(263 days)
Not Found
No
The summary describes a standard spirometer measuring physiological parameters and mentions software quality testing according to established guidelines, with no indication of AI/ML being used for data analysis or interpretation.
No
The device is described as being used to "measure ... spirometric parameters," which indicates a diagnostic or monitoring function, not a therapeutic one. It does not mention treating or alleviating any conditions.
Yes
The device is described as measuring spirometric parameters, and the term "Intended Use / Indications for Use" directly implies a medical purpose for assessment or diagnosis. The mention of its use "within the Healthcare Facility" further supports its role in medical evaluation.
No
The summary mentions electrical safety and reliability testing according to IEC 601-1-1 (Safety) and IEC 601-1-2 (EMC), which are standards for electrical medical equipment, indicating the presence of hardware. It also refers to "Device software requirements, software structure chart, software development, software revision/ modification, software identification, software verification, validation and testing are described in the data attached," which, while describing software aspects, is within the context of a device that underwent electrical safety testing. The predicate device K984031 is a spirometer, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as measuring spirometric parameters in patients. This involves measuring physiological functions directly from the patient's body (specifically, their respiratory system).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples. The device directly interacts with the patient's breath.
Therefore, the Spirovit SP-2 / PneumoCheck ® II falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
73 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
Healthcare Facility
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
Not Found
Key Metrics
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
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-2
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%
(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 dB
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.
2
FDA 510K SP-2
Non-Clinical Tests B1
-
- 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) ા
- Electrical Safety and Reliability Electrical Sarety and Rollability
All tests are passed.
-
- Data related to software quality
SCHILLER has reviewed its software development process following the quideline
- Data related to software quality
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
5
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) |
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | -------------------------------------------------- |
|---|