(256 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for a wound dressing called Biatain® Silicone Ag. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing clinical studies to prove effectiveness.
Therefore, the document does not contain information about acceptance criteria for an AI/CADe device, nor does it describe a study proving the device meets such criteria. The acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are all relevant to the evaluation of AI/CADe systems, but are not applicable to the information contained within this 510(k) submission for a wound dressing.
The document describes material properties, sterilization methods, and antimicrobial effectiveness of the wound dressing itself, not an AI system.
However, I can extract the performance data and "acceptance criteria" (which are actually performance specifications) relevant to the wound dressing as described in the document, and then explain why this information doesn't fit the template for an AI/CADe device.
Based on the provided document, here's information related to the Biatain® Silicone Ag wound dressing, organized to address your request as much as possible, while clarifying its irrelevance to AI/CADe devices:
This device is a wound dressing, not an AI/CADe system. Therefore, the questions related to AI/CADe device performance (e.g., sample size for test/training sets, expert involvement, MRMC studies, standalone algorithm performance) are not applicable to this 510(k) submission.
The acceptance criteria listed below are for the physical and biological properties of the wound dressing and its components, not for the performance of an artificial intelligence algorithm in diagnosing or detecting medical conditions.
1. Table of Acceptance Criteria and the Reported Device Performance (for the Biatain® Silicone Ag Wound Dressing):
| Acceptance Criteria Category | Specific Test/Property | Acceptance Criteria (Implied/Stated by "All tests passed...") | Reported Device Performance |
|---|---|---|---|
| Shelf Life | Real Time and Accelerated Aged shelf life testing | Meet established shelf life requirements | Passed (device designed for 2-years shelf life) |
| Packaging Integrity | Packaging transportation and integrity testing | Maintain sterility and package integrity | Passed |
| Biocompatibility | Biocompatibility according to ISO 10993-1 | Biocompatible, non-toxic, non-irritating, non-sensitizing | Passed |
| Absorption and Fluid Handling | Free swelling absorptive capacity | Meet expected fluid absorption capacity | Passed |
| Border permeability | Maintain appropriate permeability characteristics | Passed | |
| Fluid Handling Capacity (absorption & MVTR) | Optimal fluid management and moisture vapor transmission rates | Passed | |
| Waterproofness | Waterproofness per EN 13726-3 | Prevent external fluid penetration | Passed |
| Abrasion/Friction | Dynamic Friction of the PU Film per EN ISO 8295 1 2004 | Appropriate friction characteristics for the top film | Passed |
| Conformability | Conformability to body per EN 13726-4 | Conform to body contours effectively | Passed |
| Adhesive Release | Ease of release - peel adhesion per ASTM D3330/D3330M | Optimal peel adhesion for ease of application and removal | Passed |
| Antimicrobial Effectiveness (within the dressing) | Modified ATTCC 100:2012 | Fulfills ≥4 log reduction for specified microbes | Passed: Achieves ≥4 log reduction for: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. Additionally, sustains antimicrobial activity for up to 7 days. |
Statement from the document: "All tests passed the pre-determined acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes performance testing of a physical medical device (wound dressing), not an AI/CADe system. The performance tests were likely conducted on specific numbers of dressing samples in a laboratory setting, but this is not equivalent to a "test set" for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, in the context of an AI/CADe system, refers to definitive labels or diagnoses provided by experts (e.g., radiologists interpreting images, pathologists analyzing tissue). For a wound dressing, "ground truth" would refer to the accurate measurement of physical properties, adhesion, or microbiological action in a lab, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for AI ground truth labeling.
5. 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:
This information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This document concerns a wound dressing, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This refers to the performance of an AI algorithm intrinsically, without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the wound dressing, the "ground truth" for these tests are laboratory measurements and adherence to established international and national standards (e.g., ASTM, EN, ISO) for material properties, sterility, and antimicrobial effectiveness. This is based on objective scientific measurement rather than clinical outcomes or expert interpretation of diagnostic data.
8. The sample size for the training set:
This information is not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable. No training set exists for this type of device.
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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
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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
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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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5. TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/SHoltedam 13050 HumlebaekDenmark |
|---|---|
| Contact Person: | Lykke ForchhammerDirector of RA Innovation and Market ExpansionColoplast A/SHoltedam 13050 HumlebaekDenmarkTelephone: 0045-49111271Email: dklfo@coloplast.com |
| Date of Summary: | 21 February 2020 |
| Trade or ProprietaryName: | 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.
