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%, 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 Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPIROVIT SP-2 / PneumoCheck® II device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific numerical acceptance criteria for the spirometric parameters measured by the device. Instead, it relies on demonstrating equivalence to a predicate device and compliance with established standards. The reported "performance" for the new device is largely asserted as being "the same" as the predicate device or having passed relevant electrical and software standards.

Feature / Criteria	Predicate Device (SP-250) "Acceptance"	SPIROVIT SP-2 / PneumoCheck® II Reported Performance
Dimensions
Flow Sensor	7.5 cm	85x190x27 mm
Handle	10 cm	n.a. (not applicable, implies no separate handle)
Mouthpiece	Disposable	Same (Disposable)
Weight	180 g	275 g
Environmental Conditions
Operating Temp.	+10° - 40° C	Same
Storage Temp.	-10° - +50° C	Same
Relative Humidity	25% - 95% (non-condensing)	Same
Electrical Safety / EMC
ESD (Functional)	Below 4 kV (Open Air)	Same
ESD (No damage)	Below 8 kV (Open Air)	Same
Radiated Emissions	Less than 30 dB Microvolts	Same
Radiated Immunity	3 Volts per meter	Same
Data Communication	RS-232 interface	IrDA
Spirometry Standards	Not explicitly stated for predicate in comparison table, but ATS compliance is mentioned for new device.	ATS Spirometry Statement 1994 (All tests passed)
Electrical Safety Standards	Not explicitly stated for predicate in comparison table.	IEC 601-1-1 (All tests passed)
EMC Standards	Not explicitly stated for predicate in comparison table.	IEC 601-1-2 (All tests passed)
Software Quality Standards	Not explicitly stated for predicate in comparison table.	IEC 601-1-4 (All tests passed)

Discussion of Differences: The document explicitly states, "None of the above differences (1, 2 or 3) can be considered as safety relevant differences," and concludes that the submitted device is "as safe and effective as the Predicate (SP-250) device."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "B2 Clinical Tests n.a." (not applicable). This indicates that no clinical test set was used to validate the performance of the device against specific spirometric parameters in a patient population. The device's performance is demonstrated through compliance with standards and comparison to the predicate device's specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set with ground truth established by experts was performed. The "ground truth" for the device's technical specifications and compliance was established through rigorous testing against international and industry standards (ATS, IEC).

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a spirometer, a medical measurement device, not an AI-powered diagnostic imaging or interpretation tool.Therefore, no MRMC study or AI assistance comparison was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable in the context of AI. The device itself is a standalone measurement system. Its performance relies on its hardware and software implementing spirometry standards correctly, rather than an AI algorithm's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests:

Technical Specifications: The ground truth for device dimensions, weight, environmental conditions, and data communication was the design specifications of the device itself and its predicate.
Electrical Safety and EMC: The ground truth was the requirements and test methodologies specified in IEC 601-1-1, IEC 601-1-2.
Software Quality: The ground truth was the requirements and guidelines from IEC 601-1-4 and the "reviewer guidance for computer controlled medical devices undergoing 510(k) review."
Spirometry Performance: The implicit ground truth for accurate spirometric measurements is the ATS Spirometry Statement (November 11th, 1994). The document states that the device was tested to be in accordance with this standard and "All tests are passed."

8. The Sample Size for the Training Set

Not applicable, as this device does not involve machine learning or AI models that require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

FDA 510K SP-2

A5 Table of Comparison

SPIROVIT SP-250 (K984031) Predicate device:

	SP-250 (K984031)	SPIROVIT SP-2PneumoCheck ® 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%(non condensing	same
Electrostatic Discharge /Electromagnetic Compatibility:
ESD	Fully functional below 4 kV (Open Air)	same
	No damage below 8 kV(Open Air)	same
Radiated Emissions	Less than 30 dBMicrovolts	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.

{2}------------------------------------------------

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.

1. 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.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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.

{4}------------------------------------------------

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)

	for Mark N Melkers
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices

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

Prescription Use(Per 21 CFR 801.109)		OR	Over-The-Counter-Use(Optional Format 1-2-96)
------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------	----	--------------------------------------------------

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).