FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

K080734 · Viasys Healthcare GmbH · BTY · Jun 26, 2008 · Anesthesiology

Device Facts

• Record ID: K080734
• Device Name: FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
• Applicant: Viasys Healthcare GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Jun 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel). The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient. Federal U.S. law restricts this device to sale by or on the order of a physician.

Device Story

Diagnostic system for pulmonary function and ECG; combines spirometry and ECG capabilities on single hardware platform. Inputs: ultrasonic/pneumotach handle for spirometry; 12-lead surface ECG electrodes. Transforms inputs via internal database and HES (Hanover ECG System) software; provides digital filtering, rhythm analysis, and morphology interpretation. Outputs: color LCD display, ink-printer reports, SD card storage. Used in clinics/hospitals by physicians/nurses. Supports clinical decision-making by providing qualitative/quantitative cardiovascular data; requires physician reassessment. Benefits: integrated diagnostic screening for pulmonary and cardiac conditions.

Clinical Evidence

Bench testing only. Validation performed via FMEA risk analysis and functional test scripts/logs. Safety testing conducted per IEC 60601-1 and IEC 60601-2-25. EMC testing performed per EN 60601-2.

Technological Characteristics

Mains-powered (100-240V) diagnostic system. Materials: Pneumotach (Ultem 1010R), handles (ABS 1001 FRVO, Luran S778 TE), mouthpieces (Polypropylene RG835MO, HDPE Eraclene MS 80U). Sensing: ultrasonic/pneumotach for flow; 12-lead ECG amplifier. Connectivity: SD card, color LCD, ink-printer. Software: Linux-based, HES interpretation module. Dimensions: 455 x 280 x 380 mm.

Indications for Use

Indicated for patients age 4+ and weight 20kg+ for pulmonary function testing and routine 3/6/12-channel surface ECG recording. Automatic ECG interpretation contraindicated for patients <16 years and pacemaker patients. Not for intracardial use.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• FlowScreen (K062011)
• CorScreen (K070614)

Submission Summary (Full Text)

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K080734

## GENERAL INFORMATION

JUN 2 6 2008

| 1. Applicant | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------|
| Date: | May 05th, 2008 |
| Name: | VIASYS Healthcare GmbH (owned by Cardinal Health) |
| Address: | Leibnizstrasse 7<br>D-97204 Hoechberg<br>Germany |
| Contact person in Germany:<br>(Official Correspondent) | |
| Address | Thomas Rust<br>VIASYS Healthcare GmbH<br>Leibnizstrasse 7, 97204 Hoechberg<br>Germany |
| Phone: | [phone] - 383 |
| FAX: | [phone] - 62383 |
| E-mail | [e-mail]<br>or at: [e-mail] |
| Contact person in USA: | |

| (US Agent) | Yvette Lloyd |
|------------|---------------------------------|
| Address | Cardinal Health |
| | 22745 Savi Ranch Parkway |
| | Yorba Linda, CA 92887 |
| Phone/Fax: | (714) - 919 - 3247 |
| E-mail | [e-mail] |

#### 2. Trade Name

FlowScreen FlowScreen ECG FlowScreen CT

#### 3. Classification Name

Pulmonary calculator (21 CFR 868.1890, Product Code BTY) Electrocardiograph (21 CFR 870.2340, Product Code DPS)

- 4. Establishment Registration Number 9615102
#### 5. Facility Address

VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg Germany

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KC80734

#### Section 513 Device Classification 6.

#### 6.1 Classification

This is a Class II device

#### 6.2 Classification Panel

Panel 73, Anesthesiology Code BTY Panel 74, Circular System Devices, ECG Code DPS

### Reason for Premarket Notification 7. New option for FlowScreen K062011 (Combination of two VIASYS devices, K062011 + K070614)

#### Predicate Devices Descriptions 8.

- 8.1 Name
a) FlowScreen b) CorScreen

- 8.2 Predicate Device Company Viasys Healthcare GmbH
- 8.3 Predicate Device 510(k)# a) K062011 b) K070614

#### Device Description க்

## FlowScreen is an active medical device providing following characteristics:

Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card

## a) pulmonary functions

- Measurement with ultrasonic handle or pneumotach handle .
- Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) �
- Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
- Flow-Volume and Volume-Time Loop, pre/post tests .
- MVV measurement �
- Trending capabilities �
- Patient Incentive animations �
- Interpretation modules .

