DISPOSABLE SILICONE EPISTAXIS CATHETER

K973656 · Specialty Surgical Products, Inc. · EMX · Nov 18, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973656
• Device Name: DISPOSABLE SILICONE EPISTAXIS CATHETER
• Applicant: Specialty Surgical Products, 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 catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Device Story

Disposable silicone epistaxis catheter; used to control nasal hemorrhage via mechanical pressure. Device inserted into nasal cavity by clinician; functions as nasal packing post-trauma or post-surgery (septoplasty/rhinoplasty). Provides tamponade effect to stop bleeding. Simple mechanical device; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone construction; catheter form factor; mechanical tamponade principle; non-powered; disposable.

Indications for Use

Indicated for patients experiencing nasal hemorrhage due to trauma or following intranasal surgical procedures such as septoplasty and rhinoplasty.

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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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

T. Jan Varner President & C.E.O. Specialty Surgical Products, Inc. P.O. Box 218 Hamilton, Montana 59840

Re:

K973656 Disposable Sillicone Epistaxis Catheter Dated: September 22, 1997 Received: September 25, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX

Dear Mr. Varner:

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 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.

h. 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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kg+3656 510(k) Number (if known):__

Device Name: Epistaxis Catheter

Indications For Use:

The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)

.

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)