A1 ACOUSTIC RHINOMETER

K972140 · G.M. Instruments , Ltd. · BXQ · Sep 30, 1998 · Anesthesiology

Device Facts

• Record ID: K972140
• Device Name: A1 ACOUSTIC RHINOMETER
• Applicant: G.M. Instruments , Ltd.
• Product Code: BXQ · Anesthesiology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1800
• Device Class: Class 2

Intended Use

Objective measurement device in "blocked nose" situations Deviated septums e.g. Allergic rhinitis Enlarged adenoids With the possibility of absolute and pre/post surgical or treatment comparisons.

Device Story

A1 Acoustic Rhinometer provides objective assessment of nasal airway patency. Device utilizes acoustic reflection technology to measure nasal cavity cross-sectional area and volume. Used by clinicians in ENT or clinical settings to evaluate "blocked nose" conditions; specifically, deviated septums, allergic rhinitis, and enlarged adenoids. Operates by emitting sound pulses into nasal cavity; reflected sound waves are captured and processed to generate anatomical profiles. Output allows clinicians to quantify nasal obstruction, track disease progression, and assess efficacy of surgical or medical interventions. Facilitates objective pre- and post-treatment comparisons.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Acoustic rhinometry system; utilizes acoustic reflection principle to determine nasal cavity geometry. Standalone device for clinical use. No specific materials, software architecture, or connectivity standards disclosed in provided documentation.

Indications for Use

Indicated for objective measurement of nasal airway in patients with nasal obstruction, including deviated septums, allergic rhinitis, and enlarged adenoids. Used for absolute measurements and pre/post-surgical or treatment comparisons.

Regulatory Classification

Identification

A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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SEP 3 0 1998

Eric Greig Managing Director G.M. Instruments, Ltd. Unit 6, Ashgrove Ashgrove Road Kilwinning, Ayrshire KA 13 6PU Scotland, UK

Re:

K972140 Al Acoustic Rhinometer Dated: August 18, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 868.1800/Procode: 73 BXQ

Dear Mr. Greig:

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 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 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 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.ida.gowcdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin, Ph.D.

Lillian Yin. Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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510(k) Number (if known): K972140

Device Name: A1 Acoustic Rhinometer

Indications For Use:

Objective measurement device in "blocked nose" situations

Deviated septums e.g. Allergic rhinitis Enlarged adenoids

With the possibility of absolute and pre/post surgical or treatment comparisons.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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OR

Over-The-Counter Use

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