MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT

K082539 · Cardinal Health Germany 234 GmbH · BTY · Dec 2, 2008 · Anesthesiology

Device Facts

• Record ID: K082539
• Device Name: MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
• Applicant: Cardinal Health Germany 234 GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Dec 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients. 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 the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. MasterScope / MasterScope 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. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope 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. MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, 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 MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG 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 MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Device Story

MasterScope is a PC-based system for pulmonary function testing and ECG acquisition; used in clinics/hospitals by trained physicians. Pulmonary module uses ultrasonic or pneumotach handles for spirometry (VC, FVC, MV, etc.). ECG module acquires 12-lead surface ECG via amplifier; provides automated interpretation via Hanover ECG System (HES). Inputs: respiratory flow/volume signals; 12-lead ECG electrical signals. Outputs: lung function parameters, ECG waveforms, and automated diagnostic suggestions. Physician reviews all automated interpretations; output supports clinical decision-making but does not replace physician assessment. MasterScope CT version adds workflow/role-based access control for clinical trials. System connects to PC via USB; provides trending and patient incentive animations.

Clinical Evidence

Bench testing only. Safety and performance verified via FMEA, EMC testing (EN 60601-1-2), and software development standards (IEC 601-1-4). No clinical trial data presented.

Technological Characteristics

PC-based system; Windows XP/LAB software. Pulmonary: Ultrasonic (Luran S778TE) or Pneumotach (Ultem 1010R) handles. ECG: 12-lead amplifier, 1000Hz sampling (4000Hz for pacemaker detection), 19-bit resolution. Connectivity: USB. Power: 100-240V AC. Patient contact materials: Polyacetal, EVA, Polypropylene, HDPE.

Indications for Use

Indicated for patients age 4+ and weight 20kg+ for lung function measurement (COPD/Asthma) and 3/6/12-channel surface ECG recording. Automatic ECG interpretation indicated for patients 16+; contraindicated for pacemaker patients and pediatric patients <16 years. 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

• MasterScope / MasterScreen Pneumo (K071753)
• FlowScreen / FlowScreen ECG / FlowScreen CT (K080734)

Submission Summary (Full Text)

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# 510(k) Summary

### GENERAL INFORMATION

# DEC 0 2 2008

1082539

2.1087

#### 5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 08/26/2008

#### 5.2 Submitter

Name:

Cardinal Health Germany 234 GmbH (formerly Viasys Healthcare GmbH)

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

### Contact person in Germany: (Official Correspondent) Address:

Thomas Rust Cardinal Health Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany [phone] - 383 [phone] - 62383 Thomas. [e-mail]

Phone: FAX: E-mail

Contact person in the U.S .: (US Agent) Address

Yvette Lloyd Cardinal Health 22745 Savi Ranch Parkway Yorba Linda, CA 92887 (714) - 919 - 3247 [e-mail]

Phone/Fax: E-mail

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K082539
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#### Establishment Registration Number 5.3

9615102

#### 5.4 Common Name or Classification Name

Predictive pulmonary-function value calculator (CFR 868.1890 Product Code BTY)

Electrocardiograph (CFR 870.2340, Product Code DPS)

#### 5.5 Trade Name

MasterScope MasterScope ECG MasterScope CT

> this is the clinical trial version

#### 5.6 Classification

This is a Class II device

#### 5.7 Classification Panel

73 Anesthesiology Part 868 74 Circular System Devices, ECG Part 870

#### 5.8 Reason for Premarket Notification

New option to an existing Cardinal Health device. (ECG option for MasterSope K071753)

#### 5.9 Legally predicate marketed devices

MasterScope / MasterScreen Pneumo K071753 / Code BTY

FlowScreen / FlowScreen ECG / FlowScreen CT K080734 / Code BTY, DPS,

### 5.10 Predicate Device Company Cardinal Health Germany 234 GmbH (Owned by Cardinal Health Inc. - owner no. 9028292)

#### 5.11 Device Description

MasterScope / MasterScope ECG is an active device providing following characteristics:

Mains operation Personal Computer System Graphic user interface Windows XP Professional LAB Software Powerful database for storing patient- and test data

Cardinal Health

MasterScope / MasterScope ECG 16

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Ultrasonic handle Pneumotach handle/shutter ECG Amplifier

#### pulmonary functions a)

- 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 �
- MV measurement ◆
- ◆ R Occlusion (only with pneumotach handle)
- Trending capabilities .
- Patient Incentive animations �
- Interpretation modules .

#### 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 fiducially points .
- Summary of mean measurements #
- Rhythm Analysis statements .
- Signal noise detection and information �
- Specific findings on QRS complex .
- Conduction statements .
- QRS T diagnostic statements .
- Arrhythmia monitoring detection .
- . Heart Rate Variability

#### 5.12 Intended Use Statement

**Device Name:**

MasterScope MasterScope ECG MasterScope CT

Indications for Use:

The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.

