(169 days)
No
The document does not mention AI, ML, or related terms, and the performance studies focus on electrical safety and software quality according to established standards, not AI/ML model performance.
No.
The device is used to measure various lung capacities and volumes, which is a diagnostic function, not a therapeutic one. It provides data for assessment but does not directly treat a condition.
Yes
The device measures various lung function parameters (e.g., FVC, FEV1, PEF), which are used to assess respiratory health and diagnose conditions like asthma or COPD.
No
The summary describes a device that measures various spirometry parameters and mentions electrical safety and reliability testing according to standards like IEC 601-1-1 (Safety) and IEC 601-1-2 (EMC). These standards are typically applied to hardware components of medical devices, indicating the presence of hardware beyond just software. The predicate device is also a spirometer, which is a hardware device.
Based on the provided information, the Spirovit SP-250 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as measuring various lung function parameters (FVC, FEV1, etc.) in patients. This is a direct measurement of physiological function within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with the patient's respiratory system.
- Lack of IVD Indicators: There are no mentions of analyzing biological samples, reagents, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.
- Performance Studies: The performance studies focus on electrical safety, reliability, and software quality, which are typical for medical devices that interact directly with patients, not IVD devices that analyze samples.
In summary, the Spirovit SP-250 is a spirometer, a device used to measure lung function directly in a patient. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BZG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6 years of age or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- 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)
- IEC 601-1-2 (EMC)
- IEC 601-1-4 (Software Quality)
All tests are passed.
- 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.
Clinical Tests: n.a.
Conclusions from Tests: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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
1
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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.
2
FDA 510K SP-250
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Non-Clinical Tests B1
-
- Electrical Safety and Reliability
The SP-250 device has been tested to be in accordance with the following standards:
- Electrical Safety and Reliability
-
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.
-
- 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.
- Data related to software quality
-
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.
3
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.
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 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
5
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 _