(155 days)
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.
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 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 provided document is a 510(k) premarket notification for the "Atteris Antimicrobial Barrier Film Dressing" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria in the context of AI/machine learning performance.
Therefore, most of the requested information regarding AI/ML study design (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Performance Testing" section.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Preservative Effectiveness (USP 51) | Broad spectrum activity demonstrated against 5 organisms (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. Performance was sustained initially and at several points during aging. This indicates the product is preserved using PHMB. |
| Biocompatibility (ISO 10993 parts 1, 5, 10) | The device is non-cytotoxic, non-sensitizing, and non-irritating. This was demonstrated through cytotoxicity, sensitization, and irritation studies. |
| Shelf Life Stability | Real-time aging studies indicate the product is expected to be stable and effective for a shelf life of 6 months. |
Answers to other questions based on the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes in-vitro lab testing, not a clinical study with a "test set" of patients/data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference standards for the performance tests were established using recognized international standards and methods, specifically:
- USP 51 for antimicrobial effectiveness.
- ISO 10993 parts 1, 5, and 10 for biocompatibility.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a medical device (a film dressing) and its performance is evaluated through standard laboratory and biocompatibility testing, not through AI/ML performance studies.
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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.
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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)
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | 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 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
-
- Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd, Ste B200 San Antonio, Texas, 78249
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- Submitter's Contact Person William J. Coulston Quality and Regulatory Affairs
(210) 870-6534 wcoulston@rochalindustries.com
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- Date of 510(k) Summary Preparation: 29 September 2016
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- Device Name (Proprietary) Atteris™ Antimicrobial Barrier Film Dressing
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- Common Name Wound Dressing
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- Classification Name Dressing, Wound, Drug
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- Device Class Unclassified
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- Device Code FRO
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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: AtterisAntimicrobial BarrierFilm Dressing | Predicate: Kendall COPAAMD | Reference: Poly FIT+AbsorbingAntimicrobialDressing | Reference: ASAPOTCTM WoundDressing Gel | Reference: ProntosanTM GelX | |
|---|---|---|---|---|---|
| K Number | New | K071371 | K 121522 | K140483 | K130857 |
| Class | Unclassified | Unclassified | Unclassified | Unclassified | Unclassified |
| Regulation | Unknown | Unknown | Unknown | Unknown | Unknown |
| DeviceClassificationName | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug |
| ProductCode | FRO | FRO | FRO | FRO | FRO |
| Intended use | Atteris Antimicrobial BarrierFilm Dressing is a polymericsolution which forms auniform film when applied tominor wounds and damagedskin. | COPA AMD dressings areindicated for use in managementof post-surgical incisions,pressure sores, venous stasisulcers, diabetic ulcers, donorsites, abrasions, lacerations, 1stand 2nd degree burns,dermatologic disorders, otherwounds inflicted by trauma and,as a secondary dressing or coverdressing for packed wounds. | For Over-the-Counter Use,PolyFITM+ AbsorbingAntimicrobial Dressings may beused for minor abrasions, minorlacerations, minor cuts, minorscalds, and minor burns. | ASAP OTC Wound Dressingis indicated for the topicalmanagement of minor cuts,1st and 2nd degree burns, andskin irritations. | Prontosan Wound Gel X is aready to use, clear, odorless,amorphous hydrogel wounddressing that helps maintain aclean, moist woundenvironment. It is intended as abarrier to resist microbialcolonization within the dressingand reduce microbialpenetration through thedressing. |
