K Number

Device Name

Manufacturer

BIODERM, INC.

Date Cleared

1998-10-13

(53 days)

Product Code

MGP

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

K031684,K090160

Intended 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

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.

AI/ML Overview

This submission describes a 510(k) premarket notification for the BioDerm BTF Thin Film Wound Dressing, seeking substantial equivalence to already marketed devices. The study provided focuses on biocompatibility testing rather than device performance benchmarks related to its primary function (wound healing).

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and biocompatibility. There are no explicit performance acceptance criteria in terms of wound healing rates or infection reduction that the device is quantitatively measured against. Instead, the acceptance is based on meeting safety standards (biocompatibility) and having similar characteristics and intended use to legally marketed predicate devices.

Table 1: Biocompatibility Testing and Results

Test	Acceptance Criteria (Implicit: Pass all tests)	Reported Device Performance
Primary Dermal Irritation	No significant irritation (based on ISO 10993-1)	Passed
Sensitization	No significant sensitization (based on ISO 10993-1)	Passed
Cytotoxicity	No significant cytotoxic effect (based on ISO 10993-1)	Passed
Repeated Insult Patch Test	No significant irritation or sensitization after repeated exposure	Passed

Note: The document explicitly states: "Based upon the results of biocompatability tests, the device is safe and effective for its intended purpose." This is the key "acceptance criteria" met in the provided study.

Study Details for Biocompatibility Testing

Sample Size used for the test set and the data provenance:
- The document does not specify the sample size used for each biocompatibility test (e.g., number of animals or human subjects/volunteers).
- Data Provenance: Not explicitly stated, but these types of tests are typically conducted in a laboratory setting, often by contract research organizations specializing in medical device biocompatibility. The country of origin is not mentioned. The nature of these tests is prospective, as they are performed specifically for device evaluation before market entry.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For biocompatibility tests, "ground truth" is established by the standardized protocols (e.g., ISO 10993-1) and performed by trained laboratory personnel. Typically, experts in toxicology or pathology review the results against the criteria. The document does not specify the number or qualifications of these particular experts, but their expertise would be implicit in the adherence to ISO standards.
Adjudication method for the test set:
- Not applicable in the traditional sense for biocompatibility testing. The "adjudication" is the assessment of the test results against the pass/fail criteria outlined in the ISO standards, performed by the testing laboratory and reviewed by the submitter.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging devices or diagnostic aids where human interpretation is a critical component.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a physical wound dressing and does not involve an algorithm or AI.
The type of ground truth used:
- The "ground truth" for the biocompatibility study is defined by the established scientific and regulatory standards (ISO 10993-1) for assessing biological responses to medical devices. These standards dictate what constitutes an acceptable biological reaction (e.g., no irritation, no sensitization).
The sample size for the training set:
- Not applicable. Biocompatibility testing does not involve a training set as would be used in machine learning or AI development.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of evaluation.

Additional Notes from the Submission:

Substantial Equivalence: The primary strategy of this 510(k)_ is to demonstrate substantial equivalence to existing predicate devices (Smith & Nephew OpSite, 3M Tegaderm, Hollister Simplicare, J&J Bioclusive MVP, Innovative Technologies Transparent Thin Film). This is done through a comparative table highlighting similar materials, visibility, packaging, adhesive, moisture vapor permeability, sterilization, intended use, and bacterial barrier characteristics.
No Clinical Efficacy Study: There is no mention of a human clinical trial to demonstrate wound healing efficacy, infection reduction, or other performance characteristics of the dressing itself. The biocompatibility tests address safety. For 510(k) submissions, clinical data are often not required if substantial equivalence can be demonstrated through technological characteristics and non-clinical performance (like biocompatibility).
Limitations on Labeling: The FDA's response letter (pages 3-4) imposes specific limitations on what the device can be labeled for, such as not for third-degree burns, not having an accelerating effect on wound healing, not being a long-term dressing or artificial skin, and not being a "treatment or cure." These limitations reflect the scope of the substantial equivalence determination and the data provided.

Summary

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K982939

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:

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

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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

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ExternalContaminateCharacteristics	externalcontaminates	(bacteria)Effective barrierto externalcontaminates	bacteriaEffective barrierto externalcontamination	contaminates	Effective barrierto externalcontaminates	and bacteria
Indications forUse	OTC:Abrasions,lacerations,minor/superficial cuts;Minor scalds,minor burns;Minor irritationsto the skin	IV/TPNDressings;Dermal lesions;Scalds;1st or 2nd degreeburns;Donor sites;Post-operativewounds;Abrasions;Lacerations;Surgical incisedrape;Partial thicknesswounds	PrescriptionCover and protectcatheter sites andwounds;Secondarydressing;Protective cover;Secure devices tothe skinProtective eyecovering;Surgicalincisions;Skin graft donorsites;Stage I or IIpressure ulcers;Superficialwounds(abrasions, skintears, blister, 1stand 2nd degreeburns, chafedskin);Secondarydressing	OTC:Minor burns;Superficial Cuts,lacerations, andabrasions;Minor irritations ofthe skinPrescription:Non-exuding tominimally exudingwounds;Pressure sores;Lacerations/abrasions;Partial and fullthickness wounds;Surgical incisions;Second degreeburns;Donor sites;IV sites;Secondary fixationdevice	Minor burns;Donor sites;Post-operativewounds;Abrasions;Lacerations;Protectivecover;Peripheral andcentralintravenouscatheter dressing	OTC:Minor scalds andburns;Superficial woundssuch as abrasions,lacerations and cutsPrescription:Partial thicknesswounds;Pressure sores;Abrasions;Superficial burns;Lacerations;Donor sites;IV sites;Fixation device;Post-operativesurgical 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.

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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.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. 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

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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

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Indications for Use Form

510(k) Number (if known):	K982939
---------------------------	---------

Device Name: BTF™ Thin Film Wound Dressing

Indications for Use:

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
---------------	---------------------------------------------------------

Regulation Number and Section

N/A