Rabun Road Lakemont, Georgia 30552
Contact Person: A. B. Flick MD Telephone: 706 782 5064 Email: abflick@alltel.net
7.2 Date Prepared
20 August 2006
7.3 Device Name
| Trade Name: | Silvaklenz™ Antibacterial Silver Skin & Wound Cleanser |
|---|---|
| Common Name: | Silvaklenz™ |
| Classification Name: | Liquid Bandage KMF |
7.4 Predicate Devices 807.92(a)(3)
| Dermacyn Wound Cleanser | K042729 |
|---|---|
| Restore Wound Cleanser | K022670 |
| X-Static Silverseal Hydrogel Wound Dressing | K040019 |
| Acryderm Silver Antimicrobial Wound Gel | K011994 |
| Antimicrobial Barrier Wound Contact Dressing | K023612 |
1
7.5 Device Description
page 27 3
A buffered skin and wound cleansing solution that is intended for the external cleansing of dermal wounds and skin. The mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The product contains a surfactant (soap), cocamidopropyl betaine, to assist with the removal foreign material such as dirt and debris. After application the wound is rinsed with water or normal saline. The Silvaklenz Antibacterial Silver Skin & Wound Cleanser is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.
7.6 Assessment of Performance Data
Silvaklenz Antibacterial Silver Skin & Wound Cleanser has been subject to in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization) and cytotoxicity testing (Agarose Overlay Method). These tests support the safe use of Silvaklenz Antimicrobial Silver Skin & Wound Cleansing Solution in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard the MIC and MBC Dilution Methods. Zone of Inhibition, USP Antimicrobial Effectiveness Test . USP Microbial Limit Test , Bioburden Aerobic Total Count and Microbial Challenge Test.
7.7 Statement of Intended Use
OTC: 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.
Professional: To cleanse, moisten and irrigate 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.
7.8 Technological Characteristics and Substantial Equivalence Silvaklenz Antibacterial Silver Skin & Wound Cleanser is a combination
2
510(k) PreMarket Notification Medical Molecular Therapeutics LLC Silvakienz TM Antibacterial Silver Skin & Wound Cleanser Rev July 2007 3
product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, Silvaklenz Antibacterial Silver Skin & Wound Cleanser had three modes of action. One mode of action of the product is that of the device components (the pump-spray and the remaining ingredients of the aqueous solution) mechanically remove debris, necrotic tissue and foreign particles from the skin and wound surface. A second mode of action of the product is that of the cocamidopropyl betaine (drug component) reduces the surface tension and thereby assist with mechanical cleansing and debridement. A third mode of action is ionic silver (drug component) that functions as an antimicrobial agent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Molecular Therapeutics, LLC % Arthur B. Flick, MD 36 Lake Rabun Road Lakemont, Georgia 30552
Re: K063069
Trade/Device Name: Silvaklenz Antibacterial Silver Skin & Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 7, 2007 Received: June 11, 2007
Dear Dr. Flick:
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.
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.
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
4
Page 2 -- Arthur B. Flick, MD
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Vik Mark N. N Aelkerson Director Division of General, Restorative 2 and Neurological Devices 7 Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
5. INDICATIONS FOR USE
Device Name: Silvaklenz Antibacterial Silver Skin & Wound Cleanser
For the Over-The-Counter Indications:
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.
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 2063069