| Indicationsfor use | Atteris Antimicrobial BarrierFilm Dressing is intended forapplication to minor woundsand damaged skin as a liquid,film forming barrier, whichcreates a waterproof, filmdressing, protecting the woundor damaged skin. | Same as above. | Same as above | Same as above | OTC - Prontosan Wound GelX is indicated for themanagement of minor cuts.minor lacerations, minor burns(1st degree burns), andabrasions. |
| Rx or OTCuse | OTC | Rx | OTC | OTC | OTC |
| Design | Atteris™ AntimicrobialBarrier Film Dressing is a | A hydrophilic polyurethane foamthat is impregnated withPolyhexamethylene BiguanideHydrochloride (PHMB), anantimicrobial agent that protectsthe dressing from bacterialpenetration and colonization. | PolyFIT+ AbsorbingAntimicrobial Dressings aremade of synthetic,hydrophilic, fibers embeddedwith a 0.3% concentration ofPolyhexamethyleneBiguanide (PHMB). | ASAP OTC Wound Dressingis a water based gel wounddressing that contains silverhydrosol that may inhibit thegrowth of microorganismswithin the dressing. | Prontosan Wound Gel X is aready to use, clear, odorless,amorphous hydrogel wounddressing that helps maintain aclean, moist woundenvironment. The gel matrixincludes the preservative,polyhexanide, a viscositymodifying agent and a betainesurfactant. Gel X is suppliedsterile in blind ended, heatsealed polyfoil 250g tubesfined with PP screw caps. |
| polymeric solution whichforms a uniform film whenapplied to minor wounds anddamaged skin. The product isdispersed in a unique non-cytotoxic, non-stingingsolution via a standard 28mL pump spray bottle. Theproduct is biocompatible,non-stinging, fast drying, andhas low friction.Antimicrobial Barrier FilmDressing protects minorwounds and damaged skin byproviding a secure,breathable, waterproofbarrier to externalcontaminates. The filmdressing is colorless,transparent, and possessesgood oxygen and moisturevapor permeability.The antimicrobial PHMB ata concentration of 0.001%w/w is added to the productas a preservative to inhibitthe growth ofmicroorganisms within theproduct. | The high moisture content gelcontains a base matrixcomposed of hydrophilic andbuffering compounds andcontains silver fromAmerican Biotech Labs'proprietary silver hydrosolsuspension.ASAP OTC Wound Dressingis supplied in a multi-dose gelpump and a tube (collapsible,low-density polyethylenelined metal tube, sealed onone end and fitted with a popopen screw cap on the otherend). | ||||
| Performance data submittedin support of this 510kincluded in-vitro testing. | Performance data submitted insupport of this 510k includedin-vitro and animal testing. | All necessary verification andvalidation testing has beenperformed for the PolyFIT+Absorbing AntimicrobialDressings to assure substantialequivalence to the predicatedevices. | Performance data submittedin support of this 510kincluded in-vitro and animaltesting. | Biocompatibility andperformance testing wasperformed with ProntosanWound Gel X to supportsubstantial equivalence tothe predicate devices.Biocompatibility testing wasperformed in accordance withISO 10993-1. Performancetesting completed includedUSP $<51>$ and a StrikeThrough Barrier Test. Testresults met the acceptancecriteria. | |
| Performance | As a preservative, broadspectrum activity wasdemonstrated against 5organisms including Grampositive, Gram negative, andfungal types. Total kill wasachieved for 24 hours at >6log of each organism:P. aeruginosa E. coli C. albicans S. aureus A. brasiliensis | Broad spectrum activity wasdemonstrated against 6organisms including Grampositive, Gram negative, andfungal types. Total kill wasachieved for 7 consecutivedays, with a daily challenge of>6 log of each organism:P. aeruginosa E. coli C. albicans S. epidermidis S. aureus E. faecalis |
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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".
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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 copolymerHexamethyldisiloxane2,2,4-TrimethylpentaneWaterDocusate sodiumPolyhexamethylenebiguanide (PHMB) | Polyurethane foamPolyhexamethylene biguanide(PHMB) | Polyethylene oxide (PEO)Polyethylene-co-vinyl-alcohol(EVOH)Polycaprolactone(PCL)Polyhexamethylene biguanide(PHMB) | Carbopol ETD 2020WaterTriethanolamine (TEA)ASAP Solution | Hydroxyethylcellulose GlycerolWaterBetaine surfactantPolyhexanide (PHMB) |
|---|---|---|---|---|---|
| Bio-compatibility | ISO 10993 parts 1,5, and 10 | ISO 10993 parts 1, 5, 10 | All necessary verification andvalidation testing has beenperformed for the PolyFIT+Absorbing AntimicrobialDressings | ISO 10993 parts 1, 5, 10 | ISO 10993 parts 1, 5, 10 |
| Sterility | Non-sterile product that ispreserved using PHMB. | Sterilized using ETO laterchanged to gamma irradiation(see K082296). | Sterile | Non-sterile | Sterile using steamsterilization |
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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.
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- 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.
N/A