(53 days)
Not Found
Not Found
No
The summary describes a standard wound dressing with no mention of AI or ML capabilities. The device description focuses on the physical properties of the dressing.
Yes.
The device is a wound dressing intended to provide a moist wound healing environment, facilitate autolytic debridement, and act as a barrier to bacteria and contaminants, all of which are direct therapeutic actions to promote healing.
No
The device is a wound dressing designed to protect wounds and facilitate healing, not to diagnose medical conditions.
No
The device description clearly states it is a physical wound dressing made of polyurethane film and adhesive, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- BioDerm BTF Wound Dressing Function: The BioDerm BTF Wound Dressing is a topical dressing applied directly to the body to cover and protect wounds, maintain a moist healing environment, and provide a barrier to contaminants. It does not perform any tests on samples taken from the body.
The description clearly indicates its use as a physical barrier and wound management tool applied externally, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement.
OTC Indications for Use:
- Abrasions, lacerations, minor/superficial cuts;
- Minor scalds, minor burns;
- Minor irritations to the skin
Under the Care of a Health Care Professional:
- Leg ulcers, pressure ulcers (stages I and II);
- Surgical wounds (post operative wounds, donor sites);
- 1st and 2nd degree burns;
- Cover and protect catheter sites and wounds;
- Securement of medical appliances;
- Catheter securing device;
- Dermal lesions:
- Non-exuding to minimally exuding wounds
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
The BioDerm BTF Thin Film Wound Dressing is a sterile thin film dressing which consists of a polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is a transparent dressing which is permeable to moisture vapor and oxygen and intended to provide a moist wound healing environment to facilitate the normal wound healing process. The BTF Thin Film Wound Dressing provides a barrier to bacteri and external contaminates.
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
Over-the-counter use and under the care of a health care professional.
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)
Biocompatibility testing was performed in accordance with ISO 10993-1: 1995 "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" and the Draft Guidance for the Preparation of a Premarket Notification for a Non-interactive Wound Dressing. Testing included: Primary Dermal Irritation, Sensitization, Cytotoxicity, and Repeated Insult Patch Test.
Based upon the results of biocompatability tests, the device is safe and effective for its intended purpose.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the word "BIODERM" in white letters on a black oval background. The letters are large and bold, and the word is centered in the oval. There is a registered trademark symbol to the right of the word. The background is a gradient, with the black being darker at the top and bottom and lighter in the middle.
OCT 13 1998
Safety and Effectiveness Summary
August 17, 1998 Preparation Date:
- BioDerm, Inc. Submitter: 9705 International Court North St. Petersburg, FL 33716-4807 Phone: (727) 563-9001 Fax: (727) 563-0002
- Marie Teixeira Contact: Director of Quality Assurance and Regulatory Affairs
BTF™ Thin Film Wound Dressing Device Name:
Device Classification Name: Occlusive Wound Dressing
Product Code: MGP
Device Description:
The BioDerm BTF Thin Film Wound Dressing is a sterile thin film dressing which consists of a polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is a transparent dressing which is permeable to moisture vapor and oxygen and intended to provide a moist wound healing environment to facilitate the normal wound healing process. The BTF Thin Film Wound Dressing provides a barrier to bacteri and external contaminates.
Intended Use:
The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use.
OTC Indications for Use:
Abrasions, lacerations, minor/superficial cuts; Minor scalds, minor burns; Minor irritations to the skin
1
Under the Care of a Health Care Professional:
Leg ulcers, pressure ulcers (stages I and II); Surgical wounds (post operative wounds, donor sites); 1st and 2nd degree burns; Cover and protect catheter sites and wounds; Securement of medical appliances; Catheter securing device; Dermal lesions: Non-exuding to minimally exuding wounds
Substantially Equivalent Devices:
Smith & Nephew, OpSite 3M, Tegaderm Transparent Dressing Hollister, Simplicare Thin Film Wound Dressing J & J, Bioclusive MVP Transparent Dressing Innovative Technologies, Transparent Thin Film and Intelligent Thin Film Wound Dressing
Technological Characteristics:
'he BioDerm BTF Thin Film Wound Dressing is similar in design, composition and function to the predicate .evices listed in the comparative table below.
