The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital.

With the option ECG, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reassess all ECG measurements. An interpretation by SpiroSphere ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the SpiroSphere 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 SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

With the CardioSphere, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reasurements. An interpretation by CardioSphere is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere represent partial qualitative and quantitative information on the patient's cardition and no therapy or drugs can be administered based solely on the interpretation statements. The CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

Device Description

SpiroSphere is a compact spirometry device. Its Sensor Unit is batterypowered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

SpiroSphere ECG is a compact spirometry device. Its Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

The Main Unit can be powered by battery or power supply. The Main Unit is wirelessly connected to an ECG amplifier via Bluetooth.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

A printer can be connected and data (e.g. reports, screenshots) can be printed. Moreover, it is possible to transfer data by USB. Wifi. 3G. and Ethernet connections.

Pulmonary function assessments

Slow Spirometry .
Forced Spirometry .
Flow-Volume loop and Volume-Time tracing, pre/post tests ●
Trending capabilities ●

Cardiovascular assessments

12 Lead Electrocardiogram ●

AI/ML Overview

The provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, along with a device description and comparison tables to predicate devices. It discusses general information about the device, its intended use, technological characteristics, and a summary of device testing (e.g., software verification, risk analysis, electrical safety, EMC, human factors, cybersecurity, reprocessing validation). However, it does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for its interpretation software, nor does it detail a specific study proving these criteria were met.

Therefore, I cannot provide the requested information based on the given text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 28, 2024

eResearchTechnology GmbH % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K223629

Trade/Device Name: SpiroSphere, SpiroSphereECG, CardioSphere Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: BTY, DPS Dated: June 5, 2023 Received: June 5, 2023

Dear Prithul Bom:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K223629

Device Name SpiroSphere

Indications for Use (Describe)

The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

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

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

Beneficial Use (Part 31, GER 331, Subpart D)
On-Site Corrective Action (31 GER 331, Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K223629

Device Name SpiroSphere ECG

Indications for Use (Describe)

The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

The minimum age for ECG application is 4 years.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K223629

Device Name CardioSphere

Indications for Use (Describe)

The minimum age for ECG application is 4 years.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic made up of three overlapping shapes in the colors green, light blue, and dark blue. To the right of the graphic is the text "ERT" in a dark blue sans-serif font, with the registered trademark symbol above the "T". Below the text "ERT" is the tagline "Confidence at every turn" in a smaller, lighter font.

GENERAL INFORMATION

1 Type of Submission

Traditional 510(k) Submission Date 510(k) summary prepared: 21APR2023

2 Submitter

eResearchTechnology GmbH Name: Address: Sieboldstrasse3 D-97230 Estenfeld Germany

Contact person in Germany: (Official Correspondent) Address:

Kristin Feld

eResearchTechnology GmbH Sieboldstrasse 3, 97230 Estenfeld Germany

+49 9305 720 6377 +49 9305 720 70 kristin.feld@clario.com

Contact person in the U.S .: Todd Kisner

Address

Phone:

FAX:

E-mail

eResearchTechnology 1818 Market St Suite 2600 Philadelphia, PA 19103

Phone/Fax: E-mail

+1 609 779 5935 todd.kisner@clario.com

3 Establishment Registration Number

3008505660

4 Common Name or Classification Name

Predictive pulmonary-function value calculator (CFR 868.1890, Product Code BTY) Electrocardiograph (CFR 870.2340, Product Code DPS)

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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 circle is divided into three sections, colored light green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn."

5 Trade Names SpiroSphere SpiroSphere ECG CardioSphere
6 Device Classification Class II

7 Classification Panel

73 Anaesthesiology Part 868 Code BTY (primary) 74 Cardiovascular Part 870 Code DPS (secondary)

8 Reason for Premarket Notification

New option (ECG) to a cleared device (SpiroSphere K173937)

9 Legally Marketed Predicate and Reference Devices

Predicate Device: K202754 Code BTY, DPS Masterscope, Masterscope ECG, Masterscope CT, Masterscope WSSU

Reference Devices:

K173937 Code BTY SpiroSphere

K183369 Code DPS COR12

10 Predicate Device Company

eResearchTechnology GmbH

Reference Device Companies

eResearchTechnology GmbH (SpiroSphere) Corscience GmbH & Co. KG (COR12)

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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, dark blue, and light blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.

