(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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Atteris™ Antimicrobial Skin & Wound Cleanser. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the document does not contain a study that establishes clinical acceptance criteria for the device's performance in a clinical setting (e.g., wound healing rates, infection reduction rates). Instead, the studies mentioned are to demonstrate the new device is as safe and effective as the predicate based on pre-defined regulatory and biocompatibility standards.

However, I can extract information related to the performance testing that addresses aspects of safety and effectiveness as required for substantial equivalence.

Here's an attempt to organize the information based on your request, focusing on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating equivalence in safety, performance, and specific product characteristics compared to a predicate device, rather than meeting specific clinical efficacy endpoints with numerical benchmarks.

Criterion Type	Acceptance Criteria (Implied by 510(k) & Standards)	Reported Device Performance
Biocompatibility	Adherence to ISO 10993 standards for cytotoxicity, sensitization, and irritation.	Cytotoxicity: Final GLP Report - 15-03643-G1: L929 Agar Diffusion Test (Direct Contact) - ISO (Reference 4). Performance reported as non-cytotoxic.
		Sensitization: Final GLP Report - 15-03643-G4: Direct Buehler Sensitization Test - ISO (Reference 6). Performance reported as non-sensitizing.
		Irritation: Final GLP Report - 15-03643-G2: Direct Primary Skin Irritation Test - ISO (Reference 5). Performance reported as non-irritating.
Preservation	Meets USP <51> criteria for antimicrobial effectiveness, specifically inhibiting growth of target microorganisms within the product.	Preservative Effectiveness Testing (USP <51>): Results demonstrated effectiveness against 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).
Shelf Life/Stability	Device expected to maintain stability and effectiveness for a defined period.	Real-time aging study: Results indicate the product is expected to be stable and effective for a shelf life of 6 months.
Composition/Properties	Similar physical and chemical characteristics to predicate/reference devices (e.g., aqueous, density, non-sterile, not buffered).	Composition: Aqueous, ~1.0 g/ml density, non-sterile, not buffered. (Matches predicate/reference). Contains PHMB for preservation.
Intended Use	Same intended use as the predicate device (mechanical cleansing and removal of debris, dirt, foreign materials, including microorganisms).	Stated Intended Use (Rx and OTC) is consistent with the predicate device for wound and skin cleansing.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify exact sample sizes for the test sets used in the biocompatibility, preservative effectiveness, or shelf-life studies. These would typically be detailed in the full study reports referenced (e.g., Toxikon reports, USP <51> reports), but not in the 510(k) summary. For biocompatibility tests (ISO 10993), sample sizes are generally small (e.g., a few animals or cell cultures per test).
Data Provenance: The biocompatibility studies were conducted by "Toxikon" (a contract research organization presumably based in the US or an ISO-certified lab). The USP <51> testing is a standard methodology. Real-time aging studies are conducted on the manufacturer's product. The provenance of the data is generally from laboratory testing, which is prospective in nature for these specific tests. Country of origin for data is not explicitly stated but assumed to be from a reputable testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (experts establishing ground truth for a test set) is not applicable to this 510(k) safety and performance testing. The "ground truth" for these tests are the established standards:

For biocompatibility: ISO 10993 standards.
For preservative effectiveness: USP <51> monograph.
Experts (e.g., toxicologists, microbiologists) would perform and interpret the tests according to these standards, but there isn't a "ground truth" derived from expert consensus on images or clinical outcomes in the context of this submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human interpretation of data (e.g., radiology reads, pathology diagnoses), to establish a consensus "ground truth." The tests performed here are laboratory-based and follow standardized protocols; outcomes are objective measurements or categorical determinations (e.g., cytotoxic/non-cytotoxic, effective/not effective).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) clearance for an antimicrobial skin and wound cleanser, not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in the performance evaluation described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims in this submission are based on:

Standardized Laboratory Controls: For biocompatibility, the ground truth is whether the device materials elicit a toxic, irritating, or sensitizing response when compared to controls as defined by ISO 10993.
Pharmacopoeial Standards: For preservative effectiveness, the ground truth is the reduction in microbial count defined by the USP <51> antimicrobial effectiveness test.
Physical/Chemical Measurements: For shelf life and other characteristics, the ground truth is the stability of physical/chemical properties over time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K160192

Device Name Atteris Antimicrobial Skin & Wound Cleanser

Indications for Use (Describe)

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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Rochal Industries LLC 510(k) Notification Atteris™ Antimicrobial Skin and Wound Cleanser

SECTION 5

510(k) Summary

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510(k) Summary

Submitter's Name and Address 1. Rochal Industries LLC. 12719 Cranes Mill San Antonio, Texas, 78230
1. Submitter's Contact Person William J. Coulston Quality and Regulatory Affairs (210) 870-6534 wcoulston@rochalindustries.com
1. Date of 510(k) Summary Preparation: 26 July 2016
1. Device Name (Proprietary) Atteris™ Antimicrobial Skin & Wound Cleanser
1. Common Name Skin and Wound Cleanser
1. Classification Name Dressing, Wound, Drug
1. Device Class Unclassified
1. Device Code FRO
1. Comparison of Features

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Feature BeingCompared	PROPOSED DEVICEAtteris AntimicrobialSkin & WoundCleanser	PREDICATE DEVICEAnasept Antimicrobial Skinand Wound Cleanser	REFERENCE DEVICENAWAlution Skin andWound Cleanser(K141660)
		(K073547)
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Appearance	Clear, colorless solution	Clear, colorless liquid	Clear, colorless solution
Applicationmethod	Spray bottle (8 fluid oz)with trigger sprayer.	15 oz in HDPE bottle withdispensing caps and 8, & 12 ozwith Trigger sprayer and 8 oz withFinger pump sprayer.	Spray bottle (50 mL (1.8fluid oz.) - OTC);Spray bottle (8 fluid oz. (237mL) 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,PolyaminopropylBiguanide [PHMB],	Purified water, Sodium Chloride,Sodium Hypochlorite	Purified water,Cocamidopropylbetaine, ZincChloride, PHMB, Hydrochloricacid, Trace Element
Buffer	Not buffered	Not buffered	Not buffered
Sterility	Non-sterile	Non-sterile	Non-sterile

10. Description of Device

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

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Section 5: 510(k) Summary

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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.

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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 <51> 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.

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References:

Anacapa, Safety Data Sheet- Anasept Antimicrobial Skin and Wound Gel. 2015. 1.
1. Levine, J.M., Dakin's solution: past, present, and future. Adv Skin Wound Care, 2013. 26(9): p. 410-4.
1. Rochal, Atteris Antimicrobial Skin and Wound Cleanser Product Insert. 2016.
1. 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.
1. Butcher, M., PHMB: an effective antimicrobial in wound bioburden management. Br J Nurs, 2012. 21(12): p. S16, S18-21.
1. Anacapa, Anasept Antimicrobial Skin and Wound Care Products Brochure. 2015.
1. Estrela, C., et al., Mechanism of sodium hypochlorite. Braz Dent J, 2002. 13(2): p. 113-7.
1. Lineaweaver, W., et al., Topical antimicrobial toxicity. Arch Surg, 1985. 120(3): p. 267-70.
1. Moore K, G.D., Using PHMB antimicrobial to prevent wound infection. Wounds UK, 2007. 3(2): p. 96-102.

Regulation Number and Section

N/A