| BioDerm | Smith & Nephew | 3M | Hollister | J & J | Innovative Technologies | |
|---|---|---|---|---|---|---|
| Characteristic | BTF Thin Film Wound Dressing | OpSite Wound Dressing | 3M Tegaderm and 3M Tegaderm HP Transparent Dressing | Simplicare Thin Film Wound Dressing | Bioclusive MVP Transparent Dressing | Transparent Thin Film and Intelligent Thin Film Wound Dressing |
| Backing Material | Polyurethane film | Polyurethane film | Polyurethane film | Polyurethane film | Polyurethane film | Polyurethane film |
| Visibility | Transparent | Transparent | Transparent | Transparent | Transparent | Transparent |
| Primary Packaging | Peel pouch | Peel pouch | Peel pouch | Peel pouch | Peel pouch | Blister pack |
| Adhesive | Acrylic adhesive Hypoallergenic | Acrylic adhesive Hypoallergenic | Pressure sensitive acrylic adhesive | Pressure sensitive acrylic adhesive | Acrylic adhesive | Pressure sensitive acrylic adhesive |
| Moisture Vapor Permeability Characteristics | Permeable to water vapor and oxygen | Permeable to water vapor and oxygen | Good oxygen and moisture vapor permeability | High moisture vapor transmission rate Permeable to moisture vapor and oxygen | Permeable to water vapor and oxygen | Permeable to moisture vapor and oxygen |
| Sterilization | Gamma Irradiation | ETO | Gamma Irradiation | Gamma Irradiation | ETO | Gamma Irradiation |
| Intended Use | Moist wound healing environment | Moist wound healing environment | Moist wound healing environment | Moist wound healing environment | Moist wound healing environment | Moist wound healing environment |
| Bacterial Barrier and | Effective barrier to bacteria and | Impermeable to micro-organisms | Impermeable to liquids and | Barrier to bacteria and external | Impermeable to micro-organisms | Barrier to exogenous moisture |
2
| External
Contaminate
Characteristics | external
contaminates | (bacteria)
Effective barrier
to external
contaminates | bacteria
Effective barrier
to external
contamination | contaminates | Effective barrier
to external
contaminates | and bacteria |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | OTC:
Abrasions,
lacerations,
minor/
superficial cuts;
Minor scalds,
minor burns;
Minor irritations
to the skin | IV/TPN
Dressings;
Dermal lesions;
Scalds;
1st or 2nd degree
burns;
Donor sites;
Post-operative
wounds;
Abrasions;
Lacerations;
Surgical incise
drape;
Partial thickness
wounds | Prescription
Cover and protect
catheter sites and
wounds;
Secondary
dressing;
Protective cover;
Secure devices to
the skin
Protective eye
covering;
Surgical
incisions;
Skin graft donor
sites;
Stage I or II
pressure ulcers;
Superficial
wounds
(abrasions, skin
tears, blister, 1st
and 2nd degree
burns, chafed
skin);
Secondary
dressing | OTC:
Minor burns;
Superficial Cuts,
lacerations, and
abrasions;
Minor irritations of
the skin
Prescription:
Non-exuding to
minimally exuding
wounds;
Pressure sores;
Lacerations/abrasi
ons;
Partial and full
thickness wounds;
Surgical incisions;
Second degree
burns;
Donor sites;
IV sites;
Secondary fixation
device | Minor burns;
Donor sites;
Post-operative
wounds;
Abrasions;
Lacerations;
Protective
cover;
Peripheral and
central
intravenous
catheter dressing | OTC:
Minor scalds and
burns;
Superficial wounds
such as abrasions,
lacerations and cuts
Prescription:
Partial thickness
wounds;
Pressure sores;
Abrasions;
Superficial burns;
Lacerations;
Donor sites;
IV sites;
Fixation device;
Post-operative
surgical wounds;
Dermal lesions;
Trauma wounds |
Biocompatability:
Biocompatability testing was performed in accordance with ISO 10993-1: 1995 "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" and the Draft Guidance for the Preparation of a Premarket Notification for a Non-interactive Wound Dressing. Testing included: Primary Dermal Irritation, Sensitization, Cytotoxicity, and Repeated Insult Patch Test.
Based upon the results of biocompatability tests, the device is safe and effective for its intended purpose.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "U.S. Department of Health & Human Services USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Ms. Marie Teixeira Director of Quality Assurance and Regulatory Affairs BioDerm, Inc. 9705 International Court North St. Petersburg, Florida 33716-4807
Re: K982939 Trade Name: BTF™ Thin Film Wound Dressing Regulatory Class: II Product Code: MGP Dated: August 19, 1998 Received: August 21, 1998
Dear Ms. Teixeira:
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:
- 1 . This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
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
4
Page 2 - Ms. Marie Teixeira
misbranding and adulteration.
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
Indications for Use Form
| 510(k) Number (if known): | K982939 |
|---|---|
| --------------------------- | --------- |
Device Name: BTF™ Thin Film Wound Dressing
Indications for Use:
The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement.
OTC Indications for Use:
- V Abrasions, lacerations, minor/superficial cuts;
-
Minor scalds, minor burns;
-
Minor irritations to the skin
Under the Care of a Health Care Professional:
- Leg ulcers, pressure ulcers (stages I and II);
- V Surgical wounds (post operative wounds, donor sites);
-
1st and 2nd degree burns;
-
Cover and protect catheter sites and wounds;
-
Securement of medical appliances;
-
Catheter securing device;
-
Dermal lesions:
- Non-exuding to minimally exuding wounds
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21CFR 801.109) | |
| Over-the Counter Use | ✓ |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982939 |
|---|---|
| --------------- | --------------------------------------------------------- |