CAIRD TECHNOLOGY SPIROMETER

K971336 · Caird Technology · BZG · Dec 1, 1998 · Anesthesiology

Device Facts

• Record ID: K971336
• Device Name: CAIRD TECHNOLOGY SPIROMETER
• Applicant: Caird Technology
• Product Code: BZG · Anesthesiology
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Designed for Adult and Pediatric Patients. For Hospital and Clinic use only. For Prescription use only. Some of the conditions for use are as follows: Shortness of Breath . Chronic Cough Occupational Exposure to Dust or Chemicals Assist in the Diagnosis of Bronchitis . Assist in the Diagnosis of Asthma . Wheezing . Assist in the monitoring of Bronodialators .

Device Story

Medikro D9 Spirometer; diagnostic respiratory device for hospital/clinic use. Measures lung function parameters via patient exhalation/inhalation; data processed to assess respiratory health. Used by clinicians to assist in diagnosing asthma/bronchitis and monitoring bronchodilator efficacy. Provides objective pulmonary data to support clinical decision-making; aids in identifying respiratory conditions in symptomatic patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spirometer system; Class II device (Product Code: BZG). Intended for clinical/hospital use. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for adult and pediatric patients presenting with shortness of breath, chronic cough, wheezing, or occupational exposure to dust/chemicals; used to assist in the diagnosis of bronchitis and asthma, and to monitor bronchodilator therapy.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 DEC

Mr. James H. Brown Caird Technology Inc. 205 Camden Chase Columbia, SC 29223

Re : K971336 Spirometer System Requlatory Class: II (two) Product Code: 73 BZG July 17, 1998 Dated: Received: September 4, 1998

Dear Mr. Brown:

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 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). 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 (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 (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 requlatory 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971336 510(k) Number:

Medikro D9 Spirometer Device Name:

Indications For Use:

Prescription Use

- · Designed for Adult and Pediatric Patients.
- · For Hospital and Clinic use only.
- · For Prescription use only.

Some of the conditions for use are as follows:

- Shortness of Breath .
- . Chronic Cough
- Occupational Exposure to Dust or Chemicals ●
- Assist in the Diagnosis of Bronchitis .
- Assist in the Diagnosis of Asthma .
- Wheezing .
- Assist in the monitoring of Bronodialators .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lark Modoo 11-30-78

OR

Over-The-Counter Use _ _ _ _ _ _ _ _ _

(Per 21 CFR 801 108) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

(Optional Format 1-2-96)

510(k) Number