SPIROPRO SPO2

K031515 · Viasys Healthcare GmbH · DQA · Nov 14, 2003 · Cardiovascular

Device Facts

• Record ID: K031515
• Device Name: SPIROPRO SPO2
• Applicant: Viasys Healthcare GmbH
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Portable, battery-operated device combining diagnostic spirometry and pulse oximetry. Spirometry inputs via pneumotachograph pressure transducer; pulse oximetry inputs via finger clip sensor. Device processes pressure-to-flow conversions for lung parameters (Vcin, FVC, FEV1, MEF50) and dual-wavelength pulse oximetry for SpO2 and heart rate. Features graphical LCD touchscreen interface for data entry and menu navigation. Stores up to 600 measurements in non-volatile memory. Operates standalone or connected to PC via serial port for real-time display, data analysis, and long-term storage. Built-in interpretation module performs quality checks and selects best measurement results. Provides printouts to PCL-compatible printers. Used by physicians or patients to monitor pulmonary function and oxygen saturation, aiding clinical decision-making in primary care, hospital, or home settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Portable, battery-operated unit with graphical LCD touchscreen. Sensing: pneumotachograph (pressure transducer) for spirometry; dual-wavelength pulse oximetry sensor. Connectivity: serial port for PC data transmission, PCL-compatible printer support. Non-sterile, plastic patient-contact materials (mouthpiece, finger clip). Software-driven with non-volatile memory storage (600 measurements). Rechargeable battery system.

Indications for Use

Indicated for adults and children 4 years and older for the measurement of inspiratory and expiratory lung function parameters, oxygen saturation, and heart rate. Used by physicians in office/hospital/occupational medicine or by patients in the home.

Regulatory Classification

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.

Predicate Devices

• SpiroPro (K000648)
• SpirOxCard (K001995)

Submission Summary (Full Text)

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NOV 1 4 2003

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# 510(k) SUMMARY of SAFETY and EFFECTIVENESS

#### A. General Information

| <b><i>Submitter:</i></b> | VIASYS Healthcare GmbH |
|--------------------------|------------------------|
| | Leibnizstasse 7 |
| | D-97204 Hoechberg |
| | Germany |

Contact: (USA) Earl Draper SensorMedics Corp. Phone: [phone] Ext. 8461 Fax: [phone] Fax: Email: Earl. [e-mail]

Alternate (Germany) Elmar Niedermeyer VIASYS Healthcare GmbH Phone: [phone] 01149 931 4972-62361 Email: [e-mail]

Reg. No .: 9615102

Date Preapared: April 28, 2003

#### B. Device

- 1. Proprietary: SpiroPro® SpO2
- 2. Common/Generic:
- Calculator Pulmonary Function a)
- Diagnostic Spirometer and Pulse Oximeter b)

3. Classification:

- Calculator Pulmonary Function a)
- b) Diagnostic Spirometer and Pulse Oximeter
- 4. 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

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#### 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.

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## 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:<br>SpiroPro® SpO2 | Predicate Device:<br>SpiroPro®<br>(Pulmonary Function) | Same |
| 1 | Indications for<br>Use | Diagnostic Spirometry<br>(Vcin, FVC, FEV1,<br>MEF50 etc.) | Diagnostic Spirometry<br>(Vcin, FVC, FEV1,<br>MEF50 etc.) | X |
| 2 | Fundamental<br>Scientific<br>Technology | Pneumotachograph<br>pressure to flow<br>conversion technique | Pneumotachograph<br>pressure to flow<br>conversion technique | X |
| 3 | Disposable<br>Accessories | Pneumotachograph set | Pneumotachograph set | X |
| 4 | Sterile / Non-<br>Sterile | Non-Sterile | Non-Sterile | X |
| 5 | Patient Contact<br>Materials | Plastic Mouthpiece | Plastic Mouthpiece | X |
| 6 | Off-the-Shelf<br>Software<br>required for use | Option | Option | X |
| 7 | Software<br>Driven | Yes | Yes | X |

| # | Area | New Device:<br>SpiroPro® SpO2 | Predicate Device:<br>SpirOxCard®<br>(Pulse Oximetry) | Same |
|---|-----------------------------------------|----------------------------------------------------|------------------------------------------------------|------|
| 1 | Indications for<br>Use | Pulse Oximetry (Not<br>for Continuous Use) | Pulse Oximetry (Not for<br>Continuous Use) | X |
| 2 | Fundamental<br>Scientific<br>Technology | conventional dual<br>wavelength pulse<br>technique | conventional dual<br>wavelength pulse<br>technique | X |
| 3 | Accessories | Finger Clip Sensor | Finger Clip Sensor | X |
| 4 | Sterile / Non-<br>Sterile | Non-Sterile | Non-Sterile | X |
| 5 | Patient Contact<br>Materials | Plastic Finger Clip | Plastic Finger Clip | X |
| 6 | Software<br>Driven | Yes | Yes | X |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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)