(155 days)
No
The device description and performance studies focus on the physical and chemical properties of a film dressing, with no mention of AI or ML.
No.
The primary purpose of the device is to form a protective barrier on minor wounds and damaged skin, acting more as a wound dressing than as a therapeutic device designed to treat a specific medical condition. The antimicrobial agent is stated to be a preservative to inhibit the growth of microorganisms within the product itself.
No
This device is a film dressing intended to create a waterproof barrier for minor wounds and damaged skin, protecting them from external contaminants. It does not perform any diagnostic function.
No
The device is a physical product (polymeric solution in a spray bottle) intended for topical application, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for application to minor wounds and damaged skin as a barrier and dressing. This is a topical application for wound care, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a polymeric solution that forms a film on the skin. It's a physical barrier and contains a preservative. This aligns with a wound dressing, not a diagnostic test.
- Performance Studies: The performance studies focus on the antimicrobial effectiveness of the preservative within the product and biocompatibility testing. These are relevant to a wound care product, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the Atteris Antimicrobial Barrier Film Dressing is a wound care product, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
minor wounds and damaged 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 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.
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
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.
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
N/A
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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.
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 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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510(k) Summary - K161212
-
- Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd, Ste B200 San Antonio, Texas, 78249
-
- Submitter's Contact Person William J. Coulston Quality and Regulatory Affairs
(210) 870-6534 wcoulston@rochalindustries.com
-
- Date of 510(k) Summary Preparation: 29 September 2016
-
- Device Name (Proprietary) Atteris™ Antimicrobial Barrier Film Dressing
-
- Common Name Wound Dressing
-
- Classification Name Dressing, Wound, Drug
-
- Device Class Unclassified
-
- Device Code FRO
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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 $$ 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 | | | |
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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/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.
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| 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 |
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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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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.