NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001

K993921 · Ndd Medical Technologies · BZG · May 23, 2000 · Anesthesiology

Device Facts

• Record ID: K993921
• Device Name: NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
• Applicant: Ndd Medical Technologies
• Product Code: BZG · Anesthesiology
• Decision Date: May 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.

Device Story

EasyOne™ Spirometer (Frontline Model 2000 or Diagnostic Model 2001) performs diagnostic spirometry; utilizes ultrasonic flow measurement technology; inputs patient respiratory effort via disposable Spirette; processes flow data to calculate lung function parameters; outputs results for clinician review; used in general practice, specialty clinics, industrial, and hospital settings; operated by healthcare professionals; aids in respiratory diagnosis and patient management; powered by two AA alkaline batteries.

Clinical Evidence

Bench testing only. Performance testing conducted to demonstrate compliance with hardware and software requirements, including American Thoracic Society accuracy standards. Electrical safety testing per IEC601-1 and biocompatibility testing per ISO-10993 were performed.

Technological Characteristics

Ultrasonic flow measurement technology; powered by two AA alkaline batteries; includes disposable Spirette and optional cradle/printer; software-controlled; biocompatible materials per ISO-10993; electrical safety per IEC601-1.

Indications for Use

Indicated for diagnostic spirometry testing in adults and pediatric patients over 4 years of age in general practice, specialty physician, industrial, and hospital 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

• Puritan-Bennett Renaissance Spirometer (K944672)

Submission Summary (Full Text)

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K993921

## 510(k) SUMMARY

## ndd Medical Technologies

## ndd Medical Technologies EasyOne™ Spirometer

## November 17, 1999

#### Submitter Information:

| Submitter's Name: | ndd Medical Technologies<br>17 Progress Avenue<br>Chelmsford, MA 01824 |
|-------------------|------------------------------------------------------------------------|
| Telephone: | [phone] |
| Device Name: | |
| Proprietary name: | ndd Medical Technologies EasyOne™ Spirometer |

Spirometer Common Name:

Diagnostic spirometer Classification Name:

### Predicate Device Equivalence:

Substantial equivalence is claimed to the Puritan-Bennett Renaissance Spirometer, cleared for commercial distribution per K944672, and other legally marketed devices.

### Device Description:

The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries

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#### Intended Use:

The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.

#### Comparison of Technological Characteristics:

The device has the same technological characteristics as the predicate devices except for the use of ultrasonic technology for flow measurement. Testing was conducted that demonstrates this method of flow measurement is as accurate as the methods used in predicate devices and therefore substantially equivalent to the predicate devices.

#### Summary of Testing:

Performance testing was conducted to demonstrate compliance with the hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification, including requirements for accuracy defined by the American Thoracic Society.

The device was tested to demonstrate conformance to the applicable requirements contained in Section (h) (1) - (7) and Section (i) of Appendix A of the November 1993 Draft document "Reviewer Guidance for Premarket Notification Submissions".

The device was tested to demonstrate conformance with IEC601-1 requirements for electrical safety.

Biocompatibility testing was conducted in accordance with Office of Device Evaluation General Program Memorandum #G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing '

#### Conclusions:

Based on the above, we concluded that the ndd Medical Technologies EasyOne™ Spirometer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Oscar Kaelin CEO ndd Medical Technologies 17 Progress Avenue Chelmsford, MA 01824

K993921 Re: EasyOne™ Spirometer Regulatory Class: II (two) 73 BZG Product Code: Dated: March 10, 2000 March 14, 2000 Received:

Dear Mr. Kaelin:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceiver on we have determined the device is the device referenced above and wo have tions for use stated in the s Substantially equivalence (10) one caredicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate Commerce provices that have been reclassified Medical Device Imendales, I , i In accordance with the provision of therefore, market the device, subject to The general controls the general controls provisions of the Act. the general controls provisions of the entirements for annual registration, provisions of the nee on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device ID Stablemarket Approval), it may be subject to such Controls) of Class III (Frediality of regulations affecting your device auditionar concreas. In of Federal Regulations, Title 21, Parts 800 can be round in the ood equivalent determination assumes compliance co oss. If babbeanedad as a manufacturing Practice requirements, as set with the Ourlows Sty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocherar regaracter od and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Fraine of Stipen, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your action in motification submission does not affect any response to your premainedunder sections 531 through 542 of the Act obrigation you might well the electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Oscar Kaelin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your 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 be obtainsd from [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Milken

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Device Name:

ndd Medical Technologies EasyOne™ Spirometer

# Indications for Use:

The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use The ndd Medical Technologies Lasyone - Oplike and nediatric patients over
only to conduct simple diagnostic spirometry testing of adults and nospital settings only to conduct simple diagnostic spiromotive to addite the propositial settings.
4 years old, in general practice and specialty physician, industrial and hospital settings.

Muda A. Muhan
Division Sign Off

(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number .