(540 days)
No
The document describes "interpretation software intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm," but explicitly states "Automatic interpretation of the ECG is not possible for pediatric subjects... and for pacemaker subjects." It also emphasizes that a qualified physician must reassess all measurements and that the interpretation is only significant when considered with other clinical findings. There is no mention of AI, ML, or any learning capabilities.
No
The device is described as measuring and recording lung function parameters and electrocardiogram data. It provides information to support a physician's evaluation but states that "no therapy or drugs can be administered based solely on the interpretation statements." This indicates it is a diagnostic or monitoring device, not a therapeutic one.
Yes
The device measures and records lung function parameters (spirometry) and performs electrocardiogram (ECG) measurements to provide insights into a patient's cardiovascular and pulmonary conditions. The text explicitly states that the interpretation software is "intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm," and that it provides "partial qualitative and quantitative information on the patient's cardiovascular condition." These functions are characteristic of a diagnostic device, which gathers information to help physicians assess medical conditions.
No
The device description explicitly mentions hardware components such as a Sensor Unit, Main Unit, battery power, power supply, ECG amplifier, and the ability to connect a printer. It also describes physical measurements being taken (inspiratory and expiratory lung function, 12-channel surface electrocardiogram).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpiroSphere measures lung function parameters (inspiratory and expiratory) and performs electrocardiogram (ECG) measurements. These are direct measurements of physiological function within the body, not analyses of samples taken from the body.
- Intended Use: The intended use describes measuring lung function and recording ECGs to support physicians in evaluation. This aligns with in vivo diagnostic procedures, not in vitro testing.
Therefore, the SpiroSphere, including its ECG functionality, falls under the category of medical devices used for in vivo diagnostic measurements, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
BTY, DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children aged 4 years and older.
Intended User / Care Setting
physicians in the office or hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 according to IEC 60601-1-2:2014.
Software verification and validation was conducted in accordance with IEC 62304 Ed.1.1:2015.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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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:
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 | ||
| SpiroSphere ECG | CardioSphere | ||
| 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 | |||
| 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. | The SpiroSphere 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 | 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 | |||
| 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. | 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. | |||
| 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 |
| Interpretation | |||
| algorithm (ECG) | Hannover ECG System (HES) | Identical | Identical |
| Data output | Recorded and displayed on screen or | ||
| printed | 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 the | |||
| electrodes | 4 mm snap, gilded | Identical | Identical |
| Electrode type | Standard single use ECG electrodes | Identical | Identical |
| Technology of ECG | |||
| signal | Impedance measurement | Identical | Identical |
| Power supply | 5V DC via USB interface | 1x AA Alkaline (professional or | |
| rechargeable) battery or rechargeable | |||
| NiMH battery | 1x AA Alkaline (professional or | ||
| rechargeable) battery or | |||
| rechargeable 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 for | ||
| measuring the surface | |||
| electrocardiogram (ECG) of a patient. | |||
| The acquired ECG can be recorded and | |||
| displayed on a screen or printed on | |||
| paper. The COR12 ECG can be used | |||
| for applications in patients age 4 years | |||
| and older and a weight of 20 kg or | |||
| higher. The COR12 ECG is intended to | |||
| be used for routine ECG collection, | |||
| recording both under resting and stress | |||
| conditions. The measurement is | |||
| performed by trained healthcare | |||
| professionals under the direction of a | |||
| physician in healthcare facilities (e.g. | |||
| the doctor's office or hospital). | The SpiroSphere 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 | 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 | |||
| 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. | 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. | |||
| Patient population | patients age 4 years and older and a | ||
| weight of 20 kg or higher | patients age 4 years and older | patients age 4 years and older | |
| Data output | Recorded and displayed on screen or | ||
| printed | Identical | Identical | |
| Records | Under resting and stress conditions | Under resting conditions | Under resting conditions |
| Dimensions W x H x | |||
| D | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) | Identical | Identical |
| Weight (without | |||
| battery) | 200 g (0.4 lbs) | Identical | Identical |
| 12-channel Surface | |||
| ECG Recording | Yes | Identical | Identical |
| Electrodes | Standard ECG electrodes | Identical | Identical |
| Connection of the | |||
| electrodes | 4 mm snap, gilded | Identical | Identical |
| Technology of ECG | |||
| signal | Impedance measurement | Identical | Identical |
| Resolution / | |||
| Amplitude | |||
| quantisation | 1,94μV/bit ECG | Identical | Identical |
| Filter | Bandpass 0.05 Hz - 150 Hz No line | ||
| filter (50 Hz / 60 Hz) | Identical | Identical | |
| Pacemaker detection | 4000 Hz | Identical | Identical |
| Temperature range | |||
| operation | T = 10-37 °C | Identical | Identical |
| Ambient pressure | |||
| range 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 or | ||
| rechargeable) battery or rechargeable | |||
| NiMH battery | Identical | Identical | |
| Runtime | >5h with AA battery |
8h with rechargeable NiMH battery
(2850 mAh) | Identical | Identical |
| Classification
according to 60601-1
-Protection type
against electric
shock
-Protection level
against electric
shock | Device with internal power supply Type
CF | Identical | Identical |
| Recovery Time after
defibrillation |