(183 days)
No
The device description and performance studies focus on the chemical and mechanical properties of a wound cleanser, with no mention of AI or ML technologies.
No.
The device is a cleanser intended for mechanical cleansing and removal of debris, dirt, and foreign materials from wounds and skin; it is not designed to treat a disease or condition therapeutically.
No
Explanation: The device is described as a cleanser intended for mechanical cleaning and removal of debris and foreign materials from wounds and skin; it does not mention any diagnostic capabilities.
No
The device description clearly indicates it is a liquid cleanser with a chemical preservative (PHMB), 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 the mechanical cleansing and removal of debris and microorganisms from wounds and skin. This is a physical action applied directly to the body surface.
- Device Description: The description focuses on the physical properties of the cleanser and the action of the preservative within the product itself to inhibit microbial growth in the product. It does not describe a test performed on a sample taken from the body to diagnose a condition or provide information about a patient's health status.
- Lack of Diagnostic Testing: There is no mention of analyzing a biological sample (like blood, urine, tissue, etc.) or providing diagnostic information. The performance studies focus on the safety and effectiveness of the cleanser itself and the preservative's ability to inhibit microbial growth within the product.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
Product codes
FRO
Device Description
Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).
A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin, wounds, skin scrapes, cuts, lacerations, exit sites, unbroken skin
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)
Atteris Antimicrobial Skin & Wound Cleanser has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation) to demonstrate that the device is as safe and as effective as its predicate devices. The preservative effectiveness has been supported by USP `` testing. Additionally, test results have demonstrated preservative effectiveness against the following five microorganisms, Escherichia coli (ATCC No. 8739), Staphylococcus aureus (ATCC No. 6538), Pseudomonas aeruginosa (ATCC No. 27853), Staphylococcus epidermidis (ATCC No. 12228) and Candida albicans (ATCC No. 10231). The results of real-time aging study indicates the product is expected to be stable and effective for a shelf life of 6 months.
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.
Anasept Antimicrobial Skin and Wound Cleanser (K073547)
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.
NAWAlution Skin and Wound Cleanser (K141660)
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 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 an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Rochal Industries LLC Mr. William Coulston Quality Manager 12719 Cranes Mill San Antonio, Texas 78230
Re: K160192
Trade/Device Name: Atteris Antimicrobial Skin & Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2016 Received: June 28, 2016
Dear Mr. Coulston:
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 devicerelated 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.
1
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" (21 CFR 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.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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)
Device Name Atteris Antimicrobial Skin & Wound Cleanser
Indications for Use (Describe)
(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Rochal Industries LLC 510(k) Notification Atteris™ Antimicrobial Skin and Wound Cleanser
SECTION 5
510(k) Summary
4
Image /page/4/Picture/1 description: The image contains two instances of the Rochal Industries LLC logo. The logo consists of a stylized, spherical graphic to the left of the text "Rochal" in a bold, red font. Below "Rochal" is the text "INDUSTRIES LLC" in a smaller, sans-serif font. The spherical graphic is composed of alternating red and white curved bands, creating a sense of depth and movement.
