DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414

K012816 · Dynarex Corp. · FRO · Oct 17, 2002 · SU

Device Facts

• Record ID: K012816
• Device Name: DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
• Applicant: Dynarex Corp.
• Product Code: FRO · SU
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Dynarex Iodoform Packing Strip is a wound management device containing 5% iodoform. It functions as an antibacterial barrier for packing wounds. Used in clinical settings under physician direction. The device is applied topically to wounds to assist in management. It is a simple, non-electronic, non-implantable medical device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional design and intended use similarity to existing marketed devices.

Technological Characteristics

Contains 5% iodoform. Form factor is a packing strip. Non-electronic, mechanical device. No software or complex technological components.

Indications for Use

Indicated for external use only for wound packing and management as an antibacterial barrier. Restricted to prescription use by a physician.

Submission Summary (Full Text)

{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) [e-mail]

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 [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" (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 [phone] or [phone] 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