Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.

Device Description

Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.

AI/ML Overview

The provided document describes the Atteris No Sting Skin Protectant and its performance characteristics, primarily to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation (e.g., diagnostic accuracy on a test set). Instead, it details performance testing to substantiate specific product claims related to its physical and biological properties.

Therefore, many of the requested sections related to AI device evaluation (such as sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to the information contained in this document.

However, I can extract the acceptance criteria (claims) and the reported device performance from the provided text for the aspects that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic (Claim)	Acceptance Criteria (Implied)	Reported Device Performance
No Sting	Non-stinging	"NSP is non-stinging."
Barrier Film	Functions as a barrier film	"NSP is a barrier film."
Sterile	Meets sterility requirements	"NSP passed the requirements for sterility with no observed turbidity in the 10 test samples."
Breathable	Breathable	"NSP is breathable."
Biocompatible	Non-cytotoxic, non-sensitizing, non-irritating	"NSSB is non-cytotoxic, non-sensitizing, and non-irritating."
Dries in ~60 seconds	Dries in approximately 60 seconds	"NSP dries in approximately 60 seconds."
Good in Skin Folds (non-self-adherent)	Non-self-adherent	"NSP is consider non-self-adherent."
Single Patient Use (Use life-28 days after opening)	Retains performance characteristics for 28 days after opening	"product retains its performance characteristics, and it does. The Use Life is 28 days after opening..."

Summary of inapplicable AI/Software Device Evaluation Criteria:

The following items are not applicable as this document describes a physical medical device (skin protectant) and its chemical/biological properties, not an AI/software device for diagnostic or predictive purposes.

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Details of the Studies Conducted (as per the document):

No Sting:
- Study: Human testing using the Skin Trauma After Razor Shaving (STARS) bioassay.
- Purpose: To determine if the protectant caused subjective stinging when applied to skin challenged by dry shaving.
Barrier Film:
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Method: Carbon retention test method.
Sterile:
- Study: USP 71, Sterility Tests.
- Sample Size: 10 test samples.
- Conditions: After 2 months of accelerated aging.
Breathable:
- Study: Oxygen and moisture vapor transmission rate testing.
Biocompatible:
- Study: Testing consistent with ISO 10993.
- Specific Tests:
  - Cytotoxicity: L929 Agar Diffusion Test (Direct Contact); ISO Final GLP Report: 15-04007-G1. Test article: Atteris Skin Protectant on mouse fibroblast L929 cells.
  - Direct Primary Skin Irritation: ISO Final GLP Report: 15-04007-G2. Test article: Atteris Skin Protectant on abraded skin sites of New Zealand White rabbits (single topical minimum 4-hour application).
  - Direct Buehler Sensitization: ISO Final GLP Project: 15-04007-G3. Test article: Atteris Skin Protectant on albino guinea pigs (topical application).
Dries in ~60 seconds:
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Purpose: To determine dry time.
Good in Skin Folds (non-self-adherent):
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Comparison: To the commercial control, 3M Cavilon No Sting Barrier Film.
Single Patient Use (Use life-28 days after opening):
- Study: Use life testing.
- Method: Product opened, sprayed, left open for 28 days, then re-tested to confirm performance characteristics.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 26, 2016

Rochal Industries LLC Mr. William Coulston Ouality And Regulatory Affairs 12719 Cranes Mill San Antonio, Texas 78230

Re: K160684

Trade/Device Name: Atteris No-Sting Skin Protectant Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: June 15, 2016 Received: June 21, 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 yours,

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)

K160684

Device Name Atteris No-Sting Skin Protectant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Rochal Industries LLC 510(k) Notification Atteris™ No Sting Skin Protectant

510(k) Summary

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510(k) Summary

1. Submitter's Name and Address Rochal Industries LLC. 12719 Cranes Mill San Antonio, Texas, 78230
Submitter's Contact Person 2. William J. Coulston Quality and Regulatory Affairs (210) 870-6534 wcoulston@rochalindustries.com
Date of 510(k) Summary Preparation: 3. 26 July 2016
Device Name (Proprietary) 4. Atteris™ No Sting Skin Protectant
Common Name ട്. Skin Protectant
1. Classification Name Bandage, Liquid
Device Class 7. II
1. Device Code KMF

Legally Marketed Device for substantial equivalence comparison: 9.

Feature BeingCompared	PROPOSEDDEVICE	PREDICATEDEVICE
Atteris No StingSkin Protectant	3M No StingBarrier Film

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Image /page/5/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized globe made of red and gray ribbons on the left, and the company name in red on the right. The words "INDUSTRIES LLC" are written in smaller, gray letters below the name.