Device Description 11

SpiroSphere

SpiroSphere ECG

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

CardioSphere

The Main Unit can be powered by battery or power supply. The Main Unit is wirelessly connected to an ECG amplifier via Bluetooth.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

A printer can be connected and data (e.g. reports, screenshots) can be printed. Moreover, it is possible to transfer data by USB. Wifi. 3G. and Ethernet connections.

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

Image /page/8/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, 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".

Pulmonary function assessments

Slow Spirometry .
Forced Spirometry .
Flow-Volume loop and Volume-Time tracing, pre/post tests ●
Trending capabilities ●

Cardiovascular assessments

12 Lead Electrocardiogram ●

12 Intended Use/Indications for Use - SpiroSphere

The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

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

13 Intended Use/Indications for Use - SpiroSphere ECG

The SpiroSphere ECG is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

With the option ECG, electrocardiographic measurements can be made under resting conditions. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

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Image /page/9/Picture/1 description: The image shows the logo for ERT. The logo consists of a green and blue abstract shape on the left, followed by the letters "ERT" in blue. Below the letters, the text "Confidence at every turn" is written in a smaller font.

statements. The SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

14 Intended Use/Indications for Use - CardioSphere

With the CardioSphere, electrocardiographic measurements can be made under resting conditions. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reassess all ECG measurements. An interpretation by CardioSphere is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere 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 CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

15 Required Components

Power Supply (medical grade) Instructions for Use

SpiroSphere and SpiroSphere ECG: Pneumotach with Mouthpiece (ERT PT) Nose Clips

SpiroSphere ECG and CardioSphere: ECG Unit/amplifier ECG electrodes

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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. 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.

16 Summary Table of Comparison

Comparison tables with Predicate and Reference devices: MasterScope (K202754), COR12 (K183369), and SpiroSphere (K173937)

