(184 days)
No
The description focuses on standard spirometry and pulse oximetry measurements and data storage/transfer, with no mention of AI or ML algorithms for analysis or interpretation. The "built-in interpretation module" appears to be a rule-based system for quality checks and best result selection, not an AI/ML model.
No
The device measures lung function parameters, oxygen saturation, and heart rate for diagnostic and monitoring purposes, but it does not provide any therapeutic intervention.
Yes
The device description explicitly states, "Combining the two diagnostic devices into one device is very cost effective for the user," referring to the pulmonary function calculator and a pulse oximeter that are combined in this device. This indicates its diagnostic function.
No
The device description explicitly states it is a "portable, electronic measuring device" with a "very precise pressure transducer (pneumotachograph)", a "graphical LCD display", "touch-screen technology", and a "rechargeable battery". These are all hardware components. While it mentions optional software, the core device is a physical instrument.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The SpiroPro SpO2 measures lung function parameters and oxygen saturation directly from the patient's breath and pulse, respectively. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description focus on physiological measurements. The device measures inspiratory and expiratory lung function, oxygen saturation, and heart rate. These are all physiological parameters measured in vivo (within the living body), not in vitro (in glass, referring to laboratory analysis of samples).
Therefore, the SpiroPro SpO2 is a medical device used for physiological monitoring and assessment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpiroPro SpO2 is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro SpO2 measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
Product codes
DQA, BTY
Device Description
The pocket spirometer SpiroPro® SpO2 is a portable, electronic measuring device for the determination of expiratory and inspiratory parameters (Vcin, FVC, FEV1, MEF50 etc.) including Pre/Post testing, date and time stamps as well as the complete registration of spirogram and flow-volume curves by a very precise pressure transducer (pneumotachograph). The built-in interpretation module enables an easy quality check and an automatic selection of the best measuring result. The unique SpO2 option completes the range of functions of the versatile spirometer. SpO—spot and trend measurements can be performed also oxygen saturation and heart rate can be recorded over a period of 60 minutes.
Equipped with a graphical LCD display, an innovative touch-screen technology and a user-friendly graphical user interface, the SpiroPro® SpO2 provides the latest developments in technology. The input of patient data and the selection of the menu functions is realised by just touching the corresponding icon with your finger tips.
The SpiroPro® SpO2 can store up to 600 measurements in its non-volatile memory. If required also versions with higher capacity are available. The rechargeable battery allows an operation time of approximately 2 weeks. A charger that recharges the battery within 2 hours is supplied with the unit.
With the built-in communication module a direct printout of results and graphs to a PCL-compatible printer is possible. Of course, data transmission to and from a PC by a serial port is an integral part of the innovative concept. The optional software package "SpiroPro® SpO2 for Windows" receives the data all-automatically and stores them on the PC.
The unit can work stand alone or in combination with a PC for measurements with real-time display, questionnaire functionality, data analysis and long term storage.
Combining the two diagnostic devices into one device is very cost effective for the user. A pulmonary function calculator and a pulse oximeter are two devices that a physician will use on a regular basis for patient care.
The handy, modular design allows the use of the SpiroPro® SpO2 in many fields of primary care.
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
adults and children 4 years and older
Intended User / Care Setting
physicians in the office or hospital, in occupational medicine or by patients in the home.
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)
Not Found
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
NOV 1 4 2003
Image /page/0/Picture/1 description: The image shows the text 'K031515' in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the frame. The characters are bold and slightly distorted, giving them a unique, hand-drawn appearance.
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| Submitter: | VIASYS Healthcare GmbH |
|---|---|
| Leibnizstasse 7 | |
| D-97204 Hoechberg | |
| Germany |
Contact: (USA) Earl Draper SensorMedics Corp. Phone: (714) 283 2228 Ext. 8461 Fax: (714) 283 8426 Fax: Email: Earl. Draper@sensormedics.com
Alternate (Germany) Elmar Niedermeyer VIASYS Healthcare GmbH Phone: 01149 931 4972-361 01149 931 4972-62361 Email: NE@jaeger-toennies.com
Reg. No .: 9615102
Date Preapared: April 28, 2003
B. Device
-
- Proprietary: SpiroPro® SpO2
-
- Common/Generic:
- Calculator Pulmonary Function a)
- Diagnostic Spirometer and Pulse Oximeter b)
- Classification:
- Calculator Pulmonary Function a)
- b) Diagnostic Spirometer and Pulse Oximeter
-
- Class: Class II
- રું. Panel Code:
- BTY a)
- b) DQA; BZG
- Q. Regulation Number:
- a) 8868.1890
- b) §870.2700; 8681840
Page 1 of 3
1
Identification of Legally Marketed (Unmodified) Devices C.
| Pulmonary Function | |
|---|---|
| 1. Name: | SpiroPro® |
| 2. Manufacturer: | VIASYS Healthcare GmbH |
| 3. K Number: | K000648 |
| 4. Date Cleared: | February 28, 2000 |
| Pulse Oximetry | |
| 1. Name: | SpirOxCard® |
| 2. Manufacturer: | QRS Diagnostic, LLC |
| 3. K Number: | K001995 |
| 4. Date Cleared: | October 28, 1998 |
D. Description of the Device
The pocket spirometer SpiroPro® SpO2 is a portable, electronic measuring device for the determination of expiratory and inspiratory parameters (Vcin, FVC, FEV1, MEF50 etc.) including Pre/Post testing, date and time stamps as well as the complete registration of spirogram and flowvolume curves by a very precise pressure transducer (pneumotachograph). The built-in interpretation module enables an easy quality check and an automatic selection of the best measuring result. The unique SpO2 option completes the range of functions of the versatile spirometer. SpO--spot and trend measurements can be performed also oxygen saturation and heart rate can be recorded over a period of 60 minutes.
