(256 days)
No
The device description and performance studies focus on the physical properties and antimicrobial effectiveness of a wound dressing, with no mention of AI or ML.
Yes.
The device functions as a dressing for wound management by providing a moist environment, managing exudate, and offering antimicrobial activity, all of which contribute to the healing process of various wounds. These actions are directly aimed at improving a health condition.
No
The device is described as a wound dressing intended for management of exuding acute and chronic wounds. Its function is to provide a moist wound environment, manage exudate, and offer antimicrobial properties, which are all therapeutic or supportive actions, not diagnostic ones.
No
The device description clearly outlines physical components (polyurethane film, absorbing pad, silicone adhesive bi-layer, protective film) and mentions sterilization and physical performance testing, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a moist wound environment and manage exudate for wound healing. This is a therapeutic and wound care function, not a diagnostic one.
- Device Description: The description details the physical components of a wound dressing designed for absorption and antimicrobial activity. It does not describe any components or processes for analyzing biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on properties relevant to wound dressings, such as shelf life, packaging integrity, biocompatibility, absorption, wear time, waterproofness, conformability, ease of release, and antimicrobial effectiveness. These are not diagnostic performance metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
In summary, the device is a wound dressing with antimicrobial properties, which falls under the category of medical devices used for treatment and management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds.
Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The device is available as sterile, single use only. The device is intended to provide a moist environment and exudate management of acute and chronic wounds. The device maintains a moist wound providing the optimal environment for wound healing.
The device consists of:
- Polyurethane (PU) top film - a 25 um semi-permeable barrier, printed with grey dots.
- . Absorbing pad - composed of a 3.0 mm PU foam containing an anti-bacterial silver complex (silver sodium hydrogen zirconium phosphate).
- Silicone adhesive bi-layer composed of a middle PU film . with a silicone adhesive gel. The PU top film and the middle PU film are laminated together at the border.
- . Protective film - composed of three or five parts; the center part and the remaining side parts.
The device:
- . contains a silver compound (silver sodium hydrogen zirconium phosphate). In vitro testing demonstrated that Biatain® Silicone Ag has an antimicrobial effect in the dressing against the following strains of 3 gram positive bacteria, 3 gram negative bacteria, 1 yeast, and 1 mold: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. The dressing sustains antimicrobial activity for up to 7 days.
The device may be used in hospitals, healthcare facilities, and home care.
Sterilized using ethylene oxide (EO).
Prescription Use Only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, healthcare facilities, and home care
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)
Performance testing for the Biatain® Silicone Ag device was conducted according to applicable sections of voluntary standards in order to document the following properties of the subject device. The proposed changes do not impact the performance specifications: Real Time and Accelerated Aged shelf life testing [per ASTM F1980-07 (2011)] Packaging transportation and integrity testing per ASTM D4169-16 Biocompatibility according to ISO 10993-1 (2009) Free swelling absorptive capacity, wear time, border permeability, and Fluid Handling Capacity (absorption and moisture vapour transmission rate) per EN 13726-1:2002/AC2003 Waterproofness per EN 13726-3:2002 Dynamic Friction of the PU Film per EN ISO 8295 1 2004 Conformability to body per EN 13726-4:2003 Ease of release - peel adhesion per ASTM D3330/D3330M-04 Method A Antimicrobial effectiveness per modified ATTCC 100:2012. All tests passed the pre-determined acceptance criteria. No clinical data was required to support substantial equivalence.
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
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2020
Coloplast A/S Lykke Forchhammer Director of RA Holtedam 1 Humlebaek, 3050 Dk
Re: K191536
Trade/Device Name: Biatain Silicone Ag Regulatory Class: Unclassified Product Code: FRO Dated: January 16, 2020 Received: January 21, 2020
Dear Lykke Forchhammer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191536
Device Name Biatain Silicone Ag
Indications for Use (Describe)
Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds.
Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------- |
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3
5. TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/S
Holtedam 1
3050 Humlebaek
Denmark |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lykke Forchhammer
Director of RA Innovation and Market Expansion
Coloplast A/S
Holtedam 1
3050 Humlebaek
Denmark
Telephone: 0045-49111271
Email: dklfo@coloplast.com |
| Date of Summary: | 21 February 2020 |
| Trade or Proprietary
Name: | Biatain® Silicone Ag |
| Common or Usual Name: | Dressing, Wound, Drug |
| Classification and CFR: | Unclassified |
| Product Code: | FRO |
| Review Panel: | General and Plastic Surgery |
| Predicate Device: | K100218, Biatain® Ag (Coloplast A/S) |
| Reference Device: | K120828, Biatain® Silicone Ag (Coloplast A/S) |
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Device Description: The device is available as sterile, single use only. The device is intended to provide a moist environment and exudate management of acute and chronic wounds. The device maintains a moist wound providing the optimal environment for wound healing.