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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 DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® 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 toprovide a moist wound environment andexudate management. | Same | Same |
| Subject DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® Ag | Reference Device:Biatain® Silicone Ag | |
| Indications forUse | Biatain® Silicone Ag is intended toprovide a moist wound environment andexudate management of acute andchronic wounds.Biatain® Silicone Ag is indicated forthe management of exuding leg and footulcers, pressure ulcers, diabetic footulcers, superficial and partial thicknessburns, donor sites, and, traumatic andpost-operative wounds. | Biatain Ag foam dressings are indicated forwounds with moderate to high amounts ofexudate, including leg ulcers and Category II-IV pressure ulcers with delayed healing due tobacteria, or where there is a risk of infection.Biatain Ag foam dressings may be used forsecond-degree burns, donor sites,postoperative wounds and skin abrasions withdelayed healing due to bacteria, or wherethere is a risk of infection. Biatain Ag non-adhesive foam dressings are additionallyindicated for diabetic foot ulcers. Biatain Agfoam dressings may reduce odor caused bymicro-organisms in the wound. Biatain Agfoam dressings may be used to support moistwound healing on patients who are intreatment for a local or systemic infectionunder the discretion of a healthcareprofessional. Depending on the prognosis ofthe wound, Biatain Ag foam dressings may beused throughout the healing process toprovide protection for the indicated types ofwounds. Biatain Ag foam dressings aresuitable for use in combination withcompression therapy. Biatain Ag foamfiller/cavity is indicated for deep exudingwounds, including leg ulcers, pressure ulcers,diabetic foot ulcers and acute wounds. | Biatain® Silicone Ag FoamDressings are indicated for themanagement of moderately tohighly exuding leg ulcers andpressure sores. The dressing canalso be used for 2nd degree burns,donor sites, postoperative wounds,and skin abrasions. |
| PrescriptionDevice | 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 DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® Ag | Reference Device:Biatain® Silicone Ag | |
| RecommendedWear Time | Up to 7 days. Repeated use of thedevice should not exceed 30 days | Same | Same |
| Shelf Life | 2-years | 3-years | 3-years |
| Silver (Ag) | Silver Compound (Ionic)[silver sodium hydrogen zirconiumphosphate] | Same | Same |
| Silver Content | 0.95 mg/cm2 | Same | Same |
| Silver Release(within thedressing) | 24 h: 207 – 367 µg/cm248 h: 350 – 589 µg/cm272 h: 439 – 726 µg/cm296 h: 500 – 813 µg/cm2168 h: 591 – 937 µg/cm2 | Same | Same |
| Subject DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® Ag | Reference Device:Biatain® Silicone Ag | |
| AntimicrobialEffectivenesswithin theDressing | Fulfills both ≥4 log reduction (AATCC100) as described below:Fulfills ≥4 log reduction (AATCC 100)for antimicrobial effect against 3 grampositive bacteria, 3 gram negativebacteria, 1 yeast, and 1 mold:Staphylococcus aureus, Enterococcusfaecalis, Streptococcus pyogenes,Proteus mirabilis, Klebsiellapneumoniae, Escherichia coli,Aspergillus brasiliensis andMeyerozyma guilliermondii . | Effective antimicrobial activity withinthe dressing. | Effective antimicrobial activitywithin the dressing. |
| PrimaryPackaging | Paper/Polyester Film | Biatain® Ag Non-adhesive: WhitePolyester Film/Transparent PolyesterFilmBiatain® Ag Adhesive: Foil | Tyvek/Transparent Foil |
| Subject DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® Ag | Reference Device:Biatain® Silicone Ag | |
| Top Film | Vapor permeable polyurethane (PU) topfilm | Same | Same |
| Pigment:Top FilmColorant | CI Pigment Black 7Titanium dioxideAluminum hydroxide | Black iron oxideTitanium dioxideC.I Pigment Black 7 | Black iron oxideTitanium dioxide |
| Pigment:Top Film Dots | C.I. Pigment White 6C.I. Pigment Black 7Titanium chelatesAluminum oxide | Not Applicable | Not Applicable |
| Pigment:Top Film Logo | CI Pigment Black 7 | Not Applicable | Not Applicable |
| AbsorbaentPolyurethaneFoam with SilverCompound | Polyurethane (PU) foam with silvercomplex (silver sodium hydrogenzirconium phosphate) | Same | Same and contains hotmeltPressure Sensitive Adhesive (PSA) |
| PolyurethaneFoam Thickness | 3.0 mm PU foam with silver complex | 3.0 mm and 4.4 mm PU foam with silvercomplex | Same (3.0 mm PU foam withsilver complex) |
| Adhesive Bilayer | Silicone adhesive bi-layer across thedevice with perforations across theabsorbent pad | Biatain® Ag Non-adhesive Dressingshave no adhesive layer.Biatain® Ag Adhesive: Hydrocolloidadhesive 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 andShapes. | Square:7.5 x 7.5 cm10 x 10 cm12.5 x 12.5 cm15 x 15 cm17.5 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 cm10 x 10 cm12.5 x 12.5 cm |
| Subject DeviceBiatain® Silicone Ag | Predicate DeviceBiatain® Ag | Reference Device:Biatain® Silicone Ag | |
| Rectangle:10 x 20 cm10 x 30 cm | Rectangle:5 x 7 cm10 x 20 cm | Not Applicable | |
| Heel:18 x 18 cm | Heel:19 x 20 cm | Not Applicable | |
| Sacral:15 x 19 cm25 x 25 cm | Sacral:23 x 23 cm | Not Applicable |
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| Performance Data: | Performance testing for the Biatain® Silicone Ag device wasconducted according to applicable sections of voluntary standardsin order to document the following properties of the subject device.The proposed changes do not impact the performancespecifications: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 EquivalenceConclusion: | Based on the same intended use with no new patient population orwound type, similar technological characteristics and materials,and performance testing, Coloplast believes the proposed Biatain®Silicone Ag is substantially equivalent to the predicate deviceBiatain® Ag (K100218), and the reference device, Biatain®Silicone Ag (K120828) |
N/A