(70 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, or mentions of AI/ML terms. The intended use is for wound management, which typically does not involve AI/ML.
No
The intended use "WOUND MANAGEMENT CONDUIT" suggests a device used for managing wounds, which may assist in the healing process. However, the term "therapeutic device" specifically implies a device used to treat or cure a disease or medical condition. While wound management can be part of therapy, the description itself doesn't explicitly state a therapeutic intent like "treating an illness" or "restoring health." It could be a supportive or assistive device rather than a primary therapeutic one. Without more information about how it manages wounds, it's difficult to confirm it's a therapeutic device.
No
The "Intended Use / Indications for Use" states "WOUND MANAGEMENT CONDUIT," which suggests a device used for treatment or management, not diagnosis. The "FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK" part is likely irrelevant or a placeholder.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that this device is an IVD.
Here's why:
- Intended Use: The intended use is described as "WOUND MANAGEMENT CONDUIT". This clearly indicates a device used for managing wounds, which is an in-vivo application (used on or within the body). IVDs are used in vitro (outside the body) to examine specimens from the body.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical characteristics of an IVD.
- Device Description: While the device description is "Not Found", the intended use is the primary indicator here.
Therefore, based on the provided text, this device is not an IVD. It appears to be a medical device used for wound management.
N/A
Intended Use / Indications for Use
FOR GENERAL USE - N AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN
Product codes
FRO, MXI
Device Description
Dumex Iodoform Packing Strip
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2024
Dumex Medical Surgical Products, Ltd. Sharmini Atheray Manager, Quality Assurance and Regulatory Affairs 104 Shorting Road Scarborough, Ontario M1S 3S4 Canada
Re: K990332
Trade/Device Name: Dumex Iodoform Packing Strip Regulatory Class: Unclassified Product Code: FRO
Dear Sharmini Atheray:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 14, 1999. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, yu-chieh.chiu@fda.hhs.gov.
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three curved lines representing the eagle's wings and a curved line representing the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1999
Ms. Sharmini Atheray Manager, Quality Assurance and Regulatory Affairs Dumex Medical Surgical Products, LTD 104 Shorting Road Scarborough Ontario M1S3S4 Canada
K990332 Re:
Trade Name: Dumex Iodoform Packing Strip Regulatory Class: Unclassifed Product Code:MXI Dated: March 30, 1999 Received: March 31, 1999
Dear Ms. Atheray:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your boother be device is substantially equivalent (for the indications for above and we have determinedevices marketed in interstate commerce prior to May 28, use stated in the enerobare) to as Aedical Device Amendments or to devices that have been 1970, the Chactinent auto of 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 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 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 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, I ne general controls pr manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
2
Page 2 - Ms. Sharmini Atheray
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 (1 Chiainer Approval) in the Code of 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 with the Good Haandratt820) 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 regulation may round in regulation wice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have w your premation 131 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) Finis letter will and in yourse 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
3
990332 Page
of Page 1
510(k) NUMBER (IF KNOWN): K990332
DEVICE NAME: DUMEX IODOFORM PACKING STRIA
INDICATIONS FOR USE:
FOR GENERAL USE - DN
AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT
CONDUIT IN
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Sign-Off
(Division Sign-Off)
Division of General Restorative Devices K990332,
510(k) Number