ULTRACELL PACKING WITH SLEEVE

K973085 · Ultracell Medical Technologies, Inc. · EMX · Nov 18, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973085
• Device Name: ULTRACELL PACKING WITH SLEEVE
• Applicant: Ultracell Medical Technologies, Inc.
• Product Code: EMX · Ear, Nose, Throat
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4100
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.

Device Story

Ultracell Packing with Sleeve (Nasal Pack) is a surgical device used to protect tissue from trauma, absorb fluids, and prevent adhesions. It is intended for use by surgeons during surgical procedures. The device functions as a physical barrier and absorbent material. It is used in clinical settings to assist in post-operative healing and tissue protection.

Clinical Evidence

No clinical data provided; substantial equivalence determined via 510(k) regulatory pathway.

Technological Characteristics

Surgical packing material with sleeve; absorbent; physical barrier function. Class I device (21 CFR 874.4100).

Indications for Use

Indicated for use during surgery to protect tissue from trauma, absorb fluids, and act as a barrier against adhesions.

Regulatory Classification

Identification

An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

George P Korteweg Vice President Ultracell Medical Technologies, Inc. 183 Providence New London Turnpike P.O. Box 326 North Stonington, CT 06359

Re: K973085

Ultracell Packing with Sleeve (Nasal Pack) Dated: September 30, 1997 Received: October 2, 1997 Regulatory Class: I 21 CFR 874.4100/Procode: EMX 77

Dear Mr. Korteweg:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 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 marketd 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 question 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,

h.J.Liau Yu

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 297 3085

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Syverson

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973085

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)