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 Description

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.

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.

AI/ML Overview

The provided text describes the MasterScope WSSU device and its substantial equivalence to predicate devices, focusing on spirometry and ECG functions. The information relevant to acceptance criteria and study proving device performance is primarily found in the "Summary Table of Comparison" (pages 7-8) and "Summary of Device Testing" (page 12).

Here's an analysis of the provided information against the requested points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance specifications for the pulmonary function measurements, which serve as acceptance criteria.

Pulmonary Function Performance Comparison

Characteristic	Acceptance Criteria (Predicate/Reference Device)	Reported Device Performance (MasterScope WSSU)
Accuracy - PEF	0.1 to 16 L/s: ±10% of reading or +/-0.3 L/s (SpiroSphere K173937)	0.1 to 16 L/s: +/- 10% of reading or +/- 0.3 L/s
Accuracy - FEV1 and FVC	0.1 to 8 L: ± 3% of reading or +/- 0.050 L (SpiroSphere K173937)	0.1 to 8 L: +/- 3% of reading or +/- 0.050 L
Accuracy - Instantaneous flow	0.1 - 14 L/s: ± 5% or 0.2 L/s (SpiroSphere K173937)	0.1 - 14 L/s: ± 5% or 0.2 L/s
Resolution - PEF	< 5 mL/s (SpiroSphere K173937)	< 5 mL/s
Resolution - FEV1 and FVC	1 mL (SpiroSphere K173937)	1 mL

Note: The MasterScope WSSU is stated to have identical performance specifications to the reference device (SpiroSphere K173937), meaning it meets the established acceptance criteria. The document explicitly states "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." and lists the exact same performance specifications for the MasterScope WSSU as for SpiroSphere in the comparison table.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set in the context of clinical performance evaluation (e.g., number of patients or spirometry maneuvers). Instead, it refers to

"Tests were performed to confirm that the MasterScope WSSU meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005." (page 12)
"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." (page 7)

This suggests that the performance evaluation relies heavily on the prior clearance of the identical sensor unit within the SpiroSphere device, which would have undergone its own testing.
The document does not specify the country of origin of data or whether it was retrospective or prospective for the current submission's testing. It seems to leverage existing data/clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The spirometry performance is based on ATS/ERS standards, which are objective technical standards rather than expert consensus on individual cases. For the ECG interpretation, the device uses the "Hannover ECG system (HES)", but the document notes: "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." This indicates that the device's ECG interpretation is supportive, not definitive, and requires physician oversight. Therefore, direct expert ground truth establishment for a test set, as might be done for an AI diagnostic device, is not thoroughly described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. Given the nature of objective performance testing against standards rather than subjective human interpretation, a formal adjudication method as typically seen in image-based AI studies (e.g., 2+1 radiologist reads) is generally not applicable or described for this type of device.

5. 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:

A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance was not mentioned or described. This device appears to be a measurement tool with an interpretation assist (for ECG), not a primary AI diagnostic tool where human-AI interaction is the core subject of evaluation. The primary focus of the submission is demonstrating substantial equivalence through technical performance and component identity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device's performance specifications (Accuracy and Resolution) for spirometry are for the device itself, implying standalone performance. For ECG, the device uses the "Hannover ECG system (HES)" which provides "interpretation statements." However, the text explicitly states that "Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients," and "A qualified physician has to reassess all MasterScope/MasterScope ECG measurements." This suggests that even for ECG, the algorithm's output is not intended to be "standalone" without human-in-the-loop, emphasizing a supportive role. The technical performance metrics listed for spirometry are inherent to the device's measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For spirometry, the ground truth is against ATS/ERS standards 2005 for accuracy and precision. These are widely accepted objective technical standards for pulmonary function testing equipment.
For ECG, the "Hannover ECG system (HES)" provides interpretation statements. The implicit ground truth for such systems would typically involve a large dataset of ECGs with confirmed diagnoses (often by expert cardiologists or based on outcomes), but the document does not detail how HES's accuracy was validated or what constituted its ground truth in this submission. The submission focuses on the HES being part of the predicate device.

