(126 days)
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.
The Vitalograph Spirotrac Model 7000 provides a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject.
Spirotrac integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.
Its primary functions are:
Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and its subdivisions. The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc.), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift).
Record subject demographic data as input.
Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database.
Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to function as a spirometer or connect to compatible devices to acquire, view, store, and print device output. It is designed for use on adults and pediatrics (5 years and older) in professional healthcare settings.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly list acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Performance testing demonstrated that the subject device met its acceptance criteria" and details the standards and guidance documents followed. The acceptance criteria can be inferred from the compliance with these standards and regulatory guidance.
The device's performance is reported as meeting the requirements of:
- ATS/ERS (2005) waveform simulator testing
- ISO 23747:2015 - Anaesthetic and respiratory equipment -- Peak expiratory flow meters
- ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.
Inferred Acceptance Criteria & Reported Performance:
| Acceptance Criteria Category | Target / Standard (Inferred) | Reported Device Performance |
|---|---|---|
| Spirometry Measurement Accuracy & Performance | Compliance with ATS/ERS (2005) waveform simulator testing standards for spirometry parameters (e.g., FVC, PEF, FEFx, VC, FIVC, etc.). Compliance with ISO 23747:2015 for Peak Expiratory Flow (PEF) measurements. Compliance with ISO 26782:2009 for spirometers measuring time forced expired volumes. Data displayed and limits set (user or default) must align with these performance standards. | "Performance testing demonstrated that the subject device met its acceptance criteria." "Note that this testing was performed to demonstrate that the data displayed along with any limits set by user or by default, are aligned with these performance standards." The device performs spirometry measurements using single breath and multiple-breath techniques, and displays/records measured lung volumes and flow rates. |
| Software Verification & Validation (V&V) | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005" and "General Principles of Software Validation Guidance. January 2020." | "Verification and Validation was performed following Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and General Principles of Software Validation Guidance. January 2020." |
| Interoperability & Data Handling (acquiring, viewing, storing, printing data from compatible Vitalograph or third-party devices, subject demographic data, network operation, data import/export, email export, database management) | Functionality as described in the device description and comparison table, maintaining compatibility and data integrity. | Demonstrated through "Same" comparisons with the predicate device across various functionalities (e.g., ECG waveforms, ABPM, Spot Oximetry, Subject Management, Report Printing, Trending Graphs, Predicted Value Equations, Population Group Management, Data Import/Export, Database Management). |
| Operating System Compatibility | Support for Windows 7, 8, and 10. | Supports Windows 7, 8, and 10. |
| Patient Population | Adults and pediatrics 5 years and older. | Designed for use on adults and pediatrics, 5 years and older. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing involving waveform simulator testing (ATS/ERS) and compliance with ISO standards (ISO 23747, ISO 26782). These are typically bench tests using standardized simulated waveforms, not patient data. Therefore, there is no sample size of human subjects mentioned for the test set, nor is there information on data provenance (country, retrospective/prospective), as the testing appears to be entirely technical/engineering in nature (software V&V, bench testing against standards).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since the testing involved bench testing against international standards and simulated waveforms, there were no human experts establishing ground truth in the typical sense of clinical interpretation. The "ground truth" for these tests is implicitly defined by the parameters and specifications of the ATS/ERS and ISO standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As the testing was non-clinical and involved compliance with technical standards and simulated waveforms, there was no adjudication method described or likely needed for human discrepancies. The performance was measured against predefined technical specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a diagnostic spirometer software, not an AI-assisted diagnostic tool that aids human readers in interpreting complex images or data. Its primary function is to acquire, display, store, and print spirometry data, and interface with existing medical devices. The document does not suggest any AI components that perform diagnostic interpretation requiring human-in-the-loop studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance evaluation described is essentially a standalone (algorithm/software only) assessment against technical standards and simulator outputs. The V&V of the software itself and its ability to process and display data in compliance with ATS/ERS and ISO standards represents its "standalone performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the performance testing was based on international technical standards and simulated waveforms:
- ATS/ERS (2005) waveform simulator
- ISO 23747:2015 specifications
- ISO 26782:2009 specifications
These standards define the expected correct output for various spirometry maneuvers and parameters.
8. The sample size for the training set
This device did not undergo a training phase in the context of machine learning or AI. It is a software application whose functionality is based on established algorithms for spirometry and data management. Therefore, there is no training set sample size described.
9. How the ground truth for the training set was established
As there was no training set in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "knowledge" or "rules" are based on the implementation of well-established medical and engineering principles for spirometry and data processing, not on learning from a labeled dataset.
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October 14, 2020
Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K201562
Trade/Device Name: Vitalograph Spirotrac Model 7000 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: September 10, 2020 Received: September 11, 2020
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 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 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,
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
K201562
Device Name
Vitalograph Spirotrac Model 7000
Indications for Use (Describe)
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301)
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K201562
510(k) Summary Page 1 of 5
| Date Prepared: | 13-Oct-2020 |
|---|---|
| ---------------- | ------------- |
I Submitter
| Vitalograph Ireland Ltd.Gort Road Business ParkEnnis Co Clare V95 HFT4 IrelandTel - +353-65-6864100 |
|---|
| ----------------------------------------------------------------------------------------------------------------- |
| Submitter Contact: | Tony O'HanlonRegulatory Affairs / Quality Assurance Manager |
|---|---|
| Submission Correspondent: | Paul DrydenProMedic, LLC |
II Device
| Proprietary or Trade Name: | Vitalograph Spirotrac Model 7000 |
|---|---|
| Common/Usual Name: | Diagnostic spirometer |
| Classification Name: | Diagnostic spirometer (21 CFR 868.1840) |
| Regulatory Class: | II |
| Product Code: | BZG |
III Predicate Device:
| Vitalograph Model 7000, K141546 | |
|---|---|
| -- | --------------------------------- |
IV Device Description:
The Vitalograph Spirotrac Model 7000 provides a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject.
