(97 days)
Not Found
No
The document describes a passive wound dressing and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The Biatain Foam Dressing is a wound dressing used for managing wounds by absorbing exudate and protecting the wound. Its function is primarily supportive and protective in the healing process, rather than actively therapeutic in the sense of delivering a drug, altering a physiological function in a sophisticated way, or treating a disease itself through direct intervention beyond wound management.
No
The device is a foam dressing used for wound management, not for diagnosing conditions.
No
The device description clearly states it is a physical foam dressing made of polyurethane foam and film, indicating it is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of wounds (ulcers, skin tears, burns, etc.). This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a foam dressing, which is a physical barrier and absorbent material applied to the body. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on topical safety and irritation, which are relevant for a wound dressing applied to the skin, not for an IVD.
Therefore, the Biatain Foam Dressing is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
Product codes
79FRO, MGP
Device Description
The Biatain Foam Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks.
The dressing is supplied in two sizes:10x10 cm (3410) and 15x15 cm (3413). The dressings are packaged in individual blister packaging and sterilized by ß-irradiation.
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)
The topical safety of Biatain Foam Dressing has been established in the following studies:
In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing (the foam formulation) were shown to be non-cytotoxic (cytotoxicity grad ≤2).
In the intracutanous test in the rabbit of the Biatain Foam Dressing (the foam formulation) the primary irritation index was 0.0.
In the test for delayed contact hypersensitivity test using the quinea pig maximation test, the Biatain Foam Dressing (the foam formulation) showed no evidence of delayed contact hypersensitivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEC 1 6 1998
Biatain Foam Dressing 510(k) SUMMARY Page 1 of 3
- Coloplast, Inc. l. Submitter: 1955 West Oak Circle Marietta, Georgia 30062-2249
Ms. Syd Lilly Contact Person:
Date of Preparation: 30 July 1998
-
- DEVICE NAME:
| Proprietary Name: | Biatain Foam Dressing |
|---|---|
| Common name: | Topical Wound Dressing |
| Classification Name: | Wound Dressing |
-
- DEVICE CLASSIFICATION: Unclassified
-
- PRODUCT CLASSIFCATION: 79FRO
5. PREDICATE DEVICE:
Allevyn hydrocellular polyurethane dressing (Smith & Nephew Ltd. UK); K871166.
6. DEVICE DESCRIPTION:
The Biatain Foam Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks.
The dressing is supplied in two sizes:10x10 cm (3410) and 15x15 cm (3413). The dressings are packaged in individual blister packaging and sterilized by ß-irradiation.
The topical safety of Biatain Foam Dressing has been established in the following studies:
In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing (the foam formulation) were shown to be non-cytotoxic (cytotoxicity grad ≤2).
In the intracutanous test in the rabbit of the Biatain Foam Dressing (the foam formulation) the primary irritation index was 0.0.
In the test for delayed contact hypersensitivity test using the quinea pig maximation test, the Biatain Foam Dressing (the foam formulation) showed no evidence of delayed contact hypersensitivity.
1
K983163
Biatain Foam Dressing 510(k) SUMMARY Page 2 of 3
INTENDED USE: 7.
For use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
COMPARISON TO PREDICATE DEVICE 8.
Biatain Foam Dressing is similar in composition, function, and intended use to other foam wound dressings, such as Allevyn hydrocellular polyurethane dressing (Smith & Nephew Ltd. UK); K871166. A comparison is presented in the following Table.
2
16983163
Biatain Foam Dressing
| Biatain Foam Dressing | Allevyn Hydrocellular polyurethane dressing | |
|---|---|---|
| Device description | Biatain Foam Dressing provides an exudate handling system for low to highly exudating wounds. It is a highly absorbent 3-D polymer dressing. It is especially suitable for use on fragile skin due to the absence of adhesive. | Allevyn Hydrocellular dressing combines an absorbent hydrocellular pad sandwiched between a perforated non-adherent wound contact layer and a waterproof outer film. The absence of the adhesive makes it especially suitable for use on fragile skin. |
| Sizes | 10x10 cm, 15x15 cm | 5x5 cm, 10x10cm, 10x20cm, 15x15cm, 20x20 cm |
| Use (single, reusable disposable) | Single | Single |
| Intended use | For use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. Can also be used for management of 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions. It is suitable for use with compression therapy. It can be used for diabetic or infected wounds under the supervision of a health care professional. | For wound management by secondary intention on shallow, granulating wounds. It can cut, especially to dress wounds on heel, elbows and other awkward areas. It can be used in conjunction with compression therapy on venous leg ulcers. |
| Sterility | Sterile | Sterile |
ूर्
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Ms. M. Sydney Lilly Quality Assurance and Regulatory Affairs Manager Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249
K983163 Re:
Trade Name: Biatain Foam Dressing Regulatory Class: Unclassified Product Code: MGP Dated: October 29, 1998 Received: November 17, 1998
Dear Ms. Lilly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
4
Page 2 - Ms. M. Sydney Lilly
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K983163
Device Name:Biatain Foam Dressing
Indications for Use:
The Biatain Foam Dressing is indicated for use in the management of low to highly r no blatting leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoledo
ral Restorative Devi
Prescription Use
(Per 21 CFR 801.109
OR Over-The-Counter Use
(Optional Format 1-2-96)