8. The sample size for the training set:

The document does not provide information regarding the sample size for a training set. This is not a typical AI/ML device where specific training datasets are detailed in this manner. The device is primarily a measurement instrument, and its software (including HES) is presumably developed based on established algorithms rather than contemporary machine learning models that require large labeled training sets as a distinct part of the clearance process for new devices.

9. How the ground truth for the training set was established:

Since no specific "training set" and its size are mentioned, the method for establishing its ground truth is also not provided. The device is categorized as a "Predictive pulmonary-function value calculator" but operates on established physiological measurement principles and computations. The ECG interpretation component (HES) is a "black box" in terms of its internal development and training, leveraging its prior clearance within the predicate device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: Sieboldstrasse3D-97230 EstenfeldGermany
	Contact person in Germany:(Official Correspondent) Margit Kohlen
	Address: eResearchTechnology GmbHSieboldstrasse 3, 97230 EstenfeldGermany
	Phone: +49 9305 720 6376FAX: +49 9305 720 60E-mail margit.kohlen@ert.com
	Contact person in the U.S.: Mingzi Deng
	Address: eResearchTechnology1818 Market Street, Suite 1000Philadelphia, PA 19103
	Phone/Fax: 215-2825588E-mail mingzi.deng@ert.com
3	Establishment Registration Number
	3008505660
4	Common Name or Classification NamePredicted pulmonary-function value calculator(CFR 868.1890, Product Code BTY)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.

