(137 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a skin protectant, with no mention of AI or ML technologies.
No.
The device functions as a protective barrier for the skin, preventing irritation rather than treating a disease or condition.
No
The device is a skin protectant that forms a barrier on the skin; it does not diagnose any condition or disease.
No
The device description clearly states it is a "polymeric solution" supplied in a "High Density Polyethylene (HDPE) bottle with pump spray cap," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is for application to intact or damaged skin to create a protective barrier. This is a topical application for external use on the body.
- Device Description: The description reinforces that it's a polymeric solution forming a film on the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of bodily specimens in vitro.
The device described is a topical skin protectant, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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, additive friction. It is intended as a primary barrier against irritation from body fluids.
Product codes (comma separated list FDA assigned to the subject device)
KMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 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:
- 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.
- 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 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.
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.
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
§ 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.
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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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
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 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
2
Indications for Use
510(k) Number (if known)
Device Name Atteris No-Sting Skin Protectant
Indications for Use (Describe)
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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Rochal Industries LLC. The logo features a stylized globe on the left, with red and white bands wrapping around it. To the right of the globe is the company name, "Rochal," in large, red, bold letters. Below "Rochal" is the text "INDUSTRIES LLC" in smaller, gray letters.
Rochal Industries LLC 510(k) Notification Atteris™ No Sting Skin Protectant
510(k) Summary
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510(k) Summary
-
- 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
-
- Classification Name Bandage, Liquid
- Device Class 7. II
-
- Device Code KMF
Legally Marketed Device for substantial equivalence comparison: 9.
| Feature Being
Compared | PROPOSED
DEVICE | PREDICATE
DEVICE |
|-------------------------------------|-----------------------------|---------------------|
| Atteris No Sting
Skin Protectant | 3M No Sting
Barrier 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.
| Indications
for Use
(OTC) | 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, adhesive
products, and
friction. It is
intended as a
primary barrier
against irritation
from body fluids. | K955103: 3M No
Sting Barrier Film
also known as
Cavilon No Sting
Barrier Film is a
liquid intended for
use as a film-
forming product,
that upon
application to intact
or damaged skin
forms a long-lasting
waterproof barrier,
which acts as a
protective interface
between the skin
and bodily wastes,
fluids, adhesive
products, and
friction and shear.
It is intended as a
primary barrier
against irritation |
| --------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Appearance | Clear, colorless
solution | Clear, colorless
solution |
| ------------ | ------------------------------ | ------------------------------ |
|---|
10. Description of Device
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.
from body fluids.
Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.
6
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.
7
- . 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
8
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.