MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

K202754 · Eresearchtechnology GmbH · BTY · Jan 28, 2021 · Anesthesiology

Device Facts

• Record ID: K202754
• Device Name: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
• Applicant: Eresearchtechnology GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Jan 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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. A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/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 quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements. It can be used by physicians in the office or hospital. The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.

Device Story

MasterScope WSSU is a portable diagnostic system for spirometry and 12-channel surface ECG. Spirometry uses a wireless sensor unit (WSSU) with a Lilly-type pneumotachograph to measure flow/volume; data transmits via Bluetooth to a notebook. ECG option uses an amplifier to record 12-channel signals. Operated by physicians in clinics or hospitals; requires patient cooperation. Software provides protocol-driven workflows, automated data transmission, and the Hannover ECG System (HES) for signal analysis. HES provides templates, rhythm analysis, and diagnostic statements. Output is displayed on a notebook screen or printed. Physicians must reassess all automated interpretations; output serves as partial quantitative information to support clinical decision-making. Benefits include portable, standardized pulmonary and cardiac assessment.

Clinical Evidence

Bench testing only. No clinical data. Testing included software verification/validation (IEC 62304), risk analysis (ISO 14971), spirometry accuracy per ATS/ERS 2005 standards, electrical safety (IEC 60601-1, IEC 60601-2-25), electromagnetic compatibility (IEC 60601-1-2), and human factors/usability validation (IEC 62366-1). Biocompatibility supported by ISO 10993-1 and ISO 18562-1.

Technological Characteristics

Portable system comprising a notebook, wireless spirometry sensor (Lilly-type pneumotach), and optional ECG amplifier. Connectivity via Bluetooth (sensor) and USB/Wi-Fi/Ethernet (data). Power via 100-240V AC wall outlets or Li-Ion battery (sensor). ECG sampling rate 1000 Hz (4000 Hz for pacemaker detection). Software uses HES algorithm. Materials comply with ISO 10993-1/ISO 18562-1. Sterilization not applicable (single-patient use pneumotach).

Indications for Use

Indicated for measurement of inspiratory and expiratory lung function parameters and 12-channel surface ECG recording in adults and children aged 4 years and older. Not for intracardial use. Automatic ECG interpretation contraindicated for patients <16 years and pacemaker patients.

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 / MasterScope ECG / MasterScope CT (K082539)

Reference Devices

• SpiroSphere (K173937)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 28, 2021

eResearchTechnology GmbH Margit Kohlen Design Assurance Engineer Sieboldstrasse 3 Estenfeld, Bavaria 97230 Germany

Re: K202754

Trade/Device Name: MasterScope WSSU Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY, DPS Dated: December 15, 2020 Received: December 21, 2020

Dear Margit Kohlen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. Below the text is the tagline "Confidence at every turn".

# GENERAL INFORMATION

| 1 | Type of Submission |
|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Traditional 510(k) Submission |
| | Submission date: 01/28/2021 |
| 2 | Submitter |
| | Name: eResearchTechnology GmbH |
| | Address: Sieboldstrasse3<br>D-97230 Estenfeld<br>Germany |
| | Contact person in Germany:<br>(Official Correspondent) Margit Kohlen |
| | Address: eResearchTechnology GmbH<br>Sieboldstrasse 3, 97230 Estenfeld<br>Germany |
| | Phone: [phone]<br>FAX: [phone]<br>E-mail [e-mail] |
| | Contact person in the U.S.: Mingzi Deng |
| | Address: eResearchTechnology<br>1818 Market Street, Suite 1000<br>Philadelphia, PA 19103 |
| | Phone/Fax: [phone]<br>E-mail [e-mail] |
| 3 | Establishment Registration Number |
| | 3008505660 |
| 4 | Common Name or Classification Name<br>Predicted pulmonary-function value calculator<br>(CFR 868.1890, Product Code BTY)<br>Electrocardiograph (CFR 870.2340, Product Code DPS) |
| 5 | Trade Name |
| | MasterScope WSSU |
| 6 | Device Classification |
| | This is a Class II device |

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510(k) Summary

Image /page/4/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, with the top section being light green and the bottom two sections being dark blue. Below the text "ERT" is the tagline "Confidence at every turn".

#### 7 Classification Panel

73 Anesthesiology Part 868 (Code BTY) 74 Circular System Devices, ECG Part 870 (Code DPS)

#### 8 Reason for Premarket Notification

New option to an existing eResearchTechnology device

#### 9 Legally predicate marketed device

MasterScope / MasterScope ECG / MasterScope CT Code BTY, DPS K082539

## Reference device

SpiroSphere K173937 Code BTY

#### 10 Predicate Device Company

eResearchTechnology GmbH

#### Device Description 11

The MasterScope is a portable device, which can collect spirometry and ECG data.

With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph).

The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station.

With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use.

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

The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights).

MasterScope provides automated and secure data transmission to a centralized data base.

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Image /page/5/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn."

The measured data is saved into the MasterScope software and can be read out at any time.

A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet.