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

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 DeviceMasterScope CT (K082539)	Reference DeviceSpiroSphere(K173937)	MasterScope WSSU
Indicationsfor Use	The MasterScope / MasterScopeECG is intended to be used formeasurement and data collectionof lung function parameters. Thesystem performs cooperation-dependent flow volumemeasurements. Mostly it will beused for COPD and Asthmapatients.In addition it is intended formeasuring a 3/6- or 12-channelsurface electrocardiogram (ECG)of a patient. The acquired ECGcan be recorded and displayed onthe screen or printed on paper. 12-channel ECG's are analysedautomatically and suggestions forthe interpretation of the 12-channelECG can be made by the software.MasterScope / MasterScope ECGcan be used for non interpretiveapplications for patients with anage of 4 years and older and aweight of 20 kg or higher.MasterScope / MasterScope ECGis intended for use in routine ECGrecording by trained physicians inthe office or hospital. MasterScope/ MasterScope ECG is notintended for intracardial use.Automatic interpretation of theECG is not possible for pediatricpatients with an age below 16years and for pacemaker patients.MasterScope CT (Clinical Trialversion) incorporates the identicalmeasurements. In addition it offers	The SpiroSphere is acompact device tomeasure inspiratory andexpiratory lung functionparameters in adults andchildren aged 4 yearsand older.It can be used byphysicians in the officeor hospital.	MasterScope is a medicaldevice to measureinspiratory and expiratorylung function parameters.With the option ECG a 12-channel surfaceelectrocardiogram (ECG)can be measured andrecorded. It is not intendedfor intracardial use.Automatic interpretation ofthe ECG is not possible forpediatric patients with anage below 16 years and forpacemaker patients.A qualified physician has toreassess allMasterScope/MasterScopeECG measurements. Aninterpretation byMasterScope/MasterScopeECG is only significant if itis considered in connectionwith other clinical findings.ECG interpretationstatements made by theMasterScope/MasterScopeECG represent partialquantitative information onthe patient's cardiovascularconditions and no therapyor drugs can beadministered based solelyon the interpretationstatements.It can be used byphysicians in the office orhospital.
Pulmonary Function Comparison
	Predicate DeviceMasterScope CT (K082539)	Reference DeviceSpiroSphere(K173937)	MasterScope WSSU
	workflow control elements torestrict the use of the equipment(e.g. individual access rights aredefined for different user roles likeinvestigator, doctor, study nurse,trainer and service personnel).The interpretation software isintended to support the physicianin evaluation the ECG in terms ofmorphology and rhythm.A qualified physician has toreassess all MasterScope /MasterScope ECG measurements.An interpretation by MasterScope /MasterScope ECG is onlysignificant if it is considered inconnection with other clinicalfindings. ECG interpretationstatements made by theMasterScope / MasterScope ECGrepresent partial qualitative andquantitative information on thepatient's cardiovascular conditionand no therapy or drugs can beadministered based solely on theinterpretation statements.The MasterScope / MasterScopeECG / MasterScope CT is poweredfrom 100 - 240V / 50 - 60Hz walloutlets. No energy is transferred tothe patient.		The MasterScopespirometry and ECGapplication is intended tomeasure adults andchildren aged 4 years andolder. The patients must beable to understand andperform instructions of thephysician.
Patientpopulation	Adults and children 4 years andolder	Adults and children 4years and older	Adults and children 4 yearsand older
Operationprinciple	- Measurement of inspiratory andexpiratory flows and volumeswith pneumotach transducer- Calculation of lung functionparameters- Results are displayed andstored, they can be printed andexported	- Measurement ofinspiratory andexpiratory flows andvolumes withpneumotachtransducer- Calculation of lungfunction parametersResults are displayedand stored, they can beprinted and exported	- Measurement ofinspiratory and expiratoryflows and volumes withpneumotach transducer- Calculation of lungfunction parametersResults are displayed andstored, they can be printedand exported
Measure-ments	FEV1, FVC, PEF, FEF25-75, VC,IC, ERV and others acc. to ATS*	FEV1, FVC, PEF,FEF25-75, VC, IC, ERVand others acc. to ATS*	FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and othersacc. to ATS*
