BIODERM FOAM WOUND DRESSING

• K Number: K973429
• Device Name: BIODERM FOAM WOUND DRESSING
• Manufacturer: BIODERM, INC.
• Date Cleared: 1997-12-01 ( 82 days)
• Product Code: KMF
• Regulation Number: 880.5090

Intended Use

- 1. Venous stasis ulcers. - 2. Pressure sores Stages 1, 2, 3, & 4. - 3. Ulcers triggered by trauma. - 4. Drainage dressing for tracheostomy and gastrostomy tubes. - 5. Post operative incisions.

Device Description

Bioderm Foam wound Dressing

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a wound dressing and does not mention any AI or ML capabilities.

Therapeutic

Yes
The "Intended Use / Indications for Use" section lists multiple medical conditions and applications (e.g., venous stasis ulcers, pressure sores, post-operative incisions) that the device is designed to treat or manage, which is characteristic of a therapeutic device.

Diagnostic

No
The device, Bioderm Foam Wound Dressing, is intended for therapeutic purposes like dressing wounds and ulcers, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states "Bioderm Foam wound Dressing," indicating a physical, hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended uses listed are for treating various types of wounds and providing drainage for tubes. These are applications directly on or in contact with the body for therapeutic or protective purposes.
• Device Description: "Bioderm Foam wound Dressing" describes a physical dressing applied externally.
• Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
  • Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
  • Providing information about a patient's health status, disease, or condition based on the analysis of these samples.
  • Using reagents, calibrators, or control materials.

IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a wound dressing, which is a therapeutic and protective device applied to the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 1. Venous stasis ulcers.
• 2. Pressure sores Stages 1, 2, 3, & 4.
• 3. Ulcers triggered by trauma.
• 4. Drainage dressing for tracheostomy and gastrostomy tubes.
• 5. Post operative incisions.

Product codes

KMF

Device Description

Not Found

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)

Not Found

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

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Summary

0

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1997

Mr. George Worthley *President Bioderm Medical, Inc. PO Box 4882 Wheaton, Illinois 60189

Re: K973429 Bioderm Foam Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 5, 1997 Received: September 10, 1997

Dear Mr. Worthley:

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 2. of wound healing or epithelization.
• This device may not be labeled as a long-term, permanent, or no-change 3. dressing, or as an artificial (synthetic) skin.
• This device may not be labeled as a treatment or a cure for any type of 4. 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

1

Page 2 - Mr. George Worthley

registration, listing of devices, good manufacturing practices, labeling, and prohibitions against 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Aiocella

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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Page 1 of 1

510(k) Number (if known): K973429

Device Name: Bioderm Foam wound Dressing

Indications for Use:

• 1. Venous stasis ulcers.
• 2. Pressure sores Stages 1, 2, 3, & 4.
• 3. Ulcers triggered by trauma.
• 4. Drainage dressing for tracheostomy and gastrostomy tubes.
• 5. Post operative incisions.

(DO NOT WRITE BELOW THIS LINE-USE ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (ODE)

(Division Sign-Off) Division of General Res 42-9 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)