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

A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet.

Pulmonary functions

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

AI/ML Overview

The provided text describes the SpiroSphere, a device for measuring lung function, and its substantial equivalence to a predicate device (SpiroPro). However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary for premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical or performance study results you're asking for.

Here's a breakdown of why the requested information is absent:

Acceptance Criteria and Reported Device Performance (Table): The document states adherence to ATS/ERS standards (2005) for spirometry accuracy and precision and lists various parameters measured (FEV1, FVC, PEF, etc.). However, it does not provide a specific table of acceptance criteria (e.g., +/- x% accuracy) or numerical reported device performance against those criteria. It only generally states that "Tests were performed to confirm that the SpiroSphere meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005."
Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size/Ground Truth: These details are typically found in a dedicated clinical or performance study report, which is not included in this summary. The 510(k) summary only mentions general verification and validation activities and conformance to standards.

In summary, based only on the provided text, I cannot complete the table or answer the specific questions about the study details because that level of detail is not present in this FDA 510(k) summary.

The document discusses:

Device Name: SpiroSphere
Predicate Device: SpiroPro (K000648) and SpiroPro with BT (K092324)
Intended Use/Indications for Use: To measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older, usable by physicians in office or hospital.
Technological Characteristics: Uses a pneumotachograph (Lilly Type) for pressure to flow conversion, measures various parameters (FEV1, FVC, PEF, FEF25-75, VC, IC, ERV) conforming to ATS/ERS Spirometry Standards (2005).
Testing Mentioned: Software verification and validation (IEC 62304), Risk analysis (ISO 14971), electrical safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2014), wireless technology (FDA Guidance 2013), Human Factors/Usability (IEC 62366), Biocompatibility (ISO 10993-1:2009, ISO 18562:2017), Cybersecurity (FDA Guidance 2014), Reprocessing (FDA Guidance 2015).

To answer your questions thoroughly, a complete performance study report would be required, which typically contains the specific data and methodologies.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

February 15, 2019

eReserchTechnology GmbH % Dawn Tibodeau Third Party 510(k) Project Coordinator Tuv Sud America Inc. 1775 Old Highway 8 Nw New Brighton, Minnesota 55112-1891

Re: K173937

Trade/Device Name: SpiroSphere Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY Dated: December 21, 2018 Received: December 31, 2018

Dear Dawn Tibodeau:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173937

Device Name SpiroSphere

Indications for Use (Describe)

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

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

Tyne of Use (Select one or hoth, as annlicable)

	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 with three overlapping shapes 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.

GENERAL INFORMATION

1	Type of Submission	Traditional 510(k) Submission/Third Party Review
	Submission date:	07/28/2017
2	Submitter
	Name:	eResearch Technology GmbH
	Address:	Sieboldstrasse3D-97230 EstenfeldGermany
	Contact person in Germany:(Official Correspondent)	Johannes Thalhammer
	Address:	eResearch Technology GmbHSieboldstrasse 3, 97230 EstenfeldGermany
	Phone:FAX:E-mail	+49 9305 720 6376+49 9305 720 60johannes.thalhammer@ert.com
	Contact person in the U.S.:	Richard Miller
	Address	eResearch Technology1818 Market Street, Suite 1000Philadelphia, PA 19103
	Phone/Fax:E-mail	215-2825588RMiller@ert.com
3	Establishment Registration Number	3008505660
4	Common Name or Classification Name	Predicted pulmonary-function value calculator(CFR 868.1890, Product Code BTY)
5	Trade Name	SpiroSphere
6	Device Classification	This is a Class II device
7	Classification Panel	73 Anesthesiology Part 868 Code BTY

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005 510(k) Summary

Image /page/4/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 left section being light blue, and the bottom right section being dark blue. The text "ERT" is in dark blue, and below it is the tagline "Confidence at every turn" in a smaller font.

8 Reason for Premarket Notification

Introducing a (finished) device into commercial distribution (marketing) in the U.S. for the first time.

9 Legally predicate marketed device

SpiroPro K000648 Code BTY

Reference Device SpiroPro with BT Code BTY, Code DQA K092324

Predicate Device Company 10

eResearchTechnology GmbH (device was formally listed by Erich Jaeger GmbH and Carefusion Germany 234 GmbH)

11 Device Description

A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet.

Pulmonary functions

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

12 Indications for Use

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 Required Components

Power Supply (medical grade) Pneumotach with Mouthpiece (ERT PT)

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Image /page/5/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 made up of three curved shapes in green and blue. Below the text "ERT" is the tagline "Confidence at every turn".