Pulmonary / Spirometry Function Comparison
	Predicate DeviceMasterScope (K202754)	Reference DeviceSpiroSphere (K173937)	Subject Device
			SpiroSphere ECG	SpiroSphere
Intended Use /Indications for Use	MasterScope is a medicaldevice to measure inspiratoryand expiratory lung functionparameters.With the option ECG a 12-channel surfaceelectrocardiogram (ECG) canbe measured and recorded. It isnot intended for intracardial use.Automatic interpretation of theECG is not possible for pediatricpatients with an age below 16years and for pacemakerpatients.A qualified physician has toreassess allMasterScope/MasterScopeECG measurements. Aninterpretation byMasterScope/MasterScopeECG is only significant if it isconsidered in connection withother clinical findings.ECG interpretation statementsmade by the	The SpiroSphere is acompact device to measureinspiratory and expiratorylung function parameters inadults and children aged 4years and older.It can be used by physiciansin the office or hospital.	The SpiroSphere ECG is acompact device tomeasure inspiratory andexpiratory lung functionparameters in adults andchildren aged 4 years andolder.With the option ECG,electrocardiographicmeasurements can bemade under restingconditions. For thispurpose a 12-channelsurface electrocardiogramcan be measured andrecorded. The acquiredECG can be displayed onthe screen or printed onpaper. The interpretationsoftware is intended tosupport the physician inevaluation of the restingECG in terms ofmorphology and rhythm.Automatic interpretation ofthe ECG is not possible for	The SpiroSphere is acompact device tomeasure inspiratory andexpiratory lung functionparameters in adultsand children aged 4years and older.It can be used byphysicians in the officeor hospital.
MasterScope/MasterScopeECG represent partialquantitative information on thepatient's cardiovascularconditions and no therapy ordrugs can be administeredbased solely on theinterpretation statements.It can be used by physicians inthe office or hospital.The MasterScope spirometryand ECG application is intendedto measure adults and childrenaged 4 years and older. Thepatients must be able tounderstand and performinstructions of the physician.	pediatric subjects with anage below 16 years andfor pacemaker subjects. Itis not intended for intra-cardial use.A qualified physician hasto reassess all ECGmeasurements. Aninterpretation bySpiroSphere ECG is onlysignificant if it isconsidered in connectionwith other clinical findings.ECG interpretationstatements made by theSpiroSphere ECGrepresent partialqualitative and quantitativeinformation on thepatient's cardiovascularcondition and no therapyor drugs can beadministered based solelyon the interpretationstatements. TheSpiroSphere ECG is notintended for use in anEMS environment(Emergency MedicalServices Environment).The minimum age for ECGapplication is 4 years.It can be used byphysicians in the office orhospital.	Identical	Identical
Patient population	4 years and older	4 years and older	4 years and older
Operation principle	Measurement of inspiratory andexpiratory flows and volumeswith pneumotach transducerCalculation of lung functionparametersResults are displayed andstored, they can be printed andexported	Measurement of inspiratoryand expiratory flows andvolumes with pneumotachtransducerCalculation of lung functionparametersResults are displayed andstored, they can be printedand exported	Identical	Identical
Measurements	FEV1, FVC, PEF, FEF25-75,VC, IC, ERV and others acc. toATS*	FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and othersacc. to ATS*	Identical	Identical
*ATS conformity(criteria)	2005 ATS/ERS SpirometryStandards	2005 ATS/ERS SpirometryStandards	Identical	Identical
Fundamentalscientific technology	Pneumotachograph, pressure toflow conversion technique(Lilly Type Pneumotachograph)	Pneumotachograph,pressure to flow conversiontechnique(Lilly TypePneumotachograph)	Identical	Identical
User	Physicians in the office orhospital	Physicians in the office orhospital	Identical	Identical
	Laptop	Main Unit	Identical to SpiroSphere(K173937)	Identical to SpiroSphere(K173937)
Components	Sensor Unit	Sensor Unit	Identical	Identical
	ERT PT	ERT PT	Identical	Identical
Screen Display	Depends on used Laptop	162 x 122 mm	Identical to SpiroSphere(K173937)	Identical to SpiroSphere(K173937)
Interface	BluetoothUSBWifi/Ethernet	BluetoothUSBWifi/Ethernet3G	Identical to SpiroSphere(K173937)	Identical to SpiroSphere(K173937)
Energy type	Li-Ion Battery and Power Supply	Li-Ion Battery and PowerSupply	Identical	Identical

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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 ERT logo. The logo consists of a circular graphic made up of three curved shapes in blue and green, followed by the letters "ERT" in bold blue font. Below the letters, the text "Confidence at every turn" is written in a smaller blue font.

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Image /page/13/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic with three overlapping leaves in different shades of green and blue. To the right of the graphic is the text "ERT" in a bold, blue font. Below the text is the tagline "Confidence at every turn" in a smaller, lighter font.

