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 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

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

AI/ML Overview

The provided text describes a 510(k) summary for the MasterScope, MasterScope ECG, and MasterScope CT devices. However, this document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the general safety and development practices. There is no information provided regarding specific acceptance criteria, a detailed study proving device performance against these criteria, or any of the detailed aspects of a clinical study (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The text mentions "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards" and that "The software was developed according to the IEC 601-1-4 Standard" and "The EMC testing was performed according EN 60601-1-2." These are general statements about compliance with standards and safety testing, not a detailed performance study against specific acceptance criteria for the device's functional performance (e.g., accuracy of ECG interpretation or spirometry measurements).

Therefore, I cannot populate the requested table and answer many of the questions based on the provided input.

Here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for ECG interpretation or spirometry measurements) are not detailed* in the provided document.*	Specific device performance metrics against defined acceptance criteria are not reported* in the provided document.*
General safety and regulatory compliance (e.g., IEC 601-1-4, EN 60601-1-2, FMEA)	Developed in accordance with Cardinal Health development SOPs (000490-06 Design Control). Risk analysis performed via FMEA. Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of identified hazards. Software developed to IEC 601-1-4. EMC testing performed to EN 60601-1-2.

Study Information (Based on available information in the document)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document does not describe a specific clinical test set or its characteristics. It mentions the "MasterScope CT (Clinical Trial version)" but does not provide details of any clinical trial or performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not specified. No information is provided about experts or ground truth establishment for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. No information for a test set is provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No such study is mentioned or described. The device includes "Interpretation modules" for spirometry and an "Interpretation program Hanover ECG System (HES)" for ECG. The ECG interpretation states: "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." This implies the AI provides suggestions that are meant to be reviewed by a human, but no MRMC study comparing performance with and without AI assistance is described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly stated for performance metrics. While the device has automated interpretation features, the document emphasizes that a physician must reassess the measurements, suggesting it's not intended for standalone diagnostic use. No specific standalone performance study results are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified.
The sample size for the training set:
- Not specified. No information about a training set for any embedded algorithms (like the HES interpretation program) is provided.
How the ground truth for the training set was established:
- Not specified.

Summary of Missing Information:

The provided 510(k) summary focuses on the technical specifications of the MasterScope devices (pulmonary function and ECG), their intended use, and a comparison to predicate devices to establish substantial equivalence. It confirms adherence to general safety and design control standards. However, it does not include the detailed performance study information typically associated with establishing specific acceptance criteria and proving device performance through clinical or algorithmic validation tests for features like automated ECG interpretation or precise spirometry measurements.

Summary

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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 +49 931 49 72 - 383 +49 931 49 72 - 62383 Thomas. Rust@cardinalhealth.com

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 Yvette.Lloyd@cardinalhealth.com

Phone/Fax: E-mail

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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

Page 2 of 7

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K082539
p. 3 of 7

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:

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.

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:MasterScope with the newfeatures	Predicate Device:MasterScope K071753
Intended Use	Diagnostic Spirometry(VCin, VCex, etc.)	Identical
Patientpopulation	To be used as a screeningdevice to determine whether ornot a patient requires furtherdiagnosis for pulmonaryfunction disorders.	Identical
Performance(Measurements)	Tital Spirometry (VT,VCin, ERV, ...) Forced SpirometryFlow-Volume (FVC,FEV1, MEF50, ...) Maximum VoluntaryVentilation R Occlusion (only possible withpneumotach handle) Interpretation and qualityassessment compliant	Identical

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. ·

・・

.. .

Software	• Windows XP with LABSoftware	Identical
Patient userinterface	Digital handle (pressure sensor)or Digital handle (ultrasonicsensor)	Identical
Material ofpatient userinterface	Pressure sensorPneumotach: Ultem 1010RHandle (PT): Romira 1001RUltrasonic sensorUltrsonic handle: Luran S778TE	Identical
Patientcontactingaccessories	Nose ClipNose Clip padsSingle use mouthpiece for PTSingle use mouthpiece for USS	Identical
Material ofpatientcontactingaccessories	Nose Clip: PolyacetalNose Clip pads: Ethylene VinylAcetateSingle use mouthpiece (PT):Polypropylen RG835MOSingle use mouthpiece (USS):HDPE Eraclene MS 80U	Identical
Energy type	100 - 240V AC 50/60Hz	Identical

1000 - 100

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: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : : :

: :

. Previous and

: 2017-07-17 11:10:10
【

: "

ECG Function Comparison
	New Device:MasterScope with the newfeatures	Predicate Device:FlowScreen K080734
Intended Use	3/6- or 12-channelSurface ECG recording device	Identical
Application	ECG recording	Identical
Bandwidth	0 - 150 Hz digital	Identical
ECG leads	Acc. to Einthoven, Wilson,Goldberger	Identical
Leads	12 Standard	Identical
A/DResolution	2,6 µV/bit ECG, 19 bit	Identical
Sampling rateper channel	1000 Hz	Identical
Sampling ratefor pacemakerdetection	4000 Hz	Identical
Connection toPC	USB connection	Serial connection
Power supply	5V DC via USB interface	5V DC via Serial interface
Connection toelectrodes	4 mm snap connector, goldplated	Identical
Patientcontactingaccessories	• Single use electrode• Electrode cable	Identical
ECG Amplifierenclosurematerial	ABS/PC(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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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.

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

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:

Page 1 of

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).