(421 days)
Not Found
Not Found
No
The summary describes a simple wound packing strip and makes no mention of AI or ML.
No
The device is described as an "antibacterial barrier" and for "general use in wound packing and management," which focuses on wound care and protection rather than directly treating a disease or condition.
No
The document describes the device as an "antibacterial barrier" and for "general use in wound packing and management." There is no mention of it being used to diagnose conditions.
No
The device description clearly states it is a "Packing Strip," which is a physical, material-based device used for wound packing. There is no mention of software components or functions.
Based on the provided text, the Dynarex Iodoform Packing Strip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as an "antibacterial barrier and for general use in wound packing and management." This is a direct application to the body for wound care, not for testing samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on its function in wound packing and management and its equivalence to similar devices used for the same purpose. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
Therefore, the Dynarex Iodoform Packing Strip is a medical device used for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only.
Product codes
FRO
Device Description
The Dynarex Iodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Iodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex Iodoform Packing Strip is a device for general use in wound packing and management.
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
sale by or on the order of a physician
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
Not Found
N/A
0
OCT 1 7 2002
Dynarex Corporation (Pre-market Notification)
Page 14
Re: K012816
Appendix A (Summary of Safety And Effectiveness)
Submitter:
John Gagliardi, President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net
Trade Name: Dynarex Iodoform Packing Strip
Common Name: Iodoform Packing Strip
Classification Name: Unclassified
Iodoform: 5%
Summary of Safety and Effectiveness:
The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market.
Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices.
The packaging methods and packaging materials are exactly the same, respectively.
The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2002
Mr. John Gagliardi President MidWest Process Innovation, LLC 7736 Woodside Court Maineville, Ohio 45039
Re: K012816 Trade/Device Name: Dynarex Iodoform Packing Strip Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2002 Received: August 22, 2002
Dear Mr. Gagliardi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. John Gagliardi
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours, elia M. Witten, Ph.D., M.D
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
012816
Revised: 5/26/02
Dynarex Corporation Pre-market Notification
Page 5
Device Name: Dynarex Iodoform Packing Strip
Indications for Use: The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only. Federal (USA) law restricts this Iodorm
sale by or on the order of a physician sale by or on the order of a physician.
Styfe Ruvets
(Division Sign-Off) (Division Sigir On) Restorative Division of ogical Devices
510(k) Number K012816