ECG Function Comparison
	Predicate Device MasterScope(K202754)	Subject Device
		SpiroSphere ECG	CardioSphere
Intended Use /Indications for Use	MasterScope is a medical device tomeasure inspiratory and expiratory lungfunction parameters.With the option ECG a 12-channel surfaceelectrocardiogram (ECG) can bemeasured and recorded. It is not intendedfor intracardial use. Automaticinterpretation of the ECG is not possiblefor pediatric patients with an age below 16years and for pacemaker patients.A qualified physician has to reassess allMasterScope/MasterScope ECGmeasurements. An interpretation byMasterScope/MasterScope ECG is onlysignificant if it is considered in connectionwith other clinical findings. ECGinterpretation statements made by theMasterScope/MasterScope ECG representpartial quantitative information on thepatient's cardiovascular conditions and notherapy or drugs can be administeredbased solely on the interpretationstatements.It can be used by physicians in the officeor hospital.The MasterScope spirometry and ECGapplication is intended to measure adultsand children aged 4 years and older. Thepatients must be able to understand andperform instructions of the physician.	The SpiroSphere is a compact deviceto measure inspiratory and expiratorylung function parameters in adultsand children aged 4 years and older.With the option ECG,electrocardiographic measurementscan be made under restingconditions. For this purpose a 12-channel surface electrocardiogramcan be measured and recorded. Theacquired ECG can be displayed onthe screen or printed on paper. Theinterpretation software is intended tosupport the physician in evaluation ofthe resting ECG in terms ofmorphology and rhythm. Automaticinterpretation of the ECG is notpossible for pediatric subjects with anage below 16 years and forpacemaker subjects. It is not intendedfor intra-cardial use.A qualified physician has to reassessall ECG measurements. Aninterpretation by SpiroSphere ECG isonly significant if it is considered inconnection with other clinical findings.ECG interpretation statements madeby the SpiroSphere ECG representpartial qualitative and quantitativeinformation on the patient'scardiovascular condition and notherapy or drugs can be administeredbased solely on the interpretation	With the CardioSphere,electrocardiographicmeasurements can be madeunder resting conditions. For thispurpose a 12-channel surfaceelectrocardiogram can bemeasured and recorded. Theacquired ECG can be displayedon the screen or printed on paper.The interpretation software isintended to support the physicianin evaluation of the resting ECG interms of morphology and rhythm.Automatic interpretation of theECG is not possible for pediatricsubjects with an age below 16years and for pacemaker subjectsIt is not intended for intra-cardialuse.A qualified physician has toreassess all ECG measurements.An interpretation by CardioSphereis only significant if it is consideredin connection with other clinicalfindings. ECG interpretationstatements made by theCardioSphere represent partialqualitative and quantitativeinformation on the patient'scardiovascular condition and notherapy or drugs can beadministered based solely on theinterpretation statements. TheCardioSphere is not intended for
		statements. The SpiroSphere ECG isnot intended for use in an EMSenvironment (Emergency MedicalServices Environment).The minimum age for ECGapplication is 4 years.It can be used by physicians in theoffice or hospital.	use in an EMS environment(Emergency Medical ServicesEnvironment).The minimum age for ECGapplication is 4 years.It can be used by physicians in theoffice or hospital.
Patient population	patients age 4 years and older	patients age 4 years and older	patients age 4 years and older
Sampling Rate	1000 Hz	500 Hz	500 Hz
Evaluation algorithm	Hannover ECG System (HES)	Identical	Identical
Interpretationalgorithm (ECG)	Hannover ECG System (HES)	Identical	Identical
Data output	Recorded and displayed on screen orprinted	Identical	Identical
ECG parameter	Heart rate [bpm]RR interval [ms]P wave duration [ms]PR interval [ms]QRS duration [ms]QT interval [ms]Corrected QT (Friderica) [ms]Corrected QT (Bazett) [ms]P wave onset [ms]P wave end [ms]QRS interval onset [ms]QRS interval end [ms]T wave end [ms]QRS axis [degree]P wave axis [degree]T wave axis [degree]	Identical	Identical
Records	Under resting conditions	Identical	Identical
Electrodes	Standards ECG electrodes	Identical	Identical
Lead set-up /location	Standard 12 lead ECG lead set-up	Identical	Identical
Connection of theelectrodes	4 mm snap, gilded	Identical	Identical
Electrode type	Standard single use ECG electrodes	Identical	Identical
Technology of ECGsignal	Impedance measurement	Identical	Identical
Power supply	5V DC via USB interface	1x AA Alkaline (professional orrechargeable) battery or rechargeableNiMH battery	1x AA Alkaline (professional orrechargeable) battery orrechargeable NiMH battery
Data transmission	USB	Bluetooth 2.1+EDR Protocol: SPP.	Bluetooth 2.1+EDR Protocol:SPP.