The device consists of:
- Polyurethane (PU) top film - a 25 um semi-permeable barrier, printed with grey dots.
- . Absorbing pad - composed of a 3.0 mm PU foam containing an anti-bacterial silver complex (silver sodium hydrogen zirconium phosphate).
- Silicone adhesive bi-layer composed of a middle PU film . with a silicone adhesive gel. The PU top film and the middle PU film are laminated together at the border.
- . Protective film - composed of three or five parts; the center part and the remaining side parts.
The device:
- . contains a silver compound (silver sodium hydrogen zirconium phosphate). In vitro testing demonstrated that Biatain® Silicone Ag has an antimicrobial effect in the dressing against the following strains of 3 gram positive bacteria, 3 gram negative bacteria, 1 yeast, and 1 mold: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. The dressing sustains antimicrobial activity for up to 7 days.
The device may be used in hospitals, healthcare facilities, and home care.
Sterilized using ethylene oxide (EO).
Prescription Use Only.
5
Biatain® Silicone Ag is intended to provide a moist wound Indications for Use: environment and exudate management of acute and chronic wounds. Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and postoperative wounds. Technological The subject device is substantially equivalent to the predicate Characteristics: device based upon the information below.
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| | Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Coloplast A/S | Same | Same |
| 510(k) Number | K191536 | K100218 | K120828 |
| Regulatory Class | Unclassified | Same | Same |
| Classification Name | Dressing, Wound, Drug | Same | Same |
| Product Code | FRO | Same | Same |
| Intended Use | Biatain® Silicone Ag is intended to
provide a moist wound environment and
exudate management. | Same | Same |
| | Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag |
| Indications for
Use | Biatain® Silicone Ag is intended to
provide a moist wound environment and
exudate management of acute and
chronic wounds.
Biatain® Silicone Ag is indicated for
the management of exuding leg and foot
ulcers, pressure ulcers, diabetic foot
ulcers, superficial and partial thickness
burns, donor sites, and, traumatic and
post-operative wounds. | Biatain Ag foam dressings are indicated for
wounds with moderate to high amounts of
exudate, including leg ulcers and Category II-
IV pressure ulcers with delayed healing due to
bacteria, or where there is a risk of infection.
Biatain Ag foam dressings may be used for
second-degree burns, donor sites,
postoperative wounds and skin abrasions with
delayed healing due to bacteria, or where
there is a risk of infection. Biatain Ag non-
adhesive foam dressings are additionally
indicated for diabetic foot ulcers. Biatain Ag
foam dressings may reduce odor caused by
micro-organisms in the wound. Biatain Ag
foam dressings may be used to support moist
wound healing on patients who are in
treatment for a local or systemic infection
under the discretion of a healthcare
professional. Depending on the prognosis of
the wound, Biatain Ag foam dressings may be
used throughout the healing process to
provide protection for the indicated types of
wounds. Biatain Ag foam dressings are
suitable for use in combination with
compression therapy. Biatain Ag foam
filler/cavity is indicated for deep exuding
wounds, including leg ulcers, pressure ulcers,
diabetic foot ulcers and acute wounds. | Biatain® Silicone Ag Foam
Dressings are indicated for the
management of moderately to
highly exuding leg ulcers and
pressure sores. The dressing can
also be used for 2nd degree burns,
donor sites, postoperative wounds,
and skin abrasions. |
| Prescription
Device | Yes | Same | Same |
| Single Use | Yes | Same | Same |
| Sterile Device | Yes | Same | Same |
| Method of | EO | Irradiated | Same (EO) |
| Sterilization | SAL 10-6 | SAL 10-6 | SAL 10-6 |
| | Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag |
| Recommended
Wear Time | Up to 7 days. Repeated use of the
device should not exceed 30 days | Same | Same |
| Shelf Life | 2-years | 3-years | 3-years |
| Silver (Ag) | Silver Compound (Ionic)
[silver sodium hydrogen zirconium
phosphate] | Same | Same |
| Silver Content | 0.95 mg/cm2 | Same | Same |
| Silver Release
(within the
dressing) | 24 h: 207 – 367 µg/cm2