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## b) ECG functions

- . Simultaneous acquisition of the 12 standard leads
- Storage of 10 seconds of acquired ECG signal .
- Digital filters for base-line drift and mains interference suppression �
- Interpretation program Hanover ECG System (HES) providing the following . additional information:
- Representatives templates of each lead including markers on fiducial O points
- Summary of mean measurements O
- Rhythm Analysis statements O
- Signal noise detection and information O
- Specific findings on QRS complex ಂ
- Conduction statements O
- QRS T diagnostic statements O
- Arrhythmia monitoring detection o
- Heart Rate Variability 0

#### 10. Intended Use Statement

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 vears and older and a weight of 20 kg or higher. FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Federal U.S. law restricts this device to sale by or on the order of a physician.

#### 11. Required Components

FlowScreen - monitor Ultrasonic handle or pneumotach handle ECG-amplifier Disposable ECG-electrodes User manual

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K080734

:

#### 12. Summary table of comparison

| Pulmonary Function | | | | |
|--------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| # | Parameter | New Device:<br>FlowScreen | Predicate Device:<br>FlowScreen K062011 | Result |
| 1 | Intended Use | Diagnostic Spirometry<br>(VCin, VCex, etc.) | Diagnostic Spirometry<br>(VCin, VCex, etc.) | identical |
| 2 | Patient population | To be used as a<br>screening device to<br>determine whether or<br>not a patient requires<br>further diagnosis for<br>pulmonary function<br>disorders | To be used as a<br>screening device to<br>determine whether or<br>not a patient requires<br>further diagnosis for<br>pulmonary function<br>disorders | identical |
| 3 | Performance | Slow Spiormetry<br>Forced Spiormetry<br>Flow-Volume<br>MVV<br>Pre/Post Tests<br>Trending capabilities<br>Interpretation modules | Slow Spiormetry<br>Forced Spiormetry<br>Flow-Volume<br>MVV<br>Pre/Post Tests<br>Trending capabilities<br>Interpretation modules | identical |
| 4 | Patient user<br>interface | Ultrasonic handle or<br>pneumotach handle | Ultrasonic handle or<br>pneumotach handle | identical |
| 5 | Material of<br>patient user<br>interface | Pneumotach handle:<br>Pneumotach (Ultem<br>1010R, handle (Romira<br>ABS 1001 FRVO),<br>mouthpiece<br>(Polypropylene<br>RG835MO)<br>Ultrasonic handle:<br>handle (Luran S778 TE),<br>mouthpiece (HDPE<br>Eraclene MS 80U) | Pneumotach handle:<br>Pneumotach (Ultem<br>1010R, handle (Romira<br>ABS 1001 FRVO),<br>mouthpiece<br>(Polypropylene<br>RG835MO)<br>Ultrasonic handle:<br>handle (Luran S778 TE),<br>mouthpiece (HDPE<br>Eraclene MS 80U) | identical |
| 6 | Patient<br>contacting<br>accessories | Mouthpiece<br>Nose clip<br>Nose pads | Mouthpiece<br>Nose clip<br>Nose pads | identical |
| 7 | Material of<br>patient<br>contacting<br>accessories | Nose clip: Polyacetal<br>Nose pads: Ethylene<br>Vinyl Acetate | Nose clip: Polyacetal<br>Nose pads: Ethylene<br>Vinyl Acetate | identical |
| 8 | Dimensional<br>specification | 455 x 280 x 380 (W x H<br>x D) | 455 x 280 x 380 (W x H<br>x D) | Identical |
| 9 | Software | Data acquisition<br>Data calculation<br>Calc. of predicted values<br>Data analysis<br>Data interpretation<br>Data storage<br>Data output<br>Data input | Data acquisition<br>Data calculation<br>Calc. of predicted values<br>Data analysis<br>Data interpretation<br>Data storage<br>Data output<br>Data input | Identical |