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

### Possible Configurations:

MasterScope will be delivered in the following configurations:

- MasterScope WSSU:
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) o
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) O and ECG Amplifier
- MasterScope ECG: .
- o Notebook with ECG Amplifier
- pulmonary functions a)
- Measurement with pneumotachograph ●
- Slow spirometrv ●
- Forced spirometry ●
- Flow-Volume and Volume- Time Loop, pre/post tests
- . Trending capabilities
- . Patient Incentive animations
- 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 ●

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Image /page/6/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.

#### 12 Intended Use Statement

MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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.

A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/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 quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.

It can be used by physicians in the office or hospital.

The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.

#### 13 Required Components

Notebook (MasterScope Software) Instruction for Use

MasterScope WSSU:

- Wireless Spirometry Sensor Unit (WSSU) ●
- . Pneumotach with Mouthpiece (ERT PT)
- Charging Station (WSCS) with Power Supply (medical grade) ●
- Calibration syringe (manufacturer Vyaire) ●
- Nose clips (manufacturer Quosina)

MasterScope ECG:

- ECG Amplifier ●
- . ECG electrodes (manufacturer AMBU or Welch Allyn)

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Image /page/7/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.

#### 14 Summary Table of Comparison

Comparison with MasterScope CT (K082539) and SpiroSphere (K173937)

The Sensor Unit used in MasterScope WSSU device is cleared under SpiroSphere (K173937). The Sensor Unit is supplied in its final finished form and is identical to the reference predicate device.

