(416 days)
No
The summary describes a standard spirometry device and does not mention any AI or ML capabilities.
No
The device measures lung function parameters but does not provide therapy or treatment. Its function is diagnostic/monitoring.
Yes
The device is described as measuring lung function parameters and providing pulmonary function tests (slow spirometry, forced spirometry, flow-volume loop, and volume-time tracing), which are used to evaluate and diagnose respiratory conditions. It is used by physicians in a medical setting, further indicating its diagnostic purpose.
No
The device description explicitly mentions a "Sensor Unit" and a "Main Unit," both of which are hardware components. It also describes the device as a "compact spirometry device," indicating a physical instrument.
Based on the provided information, the SpiroSphere is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- SpiroSphere Function: The SpiroSphere directly measures lung function parameters by having the patient breathe into the device. It does not analyze biological specimens.
- Intended Use: The intended use describes measuring lung function parameters, not analyzing biological samples.
- Device Description: The description focuses on the mechanics of measuring airflow and volume, not on handling or analyzing biological specimens.
Therefore, the SpiroSphere falls under the category of a medical device used for physiological measurement, but not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
BTY
Device Description
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
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
Used by physicians in the office or hospital, Prescription Use
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 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.
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SpiroPro K000648
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
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: | Sieboldstrasse3 | |
| D-97230 Estenfeld | ||
| Germany | ||
| Contact person in Germany: | ||
| (Official Correspondent) | Johannes Thalhammer | |
| Address: | eResearch Technology GmbH | |
| Sieboldstrasse 3, 97230 Estenfeld | ||
| Germany | ||
| Phone: | ||
| FAX: | ||
| +49 9305 720 6376 | ||
| +49 9305 720 60 | ||
| johannes.thalhammer@ert.com | ||
| Contact person in the U.S.: | Richard Miller | |
| Address | eResearch Technology | |
| 1818 Market Street, Suite 1000 | ||
| Philadelphia, PA 19103 | ||
| Phone/Fax: | ||
| 215-2825588 | ||
| RMiller@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 |
4
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
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
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 Device
SpiroPro (K000648) | Reference Device
SpiroPro with BT
(K092324) | SpiroSphere |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | The SpiroPro is a portable,
battery operated device
and can be used by
physicians in the office or
hospital, in occupational
medicine or by patients at
home.
The SpiroPro measures
inspiratory and expiratory
lung function parameter in
adults and children from 4
years on according the
ATS recommendations for
diagnostic devices.
Results are displayed
graphical and numerical on
the display of the device.
Optional the results can be
printed on an external
printer or transferred to a
PC. SpiroPro can save all
data in the internal non-
volatile memory for later
retrieval, print-out or
transfer to a PC. | The SpiroPro is a portable,
battery operated device
and can be used by
physicians in the office or
hospital, in occupational
medicine or by patients in
the home. The SpiroPro
measures inspiratory and
expiratory lung function
parameters in adults and
children 4 years and older.
In addition to the
pulmonary function
measurements, oxygen
saturation and heart rate
can be recorded. | 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. |
| Patient
population | Adults and children 4
years and older | Adults and children 4 years
and older | Adults and children 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 | - 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 |
| 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 Spirometry
Standards | 2005 ATS/ERS Spirometry
Standards | 2005 ATS/ERS
Spirometry Standards |
| Fundamental
scientific
technology | Pneumotachograph,
pressure to flow
conversion technique | Pneumotachograph,
pressure to flow
conversion technique | Pneumotachograph,
pressure to flow
conversion technique |
| | (Lilly Type
Pneumotachograph) | (Lilly Type
Pneumotachograph) | (Lilly Type
Pneumotachograph) |
| | Mouthpiece (single patient
use) | Mouthpiece (single patient
use) | Mouthpiece (single patient
use) |
| Components | Pneumotach (single
patient use) | Pneumotach (single
patient use) | Pneumotach (single
patient use) |
| | Medical Grade Power
Supply | Medical Grade Power
Supply | Medical Grade Power
Supply |
| Screen Display | 54 x 35 mm | 54 x 35 mm | 162 x 122 mm |
| Interface | RS232 Interface | USB, RS232 Interface and
Bluetooth interface | Bluetooth
USB
Wifi/Ethernet
3G |
| Energy type | Li-Ion Battery | Li-Ion Battery | Main Unit:
Li-Ion Battery and Power
Supply
Sensor Unit:
Unit: Li-Ion Battery |
| Bluetooth
interface | None | WML-C46 (Mitsumi) | Sensor Unit:
Silicon Laboratories,
BT121 |
| Wi-Fi/BT interface | None | None | Main Unit:
Texas Instruments
WL18xxMOD |
| 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.
8
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.