Equipped with a graphical LCD display, an innovative touch-screen technology and a user-friendly graphical user interface, the SpiroPro® SpO2 provides the latest developments in technology. The input of patient data and the selection of the menu functions is realised by just touching the corresponding icon with your finger tips.
The SpiroPro® SpO2 can store up to 600 measurements in its non-volatile memory. If required also versions with higher capacity are available. The rechargeable battery allows an operation time of approximately 2 weeks. A charger that recharges the battery within 2 hours is supplied with the unit.
With the built-in communication module a direct printout of results and graphs to a PCL-compatible printer is possible. Of course, data transmission to and from a PC by a serial port is an integral part of the innovative concept. The optional software package "SpiroPro® SpO2 for Windows" receives the data all-automatically and stores them on the PC.
The unit can work stand alone or in combination with a PC for measurements with real-time display, questionnaire functionality, data analysis and long term storage.
Combining the two diagnostic devices into one device is very cost effective for the user. A pulmonary function calculator and a pulse oximeter are two devices that a physician will use on a regular basis for patient care.
The handy, modular design allows the use of the SpiroPro® SpO2 in many fields of primary care.
E. Intended Use Statement
The SpiroPro SpO2 is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro SpO2 measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
2
Required Components F.
- SpiroPro® SpO2 (with Nonin® Xpod Patient Cable Oximeter) -
- Nonin Finger Clip Sensor -
- Pneumotachograph set -
- Plastic Disposable Mouthpiece -
- -User Manual
- Windows Software (Option) -
Summary Table of Comparisons G.
The following summary tables of comparisons compare the modified device (SpiroPro® SpO2) to the predicate devices, SpiroPro® and QRS Diagnostic SpirOxCard, for Pulmonary Function and Pulse Oximetry respectively.
| Pulmonary Function | ||||
|---|---|---|---|---|
| # | Area | New Device: | ||
| SpiroPro® SpO2 | Predicate Device: | |||
| SpiroPro® | ||||
| (Pulmonary Function) | Same | |||
| 1 | Indications for | |||
| Use | Diagnostic Spirometry | |||
| (Vcin, FVC, FEV1, | ||||
| MEF50 etc.) | Diagnostic Spirometry | |||
| (Vcin, FVC, FEV1, | ||||
| MEF50 etc.) | X | |||
| 2 | Fundamental | |||
| Scientific | ||||
| Technology | Pneumotachograph | |||
| pressure to flow | ||||
| conversion technique | Pneumotachograph | |||
| pressure to flow | ||||
| conversion technique | X | |||
| 3 | Disposable | |||
| Accessories | Pneumotachograph set | Pneumotachograph set | X | |
| 4 | Sterile / Non- | |||
| Sterile | Non-Sterile | Non-Sterile | X | |
| 5 | Patient Contact | |||
| Materials | Plastic Mouthpiece | Plastic Mouthpiece | X | |
| 6 | Off-the-Shelf | |||
| Software | ||||
| required for use | Option | Option | X | |
| 7 | Software | |||
| Driven | Yes | Yes | X |
| # | Area | New Device:
SpiroPro® SpO2 | Predicate Device:
SpirOxCard®
(Pulse Oximetry) | Same |
|---|-----------------------------------------|----------------------------------------------------|------------------------------------------------------|------|
| 1 | Indications for
Use | Pulse Oximetry (Not
for Continuous Use) | Pulse Oximetry (Not for
Continuous Use) | X |
| 2 | Fundamental
Scientific
Technology | conventional dual
wavelength pulse
technique | conventional dual
wavelength pulse
technique | X |
| 3 | Accessories | Finger Clip Sensor | Finger Clip Sensor | X |
| 4 | Sterile / Non-
Sterile | Non-Sterile | Non-Sterile | X |
| 5 | Patient Contact
Materials | Plastic Finger Clip | Plastic Finger Clip | X |
| 6 | Software
Driven | Yes | Yes | X |
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
Erich Jaeger GmbH c/o Mr. Earl W. Draper SensorMedics, Inc. 22705 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K031515
Trade/Device Name: SpiroPro SpO2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BTY Dated: August 26, 2003 Received: August 28, 2003
Dear Mr. Draper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Earl W. Draper
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO3151515 510(k) Number:
SpiroPro SpO2 Device Name:
Indications For Use:
The SpiroPro SpO2 is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro SpO2 measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S
Division Sign-Off) Ivision of Anesthesiology, General Hospital, ontrol, Dental Devices
510(k) Number: K031575
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)