| Pulmonary Function Comparison | | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device<br>MasterScope CT (K082539) | Reference Device<br>SpiroSphere<br>(K173937) | MasterScope WSSU |
| Indications<br>for Use | The MasterScope / MasterScope<br>ECG is intended to be used for<br>measurement and data collection<br>of lung function parameters. The<br>system performs cooperation-<br>dependent flow volume<br>measurements. Mostly it will be<br>used for COPD and Asthma<br>patients.<br>In addition it is intended for<br>measuring a 3/6- or 12-channel<br>surface electrocardiogram (ECG)<br>of a patient. The acquired ECG<br>can be recorded and displayed on<br>the screen or printed on paper. 12-<br>channel ECG's are analysed<br>automatically and suggestions for<br>the interpretation of the 12-channel<br>ECG can be made by the software.<br>MasterScope / MasterScope ECG<br>can be used for non interpretive<br>applications for patients with an<br>age of 4 years and older and a<br>weight of 20 kg or higher.<br>MasterScope / MasterScope ECG<br>is intended for use in routine ECG<br>recording by trained physicians in<br>the office or hospital. MasterScope<br>/ MasterScope ECG is not<br>intended for intracardial use.<br>Automatic interpretation of the<br>ECG is not possible for pediatric<br>patients with an age below 16<br>years and for pacemaker patients.<br>MasterScope CT (Clinical Trial<br>version) incorporates the identical<br>measurements. In addition it offers | The SpiroSphere is a<br>compact device to<br>measure inspiratory and<br>expiratory lung function<br>parameters in adults and<br>children aged 4 years<br>and older.<br>It can be used by<br>physicians in the office<br>or hospital. | MasterScope is a medical<br>device to measure<br>inspiratory and expiratory<br>lung function parameters.<br>With the option ECG a 12-<br>channel surface<br>electrocardiogram (ECG)<br>can be measured and<br>recorded. It is not intended<br>for intracardial use.<br>Automatic interpretation of<br>the ECG is not possible for<br>pediatric patients with an<br>age below 16 years and for<br>pacemaker patients.<br>A qualified physician has to<br>reassess all<br>MasterScope/MasterScope<br>ECG measurements. An<br>interpretation by<br>MasterScope/MasterScope<br>ECG is only significant if it<br>is considered in connection<br>with other clinical findings.<br>ECG interpretation<br>statements made by the<br>MasterScope/MasterScope<br>ECG represent partial<br>quantitative information on<br>the patient's cardiovascular<br>conditions and no therapy<br>or drugs can be<br>administered based solely<br>on the interpretation<br>statements.<br>It can be used by<br>physicians in the office or<br>hospital. |
| Pulmonary Function Comparison | | | |
| | Predicate Device<br>MasterScope CT (K082539) | Reference Device<br>SpiroSphere<br>(K173937) | MasterScope WSSU |
| | workflow control elements to<br>restrict the use of the equipment<br>(e.g. individual access rights are<br>defined for different user roles like<br>investigator, doctor, study nurse,<br>trainer and service personnel).<br>The interpretation software is<br>intended to support the physician<br>in evaluation the ECG in terms of<br>morphology and rhythm.<br>A qualified physician has to<br>reassess all MasterScope /<br>MasterScope ECG measurements.<br>An interpretation by MasterScope /<br>MasterScope ECG is only<br>significant if it is considered in<br>connection with other clinical<br>findings. ECG interpretation<br>statements made by the<br>MasterScope / MasterScope ECG<br>represent partial qualitative and<br>quantitative information on the<br>patient's cardiovascular condition<br>and no therapy or drugs can be<br>administered based solely on the<br>interpretation statements.<br>The MasterScope / MasterScope<br>ECG / MasterScope CT is powered<br>from 100 - 240V / 50 - 60Hz wall<br>outlets. No energy is transferred to<br>the patient. | | The MasterScope<br>spirometry and ECG<br>application is intended to<br>measure adults and<br>children aged 4 years and<br>older. The patients must be<br>able to understand and<br>perform instructions of the<br>physician. |
| Patient<br>population | Adults and children 4 years and<br>older | Adults and children 4<br>years and older | Adults and children 4 years<br>and older |
| Operation<br>principle | - Measurement of inspiratory and<br>expiratory flows and volumes<br>with pneumotach transducer<br>- Calculation of lung function<br>parameters<br>- Results are displayed and<br>stored, they can be printed and<br>exported | - Measurement of<br>inspiratory and<br>expiratory flows and<br>volumes with<br>pneumotach<br>transducer<br>- Calculation of lung<br>function parameters<br>Results are displayed<br>and stored, they can be<br>printed and exported | - Measurement of<br>inspiratory and expiratory<br>flows and volumes with<br>pneumotach transducer<br>- Calculation of lung<br>function parameters<br>Results are displayed and<br>stored, they can be printed<br>and exported |
| Measure-<br>ments | FEV1, FVC, PEF, FEF25-75, VC,<br>IC, ERV and others acc. to ATS* | FEV1, FVC, PEF,<br>FEF25-75, VC, IC, ERV<br>and others acc. to ATS* | FEV1, FVC, PEF, FEF25-<br>75, VC, IC, ERV and others<br>acc. to ATS* |
| Pulmonary Function Comparison | | | |
| | Predicate Device<br>MasterScope CT (K082539) | Reference Device<br>SpiroSphere<br>(K173937) | MasterScope WSSU |
| | Measuring Range<br>- PEF: 0 to +/- 16 L/s<br>- FEV1 and FVC: 0.1 to 8 L | Measuring Range<br>- PEF: 0.1 to 16 L/s<br>- FEV1 and FVC: 0.1 to<br>8 L | Measuring Range<br>- PEF: 0.1 to 16 L/s<br>- FEV1 and FVC: 0.1 to 8<br>L |
| Performanc-<br>e Specifica-<br>tions | Accuracy<br>- PEF:<br>0 to 14 L/s: +/- 5%/0.2 L/s<br>- FEV1 and FVC:<br>0.5 to 8 L: +/- 3%/0.05 L | Accuracy<br>- PEF:<br>0,1 to 16L/s: ±10% of<br>reading or +/-0,3 L/s<br>- FEV1 and FVC:<br>0,1 to 8 L: ± 3% of<br>reading or +/- 0,050 L<br>Instantaneous flow:<br>0.1 - 14 L/s: ± 5% or 0.2<br>L/s | Accuracy<br>- PEF: 0.1 to 16 L/s: +/-<br>10% of reading or +/- 0,3<br>L/s<br>- FEV1 and FVC: 0.1 to 8<br>L: +/- 3% of reading or +/-<br>0,050 L<br>Instantaneous flow:<br>0.1 - 14 L/s: ± 5% or 0.2 L/s |
| | Resolution<br>- PEF: 10 mL/s<br>- FEV1 and FVC: 1 mL | Resolution<br>- PEF: < 5 mL/s<br>- FEV1 and FVC: 1 mL | Resolution<br>- PEF: < 5 mL/s<br>- FEV1 and FVC: 1 mL |
| *ATS<br>conformity<br>(criteria) | 2005 ATS/ERS Spirometry<br>Standards | 2005 ATS/ERS<br>Spirometry Standards | 2005 ATS/ERS Spirometry<br>Standards |
| Fundamen-<br>tal scientific | Pneumotachograph, pressure to<br>flow conversion technique | Pneumotachograph,<br>pressure to flow<br>conversion technique | Pneumotachograph,<br>pressure to flow conversion<br>technique |
| technology | (Lilly Type Pneumotachograph) | (Lilly Type<br>Pneumotachograph) | (Lilly Type<br>Pneumotachograph) |
| Component<br>s | Pneumotach (single patient use) | ERT Pneumotach (single<br>patient use) | ERT Pneumotach (single<br>patient use) |
| | USB connection to PC | Medical Grade Power<br>Supply (Main Unit) | Medical Grade Power<br>Supply (Charging Station) |
| Screen<br>Display | 162 x 122 mm or higher | 162 x 122 mm | identical |
| Interface<br>Sensor | USB | Bluetooth | Bluetooth |
| Energy type | Digital Handle<br>USB Cable connection | Sensor Unit<br>Li-Ion Battery charged<br>via main unit | Sensor Unit<br>Li-Ion Battery charged via<br>Charging Station |

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Image /page/8/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic with three sections in green and blue, followed by the letters "ERT" in blue. Below the letters is the text "Confidence at every turn" in a smaller font.

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Image /page/9/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The graphic is divided into three sections, with the top section being light green and the bottom two sections being blue. Below the text "ERT" is the tagline "Confidence at every turn".

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Image /page/10/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. Below the text is the tagline "Confidence at every turn".

# Comparison with MasterScope ECG (K082539)

| ECG Function Comparison | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | MasterScope ECG (K082539) | MasterScope WSSU with ECG…