(63 days)
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No
The summary describes a wound dressing and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No.
The device is a wound dressing, which is a medical device used for treatment, but it is not typically categorized as a therapeutic device in the same vein as those that provide active therapy (e.g., electrical stimulation, laser therapy). It supports the healing process but doesn't actively "produce" a therapeutic effect itself.
No
The device, "Bioderm Calcium Alginate Wound Dressing," is a wound dressing. Its intended uses are for treating existing conditions (various types of ulcers and surgical wounds), not for identifying or diagnosing a disease or condition.
No
The device description explicitly states "Bioderm Calcium Alginate Wound Dressing," which is a physical wound dressing, not software.
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 (ulcers, surgical wounds). These are conditions affecting the body directly, not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The device is a "Calcium Alginate Wound Dressing." This is a topical dressing applied to the wound, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnostic or monitoring purposes based on sample analysis
- Reagents, calibrators, or controls typically associated with IVDs
- Any form of testing or analysis performed in vitro.
Therefore, the Bioderm Calcium Alginate Wound Dressing is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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- Venous Stasis Ulcers
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- Pressure Ulcers
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- Diabetic Ulcers
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- Surgical Wounds
Product codes
KMF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 1998
Mr. George Worthley President BioDerm, Incorporated P.O. Box 4882 Wheaton, Illinois 60189
Re: K980451
Trade Name: Bioderm Calcium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: January 27, 1998 Received: February 5, 1998
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 of 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.
1
Page 2 - Mr. Worthley
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,
pooley
$\hbar$
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
2
Bioderm, Inc.
Page 3. of 3.
510(k) Number (if known): K980451
Device Name: Bioderm Calcium AlginateWound Dressing
Indications for Use: REVISED
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- Venous Stasis Ulcers
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- Pressure Ulcers
...
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- Diabetic Ulcers
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- Surgical Wounds
(DO NOT WRITE BELOW THIS LINE-USE ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980481 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---------------------- |
(Optional Format 1-2-96)