The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 10/ FVC, FEF 0.2.1.2, FEF 25.75%, FEF 75.85% , PEF 50%, FEF 50%, FEF 75%, FIVC, FIV 10, FIV 10 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, 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 to extract the acceptance criteria and study details for the SPIROVIT SP-250 device:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of accuracy for the spirometry measurements (FVC, FEV1, etc.). Instead, the device's performance is asserted by demonstrating compliance with existing standards and deeming it "as safe and effective as the Predicate (SP-100) Device."

However, the "Non-Clinical Tests B1" section implicitly sets compliance with certain standards as the acceptance criteria. Based on the provided text, the criteria and the device's reported performance are:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ATS Spirometry Statement Medical Section of the American Lung Association November - 11th 1994	All tests passed
IEC 601-1-1 (Safety)	All tests passed
IEC 601-1-2 (EMC)	All tests passed
IEC 601-1-4 (Software Quality)	All tests passed; review of software development process compliant with "reviewer guidance for computer controlled medical devices undergoing 510 (k) review"

Study Information

Based on the provided text, there is no detailed information about a clinical study with a test set, ground truth experts, or training data. The document explicitly states:

B2 Clinical Tests: n.a. (not applicable)

This indicates that a formal clinical study, as one might expect for a diagnostic device with specific performance metrics, was not conducted or at least not reported in this 510(k) summary. The submission relies on non-clinical testing and substantial equivalence to the predicate device.

Given the "n.a." for clinical tests, the following points cannot be answered from the provided document:

Sample size used for the test set and the data provenance: Not applicable (no clinical test set described).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no clinical test set described).
Adjudication method for the test set: Not applicable (no clinical test set described).
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 (no clinical study, no mention of AI assistance).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no standalone performance study described beyond compliance with technical standards).
The type of ground truth used: Not applicable (no clinical test set described).
The sample size for the training set: Not applicable (no training set described for an algorithm, as this is a device for vital capacity measurement, not an AI/ML diagnostic).
How the ground truth for the training set was established: Not applicable.

Summary of Device Proving Acceptance:

The device, SPIROVIT SP-250, proves it meets its "acceptance criteria" by demonstrating compliance with established medical and electrical safety standards: the ATS Spirometry Statement, IEC 601-1-1 (Safety), IEC 601-1-2 (EMC), and IEC 601-1-4 (Software Quality). The submission asserts that "All tests are passed." The FDA's 510(k) clearance is based on this non-clinical testing and the device's substantial equivalence to a legally marketed predicate device (SPIROVIT SP-100), rather than a specific clinical performance study detailing accuracy metrics.

Summary

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4/30/99

FDA 510K SP-250

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510 K Summary

according to 21 CFR 807.92

A1 Address

SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Contact Name: Tel: Date:

Mr. Markus Buetler 001 41 41 766 4252 28. April 1999

A2 Device Name

Trade Name: SPIROVIT SP-250 2. Common Name: Spirometer, Pulmonary Function Test Device

A3 Legally Marketed Device

Legally Marketed Device to which this submitted device is compared: SP-100 (K896120).

A4 Intended Use

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Table of Comparison A5

Predicate device:

SPIROVIT SP-100 (K896120)

	SP-100 (K896120)	SP-250
Dimensions:
Flow Sensor	15.5 cm	(1) 7.5 cm
Handle	9 cm	(1) 10 cm
Sensor	fixed	(1) disposable
Weight:	340 g	(2) 180 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)No damage below 8 kV (Open Air)	same
Radiated Emissions	Less than 30 dB Microvolts	same
Radiated Immunity	Less than 3 Volts per meter	same
Data Communication	12 bit serial	(3) RS-232 interface

Discusson of Differences:

Discussion of Directores (1, 2 or 3) can be considered as safety relevant differences. Norte of the above diferences (1, 2 or 0) our bo considered as the Predicate (SP-100) device.

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FDA 510K SP-250

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Non-Clinical Tests B1

1. Electrical Safety and Reliability
  The SP-250 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) i
IEC 601-1-2 (EMC) ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
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 guideline " reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ ooktion, software identification, software verification, validation and testing are described in the data attached.
B2 Clinical Tests
n.a.

Conclusions from Tests B3

The fulfilment of the above standards ensures the safety and effectiveness of the submitted device. We The familinent of the above octinaties as as and effective as the Predicate (SP-100) Device.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

Mr. Markus Buetler SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

K984031 Re: SPIROVIT SP-250 SFIROVII Class: II (two) Regulator]
Product Code: 73 BZG February 26, 1999 Dated: Dated:

Dear Mr. Buetler:

Dear Mr. Buelter. we have reviewed your Section 510 (k) notification of the ender is and we device referenced above and we have detections for use stated as the
substantially equivalent (for the indications for use stated into of the enclosure) to legally marketed predicate devices marketed in
enclosure) to legally marketed predicate devices marketed data enclosure) to Legally marketed predicate devices macket of the interstate commerce prior to May 28, 1976, the enacement accomments and Medical Device Amendients, or to devices that have been and in accordance with the provisions of the redetar room beys, subject to
cosmetic Act (Act). You may, the Act. The general controls Cosmetic Act (Act). You may, the Act. The general controls
the general controls provisions of the Act. The general controls the general controls provisions of the Act. "The general registration,
the general of the Act include requirements for annual registration, erovisions of the Act include requirements for annually of the labeling, and ling, and ling, and list in the listing of devices, good manniatitiring pro-

ff your devile is classified (see above) into either class II (Special If your device is class III (Premarket Approval), it may be subject to such IT your be additional controls. Existing major regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 can be found in the Code of Federal Regulation assumes compliance
to 895. A substantially equivalent delermination assumes as set to 895. A substantially equivalent determinates as set
with the Current Good Manufacturing Practice requirements, as set with the Current Good Manufacturing Fractics Logical Devices:
forth in the Quality System Regulation (QS) for Medical Devices:
Christian (2) CER Rart 800) and that, through p forth in the Quality System Regulation (QS) 108 Novemberiodic QS
General regulation (21 CFR Part 820) and that, through perify succify su General regulation (2) CFR Part 820) and chat, enroadyo (
inspections, the Food and Drug Admistiration (FDA) will werking in inspections. Failure to comply with the GMP regulation may result in
assumptions. Failure to comply with the GMP regulation may no assumptions. Failure to comply with the can isonester announcements
regulatory action. In the Federal Register. Plaase note: this regulatory action. In addition, Primalias paster. Please note:
concerning your device in the retification submission does not af concerning your device in the redocal Registion does not affect any
response to your premarket notification 532 of the Act response to your premirket holifications 531 through 542 of the Act
obligation you might Flootronic Radiation Control provision obligation you might have under sections 351 cm one of 1999
for devices under the Electronic Product Radiation Control provisions,
the devices under as magulations for devices and 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 prodicate 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 toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/doma/domamain.html".

Sincerely yours,

Thomas J. Allelson

Thomas J. Čallahan, 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 1 of 1

510(k) Number: K984031

Device Name: SCHILLER AG, Spirovit-250 Diagnostic Spirometer

Indications For Use:

The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV, JFVC, FEF 25-12, FEF 25-75%, FEF 75-85% PEF, FEF259, FEF50%, FEF75%, FIVC, FIV, JFIVC, PIF, FIF_0%, SVC, ERV, IRV, TV, MVV, MV, RR and TV, in patients 6 years of age or older.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Arthur A. Richards, L.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

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).