Who is the manufacturer of Atteris Antimicrobial Skin Protectant?

Rochal Industries, LLC filed the 510(k) submission for Atteris Antimicrobial Skin Protectant (K161212).

What is the FDA product code for Atteris Antimicrobial Skin Protectant?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Atteris Antimicrobial Skin Protectant?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Atteris Antimicrobial Skin Protectant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Atteris Antimicrobial Skin Protectant

K161212 · Rochal Industries, LLC · FRO · Sep 30, 2016 · SU

Device Facts

Record ID	K161212
Device Name	Atteris Antimicrobial Skin Protectant
Applicant	Rochal Industries, LLC
Product Code	FRO · SU
Decision Date	Sep 30, 2016
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.

Device Story

Atteris Antimicrobial Barrier Film Dressing is a polymeric solution applied via a 28 mL pump spray bottle to minor wounds and damaged skin. Upon application, the solution dries to form a colorless, transparent, waterproof, and breathable film barrier. The device incorporates 0.001% w/w PHMB as a preservative to inhibit microbial growth within the product. It is intended for over-the-counter use by patients to protect minor wounds and damaged skin from external contaminants. The film provides a secure, low-friction, non-stinging, and biocompatible protective layer that maintains oxygen and moisture vapor permeability. The device is non-sterile and shelf-stable.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation) and USP 51 preservative effectiveness testing. In-vitro testing demonstrated broad-spectrum antimicrobial activity against P. aeruginosa, E. coli, C. albicans, S. aureus, and A. brasiliensis with >6 log reduction over 24 hours.

Technological Characteristics

Polymeric solution containing acrylate copolymer, hexamethyldisiloxane, 2,2,4-trimethylpentane, water, docusate sodium, and 0.001% PHMB. Form factor: liquid in HDPE pump spray bottle. Principle: film-forming barrier. Biocompatibility: ISO 10993-1, 5, 10. Sterility: non-sterile, preserved.

Indications for Use

Indicated for application to minor wounds and damaged skin in patients requiring a waterproof, film-forming barrier dressing. Suitable for over-the-counter use.

Predicate Devices

Kendall COPA AMD (K071371)

Reference Devices

Poly FIT+ Absorbing Antimicrobial Dressing (K121522)
ASAP OTC Wound Dressing Gel (K140483)
Prontosan Gel X (K130857)

Related Devices

K160684 — Atteris No-Sting Skin Protectant · Rochal Industries, LLC · Jul 26, 2016
K022645 — CURAD · Beiersdorf AG · Nov 5, 2002
K032948 — ELASTIC SKIN LIQUID BANDAGE · Medpak, LLC · Jun 25, 2004
K190224 — Medline Burn and Wound Dressing (OTC) · Medline Industries, Inc. · Mar 8, 2019
K171148 — Aleo BME Liquid Bandage · Aleo Bme, Inc. · Jan 12, 2018

Submission Summary (Full Text)