Indicationsfor Use(OTC)	Atteris No StingSkin Protectant isintended forapplication to intactor damaged skin asa liquid, film-forming product,which creates along- lastingwaterproof barrier,protecting the skinfrom bodily wastes,fluids, adhesiveproducts, andfriction. It isintended as aprimary barrieragainst irritationfrom body fluids.	K955103: 3M NoSting Barrier Filmalso known asCavilon No StingBarrier Film is aliquid intended foruse as a film-forming product,that uponapplication to intactor damaged skinforms a long-lastingwaterproof barrier,which acts as aprotective interfacebetween the skinand bodily wastes,fluids, adhesiveproducts, andfriction and shear.It is intended as aprimary barrieragainst irritation
---------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Appearance	Clear, colorlesssolution	Clear, colorlesssolution
------------	------------------------------	------------------------------

10. Description of Device

from body fluids.

Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.

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Image /page/6/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo features a stylized globe on the left, with red and gray bands wrapping around it. To the right of the globe is the company name, "Rochal" in large, red letters, with "INDUSTRIES LLC" in smaller, gray letters underneath.

11. Intended Use of Device

Atteris No Sting Skin Protectant is intended for over-the-counter (OTC) use as follows:

. Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a longlasting waterproof barrier, protecting the skin from bodily wastes, fluids, adhesive products, and friction.
. It is intended as a primary barrier against irritation from body fluids.

These indications are similar to that of the predicate device.

12. Device Technological Characteristics

Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant is manufactured under Good Manufacturing Practices (GMP) guidelines.

13. Performance Testing

Atteris No Sting Skin Protectant has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization) to demonstrate the device is as safe and as effective as its predicate device. The product is gamma sterilized and sterility has been verified using USP 71, Sterility Tests. The results of accelerated aging study indicates the product is expected to be stable and effective for a shelf life of 12 months.

The No Sting Skin Protectant has the following characteristics and was tested to confirm the substantiation of these claims. See below:

. No Sting - this claim was supported by human testing using the Skin Trauma After Razor Shaving (STARS) bioassay to determine if NSP caused subjective stinging when applied to skin that had been challenged by dry shaving. NSP is non-stinging.

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. Barrier Film - Human testing was conducted at cyberDERM Clinical Studies to determine barrier function using a carbon retention test method. NSP is a barrier film.
. Sterile - Based on USP 71, after 2 month of accelerated aging, the Atteris No Sting Skin Protectant (NSP) passed the requirements for sterility with no observed turbidity in the 10 test samples.
. Breathable - Breathability was assessed by using oxygen and moisture vapor transmission rate testing. NSP is breathable.
. Biocompatible - Testing consistent with ISO 10993 (Cytotoxicity, Sensitization, and Irritation) testing was conducted.
- Cytotoxicity Study Summary L929 Agar Diffusion Test (Direct Contact) - ISO Final GLP Report: 15-04007-G1 Test Article Name: Atteris Skin Protectant The potential biological reactivity of a mammalian cell culture (mouse fibroblast L929) in response to exposure to the test article, Atteris Skin Protectant, was determined.
- Direct Primary Skin Irritation Test - ISO Final GLP Report: 15-04007-G2 Test Article Name: Atteris Skin Protectant The test article, Atteris Skin Protectant, was evaluated for its potential to produce Primary Skin Irritation after a single topical minimum 4 hour application to abraded skin sites of New Zealand White rabbits.
- Direct Buehler Sensitization Test - ISO Final GLP Project: 15-04007-G3 Test Article Name: Atteris Skin Protectant The test article, Atteris Skin Protectant, was evaluated for its potential to produce skin sensitization reactions following topical application to albino guinea pigs.
- . NSSP is non-cytotoxic, non-sensitizing, and non-irritating.
. Dries in ~60 seconds - Human testing was conducted at cyberDERM Clinical Studies to determine dry time. NSP dries in approximately 60 seconds.
. Good in Skin Folds (non-self-adherent) - Human testing was conducted at cyberDERM Clinical Studies to determine self-adherence of NSP in comparison to the commercial control, 3M Cavilon No Sting Barrier Film. NSP is consider non-self-adherent.
. Single Patient Use (Use life-28 days after opening) - Use life testing was conducted in which the product was opened, sprayed, and left open. Testing

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was conducted after 28-days to confirm the product retains its performance characteristics, and it does. The Use Life is 28 days after opening, after which the product should be discarded.

The previously mentioned testing was conducted to substantiate the claims of the Atteris No Sting Skin Protectant, which is substantially equivalent to the predicate device 3M's Cavilon Barrier Film since the two products have similar claims, intended uses, and formulation.

14. Substantial Equivalence Conclusion

As discussed in this 510(k) submission. Atteris No Sting Skin Protectant is similar in function and has the same intended use as the predicate device, 3M No Sting Barrier Film. 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 No Sting Skin Protectant 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.

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.