SPIROBANK PORTABLE PC BASED SPIROMETER

K973456 · Futuremed America, Inc. · BZG · Jul 22, 1998 · Anesthesiology

Device Facts

• Record ID: K973456
• Device Name: SPIROBANK PORTABLE PC BASED SPIROMETER
• Applicant: Futuremed America, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations. The tests can be performed in adults and pediatrics, in the hospital, clinic and at home. Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.

Device Story

Spirobank is a portable, PC-based spirometer for measuring respiratory function. Device captures airflow data to calculate >20 functional parameters, including FVC, VC, IVC, and MVV. It performs automatic diagnosis using an 11-scale classification based on ATS recommendations; calculates test repeatability and acceptability indices. Used in hospitals, clinics, or home settings by clinicians or patients. Results displayed on integrated LCD, printed via external printer, or transferred to PC for storage and review. Memory stores hundreds of test results. Facilitates respiratory health assessment and monitoring.

Clinical Evidence

No clinical data provided; device functionality is based on adherence to ATS recommendations for spirometry testing and classification.

Technological Characteristics

Portable PC-based spirometer; features integrated LCD display, internal memory for data storage, and connectivity for external printers and PC data transfer. Operates via functional parameter measurement and automated diagnostic classification based on ATS standards.

Indications for Use

Indicated for performing FVC, VC, IVC, and MVV respiratory profile tests in adult and pediatric populations in hospital, clinic, 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 1998

Mr. Michael Davidson Futuremed America, Inc. 15700 Devonshire Street Granada Hills, CA 91344-7225

Re: K973456 "SPIROBANK" Portable PC Based Spirometer Requlatory Class: II (two) Product Code: 73 BZG Dated: April 24, 1998 Received: April 27, 1998

Dear Mr. Davidson:

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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Page 2 - Mr. Michael Davidson

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.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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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| Page | ___ of ___ |
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| 510(k) Number (if known): | (K) 973456 |
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| Device Name: | SPIROBANK |

Indications For Use:

Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.

The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.

Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.

R. Ramgoolie

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

York Madra 7-20-98

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ 10200xpace = 201, 1091 510(k) Number_ (Optional Format 1-2-98)