NOSEBLEED NOSECLIP

K981966 · Michael M. Knott, M.D. · EMX · Aug 14, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981966
• Device Name: NOSEBLEED NOSECLIP
• Applicant: Michael M. Knott, M.D.
• Product Code: EMX · Ear, Nose, Throat
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4100
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.

Device Story

Nosebleed Noseclip is a mechanical device designed to treat simple anterior nosebleeds. It is applied externally to the nose to provide compression. The device is intended for use by patients or caregivers in various settings, including home, work, school, or hospital. By applying pressure to the nasal area, the clip assists in hemostasis, potentially benefiting the patient by stopping minor bleeding without requiring professional medical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's similarity to legally marketed predicate devices.

Technological Characteristics

Mechanical noseclip for external application. Dimensions and materials are not specified. The device is a passive, non-powered, non-software, non-sterile mechanical accessory.

Indications for Use

Indicated for the treatment of simple anterior (front) nosebleeds in adults and children. Contraindicated for use on infants.

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.

Predicate Devices

• Snuffer - Vacumed (Ventura, CA)
• Noseclip - Qosinna (Edgewood, NY)
• Noseclip - AMSCO (Pittsburgh, PA)

Submission Summary (Full Text)

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## Michael M. Knott, M.D., Inc.

Michael M. Knott, M.D. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

P.O. Box 5577 355 Rose Pine Ct. Tahoe City, CA 96145 [phone] Fax [phone] Pager [phone] Box #1906 Email [e-mail]

## Non-Confidential Summary of Safety and Effectiveness

June 3, 1998

Michael M. Knott, MD 355 Rose Pine Court Tahoe City CA 96145-5577 Tel [phone]

Official Contact: Proprietary or Trade Name: Common/Usual Name: Classification Name: Predicate Devices:

Michael M. Knott, MD Nosebleed Noseclip Noseclip Anesthesiology "Snuffer" - Vacumed, Ventura CA Noseclip - Qosinna, Edgewood NY Noseclip - AMSCO, Pittsburgh PA

Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.

Indicated Use - The treatment of simple anterior (front) nosebleeds.

Environment of Use - Anywhere the device may be safely applied: home, work, school, or hospital.

Patient Population - Adult and children (not for use on infants)

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | 4 1998

Michael M. Knott, M.D. P.O. Box 5577 355 Rose Pine Ct. Tahoe City, CA 96145 Re:

K981966 Nosebleed Noseclip Dated: May 28, 1998 Received: June 4, 1998 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX

Dear Mr. Knott:

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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510ks) 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/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

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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# ICATIONS FOR USE

Pursuant to the Notice of February 6, 1996 regarding listing of Indication for Use on a separate sheet, the following is per that request.

| 510(k) Number: | 981966 (To be assigned) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Nosebleed Noseclip |
| Intended Use: | The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seppman

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per CFR 801.109)

:

or

Over-the-counter Use __