{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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 30, 2016 Rochal Industries LLC William Coulston Quality And Regulatory Affairs 12719 Cranes Mill San Antonio, Texas 78230 Re: K161212 Trade/Device Name: Atteris Antimicrobial Barrier Film Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2016 Received: April 28, 2016 Dear William 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) K161212 Device Name Atteris Antimicrobial Barrier Film Dressing ### Indications for Use (Describe) Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | _ | Prescription Use (Part 21 CFR 801 Subpart D) |X 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized globe on the left and the company name on the right. The globe is made up of curved red and gray stripes. The company name is written in red, with "Rochal" in a larger font than "INDUSTRIES LLC". # 510(k) Summary - K161212 - 1. Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd, Ste B200 San Antonio, Texas, 78249 - 2. Submitter's Contact Person William J. Coulston Quality and Regulatory Affairs (210) 870-6534 wcoulston@rochalindustries.com - 3. Date of 510(k) Summary Preparation: 29 September 2016 - 4. Device Name (Proprietary) Atteris™ Antimicrobial Barrier Film Dressing - 5. Common Name Wound Dressing - 6. Classification Name Dressing, Wound, Drug - 7. Device Class Unclassified - 8. Device Code FRO {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Rochal Industries LLC. The logo consists of a stylized globe on the left and the company name on the right. The globe is made up of red and gray stripes that wrap around it. The company name is written in red, with "Rochal" in a larger font than "INDUSTRIES LLC". #### 9. Legally Marketed Device for substantial equivalence comparison: | | Proposed: Atteris Antimicrobial Barrier Film Dressing | Predicate: Kendall COPA AMD | Reference: Poly FIT +Absorbing Antimicrobial Dressing | Reference: ASAP OTCTM Wound Dressing Gel | Reference: ProntosanTM Gel X | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | New | K071371 | K 121522 | K140483 | K130857 | | Class | Unclassified | Unclassified | Unclassified | Unclassified | Unclassified | | Regulation | Unknown | Unknown | Unknown | Unknown | Unknown | | Device Classification Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | | Product Code | FRO | FRO | FRO | FRO | FRO | | Intended use | Atteris Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. | COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. | For Over-the-Counter Use, PolyFITM+ Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. | ASAP OTC Wound Dressing is indicated for the topical management of minor cuts, 1st and 2nd degree burns, and skin irritations. | Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. | | Indications for use | Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin. | Same as above. | Same as above | Same as above | OTC - Prontosan Wound Gel X is indicated for the management of minor cuts. minor lacerations, minor burns (1st degree burns), and abrasions. | | Rx or OTC use | OTC | Rx | OTC | OTC | OTC | | Design | Atteris™ Antimicrobial Barrier Film Dressing is a | A hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization. | PolyFIT+ Absorbing Antimicrobial Dressings are made of synthetic, hydrophilic, fibers embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB). | ASAP OTC Wound Dressing is a water based gel wound dressing that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. | Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. Gel X is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fined with PP screw caps. | | | polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is dispersed in a unique non- cytotoxic, non-stinging solution via a standard 28 mL pump spray bottle. The product is biocompatible, non-stinging, fast drying, and has low friction. Antimicrobial Barrier Film Dressing protects minor wounds and damaged skin by providing a secure, breathable, waterproof barrier to external contaminates. The film dressing is colorless, transparent, and possesses good oxygen and moisture vapor permeability. The antimicrobial PHMB at a concentration of 0.001% w/w is added to the product as a preservative to inhibit the growth of microorganisms within the product. | | | The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP OTC Wound Dressing is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a pop open screw cap on the other end). | | | | Performance data submitted in support of this 510k included in-vitro testing. | Performance data submitted in support of this 510k included in-vitro and animal testing. | All necessary verification and validation testing has been performed for the PolyFIT+ Absorbing Antimicrobial Dressings to assure substantial equivalence to the predicate devices. | Performance data submitted in support of this 510k included in-vitro and animal testing. | Biocompatibility and performance testing was performed with Prontosan Wound Gel X to support substantial equivalence to the predicate devices. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing completed included USP $<51>$ and a Strike Through Barrier Test. Test results met the acceptance criteria. | | Performance | As a preservative, broad spectrum activity was demonstrated against 5 organisms including Gram positive, Gram negative, and fungal types. Total kill was achieved for 24 hours at >6 log of each organism: P. aeruginosa E. coli C. albicans S. aureus A. brasiliensis | Broad spectrum activity was demonstrated against 6 organisms including Gram positive, Gram negative, and fungal types. Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism: P. aeruginosa E. coli C. albicans S. epidermidis S. aureus E. faecalis | | | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Rochal Industries LLC. The logo consists of a stylized globe on the left and the company name on the right. The globe is made up of red and gray curved stripes. The company name is written in red, with "INDUSTRIES LLC" in smaller letters below "Rochal". {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized globe made of red and white ribbons on the left, and the word "Rochal" in red on the right. Below the word "Rochal" is the text "INDUSTRIES LLC" in a smaller, lighter font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized globe on the left, with red and white stripes wrapping around it. To the right of the globe is the text "Rochal" in a bold, red font, with "INDUSTRIES LLC" in a smaller, gray font underneath. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized globe made of red and gray stripes on the left. To the right of the globe is the company name, "Rochal" in red, with the words "INDUSTRIES LLC" in smaller gray font underneath. | Materials | Acrylate copolymer Hexamethyldisiloxane 2,2,4-Trimethylpentane Water Docusate sodium Polyhexamethylene biguanide (PHMB) | Polyurethane foam Polyhexamethylene biguanide (PHMB) | Polyethylene oxide (PEO) Polyethylene-co-vinyl-alcohol (EVOH) Polycaprolactone (PCL) Polyhexamethylene biguanide (PHMB) | Carbopol ETD 2020 Water Triethanolamine (TEA) ASAP Solution | Hydroxyethylcellulos e Glycerol Water Betaine surfactant Polyhexanide (PHMB) | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Bio- compatibility | ISO 10993 parts 1,5, and 10 | ISO 10993 parts 1, 5, 10 | All necessary verification and validation testing has been performed for the PolyFIT+ Absorbing Antimicrobial Dressings | ISO 10993 parts 1, 5, 10 | ISO 10993 parts 1, 5, 10 | | Sterility | Non-sterile product that is preserved using PHMB. | Sterilized using ETO later changed to gamma irradiation (see K082296). | Sterile | Non-sterile | Sterile using steam sterilization | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo features a stylized globe made of red and gray ribbons on the left. To the right of the globe is the company name, "Rochal" in large, bold, red letters, with "INDUSTRIES LLC" in smaller letters underneath. ## 10. Description of Device Atteris™ Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is biocompatible, non-stinging, and fast drying. The barrier film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris Antimicrobial Barrier Film Dressing will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap. ## 11. Indications For Use of Device Atteris Antimicrobial Barrier Film Dressing is intended for over-thecounter (OTC) use as follows: Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin. These indications are similar to that of the predicate device and referencedevices. #### Device Technological Characteristics 12. Atteris Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris Antimicrobial Barrier Film Dressing is manufactured under Good Manufacturing Practices (GMP) guidelines. #### Performance Testing 13. Atteris Antimicrobial Barrier Film Dressing (ABF) has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation) to demonstrate the device is as safe and as effective as its predicate device. The product is preserved and preservative effectiveness has been verified using USP 51. The results of real-time aging studies indicates the product is expected to be stable and effective for a shelf life of 6months. The Antimicrobial Barrier Film Dressing (ABF) has the following characteristics and was tested to confirm the substantiation of these claims. See below: - Preserved - Based on USP 51 initially and at several points during aging. - . Biocompatible - Testing consistent with ISO 10993 (Cytotoxicity, Sensitization, and Irritation) testing was conducted. ABF is noncytotoxic, non-sensitizing, and non-irritating. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows 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 "Rochal" in red, bold letters on the right. Below the company name, the words "INDUSTRIES LLC" are written in smaller, gray letters. - Other performance characteristics. . The previously mentioned testing was conducted to substantiate the claims of the Atteris Antimicrobial Barrier Film Dressing, which is substantially equivalent to the predicate device Kendall COPA AMD since the two products have similar claims and intended uses. #### Substantial Equivalence Conclusion 14. As discussed in this 510(k) submission, Atteris Antimicrobial Barrier Film Dressing is similar in function and has the same intended use as the predicate device, Kendall COPA AMD (K071371). 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 Barrier Film Dressing is substantially equivalent to the predicate device, as it has the same intended use for minor wounds as the predicate; and b) demonstrates the device is as safe and effective as the legally marketed predicate device.