SPIROCARD

K973138 · Qrs Diagnostic, LLC · BZG · Oct 28, 1998 · Anesthesiology

Device Facts

• Record ID: K973138
• Device Name: SPIROCARD
• Applicant: Qrs Diagnostic, LLC
• Product Code: BZG · Anesthesiology
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

To be used as a Diagnostic Spirometer, measuring FVC, MVV and SVC breathing functions.

Device Story

SpiroCard is a diagnostic spirometer measuring patient exhalation and inhalation volume and rate. Device utilizes a pneumotachometer mouthpiece and connecting tube to generate pressure signals; pressure sensor converts these to electrical signals. Unlike the predicate PFM-7000 desktop unit, SpiroCard is a PC Card-based device; it offloads all processing, user interface, and reporting functions to a host computing device. Physicians use the resulting spirometric data (FVC, MVV, SVC, FEF) to assist in diagnosing and treating respiratory diseases. Benefits include portability and integration with existing PC infrastructure while maintaining measurement accuracy consistent with established clinical standards.

Clinical Evidence

Bench testing only. The device was validated using a Pulmonary Waveform Generator to produce American Thoracic Society (ATS) Standard waveforms. Results demonstrated that the SpiroCard met all performance specifications and provided results equivalent to the predicate device.

Technological Characteristics

PC Card-based diagnostic spirometer. Uses a pneumotachometer for flow measurement and a high-resolution pressure sensor. Connectivity via host PC interface. No new patient-contact materials introduced compared to predicate. Software-based processing performed on host computer.

Indications for Use

Indicated for diagnostic spirometry in male and female patients, pediatric to adult. Used for measuring FVC, MVV, SVC, and FEF. Prescription use only in hospital, clinical, or home settings.

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.

Predicate Devices

• PFM Professional 7000 (K932278)

Submission Summary (Full Text)

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## OCT 28 1998 510(k) SUMMARY

| MANUFACTURE'S | |
|----------------------|----------------------------------------------------------|
| ADDRESS: | Mailing - PO Box 47304 |
| | Facilities - 14030 23rd Ave. North |
| | Plymouth, MN 55447 |
| PHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| CONTACT: | Kevin J. Driscoll, Quality Assurance, Regulatory Affairs |
| | Ext: 924 |
| TRADE NAME: | SpiroCard |
| CLASSIFICATION NAME: | Diagnostic Spirometer |
| CLASSIFICATION: | Class II, according to 21 CFR, 868.1840 |
| MODIFICATION OF | 510(k) #K932278 Advanced Medical Systems Corp |

PFM Professional 7000

## DEVICE SUMMARY:

The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases.

The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy.

The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.

- TESTS: The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms. The results of both tests supported substantial equivalence and met specifications.
- To be used as a Diagnostic Spirometer, measuring FVC, MVV and SVC INTENDED USE: breathing functions.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 8 1998

Mr. Kevin J. Driscoll QRS Diagnostic, LLC 14755 27th Avenue North Plymouth, MN 55447

Re : K973138 SpiroCard Requlatory Class: II (two) Product Code: 73 BZG Dated: July 31, 1998 Received: August 5, 1998

Dear Mr. Driscoll:

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 reqistration, 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 A substantially equivalent determination assumes compliance to 895. 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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Page 2 - Mr. Kevin J. Driscoll

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 requlation 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. Callahan

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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510(k) Number: K973138

Device Name: SpiroCard

Indications for Use:

- Diagnostic Spirometry .
- Patient Population: Male/Female, Podistric to Adult .
- Device Functionality: Diagnostic Spirometry ●
- Spirometric Parameters: FVC, MVV, SVC, and FEF ●
- . Environment of Use: Hospital, Clinical and Home Use
- Prescription device by a physician ●

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lark Mudos 10-28-98

(Division Sign-Off) Division of Cardiovascular, Respiratory, > Prescription Use and Neurological Devices OVER-THE-COUNTER USE (optional Form 1-2-96) 510(k) Number .