← Product Code [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY) · K223629 # SpiroSphere, SpiroSphereECG, CardioSphere (K223629) _Eresearchtechnology GmbH · BTY · May 28, 2024 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94diagnostic-devices/BTY/K223629 ## Device Facts - **Applicant:** Eresearchtechnology GmbH - **Product Code:** [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY.md) - **Decision Date:** May 28, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1890 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric, 3rd-Party Reviewed ## Intended 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. 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. 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, 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. ## Device Story SpiroSphere/CardioSphere are compact devices for pulmonary function testing and 12-channel resting ECG. Spirometry uses pneumotach transducer for flow/volume measurement. ECG option uses wireless amplifier (Bluetooth) to acquire surface signals. Devices used in office/hospital by physicians. Output includes lung function parameters (FEV1, FVC, etc.) and ECG morphology/rhythm interpretation. Interpretation software supports physician evaluation; requires qualified physician reassessment. Provides partial qualitative/quantitative cardiovascular data; not for therapy/drug administration decisions. Benefits include integrated diagnostic assessment of pulmonary and cardiovascular status. ## Clinical Evidence Bench testing only. No clinical data. Performance testing confirmed spirometry accuracy/precision per ATS/ERS 2005 standards. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Software verification/validation conducted per IEC 62304. ## Technological Characteristics Pneumotachograph (Lilly type) for spirometry; 12-channel surface ECG amplifier. Connectivity: Bluetooth 2.1+EDR, USB, Wifi, 3G, Ethernet. Power: Li-Ion battery or power supply (Main Unit); AA/NiMH battery (ECG amplifier). Dimensions: 8.0 x 9.3 x 2.1 cm. Software: Hannover ECG System (HES) for interpretation. Standards: IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62366-1. ## Regulatory Identification A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations. ## Predicate Devices - Masterscope ([K202754](/device/K202754.md)) ## Reference Devices - SpiroSphere ([K173937](/device/K173937.md)) - COR12 ([K183369](/device/K183369.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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." {3}------------------------------------------------ # 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. 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. 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.* 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." {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223629 Device Name CardioSphere ### Indications for Use (Describe) 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. | 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.* 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." {5}------------------------------------------------ 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) {6}------------------------------------------------ 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) {7}------------------------------------------------ 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 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 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. ### 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. 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 {9}------------------------------------------------ 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 {10}------------------------------------------------ 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 Device
MasterScope (K202754) | Reference Device
SpiroSphere (K173937) | Subject Device | | | | | | SpiroSphere ECG | SpiroSphere | | Intended Use /
Indications for Use | MasterScope 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 | 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. | 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 | 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. | | 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. | 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. | Identical | Identical | | | Patient population | 4 years and older | 4 years and older | 4 years and older | | | Operation principle | Measurement of inspiratory and
expiratory flows and volumes
with pneumotach transducer
Calculation of lung function
parameters
Results are displayed and
stored, they can be printed and
exported | Measurement of inspiratory
and expiratory flows and
volumes with pneumotach
transducer
Calculation of lung function
parameters
Results are displayed and
stored, they can be printed
and exported | Identical | Identical | | Measurements | FEV1, FVC, PEF, FEF25-75,
VC, IC, ERV and others acc. to
ATS* | FEV1, FVC, PEF, FEF25-
75, VC, IC, ERV and others
acc. to ATS* | Identical | Identical | | *ATS conformity
(criteria) | 2005 ATS/ERS Spirometry
Standards | 2005 ATS/ERS Spirometry
Standards | Identical | Identical | | Fundamental
scientific technology | Pneumotachograph, pressure to
flow conversion technique
(Lilly Type Pneumotachograph) | Pneumotachograph,
pressure to flow conversion
technique
(Lilly Type
Pneumotachograph) | Identical | Identical | | User | Physicians in the office or
hospital | Physicians in the office or
hospital | 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 | Bluetooth
USB
Wifi/Ethernet | Bluetooth
USB
Wifi/Ethernet
3G | Identical to SpiroSphere
(K173937) | Identical to SpiroSphere
(K173937) | | Energy type | Li-Ion Battery and Power Supply | Li-Ion Battery and Power
Supply | Identical | Identical | {11}------------------------------------------------ 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". {12}------------------------------------------------ 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. {13}------------------------------------------------ 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 | | | |… --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94diagnostic-devices/BTY/K223629](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94diagnostic-devices/BTY/K223629) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com