48 h: 350 – 589 µg/cm2
72 h: 439 – 726 µg/cm2
96 h: 500 – 813 µg/cm2
168 h: 591 – 937 µg/cm2 | Same | Same |
| | Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag |
| Antimicrobial
Effectiveness
within the
Dressing | Fulfills both ≥4 log reduction (AATCC
100) as described below:
Fulfills ≥4 log reduction (AATCC 100)
for antimicrobial effect against 3 gram
positive bacteria, 3 gram negative
bacteria, 1 yeast, and 1 mold:
Staphylococcus aureus, Enterococcus
faecalis, Streptococcus pyogenes,
Proteus mirabilis, Klebsiella
pneumoniae, Escherichia coli,
Aspergillus brasiliensis and
Meyerozyma guilliermondii . | Effective antimicrobial activity within
the dressing. | Effective antimicrobial activity
within the dressing. |
| Primary
Packaging | Paper/Polyester Film | Biatain® Ag Non-adhesive: White
Polyester Film/Transparent Polyester
Film
Biatain® Ag Adhesive: Foil | Tyvek/Transparent Foil |
| | Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag |
| Top Film | Vapor permeable polyurethane (PU) top
film | Same | Same |
| Pigment:
Top Film
Colorant | CI Pigment Black 7
Titanium dioxide
Aluminum hydroxide | Black iron oxide
Titanium dioxide
C.I Pigment Black 7 | Black iron oxide
Titanium dioxide |
| Pigment:
Top Film Dots | C.I. Pigment White 6
C.I. Pigment Black 7
Titanium chelates
Aluminum oxide | Not Applicable | Not Applicable |
| Pigment:
Top Film Logo | CI Pigment Black 7 | Not Applicable | Not Applicable |
| Absorbaent
Polyurethane
Foam with Silver
Compound | Polyurethane (PU) foam with silver
complex (silver sodium hydrogen
zirconium phosphate) | Same | Same and contains hotmelt
Pressure Sensitive Adhesive (PSA) |
| Polyurethane
Foam Thickness | 3.0 mm PU foam with silver complex | 3.0 mm and 4.4 mm PU foam with silver
complex | Same (3.0 mm PU foam with
silver complex) |
| Adhesive Bilayer | Silicone adhesive bi-layer across the
device with perforations across the
absorbent pad | Biatain® Ag Non-adhesive Dressings
have no adhesive layer.
Biatain® Ag Adhesive: Hydrocolloid
adhesive border | Perforated Silicone adhesive bi-
layer on the border |
| Protective Film
(Release Liner) | Polypropylene (PP)
3 and 5-piece design | Polyethylene (PE)
2 and 3-piece design | Polyethylene (PE)
3-piece design |
| Device Sizes and
Shapes. | Square:
7.5 x 7.5 cm
10 x 10 cm
12.5 x 12.5 cm
15 x 15 cm
17.5 x 17.5 cm | Square:
10 x 10 cm (non-adhesive)
12.5 x 12.5 cm (adhesive)
15 x 15 cm (non-adhesive)
18 x 18 cm (adhesive)
20 x 20 cm (non-adhesive) | Square:
7.5 x 7.5 cm
10 x 10 cm
12.5 x 12.5 cm |
| Subject Device
Biatain® Silicone Ag | Predicate Device
Biatain® Ag | Reference Device:
Biatain® Silicone Ag | |
| Rectangle:
10 x 20 cm
10 x 30 cm | Rectangle:
5 x 7 cm
10 x 20 cm | Not Applicable | |
| Heel:
18 x 18 cm | Heel:
19 x 20 cm | Not Applicable | |
| Sacral:
15 x 19 cm
25 x 25 cm | Sacral:
23 x 23 cm | Not Applicable | |
7
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9
10
11
12
| Performance Data: | Performance testing for the Biatain® Silicone Ag device was
conducted according to applicable sections of voluntary standards
in order to document the following properties of the subject device.
The proposed changes do not impact the performance
specifications:
Real Time and Accelerated Aged shelf life testing [per ASTM F1980-07 (2011)] Packaging transportation and integrity testing per ASTM D4169-16 Biocompatibility according to ISO 10993-1 (2009) Free swelling absorptive capacity, wear time, border permeability, and Fluid Handling Capacity (absorption and moisture vapour transmission rate) per EN 13726-1:2002/AC2003 Waterproofness per EN 13726-3:2002 Dynamic Friction of the PU Film per EN ISO 8295 1 2004 Conformability to body per EN 13726-4:2003 Ease of release - peel adhesion per ASTM D3330/D3330M-04 Method A Antimicrobial effectiveness per modified ATTCC 100:2012 All tests passed the pre-determined acceptance criteria. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Data | No clinical data was required to support substantial equivalence. |
| Substantial Equivalence
Conclusion: | Based on the same intended use with no new patient population or
wound type, similar technological characteristics and materials,
and performance testing, Coloplast believes the proposed Biatain®
Silicone Ag is substantially equivalent to the predicate device
Biatain® Ag (K100218), and the reference device, Biatain®
Silicone Ag (K120828) |