(17 days)
Not Found
No
The device description and supporting information focus solely on the physical components and antimicrobial properties of a wound dressing. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is a wound dressing containing silver to manage exuding wounds with a risk of infection, aiding in the healing process of various wound types like ulcers and burns. This addresses a medical condition (wounds) with the intent to heal or manage it, which falls under the definition of a therapeutic device.
No
The device is a wound dressing designed for the management of exuding wounds, not for diagnosing medical conditions. Its function is therapeutic (to help wounds heal), not diagnostic.
No
The device description clearly outlines physical components like foam, films, adhesives, and a release liner, indicating it is a physical wound dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds (leg ulcers, pressure sores, burns, etc.). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing designed to absorb exudate and provide an antimicrobial barrier. It does not perform any tests on biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Anatomical Site: The anatomical sites are external wounds, not internal body fluids or tissues typically used for in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part.
The foam contains silver, which is released upon contact with wound exudate.
The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers.
The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.
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.
Not Found
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
K120828
page 1 of 2
510(k) Summary
APR - 5 2012
Biatain Silicone Ag Foam Dressings
The assigned 510(k) number is:
510(k) Owner's Name:
Coloplast A/S
Contact Person:
Rebeka A. Stoltman Manager, Regulatory Affairs Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411
(612) 302-4997 Telephone: Facsimile: (612) 287-4138 Email: usrst@coloplast.com
Date Prepared:
March 16, 2012
Device Name and Classification
Trade Name: Common Name: Classification: Classification Name: Product Code:
Biatain Silicone Ag Foam Dressings Topical Wound Dressing Unclassified; 21 CFR § 878.4020 Dressing, Wound, Drug FRO
Manufacturer
Coloplast A/S Holtedam 1 3050 Humlebaek, Denmark
Establishment Registration: 9610694 Owner/Operator: 8010144
Biatain Silicone Ag Foam Dressing
-Confidential-
Page 322 of 324
1
· Device Description
Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part.
The foam contains silver, which is released upon contact with wound exudate.
The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers.
The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.
Substantial Equivalence Claim
The modified Coloplast Biatain Silicone Ag Foam Dressings are substantially equivalent in performance, indications, design and materials to Coloplast's currently marketed Biatain Ag Adhesive Dressings, which were cleared under 510(k) K100218.
Indications for Use
Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.
Summary & Conclusions of the Nonclinical Tests Submitted
Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S % Coloplast Corporation Ms. Rebeka Stoltman 1601 West River Road North Minneapolis, Minnesota 55411
Re: K120828
Trade/Device Name: Biatain Silicone Ag Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 16, 2012 Received: March 19, 2012
Dear Ms. Stoltman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
APR - 5 2012
3
Page 2 - Ms. Rebeka Stoltman
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erine D. Keith
C. Mark N. Malkerson
- Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120828
Device Name: Biatain Silicone Ag Foam Dressing
Indications for Use:
Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120928