ECG Amplifier Comparison
Reference Device COR12(K183369)			Subject Device
		SpiroSphere ECG	CardioSphere
Intended Use /Indications for Use	The COR12 ECG is intended formeasuring the surfaceelectrocardiogram (ECG) of a patient.The acquired ECG can be recorded anddisplayed on a screen or printed onpaper. The COR12 ECG can be usedfor applications in patients age 4 yearsand older and a weight of 20 kg orhigher. The COR12 ECG is intended tobe used for routine ECG collection,recording both under resting and stressconditions. The measurement isperformed by trained healthcareprofessionals under the direction of aphysician in healthcare facilities (e.g.the doctor's office or hospital).	The SpiroSphere is a compact deviceto measure inspiratory and expiratorylung function parameters in adultsand children aged 4 years and older.With the option ECG,electrocardiographic measurementscan be made under restingconditions. For this purpose a 12-channel surface electrocardiogramcan be measured and recorded. Theacquired ECG can be displayed onthe screen or printed on paper. Theinterpretation software is intended tosupport the physician in evaluation ofthe resting ECG in terms ofmorphology and rhythm. Automaticinterpretation of the ECG is notpossible for pediatric subjects with anage below 16 years and forpacemaker subjects. It is notintended for intra-cardial use.A qualified physician has to reassessall ECG measurements. Aninterpretation by SpiroSphere ECG isonly significant if it is considered in	With the CardioSphere,electrocardiographicmeasurements can be madeunder resting conditions. For thispurpose a 12-channel surfaceelectrocardiogram can bemeasured and recorded. Theacquired ECG can be displayedon the screen or printed onpaper. The interpretationsoftware is intended to supportthe physician in evaluation of theresting ECG in terms ofmorphology and rhythm.Automatic interpretation of theECG is not possible for pediatricsubjects with an age below 16years and for pacemakersubjects. It is not intended forintra-cardial use.A qualified physician has toreassess all ECGmeasurements. An interpretationby CardioSphere is only
		connection with other clinicalfindings. ECG interpretationstatements made by the SpiroSphereECG represent partial qualitative andquantitative information on thepatient's cardiovascular conditionand no therapy or drugs can beadministered based solely on theinterpretation statements. TheSpiroSphere ECG is not intended foruse in an EMS environment(Emergency Medical ServicesEnvironment).The minimum age for ECGapplication is 4 years.It can be used by physicians in theoffice or hospital.	significant if it is considered inconnection with other clinicalfindings. ECG interpretationstatements made by theCardioSphere represent partialqualitative and quantitativeinformation on the patient'scardiovascular condition and notherapy or drugs can beadministered based solely on theinterpretation statements. TheCardioSphere is not intended foruse in an EMS environment(Emergency Medical ServicesEnvironment).The minimum age for ECGapplication is 4 years.It can be used by physicians inthe office or hospital.
Patient population	patients age 4 years and older and aweight of 20 kg or higher	patients age 4 years and older	patients age 4 years and older
Data output	Recorded and displayed on screen orprinted	Identical	Identical
Records	Under resting and stress conditions	Under resting conditions	Under resting conditions
Dimensions W x H xD	8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in)	Identical	Identical
Weight (withoutbattery)	200 g (0.4 lbs)	Identical	Identical
12-channel SurfaceECG Recording	Yes	Identical	Identical
Electrodes	Standard ECG electrodes	Identical	Identical
Connection of theelectrodes	4 mm snap, gilded	Identical	Identical
Technology of ECGsignal	Impedance measurement	Identical	Identical
Resolution /Amplitudequantisation	1,94μV/bit ECG	Identical	Identical
Filter	Bandpass 0.05 Hz - 150 Hz No linefilter (50 Hz / 60 Hz)	Identical	Identical
Pacemaker detection	4000 Hz	Identical	Identical
Temperature rangeoperation	T = 10-37 °C	Identical	Identical
Ambient pressurerange operation	700 to 1060 hPa (525 to 795 mmHg)	Identical	Identical
Humidity (operation,storage, transport)	5 – 95% RH (not condensing)	Identical	Identical
Power supply	1x AA Alkaline (professional orrechargeable) battery or rechargeableNiMH battery	Identical	Identical
Runtime	>5h with AA battery>8h with rechargeable NiMH battery(2850 mAh)	Identical	Identical
Classificationaccording to 60601-1-Protection typeagainst electricshock-Protection levelagainst electricshock	Device with internal power supply TypeCF	Identical	Identical
Recovery Time afterdefibrillation	< 8 seconds	Identical	Identical
Electromagneticcompatibility (EMC)according to 60601-1-2 and 60601-2-25- Emission- Immunity	CISPR 11 Class BIEC 61000-4 parts 2, 3, 6, 8	Identical	Identical
Data transmission	Bluetooth 2.1+EDR Protocol: SPP.	Identical	Identical

