(42 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description appears to be a wound filler.
Yes
The device is described as a "WOUND FILLER" for various types of ulcers, which indicates its use in treating medical conditions.
No
The device is described as a "WOUND FILLER," which suggests a therapeutic function (filling wounds) rather than a diagnostic one (identifying or characterizing disease). The intended uses are types of ulcers, which are conditions that would be treated rather than diagnosed by a wound filler.
No
The device description explicitly states "FERRIS ... LOLLEWIC CARLY WOUND FILLER", which strongly suggests a physical product (a wound filler) rather than a software-only device. The lack of any mention of software, image processing, AI, or input imaging modality further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating various types of ulcers (Arterial, Pressure, Venous, Diabetic). This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is described as a "WOUND FILLER". This further supports its use in treating wounds, not diagnosing them.
- Lack of Diagnostic Information: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided text, this device is a therapeutic wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers
Product codes
KMF
Device Description
PolyMem PolyWic Sterile Cavity Wound Filler
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Mr. Theodore R. Thorsen Director, Quality Assurance Ferris Manufacturing Corp. 16 West 300 83rd Street Burr Ridge, Illinois 60521
K990906 Re:
K970706
Trade Name: PolyMem PolyWic Sterile Cavity Wound Filler Regulatory Class: Unclassifed Product Codc: KMF Dated: March 17, 1999 Received: March 18, 1999
Dear Mr. Thorsen:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becalled by equivalent (for the indications for the indications for above and we have decemined the devices marketed in interstate commerce prior to May 28, use stated in the enclosure) to devices markets in the endments or to devices that have been 1976, the enactified 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 (the Act). Tou may, therefore, maxicolo, maxicotic 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 I he labeling claims fisted above would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, I he general controls provisions or ring practices, labeling, and prohibitions against misbranding and adulteration.
1
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 to U.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
2
Page | of |
510(k) Number (if known):_ K990906
Device Name: FERRIS ... LOLLEWIC CARLY WOUND FILLER
Indications For Use:
Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers
Diabetic Ulcers
· ……
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990906 |
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
ﺮﯾﮯ۔ ۔
(Optional Format 1-2-96)