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 the screen or printed on paper. 12channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

MasterScope / MasterScope 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. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope 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.

MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).

ﺘﮯ

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### 5 510(k) Summary

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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 MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG 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 MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

#### 5.13 Required Components

Notebook Pneumotach handle/shutter or Ultrasonic handle or/and ECG Amplifier Accessories User Manual

#### 5.14 Summary Table of Comparision

| Pulmonary Function Comparison | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | New Device:<br>MasterScope with the new<br>features | Predicate Device:<br>MasterScope K071753 |
| Intended Use | Diagnostic Spirometry<br>(VCin, VCex, etc.) | Identical |
| Patient<br>population | To be used as a screening<br>device to determine whether or<br>not a patient requires further<br>diagnosis for pulmonary<br>function disorders. | Identical |
| Performance<br>(Measurements) | Tital Spirometry (VT,<br>VCin, ERV, ...) Forced Spirometry<br>Flow-Volume (FVC,<br>FEV1, MEF50, ...) Maximum Voluntary<br>Ventilation R Occlusion (only possible with<br>pneumotach handle) Interpretation and quality<br>assessment compliant | Identical |

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・・

.. .

| Software | • Windows XP with LAB<br>Software | Identical |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Patient user<br>interface | Digital handle (pressure sensor)<br>or Digital handle (ultrasonic<br>sensor) | Identical |
| Material of<br>patient user<br>interface | Pressure sensor<br>Pneumotach: Ultem 1010R<br>Handle (PT): Romira 1001R<br>Ultrasonic sensor<br>Ultrsonic handle: Luran S778TE | Identical |
| Patient<br>contacting<br>accessories | Nose Clip<br>Nose Clip pads<br>Single use mouthpiece for PT<br>Single use mouthpiece for USS | Identical |
| Material of<br>patient<br>contacting<br>accessories | Nose Clip: Polyacetal<br>Nose Clip pads: Ethylene Vinyl<br>Acetate<br>Single use mouthpiece (PT):<br>Polypropylen RG835MO<br>Single use mouthpiece (USS):<br>HDPE Eraclene MS 80U | Identical |
| Energy type | 100 - 240V AC 50/60Hz | Identical |

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| ECG Function Comparison | | |
|---------------------------------------------|-----------------------------------------------------|-----------------------------------------|
| | New Device:<br>MasterScope with the new<br>features | Predicate Device:<br>FlowScreen K080734 |
| Intended Use | 3/6- or 12-channel<br>Surface ECG recording device | Identical |
| Application | ECG recording | Identical |
| Bandwidth | 0 - 150 Hz digital | Identical |
| ECG leads | Acc. to Einthoven, Wilson,<br>Goldberger | Identical |
| Leads | 12 Standard | Identical |
| A/D<br>Resolution | 2,6 µV/bit ECG, 19 bit | Identical |
| Sampling rate<br>per channel | 1000 Hz | Identical |
| Sampling rate<br>for pacemaker<br>detection | 4000 Hz | Identical |
| Connection to<br>PC | USB connection | Serial connection |
| Power supply | 5V DC via USB interface | 5V DC via Serial interface |
| Connection to<br>electrodes | 4 mm snap connector, gold<br>plated | Identical |
| Patient<br>contacting<br>accessories | • Single use electrode<br>• Electrode cable | Identical |
| ECG Amplifier<br>enclosure<br>material | ABS/PC<br>(no patient contacting part) | Santoprene TPV 281-87 MED |

Cardinal Health

:

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### 5 510(k) Summary

#### Summary of Device Testing 5.15

The following practices were followed and monitored for development of the MasterScope with the new option ECG:

The new option for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 -Design Control).

The risk analysis method used to assess the impact of the MasterScope with the new option ECG was a Failure Modes and Effects Analysis (FMEA).

Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.

The software was developed according to the IEC 601-1-4 Standard.

The EMC testing was performed according EN 60601-1-2.

#### 5.16 Conclusions

Based on the above, Cardinal Health Germany 234 GmbH concludes that the MasterScope with the ECG option is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.

Cardinal Health

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 2 2008

Mr. Thomas Rust Regulatory Affairs Manager Cardinal Health Germany 234 GmbH Leibnizstrasse 7 Hoechberg, Bavaria GERMANY 97204

Re: K082539

Trade/Device Name: MasterScope, MasterScope ECG, MasterScope CT Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY, DPS Dated: August 26, 2008 Received: September 3, 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 vour 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. 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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Suste G. Michaels m-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

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### Indications for Use

510(k) Number (if known):

Device Name:

MasterScope MasterScope ECG MasterScope CT

Indications for Use:

The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.

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 the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

MasterScope / MasterScope 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. MasterScope / MasterScope ECG is Intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatic patients with an age below 16 years and for pacemaker patients.

MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, 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 MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG 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 MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suatt y. McheuDns

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

K082 539 510(k) Number:

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