Pulmonary Function Comparison
	Predicate DeviceMasterScope CT (K082539)	Reference DeviceSpiroSphere(K173937)	MasterScope WSSU
	Measuring Range- PEF: 0 to +/- 16 L/s- FEV1 and FVC: 0.1 to 8 L	Measuring Range- PEF: 0.1 to 16 L/s- FEV1 and FVC: 0.1 to8 L	Measuring Range- PEF: 0.1 to 16 L/s- FEV1 and FVC: 0.1 to 8L
Performanc-e Specifica-tions	Accuracy- PEF:0 to 14 L/s: +/- 5%/0.2 L/s- FEV1 and FVC:0.5 to 8 L: +/- 3%/0.05 L	Accuracy- PEF:0,1 to 16L/s: ±10% ofreading or +/-0,3 L/s- FEV1 and FVC:0,1 to 8 L: ± 3% ofreading or +/- 0,050 LInstantaneous flow:0.1 - 14 L/s: ± 5% or 0.2L/s	Accuracy- PEF: 0.1 to 16 L/s: +/-10% of reading or +/- 0,3L/s- FEV1 and FVC: 0.1 to 8L: +/- 3% of reading or +/-0,050 LInstantaneous flow:0.1 - 14 L/s: ± 5% or 0.2 L/s
	Resolution- PEF: 10 mL/s- FEV1 and FVC: 1 mL	Resolution- PEF: < 5 mL/s- FEV1 and FVC: 1 mL	Resolution- PEF: < 5 mL/s- FEV1 and FVC: 1 mL
*ATSconformity(criteria)	2005 ATS/ERS SpirometryStandards	2005 ATS/ERSSpirometry Standards	2005 ATS/ERS SpirometryStandards
Fundamen-tal scientific	Pneumotachograph, pressure toflow conversion technique	Pneumotachograph,pressure to flowconversion technique	Pneumotachograph,pressure to flow conversiontechnique
technology	(Lilly Type Pneumotachograph)	(Lilly TypePneumotachograph)	(Lilly TypePneumotachograph)
Components	Pneumotach (single patient use)	ERT Pneumotach (singlepatient use)	ERT Pneumotach (singlepatient use)
	USB connection to PC	Medical Grade PowerSupply (Main Unit)	Medical Grade PowerSupply (Charging Station)
ScreenDisplay	162 x 122 mm or higher	162 x 122 mm	identical
InterfaceSensor	USB	Bluetooth	Bluetooth
Energy type	Digital HandleUSB Cable connection	Sensor UnitLi-Ion Battery chargedvia main unit	Sensor UnitLi-Ion Battery charged viaCharging 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
Intended Use /Indications forUse	MasterScope is a medical device tomeasure inspiratory and expiratorylung function parameters in adults andchildren aged 4 years and older.With the option ECG a 12-channelsurface electrocardiogram (ECG) canbe measured and recorded. It is notintended for intracardial use.MasterScope is a portable, mainspower independent, active diagnosticmedical device for transient application(≤ 60 min). It can be used byphysicians in the office or hospital.	MasterScope is a medical device tomeasure inspiratory and expiratorylung function parameters. With theoption ECG a 12-channel surfaceelectrocardiogram (ECG) can bemeasured and recorded. It is notintended for intracardial use.Automatic interpretation of the ECG isnot possible for pediatric patients withan age below 16 years and forpacemaker patients.A qualified physician has to reassessall MasterScope/MasterScope ECGmeasurements. An interpretation byMasterScope/MasterScope ECG isonly significant if it is considered inconnection with other clinical findings.ECG interpretation statements madeby the MasterScope/MasterScopeECG represent partial quantitativeinformation on the patient'scardiovascular conditions and notherapy or drugs can be administeredbased solely on the interpretationstatements.It can be used by physicians in theoffice or hospital.The MasterScope spirometry and ECGapplication is intended to measureadults and children aged 4 years andolder. The patients must be able tounderstand and perform instructions ofthe physician.
Patient population	Adults and children 4 years and older	Adults and children 4 years and older
Operationprinciple	Measurement of 12-channel surfaceelectrocardiogram	Measurement of 12-channel surfaceelectrocardiogram
Application Time	Transient application (≤ 60 min)	Transient application (≤ 60 min)
ECG leads	acc. to Einthoven, Wilson, Goldberger	acc. to Einthoven, Wilson, Goldberger
Leads	12 standard	12 standard
Bandwidth	0 - 150 Hz digital	0 - 150 Hz digital
A/D resolution	2.6 µV/bit ECG, 19 bit	2.6 µV/bit ECG, 19 bit
Sampling rate perchannel	1000 Hz	1000 Hz
Sampling rate forpacemakerdetection	4000 Hz	4000 Hz
Data transfer/connection to PC	USB connection	USB connection
Power supply	5V DC via USB interface	5V DC via USB interface
Connection toelectrodes	4 mm snap connector, gold plated	4 mm snap connector, gold plated
Patientcontactingaccessories	● Single use electrode● Electrode cable	● Single use electrode● Electrode cable
ECG Amplifierenclosurematerial	ABS/PC(no patient contacting part)	ABS/PC(no patient contacting part)
ECGinterpretationsoftware	Hannover ECG system (HES)	Hannover ECG system (HES)

