SPIROVIT SP-2, PNEUMOCHECK II

K992823 · Schiller AG · BZG · May 12, 2000 · Anesthesiology

Device Facts

• Record ID: K992823
• Device Name: SPIROVIT SP-2, PNEUMOCHECK II
• Applicant: Schiller AG
• Product Code: BZG · Anesthesiology
• Decision Date: May 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirovit SP-2 / PneumoCheck ® Il can be used to measure the following spirometric parameters within the Healthcare Facility: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 1.0 / FVC, FEF 0.2-1.2, FEF 26-75%, FEF 75-85%, PEF, FEF 25%, FEF 50%, FEF 75%, FIVC, FIV 1.0, FIV 1.0 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, MV, RR, TV, in patients 6 years of age or older.

Device Story

Spirovit SP-2/PneumoCheck II is a handheld spirometer used in healthcare facilities to measure pulmonary function parameters. Device captures respiratory flow data via a flow sensor and disposable mouthpiece; processes signals to calculate parameters including FVC, FEV1, and MVV. Operated by healthcare professionals to assess patient lung function; output used for clinical decision-making regarding respiratory health. Device features IrDA data communication for connectivity. Benefits include objective assessment of patient respiratory status.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ATS Spirometry Statement (1994), IEC 601-1-1 (safety), IEC 601-1-2 (EMC), and IEC 601-1-4 (software quality).

Technological Characteristics

Handheld spirometer with flow sensor. Dimensions: 85x190x27 mm; Weight: 275 g. Connectivity: IrDA. Standards: ATS Spirometry Statement (1994), IEC 601-1-1, IEC 601-1-2, IEC 601-1-4. Operating temp: +10° to +40°C. Relative humidity: 25%-95% (non-condensing).

Indications for Use

Indicated for patients 6 years of age or older requiring measurement of spirometric parameters (FVC, FEV1, FEF, PEF, etc.) within a healthcare facility.

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

• SPIROVIT SP-250 (K984031)

Submission Summary (Full Text)

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MAY 1 2 2000

K992f23

FDA 510K SP-2

# 510 K Summary

according to 21 CFR 807.92

- A1 Address
SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

| Contact Name: | Mr. Markus Buetler |
|----------------|--------------------|
| Tel: | 001 41 41 766 4252 |
| (Date: | 9th December 1999) |
| Revision Date: | 4th May 2000 |

- A2 Device Name
- SPIROVIT SP-2 / PneumoCheck® Il 1. Trade Name: Spirometer, Pulmonary Function Test Device 2. Common Name:
- A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: SP-250 (K984031).

#### A4 Intended Use

The Spirovit SP-2 / PneumoCheck ® Il can be used to measure the following spirometric parameters within the Healthcare Facility:

Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 1.0 / FVC, FEF 0.2-1.2, FEF 26-75%, FEF 75-85%, PEF, FEF 25%, FEF 50%, FEF 75%, FIVC, FIV 1.0, FIV 1.0 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, MV, RR, TV, in patients 6 years of age or older.

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### FDA 510K SP-2

### A5 Table of Comparison

SPIROVIT SP-250 (K984031) Predicate device:

| | SP-250 (K984031) | SPIROVIT SP-2<br>PneumoCheck ® II |
|-------------------------------------------------------------|----------------------------------------|-----------------------------------|
| Dimensions: | | |
| Flow Sensor | 7.5 cm | 1) 85x190x27 mm |
| Handle | 10 cm | n.a. |
| Mouthpiece | disposable | same |
| Weight: | 180 g | 2) 275 g |
| Environmental Conditions: | | |
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95%<br>(non condensing | same |
| Electrostatic Discharge /<br>Electromagnetic Compatibility: | | |
| ESD | Fully functional below 4 kV (Open Air) | same |
| | No damage below 8 kV<br>(Open Air) | same |
| Radiated Emissions | Less than 30 dB<br>Microvolts | same |
| Radiated Immunity | 3 Volts per meter | same |
| Data Communication | RS-232 interface | (3) IrDA |

Discussion of Differences:

None of the above differences (1, 2 or 3) can be considered as safety relevant differences.