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| ECG Function | | | | |
|--------------|------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-----------|
| # | Parameter | New Device:<br>FlowScreen | Predicate Device:<br>CorScreen K070614 | Result |
| 1 | Intended Use | 3/6- or 12-channel<br>surface ECG recording<br>device | 3/6- or 12-channel<br>surface ECG recording<br>device | identical |
| 2 | Input dynamic<br>range | +/- 300mV @ DC | +/- 300mV @ DC | identical |
| 3 | Frequency<br>response<br>Bandwidth | 0,05 - 150 Hz /<br>According to EC11 and<br>IEC 60601-2-51 | 0,05 - 150 Hz /<br>According to EC11 and<br>IEC 60601-2-51 | identical |
| 4 | A/D conversion | 24 bits | 24 bits | identical |
| 5 | Leads | 12 Standard | 12 Standard | identical |
| 6 | Paper Speed | 25 50 mm/s +/-5%<br>According to EC11 | 25 50 mm/s +/-5%<br>According to EC11 | identical |
| 7 | Recorder<br>Sensitivity | 5 10 20 mm/s<br>According to EC11 | 5 10 20 mm/s<br>According to EC11 | identical |
| 8 | Writing System | Ink-printer US-letter and<br>DIN-A4 size | Ink-printer US-letter and<br>DIN-A4 size | Identical |
| 9 | Printed<br>Channels | 1/2/6/12 | 1/2/6/12 | Identical |
| 10 | Paper | US-Letter and DIN-A4 | US-Letter and DIN-A4 | Identical |
| 11 | Mode of<br>operation | Manual | Manual | Identical |
| 12 | Input/output | SD Memory card | SD Memory card | Identical |
| 13 | Display | | | |
| 14 | Size | 320 x 240 pixels | 320 x 240 pixels | Identical |
| 15 | No. of displayed<br>channels | 1/3/6/12 | 1/3/6/12 | Identical |
| 16 | Trace speeds | 5 10 25 50 mm/s | 5 10 25 50 mm/s | Identical |
| 17 | Sensitivity | 5 10 20 40 mm/mV | 5 10 20 40 mm/mV | Identical |

.

KOBA

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K080734

| Hardware platform | | |
|------------------------------------------|--------------------|-------------------|
| FlowScreen | FlowScreen K062011 | CorScreen K070614 |
| Power supply | Identical | Identical |
| Mainboard | Identical | Identical |
| Connector board | Identical | Identical |
| Interfaces | Identical | Identical |
| Color printer | Identical | Identical |
| Keyboard | Identical | Identical |
| Color display | Identical | Identical |
| Enclosure | Identical | Identical |
| Hardware patient user interfaces | | |
| Patient user interface pneumotach handle | Identical | ---------- |
| Patient user interface USS-handle | Identical | ---------- |
| ECG Amplifier | ---------- | Identical |
| Accessories | | |
| Mouthpiece | Identical | ---------- |
| Nose clip | Identical | ---------- |
| ECG electrodes | ---------- | Identical |
| Software / Firmware / Operating System | | |
| Boot loader (u-boot) | Identical | Identical |
| Operating system (Linux) | Identical | Identical |
| Firmware: | | |
| Base module | Identical | Identical |
| Spirometry module | Identical | ---------- |
| ECG module | ---------- | Identical |

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K080734

#### 13. Summary of non-clinical performance tests

The following practices were followed and monitored for development of the FlowScreen / FlowScreen ECG / FlowScreen CT:

The risk analysis method used to assess the impact of the FlowScreen with the new option ECG was a Failure Modes and Effects Analysis (FMEA). The risk analysis and risk control document number is 651003 17.

The design validation tests that were performed as a result of this risk analysis assessment and functional specifications are documented in document "Validation test script" and "validation test log" with document number 671003 32 (Test Script), 671003 33 (Test Log), 671003 40 (Test Script Workflow ECG) and 671003 41 (Test Log Workflow ECG).

The safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. The document numbers for the performed safety tests according IEC 60601-1 are 407.267.2 and 71320123. The document number according IEC60601-2-25 is 407.267.3.

The EMC testing was performed according EN60601-2 with the document numbers 266.182 and 267.281.

### Conclusion:

Based on the above, VIASYS HEALTHCARE GMBH concludes, that FlowScreen is determined substantially equivalent to the legally marketed predicate VIASYS devices and is safe and effective for its intended use, and performs at least as well as the predicate devices. The FlowScreen / FlowScreen ECG / FlowScreen CT is a combination of FlowScreen K062011 and CorScreen K070614 on the identical hardware base.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 6 2008

Mr. Thomas Rust Regulatory Affairs Manager VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg GERMANY

Re: K080734

Trade/Device Name: FlowScreen FlowScreen ECG FlowScreen CT

Regulation Number: 21 CFR 868.1890

Regulation Name: Predictive Pulmonary Function Value Calculator Regulatory Class: II Product Code: BTY,DPS Dated: May 7, 2008 Received: May 12, 2008

Dear Mr. Rust:

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 your 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.

{8}------------------------------------------------

Page 2 - Mr. Rust

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 (OS) 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/industry/support/index.html.

Sincerely yours,

Clare

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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510(k) Number (if known): K080734

Device Name:

FlowScreen FlowScreen ECG FlowScreen CT

Indications for Use:

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Federal U.S. law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

NEEDED)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080734

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