RHINOSTREAM RHINOMANOMETER MODULE

K022311 · Rhino Metrics A/S · BXQ · Oct 4, 2002 · Anesthesiology

Device Facts

• Record ID: K022311
• Device Name: RHINOSTREAM RHINOMANOMETER MODULE
• Applicant: Rhino Metrics A/S
• Product Code: BXQ · Anesthesiology
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1800
• Device Class: Class 2

Intended Use

A Rhinomanometer is a medical instrument, intended to measure nasal airway pressure up to 5 centimeters H2O. (500Pa) and air flow up to 1000 ml/s. which is useful to the physician in studying the nasal decongestion of the nasal This is a not it as re procedures, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.

Device Story

RhinoStream Rhinomanometer measures nasal airway pressure and airflow; utilizes manometer probe with pressure transducers; connects to computer via insulated cable. Operates by measuring air pressure (up to 5 cm H2O) and airflow (up to 1000 ml/s) during inspiration and expiration. Used in clinical settings by physicians to assess nasal decongestion, polyps, adenoids, and septal deviations. Software on Windows 95/98 platform records data in ASCII format, maintains patient database, and enables printing/exporting of results. Disposable polystyrene nose adapters used for patient interface. Provides objective quantification of nasal airway function to assist clinical decision-making regarding surgical or pharmacological interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Manometer probe with pressure transducers; measures pressure up to 5 cm H2O (500 Pa) and airflow up to 1000 ml/s. Disposable polystyrene nose adapters. Connectivity via insulated cable to Windows 95/98 PC. Software-based data acquisition, storage (ASCII), and reporting.

Indications for Use

Indicated for patients requiring assessment of nasal airway resistance and airflow. Used by physicians to diagnose nasal decongestion, polyps, deviated septums, or enlarged adenoids, and to evaluate changes in nasal passage volume resulting from allergies, surgical procedures, or medication responses.

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.

Predicate Devices

• Mercury Medical Rhinomanometer (K902120)

Submission Summary (Full Text)

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OCT 04 2002

ОСТОО 4 2002

## Section K

# 510 (k) Summary

| Date Prepared | August 21, 2002 | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510 (k) no. | | |
| Submitter | RhinoMetrics A/S<br>Industrivej 9,<br>3540 Lynge<br>Denmark | |
| Contact | Erland Fuglsbjerg, Export Manager<br>or<br>Dan Eggan, Manager of Regulatory Affairs | |
| Device Name | RhinoStream Rhinomanometer | |
| Common/Usual/<br>Classification name | Rhinoanemometer | |
| Predicate device | Mercury Medical Rhinomanometer | |
| Device description | The RhinoStream Rhinomanometer module is designed<br>to objectively and quickly measure and quantify a<br>dynamic measure of the patient ability breath through the<br>nasal airway passages. | |
| Intended use | The module and its predicate device are intended to be<br>for rhinomanometry measurements and both devices use<br>a manometer probe with pressure transducers to<br>measure the airflow during expiration and inspiration. | |

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## Section G

## Substantial Equivalency Comparison

| Description | Mercury Medical. Rhinomanometer (K) 902120 | RhinoStream Rhinomanometer |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | To provide rhinomanometry measurements | To provide rhinomanometry measurements |
| General indication | To determine the resistance and airflow of the nasal cavity during inspiration and expiration. | To determine the resistance and airflow of the nasal cavity during inspiration and expiration |
| Specific indications | Diagnosing nasal decongestion, polyps, or enlarged adenoids and evaluating changes in the volume of the nasal passage due to allergies, surgical procedures or medications | Diagnosing nasal decongestion, polyps, or enlarged adenoids and evaluating changes in the volume of the nasal passage due to allergies, surgical procedures or medications |
| Technological characteristics | Utilizes a manometer probe which measures air pressure up to 60 centimeters water pressure | Utilizes a manometer probe which measures air pressure up to 5 centimeters water pressure (500 Pa) and air flow up to 1000 ml/s. Although the pressure value is lower than the predicate device, this does not raise concerns as the device measures pressure in relation to the current airflow. A higher pressure would require a higher airflow |
| Probe connection | The probe is handheld and connected to a mask. | The probe is connected to a computer with an insulated cable |
| Software platform | No software | The computer includes Windows 95/98 based software. |
| Usage | Challenge comparison | Challenge comparison |
| Data storage | Data storage not available. | Data storage in ASCI format and Windows 95/98 based software available. Includes an individual patient database and a browser database function for clinical use. |
| Print function | Results can not be printed | Results can be printed and exported to other Windows 95/98 based applications. |
| Nose adapter | No adapters available | Polystyrene disposable adapter |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 4 2002

RhinoMetrics A/S cio Daniel Eggan Manager of Regulatory Affairs/ QA 9675 West 95th Street Minneapolis, MN 55344

Re: K022311

> Trade Name: RhinoStream Rhinomanometer Module Classification Regulation Number: 868.1800 Regulatory Class: II Product Code: BXQ Dated: July 15, 2002 Received: July 17, 2002

Dear Mr. Eggan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must compiy with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### Section A

#### Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: RhinoMetrics A/S

K0923 510(k) Number (if known):

Device Name: RhinoStream Rhinomanometer

Indications For Use:

A Rhinomanometer is a medical instrument, intended to measure nasal airway pressure up to 5 centimeters H2O. (500Pa) and air flow up to 1000 ml/s.

(2001 a) and in the now ap to roove. which is useful to the physician in studying the nasal decongestion of the nasal This is a not it as re procedures, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Prescription Use
(Per 21 CFR 801.109)

Auraklut

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Dr

510(k) Number