DYNAREX DRAIN SPONGE

K991694 · Dynarex Corp. · KMF · Jul 15, 1999 · General Hospital

Device Facts

• Record ID: K991694
• Device Name: DYNAREX DRAIN SPONGE
• Applicant: Dynarex Corp.
• Product Code: KMF · General Hospital
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.

Device Story

Sterile drain sponge; non-woven material; features pre-cut fenestration. Designed for placement around tracheostomy or IV tubes. Functions as absorbent dressing to manage exudate and fluids at insertion sites. Used in clinical or home settings by healthcare providers or patients/caregivers. Provides physical barrier and fluid management to maintain site hygiene.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-woven fabric dressing; pre-cut fenestration; sterile; disposable.

Indications for Use

Indicated for use around tracheostomy or IV tubes to absorb exudate and fluids in patients requiring such medical access.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Mr. John G. Moulden Senior Vice President Dynarex Corporation One International Boulevard Brewster, New York 10509

Re: K991694 Trade Name: Drain Sponge Regulatory Class: Unclassified Product Code: KMF Dated: May 6, 1999 Received: May 18, 1999

Dear Mr. Moulden:

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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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## Page 2 -- Mr. John G. Moulden

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 [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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Wilson, Ph.D., M.P.

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

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K991694
Page of

To be assigned 510(K) NUMBER (IF KNOWN) : Sterile Drain Sponges DEVICE NAME :

INDICATIONS FOR USE:

Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.

(SESSED DO NOT WRISE BELCW CHIS LINE-CONTINUE ON ANCIHER PAGE
(SESSION)

Concurrence of cortification of Device svaluation Tober

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter-Use (Optional Format 1-2-96)

Division Sign-Off

aral Restorative Devices

Sent 10/15/98

Dwayne