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Image /page/15/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".

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Image /page/16/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".

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Image /page/17/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, the bottom section being dark blue, and the section in between being light blue. Below the text "ERT" is the tagline "Confidence at every turn".

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17 Comparison Summary

Intended Use

The intended use of the Subject Device is the same as for the Predicate Device.

Technological Characteristics

The Predicate Device MasterScope (K202754) and the Reference Devices SpiroSphere (K173937) and COR12 (K183369) are presently in commercial distribution globally including in the United States of America.

The Subject Device uses the same fundamental scientific technology as the Reference Devices and is substantially equivalent in function and application to the Predicate Device.

Biocompatibility

No new biocompatibility testing has been conducted, as the biocompatibility testing for the Reference Devices remains appropriate for this submission.

Differences

The Subject Device consists of a Main Unit for display and a ● wireless ECG amplifier for measurement.
The Subject Device provides a high resolution, color touch screen instead of a high-resolution graphical LCD touch screen
The Subject Device provides an additional 3G interface to enable ● communication.

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18 Summary of Device Testing

The following practices were followed and monitored for development of the Subject Device:

The device was developed and tested according to GMP Standard ● Operating Procedures for Medical Devices.
. Software verification and validation was conducted in accordance with IEC 62304 Ed.1.1:2015.
Risk analysis of the Subject Device was performed according to o ISO 14971:2019.
Tests were performed to confirm that the Subject Device spirometry . function 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 and IEC 60601-2-25:2011 to demonstrate conformance with the requirements for basic safety and essential performance.
The Electro Magnetic Compatibility testing was performed o 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.
The FDA quidance "Information to Support a Claim of . Electromaqnetic Compatibility (EMC) of Electrically-Powered Medical Devices" from 2016 was considered.
Human Factors/Usability Engineering validation according to IEC . 62366-1: 2015 and the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" from 2016
The FDA Guidance "Content of Premarket Submissions for . Management of Cybersecurity in Medical Devices" from 2014 and the Draft Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" from 2018 has

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been considered in the device design and all requirements are fulfilled.

Final Guidance for Industry and FDA Staff: Reprocessing Medical . Devices in Health Care Settings: Validation Methods and Labeling from 2015 has been considered.

19 Conclusion

Based on the intended use of the SpiroSphere / SpiroSphere ECG / CardioSphere and the results of the electrical safety testing and performance testing provided in the 510(k), the Subject Device has been found to be substantially equivalent to the Predicate Device Masterscope (K202754).

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Subject Device should perform as intended in the specified use conditions.

eResearchTechnology GmbH contends that the SpiroSphere / SpiroSphere ECG / CardioSphere is substantially equivalent to the current legally marketed device MasterScope (K202754). The Subject Device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

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).