We consider the submitted device to be as safe and effective as the Predicate (SP-250) device.

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### FDA 510K SP-2

#### Non-Clinical Tests B1

- 1. Electrical Safety and Reliability Electrical Sarety and Rollability
The SPIROVIT SP-2 / PneumoCheck ® Il device has been tested to be in accordance with the following standards:
- ATS Spirometry Statement Medical Section of the American Lung Association November 11th 1994
- IEC 601-1-1 (Safety)
- IEC 601-1-2 (EMC) ।
- IEC 601-1-4 (Software Quality) ા

All tests are passed.

- 4) Data related to software quality
SCHILLER has reviewed its software development process following the quideline

reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ modification, software identification, software verification, validation and testing are described in the data attached.

- B2 Clinical Tests п.а.
- ਤਿਤ Conclusions from Tests

The fulfilling of the above standards ensures the safety and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate (SP-250) Device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 12 2000

Mr. Markus Buetler Schiller AG Altgasse 68, Postfach CH-6341 BAAR SWITZERLAND

K992823 Re: Spirovit SP-2/PnuemoCheck II Regulatory Class: II (two) Product Code: 73 BZG Dated: March 7, 2000 Received: March 9, 2000

Dear Mr. Buetler:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your beceion of (it). I device is a croted in the device referenced above and wo marications for use stated in the substantially equivatent (rol case devices marketed in enclosure) to legally marketed productions the enactment date of the interstate Commerce prior co nay costs that have been reclassified
Medical Device Amendments, or to devices Traderal Feed. Drug, and Medical Device Amendments) of or as the Federal Food, Drug, and in accordance with the provisions of the device, subject to
Cosmetic Act (Act). You may, therefore, market general gontrol Cosmeric Act (ACC). Iou maj) cost the Act. The general control the general control provisions of the ents for annual registration, provisions of the noe modeling practice, labeling, and fisting of devices, given , given ding and adulteration.

If your device is classified (see above) into either class II (Special If your device Is classified (see above), it may be subject to such Controls) or Class III (Fremarket ipprovuly ons affecting your device additional Collective major Regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, accumen common commission can be found in the code of reacharderermination assumes compliance
to 895. A substantially equivalent determination as sof CO 695. A Substancially Stactice requirements, as set with the Current Cood nation (QS) for Medical Devices:
forth in the Quality System Regulation (DS) for through posicalic Torth In the Quarry byosem arg ... 201 and that, through periodic QS General regulation (2) orn rur administration (FDA) will verify such Inspections, the rood and bray with the GMP regulation may result in assumptions. Fallure co comply areas publish further announcements
regulatory action. In addition, FDA may publish Plance noter this regulatory action. In address, and the Federal Register. Please not offect concerning your device in the ideasing submission does not affect any
response to your premarket notification who f 12 of the Act response to your premained ware sections 531 through 542 of the Act obligation you might have ander because of the control provisions, for devices, or other Federal laws or regulations.

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Page 2 - Mr. Markus Buetler

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 be obsainsa mumber [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark McMullisson

James E. Dillard III

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K 992823

Device Name: SPIROVIT SP-2

Indications For Use:

The Spirovit SP-2 / PneumoCheck ® II can be used to measure the following spirometric parameters within the Healthcare Facility:

Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 1.0 / FVC, FEF 0.2-1.2, FEF 25-75%, FEF 75-85%, ( = = +) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 6 years of age or older.

(PLEASE DO NO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>for</i> Mark N Melkers |
|-------------------------------------------------------------------|---------------------------|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |

| 510(k) Number | K992823 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;"> <svg height="20" width="20"> <path d="M4 10 L8 14 L16 6" fill="none" stroke="black" stroke-width="2"></path> </svg> </div> | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
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