VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K

K972922 · Interview Medical Technology Corp. · EMX · Oct 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972922
• Device Name: VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K
• Applicant: Interview Medical Technology Corp.
• Product Code: EMX · Ear, Nose, Throat
• Decision Date: Oct 8, 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 also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Device Story

Vyker Silicone Epistaxis Catheter V-27030 is a medical device used to control nasal hemorrhage. It functions as a nasal packing tool. Used in clinical settings by healthcare professionals following trauma or intranasal surgeries (e.g., septoplasty, rhinoplasty). The device provides mechanical tamponade to stop bleeding. It is a prescription-only device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone construction; catheter-based form factor for nasal packing; mechanical tamponade principle of operation.

Indications for Use

Indicated for patients experiencing nasal hemorrhage due to trauma or requiring postoperative nasal packing 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Louis R. Matson President & C.E.O. InterView Medical Technology Corporation 3941 Park Drive, Suite 20-325 El Dorado Hills, California 95762

Re:

K972922 Vyker Silicone Epistaxis Catheter V-27030 Dated: August 5, 1997 Received: August 8, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX

Dear Mr. Matson:

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, 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 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.

Wiliau 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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K472422 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 also be used as 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)

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Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K972922 |
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| Prescription Use (Per 21 CFR 801.109) <img alt="check mark" src="check_mark.png"/> | OR | Over-The-Counter Use ____ |
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