510(k) Summary
- Submitter's Name and Address 1. Rochal Industries LLC. 12719 Cranes Mill San Antonio, Texas, 78230
-
- Submitter's Contact Person William J. Coulston Quality and Regulatory Affairs (210) 870-6534 wcoulston@rochalindustries.com
-
- Date of 510(k) Summary Preparation: 26 July 2016
-
- Device Name (Proprietary) Atteris™ Antimicrobial Skin & Wound Cleanser
-
- Common Name Skin and Wound Cleanser
-
- Classification Name Dressing, Wound, Drug
-
- Device Class Unclassified
-
- Device Code FRO
-
- Comparison of Features
5
| Feature Being
Compared | PROPOSED DEVICE
Atteris Antimicrobial
Skin & Wound
Cleanser | PREDICATE DEVICE
Anasept Antimicrobial Skin
and Wound Cleanser | REFERENCE DEVICE
NAWAlution Skin and
Wound Cleanser
(K141660) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | | (K073547) | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Appearance | Clear, colorless solution | Clear, colorless liquid | Clear, colorless solution |
| Application
method | Spray bottle (8 fluid oz)
with trigger sprayer. | 15 oz in HDPE bottle with
dispensing caps and 8, & 12 oz
with Trigger sprayer and 8 oz with
Finger pump sprayer. | Spray bottle (50 mL (1.8
fluid oz.) - OTC);
Spray bottle (8 fluid oz. (237
mL) or 16 fluid oz. (473 mL)
- Rx) |
| Characteristics | Aqueous | Aqueous | Aqueous |
| Density | ~ 1.0 g/ml | ~1.0 g/ml | 0.9 - 1 g/ml |
| Materials | Purified Water,
Poloxamer 407,
Sodium Chloride,
Ethylhexylglycerin,
Hypromellose, Octane-
1,2-diol,
Polyaminopropyl
Biguanide [PHMB], | Purified water, Sodium Chloride,
Sodium Hypochlorite | Purified water,
Cocamidopropylbetaine, Zinc
Chloride, PHMB, Hydrochloric
acid, Trace Element |
| Buffer | Not buffered | Not buffered | Not buffered |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
10. Description of Device
Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).
A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.
11. Intended Use of Device
Atteris Antimicrobial Skin & Wound Cleanser is intended for over-the-counter (OTC) and professional use as follows:
- a. For Over-the-Counter Use: Atteris Antimicrobial Skin & Wound Cleanser is
6
Section 5: 510(k) Summary
Image /page/6/Picture/1 description: The image contains the logo for Rochal Industries LLC. The logo features a stylized globe made of red and gray stripes on the left. To the right of the globe is the company name, "Rochal" in large, red, bold letters. Below the company name, in smaller letters, is the text "INDUSTRIES LLC".
intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
- Professional Use: (Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is b. intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
12. Device Technological Characteristics
- Atteris Antimicrobial Skin & Wound Cleanser is a clear isotonic solution to aid a. in the mechanical removal of debris and foreign material from the application site. This is accomplished through the flow of the solution moving across the application site with or without the assistance of a suitable wound dressing. Atteris Antimicrobial Skin & Wound Cleanser solution contains PHMB that inhibits the growth of microorganisms within the solution. The Atteris Antimicrobial Skin and Wound Cleanser is similar in form, fit, and function to the primary predicate device, which is legally marketed. The ingredients more closely match the reference device, NAWAlution however, the primary component in all devices is purified water, as shown above. The main ingredient is water. Sodium chloride and EDTA are added to the formulation to match the osmolality and pH to that of healthy tissue. Hypromellose is added to increase the viscosity of the fluid. Sensivas (2-Ethylhexylglycerin and 2-ethylhexylglycerin and 1,2-octanediol) were added as moisturizers. Poloxamer 407 was used as a surfactant to incorporate Sensivas into the formulation. Finally, PHMB was used as a preservative.
- b. Anasept Antimicrobial Skin and Wound Cleanser uses sodium hypochlorite as a preservative. This is a buffered solution and at this concentration (0.057%) [1] is non-cytotoxic [2]. It is non-irritating and non-sensitizing [1]. Anasept Antimicrobial Skin and Wound Cleanser is a modified Dakin's solution, which has been used for over 100 years to disinfect wounds [2]. Although Atteris Antimicrobial Skin and Wound Cleanser (AWC) uses a different preservative (PHMB) to protect the contents of the bottle, it is also a buffered solution [3] is non-cytotoxic [4]. It is also non-irritating [5] and non-sensitizing [6]. PHMB has been used for decades in a wide range of applications including as a preservative in cosmetics and contact lens solutions and as a swimming pool sanitizer [7].
The similarities and differences of the preservatives are summarized in Figure 1.
