(97 days)
No
The device description and intended use clearly describe a physical wound dressing with no mention of software, algorithms, or any technology related to AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is a dressing used for wound management, which is supportive care rather than a therapeutic device that actively treats disease or injury.
No
The device is a dressing used for wound management, not for diagnosing conditions. Its intended use is for treating various types of wounds, not for identifying diseases or conditions.
No
The device description clearly states it is a physical dressing made of polyurethane foam, film, and hydrocolloid adhesive, and it is sterilized by ß-irradiation, indicating it is a hardware device.
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 various types of wounds and burns. 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 wound dressing made of foam and adhesive. This is a physical barrier and absorbent material, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological fluids, tissues, or other samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the topical safety of the dressing, which is relevant to its use as a wound care product, not a diagnostic device.
Therefore, the Biatain Foam Adhesive 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 medium exudating leg ulcers, 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.
The Biatain Foam Adhesive Dressing is indicated 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 (comma separated list FDA assigned to the subject device)
79FRO, MGP
Device Description
The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive.
The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches 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 Adhesive Dressing has been established in the following studies:
The foam formulation:
In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2).
In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing the primary irritation index was 0.0.
In the test for delayed contact hypersensitivity test using the guinea pig maxi mation test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity.
The Adhesive
The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed.
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
DFC 6 1009
510(k) SUMMARY Biatain Foam Adhesive Dressing Page 1 of 3
Coloplast Corporation Submitter: 1. 1955 West Oak Circle Marietta, Georgia 30062-2249
Contact Person: Ms. Syd Lilly
Date of Preparation: July 30, 1998
-
- DEVICE NAME:
Proprietary Name: Biatain Foam Adhesive Dressing Topical Wound Dressing Common name: Classification Name: Wound Dressing
- DEVICE NAME:
DEVICE CLASSIFICATION: 3. Unclassified
PRODUCT CLASSIFICATION NUMBER: 79FRO 4.
5. PREDICATE DEVICE:
Tielle Hydropolymer Dressing (J&J Ltd. UK); 946245.
DEVICE DESCRIPTION: 6.
The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive.
The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches and sterilized by ß-irradiation.
The topical safety of Biatain Foam Adhesive Dressing has been established in the following studies:
The foam formulation:
In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2).
In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing the primary irritation index was 0.0.
1
K983173
510(k) SUMMARY Biatain Foam Adhesive Dressing Page 2 of 3
In the test for delayed contact hypersensitivity test using the guinea pig maxi mation test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity.
The Adhesive
The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed.
7. INTENDED USE:
For use in the management of low to medium exudating leg ulcers, 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 Adhesive Dressing is similar in composition, function, and inten ded use to other foam wound dressings, such as Tielle Hydropolymer Dressing (J&J Ltd. UK); K946245. A comparison is presented in the following Table.
2
|6983173
510(k) SUMMARY Biatain Foam Adhesive Dressing
| | Biatain Foam Adhesive
Dressing | Tielle Hydropolymer Dressing |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | Biatain Foam Adhesive
Dressing provides an exudate
handling system for low to
medium exudating wounds. It
is a highly absorbent 3-D
polymer dressing. It has a
hydrocolloid
adhesive and a central 3-D
polymer absorbent pad with a
waterproof semi-permeable
film backing | Tielle Hydropolymer Dressing
provides an exudate handling
system for low to moderate
exudating wounds. It is a highly
absorbent dressing. The
absorbent material is a synthetic
polymer. The island dressng
provides a moist wound
environment that aids in the
wound healing process. During
use the absorbent island gently
expands as it takes up exudate. |
| Sizes | 120x120 cm, 180x180 cm | 7x9 cm, 11x11 cm, 15x15 cm,
15x20 cm, 18x18 cm, 18x18 cm
sacrum |
| Use (single,
reusable
disposable) | Single | Single |
| Intended use | For use in the management of
low to medium exudating leg
ulcers, 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 abraisons.
It can be used for diabetic or
infected wounds under the | For use in the management of
both chronic and superficial, low
to moderate exudating wounds,
including the following: Pressure
sores (all stages) and venous
ulcers.
It is suitable for use under
compression bandaging |
| | supervision of a health care
professional.
Is suitable for use under | |
| | compression bandaging | |
| Sterility | Sterile | Sterile |
:
:
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 6 1998
Ms. M. Sydney Lilly Quality Assurance and Regulatory Affairs Manager Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249
Re: K983173
Trade Name: Biatain Foam Adhesive Dressing Regulatory Class: Unclassified Product Code: MGP Dated: November 4, 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 vour 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):
Device Name: Biatain Foam Adhesive Dressing
Indications for Use:
The Biatain Foam Adhesive Dressing is indicated 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Restorative Devices
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)