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Image /page/11/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 blue, green, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn".

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Image /page/12/Picture/1 description: The image shows the logo for ERT, a company that provides clinical trial endpoint technology and services. The logo consists of a circular graphic with three sections in different colors: light blue, green, and dark blue. To the right of the graphic is the company name "ERT" in a bold, dark blue font. Below the company name is the tagline "Confidence at every turn" in a smaller, lighter blue font.

15 Summary of Device Testing

The following practices were followed and monitored for development of the MasterScope WSSU

. The device was developed and tested according to GMP Standard Operating Procedures for Medical Devices.
. Software verification and validation was done in accordance with IEC 62304 Ed.1.1:2015.
. Risk analysis of the MasterScope and WSSU was performed according to ISO 14971:2007.
Tests were performed to confirm that the MasterScope WSSU meets the . recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005.
The electrical safety testing was performed according to IEC 60601-. 1:2012 to demonstrate conformance with the requirements for basic safety and essential performance.
. The Electro Magnetic Compatibility testing was performed according to IEC 60601-1-2:2014.
. The FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" from 2013 was considered for the 3G/BT/WIFI functions and all requirements are fulfilled.
Human Factors/Usability Engineering validation according to IEC 62366-1: . 2015. IEC 60601-1-6:2013. and the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" from 2016 demonstrated the safety and efficacy of the device.
. Material Certification provided to support Biocompatibility evaluation in accordance with ISO 10993-1:2009 and ISO 18562-1:2017.
. The FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" from 2014 has been considered in the device design and all requirements are fulfilled.
The electrical safety testing for ECG was performed according to IEC . 60601-2-25:2011 to demonstrate conformance with the requirements for basic safety and essential performance of electrocardiographs

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Image /page/13/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic with three curved shapes in green and blue, followed by the letters "ERT" in blue. Below the letters, the text "Confidence at every turn" is written in a smaller font.

16 Comparison Summary

Intended Use

The intended use of the MasterScope WSSU device is comparable to the predicate device MasterScope CT-the MasterScope WSSU can also be connected with an option for ECG measurement.

Technological Characteristics

The predicate device MasterScope CT is presently in commercial distribution globally including the United States of America. The MasterScope WSSU has the similar technological characteristics and is similar in design, function, and application to the predicate device.

The technological characteristics are the same as the predicate device.

Biocompatibility

There have been no changes in material and biocompatibility.

All material used is identical to referenced device. Manufacturing process is identical to referenced device.

The Wireless Spirometry Sensor Unit and ERT PT are exactly the same as already used in the referenced device SpiroSphere.

Therefore, now new issues of biocompatibility are raised with regard to the referenced device.

Differences

The intended use of MasterScope CT, MasterScope WSSU and SpiroSphere ● devices are identical to the fact that they are compact/portable diagnostic devices to measure inspiratory and expiratory lung function parameters in adults and children. All devices can be used by physicians in the office or hospital. MasterScope CT and MasterScope WSSU can be optionally delivered with an additional ECG amplifier.
. The MasterScope WSSU is using a wireless sensor instead of the USB Digital Handle to measure inspiratory and expiratory lung function parameters. MasterScope WSSU connects the sensor unit to a notebook via Bluetooth. MasterScope CT using a Digital Handle with USB connection to the notebook. Thus, with both models the sensor is connected to a notebook with MasterScope Software installed.

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Image /page/14/Picture/1 description: The image is a 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, with the top section being light green, the bottom section being dark blue, and the middle section being white. The text "ERT" is in a dark blue font, and below it is the tagline "Confidence at every turn" in a smaller, lighter blue font.

The software on the notebook shows the same user interface for both models. The Bluetooth connection was tested for EMC and wireless coexistence. There is no impact on usability, safety or efficacy of the device.

. The Digital Handle receives the power via the USB cable from the notebook, which is connected to a mains plug. The wireless sensor unit of MasterScope WSSU and Spirosphere is equipped with a Li-lon Battery for power supply. The battery is charged via a charger. SpiroSphere has a charger implemented in the Main Unit that is connected to a mains pluq via a Medical Grade Power Supply. MasterScope WSSU is delivered with a separate charging station, which is connected to a mains plug via a Medical Grade Power Supply. The design of this
charging station is adapted to the implemented one in SpiroSphere Main Unit and uses the same technology. The devices conformed to IEC60601-1:2012.
. The display is specified with minimum the same size as for SpiroSphere (162 x 122 mm) or higher, dependent on the notebook type. The display of user interface and measurement results will be adapted to the screen size for readability. No influence on usability or safety and efficacy was found.

17. Conclusions

Based on the intended use of the MasterScope WSSU and the results of the nonclinical, bench testing and performance testing provided in the 510(k), the MasterScope WSSU is found to be substantially equivalent to the predicate device MasterScope CT.

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).