Instruction for Use NoseClips

Summary Table of Comparison 14

Comparison with SpiroPro (K000648) and SpiroPro with BT (K092324)

	Predicate DeviceSpiroPro (K000648)	Reference DeviceSpiroPro with BT(K092324)	SpiroSphere
Intended Use /Indications forUse	The SpiroPro is a portable,battery operated deviceand can be used byphysicians in the office orhospital, in occupationalmedicine or by patients athome.The SpiroPro measuresinspiratory and expiratorylung function parameter inadults and children from 4years on according theATS recommendations fordiagnostic devices.Results are displayedgraphical and numerical onthe display of the device.Optional the results can beprinted on an externalprinter or transferred to aPC. SpiroPro can save alldata in the internal non-volatile memory for laterretrieval, print-out ortransfer to a PC.	The SpiroPro is a portable,battery operated deviceand can be used byphysicians in the office orhospital, in occupationalmedicine or by patients inthe home. The SpiroPromeasures inspiratory andexpiratory lung functionparameters in adults andchildren 4 years and older.In addition to thepulmonary functionmeasurements, oxygensaturation and heart ratecan be recorded.	The SpiroSphere is acompact device tomeasure inspiratory andexpiratory lung functionparameters in adults andchildren aged 4 years andolder.It can be used byphysicians in the office orhospital.
Patientpopulation	Adults and children 4years and older	Adults and children 4 yearsand older	Adults and children 4years and older
Operationprinciple	- Measurement ofinspiratory andexpiratory flows andvolumes withpneumotach transducer- Calculation of lungfunction parameters- Results are displayedand stored, they can beprinted and exported	- Measurement ofinspiratory andexpiratory flows andvolumes withpneumotach transducer- Calculation of lungfunction parameters- Results are displayedand stored, they can beprinted and exported	- Measurement ofinspiratory andexpiratory flows andvolumes withpneumotach transducer- Calculation of lungfunction parameters- Results are displayedand stored, they can beprinted and exported
Measurements	FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and	FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and	FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and
	others acc. to ATS*	others acc. to ATS*	others acc. to ATS*
*ATS conformity(criteria)	1994 ATS/ERS SpirometryStandards	2005 ATS/ERS SpirometryStandards	2005 ATS/ERSSpirometry Standards
Fundamentalscientifictechnology	Pneumotachograph,pressure to flowconversion technique	Pneumotachograph,pressure to flowconversion technique	Pneumotachograph,pressure to flowconversion technique
	(Lilly TypePneumotachograph)	(Lilly TypePneumotachograph)	(Lilly TypePneumotachograph)
	Mouthpiece (single patientuse)	Mouthpiece (single patientuse)	Mouthpiece (single patientuse)
Components	Pneumotach (singlepatient use)	Pneumotach (singlepatient use)	Pneumotach (singlepatient use)
	Medical Grade PowerSupply	Medical Grade PowerSupply	Medical Grade PowerSupply
Screen Display	54 x 35 mm	54 x 35 mm	162 x 122 mm
Interface	RS232 Interface	USB, RS232 Interface andBluetooth interface	BluetoothUSBWifi/Ethernet3G
Energy type	Li-Ion Battery	Li-Ion Battery	Main Unit:Li-Ion Battery and PowerSupplySensor Unit:Unit: Li-Ion Battery
Bluetoothinterface	None	WML-C46 (Mitsumi)	Sensor Unit:Silicon Laboratories,BT121
Wi-Fi/BT interface	None	None	Main Unit:Texas InstrumentsWL18xxMOD
Ethernet	None	None	10/100 MBit Ethernet
3G Interface	None	None	Sierra Wireless HL 8548

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Image /page/6/Picture/1 description: The image is a logo for ERT. The logo consists of a circular design with three sections in green and blue, along with the text "ERT" in a bold, blue font. Below the text, there is a tagline that reads "Confidence at every turn" in a smaller font.

15 Comparison Summary

Intended Use

The intended use of the SpiroSphere device is the same as in the predicate device SpiroPro.

Technological Characteristics

The predicate device SpiroPro and the reference device SpiroPro with BT are presently in commercial distribution globally including the United States of America. The SpiroSphere has the same fundamental scientific

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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 made up of three curved shapes in green and blue. Below the text "ERT" is the tagline "Confidence at every turn".

technology and is substantial equivalent in function and application to the predicate device.

Biocompatibility

No new issues of biocompatibility have been raised with regard to the SpiroPro.

Differences

The SpiroSphere consists of a main unit for display and a sensor ● unit for measurement.
The SpiroSphere provides a high resolution, color touch screen instead of a high-resolution graphical LCD touch screen
. The SpiroSphere provides additional state of the art interfaces (Bluetooth, 3G, Wi-Fi, Ethernet, USB) to enable communication.
The SpiroSphere provides additional Predicted Values (GLI 2012)
SpiroSphere complies to the 2005 ATS/ERS Spirometry Standards ●

16 Summary of Device Testing

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

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 62304:2006.
Risk analysis of the SpiroSphere was performed according to ISO ● 14971:2007.
Tests were performed to confirm that the SpiroSphere 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.

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Image /page/8/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 made up of three curved shapes in green and blue. Below the text "ERT" is the tagline "Confidence at every turn".

. 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 was done according to IEC 62366 Edition 1.1: 2014.
. Biocompatibility was evaluated in accordance with ISO 10993-1:2009 and ISO 18562:2017
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.
. Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling from 2015 has been considered.

17 Conclusion

Based on the intended use of the SpiroSphere and the results of the electronic safety testing and performance testing provided in the 510(k), the SpiroSphere is found to be substantially equivalent to the predicate device SpiroPro.

The non-clinical data as well as the hardware and software verification and validation demonstrate that the SpiroSphere device should perform as intended in the specified use conditions.

eResearchTechnology GmbH believes that the SpiroSphere is substantially equivalent to the current legally marketed device SpiroPro. The SpiroSphere has the same technological characteristics and was determined to be as safe and as effective as the predicate device.

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).