7
Image /page/7/Figure/1 description: This image is a Venn diagram comparing two antimicrobial skin and wound cleansers, Atteris and Anasept. The "New Device" category lists Atteris Antimicrobial Skin and Wound Cleanser, with PHMB as a preservative. The "Predicate" category lists Anasept Antimicrobial Skin and Wound Cleanser, with Sodium hypochlorite as a preservative. The overlapping section, "Both Products," includes properties like being a buffered solution, non-cytotoxic, non-irritating, non-sensitizing, and having a preservative with decades of safe use.
Figure 1: Similarities Between Anasept and Atteris Wound Cleansers
In summary, both Anasept and Atteris Antimicrobial Skin and Wound Cleanser (AWC) are buffered solutions with preservatives to protect the solution from contaminants. Both preservatives (PHMB and sodium hypochlorite) have a long history of use.
13. Performance Testing
Atteris Antimicrobial Skin & Wound Cleanser has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation) to demonstrate that the device is as safe and as effective as its predicate devices. The preservative effectiveness has been supported by USP testing. Additionally, test results have demonstrated preservative effectiveness against the following five microorganisms, Escherichia coli (ATCC No. 8739), Staphylococcus aureus (ATCC No. 6538), Pseudomonas aeruginosa (ATCC No. 27853), Staphylococcus epidermidis (ATCC No. 12228) and Candida albicans (ATCC No. 10231). The results of real-time aging study indicates the product is expected to be stable and effective for a shelf life of 6 months.
14. Substantial Equivalence Conclusion
As discussed in this 510(k) submission, Atteris Antimicrobial Skin & Wound Cleanser is similar in function and has the same intended use as the predicate device, Anasept Antimicrobial Skin and Wound Cleanser. The safety evaluation meets the requirements as detailed by USP and ISO.
On the basis of the information presented in this 510(k) submission, Rochal Industries LLC. concludes a) that Atteris Antimicrobial Skin & Wound Cleanser is substantially equivalent to the predicate device, as it has the same intended use as the predicate; and b) demonstrates the device is as safe and effective as the legally marketed predicate device.
8
Image /page/8/Picture/0 description: The image shows the title "Section 5: 510(k) Summary" at the top. Below the title is the Rochal Industries LLC logo. The logo consists of a red and silver swirl on the left and the company name in red on the right. The words "INDUSTRIES LLC" are in smaller font below the company name.
References:
- Anacapa, Safety Data Sheet- Anasept Antimicrobial Skin and Wound Gel. 2015. 1.
-
- Levine, J.M., Dakin's solution: past, present, and future. Adv Skin Wound Care, 2013. 26(9): p. 410-4.
-
- Rochal, Atteris Antimicrobial Skin and Wound Cleanser Product Insert. 2016.
-
- Toxikon, Rochal Wound Cleanser Final GLP Report - 15-03643-G1 : L929 Agar Diffusion Test (Direct Contact) - ISO. 2015.
- న్. Toxikon, Rochal Wound Cleanser Final GLP Report - 15-03643-G2 : Direct Primary Skin Irritation Test - ISO. 2015.
- Toxikon, Rochal Wound Cleanser Final GLP Report 15-03643-G4 : Direct Buehler Sensitization Test -6. ISO. 2015.
-
- Butcher, M., PHMB: an effective antimicrobial in wound bioburden management. Br J Nurs, 2012. 21(12): p. S16, S18-21.
-
- Anacapa, Anasept Antimicrobial Skin and Wound Care Products Brochure. 2015.
-
- Estrela, C., et al., Mechanism of sodium hypochlorite. Braz Dent J, 2002. 13(2): p. 113-7.
-
- Lineaweaver, W., et al., Topical antimicrobial toxicity. Arch Surg, 1985. 120(3): p. 267-70.
-
- Moore K, G.D., Using PHMB antimicrobial to prevent wound infection. Wounds UK, 2007. 3(2): p. 96-102.