Spirotrac integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.
Its primary functions are:
Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and its subdivisions. The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc.), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift).
Record subject demographic data as input.
Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database.
Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.
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510(k) Summary Page 2 of 5
V Indications for Use:
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.
Environments of use: Professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
VI Modifications
A new code base, rewrite of the application, use of interfacing with latest Windows technology, User Interface etc. There were no changes to the algorithm.
Mechanical:
None, this is a software only device
Electrical:
None, this is a software only device
Materials:
None, this is a software only device
Software:
A new code base, rewrite of the application, use of interfacing with latest Windows technology, User Interface etc.
VII Comparison of Technological Characteristics and Performance with the Predicate
Table 1 is a comparison - Subject Device vs. the Predicate, K141546 including technological characteristics and performance.
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510(k) Summary
Table 1: Comparison of the Model 7000 Spirotrac vs. the Predicate
| Predicate | Subject | Comparison | |
|---|---|---|---|
| Model 7000 Spirotrac | Vitalograph Spirotrac Model 7000 | ||
| K# | K141546 | K201562 | |
| Product Code | BZG | BZG | Same |
| CFR | 868.1840 | 868.1840 | Same |
| Classification | Spirometer, diagnostic | Spirometer, diagnostic | Same |
| Indications for Use | The Vitalograph Model 7000 Spirotrac is intendedfor use by or on the order of a physician in ahospital or clinic setting. The product is designedfor use on both adult and pediatric patients. Thedevice is a PC based software application which isintended to be used as a spirometer or connect tocompatible Vitalograph or third party devices toacquire, view, store and print the device output. | The Vitalograph Spirotrac Model 7000 is aPC-based software application intended to beused as a spirometer or connect to compatibleVitalograph or third party devices to acquire,view, store and print the device output. Theproduct is designed for use on adults andpediatrics, 5 years and older, in a variety ofprofessional healthcare environments, e.g.primary care, hospitals and occupationalhealth centers under the supervision of ahealthcare provider. | The indications for usehave been updated fromthe predicate K141546which was not specificregarding the type oftesting performed,patient population orenvironments of use.Otherwise the indicationsfor use are the same. |
| Fundamental scientific technology | Digital data communication | Digital data communication | Same |
| Spirometry - acquire, view,store and print measures andwaveforms of pulmonaryfunction | Yes | Yes | Same |
| ECG waveforms -view, store, print | Yes | Yes | Same |
| ECG waveforms - acquire | Yes, From compatible device. | Yes, From compatible device. | Same |
| ECG waveform- view, store, print | Yes | Yes | Same |
| ECG Interpretation viaalgorithms | Yes | Yes | Same |
| Ambulatory Blood Pressure -retrieve, view, store and printpatient ambulatory bloodpressure history | Yes, from compatible device. | Yes, from compatible device. | Same |
| Predicate | Subject | Comparison | |
| Model 7000 Spirotrac | Vitalograph SpirotracModel 7000 | ||
| K# | K141546 | K201562 | |
| Spot Oximetry download, view.Weight | Yes, From compatible device.Manual entry or download via connection tocompatible device | Yes, From compatible device.Manual entry or download via connectionto compatible device | Same |
| Microsoft windows OperatingSystems Supported: | Yes, Windows 7 and 8 | Yes, Windows 7, 8 and 10 | Support for neweroperating system |
| Database: | MS SQL Server | MS SQL Server | Same |
| Where used | Hospital, Health center, primary care practicesand clinics | Hospital, Health center, primary carepractices and clinics | Same |
| Networked operation | Yes | Yes | Same |
| Subject Management:Demographic Entry, Maintenanceand Deletion | Yes | Yes | Same |
| Report Printing | Yes | Yes | Same |
| Spirometry testing | Yes | Yes | Same |
| Trending Graphs for SpirometryResults | Yes | Yes | Same |
| Spirometry Predicted ValueEquations | Yes | Yes | Same |
| Population Group Management | Yes | Yes | Same |
| Data Import/Export | Yes | Yes | Same |
| Subject and Spirometry DataExport | Yes | Yes | Same |
| Manual data entry of results | Yes | Yes | Same |
| Data export via Email | Yes | Yes | Same |
| Database Management | Yes | Yes | Same |
| Color Display | Yes | Yes | Same |
| Population groups | Adult, Pediatric | Adult, Pediatric (5 years and above) | Same |
| Communication | Bluetooth, USB, | Bluetooth, USB, | Same |
| Storage | Dependent on storage media | Dependent on storage media | Same |
| Biocompatibility | No patient contact | No patient contact | Same |
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K201562
510(k) Summary
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VIII Performance Data
Non-clinical Testing
Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:
Software
Verification and Validation was performed following Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and General Principles of Software Validation Guidance. January 2020.
Bench
- ATS / ERS (2005) waveform simulator testing
- ISO 23747:2015- Anaesthetic and respiratory equipment -- Peak expiratory flow meters ● for the assessment of pulmonary function in spontaneously breathing humans
- ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.
Note that this testing was performed to demonstrate that the data displayed along with any limits set by user or by default, are aligned with these performance standards.
There is no hardware so electrical safety, electromagnetic compatibility, biocompatibility, and cleaning testing were not required.
Substantial Equivalence Conclusion
The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device are substantially equivalent.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).