VITALOGRAPH MODEL 7000 SPIROTRAC
Device Facts
| Record ID | K141546 |
|---|---|
| Device Name | VITALOGRAPH MODEL 7000 SPIROTRAC |
| Applicant | Vitalograph (Ireland) , Ltd. |
| Product Code | BZG · Anesthesiology |
| Decision Date | Sep 3, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1840 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric, 3rd-Party Reviewed |
Indications for Use
The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediativ patients. The device is a PC based software application which is 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.
Device Story
PC-based software application; functions as spirometer or central hub for compatible medical devices. Inputs: spirometry maneuvers (single/multiple-breath), demographic data; data downloads from pulse oximeters, blood pressure monitors, weight scales, ECG devices via wired/wireless (Bluetooth/USB) connections. Operation: clinician-operated in hospitals/clinics; navigation via keyboard, mouse, or touchscreen. Output: display/print of lung volumes, flow rates (VC, FIVC, FVC, PEF, FEFx, MVV), and integrated data from connected devices. Clinical utility: supports diagnosis/monitoring of pulmonary function and patient health status; stores data in MS SQL Server database. Benefits: centralized patient record management; eliminates manual data entry errors via automated device integration.
Clinical Evidence
Bench testing only. Validation performed against international standards: ISO 26782 (spirometers), ISO 23747 (peak expiratory flow meters), and ATS/ERS 2005 (lung function testing). Interface validation confirmed data integrity for third-party device downloads. All tests demonstrated satisfactory results.
Technological Characteristics
PC-based software application; MS SQL Server database. Connectivity: wired/wireless (Bluetooth, USB). Standards: ISO 26782, ISO 23747, ATS/ERS 2005. Features: spirometry measurement, data integration from third-party pulse oximetry, blood pressure, weight, and ECG devices. Non-sterile.
Indications for Use
Indicated for use by or on the order of a physician in hospital or clinic settings for adult and pediatric patients. Used as a spirometer or to acquire, view, store, and print data from compatible Vitalograph or third-party devices (pulse oximetry, blood pressure, weight, ECG).
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
Vitalograph (Ireland) Ltd. C/O Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K141546
Trade/Device Name: Vitalograph Model 7000 Spirotrac Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: August 15, 2014 Received: August 19, 2014
Dear Mr. Job:
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. 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.
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Page 2 - Mr. Job
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K141546
### Device Name
Vitalograph Model 7000 Spirotrac
#### Indications for Use (Describe)
The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediativ patients. The device is a PC based software application which is 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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# 510K Summary as required by 21 CFR 807.92
1. Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
Tel: +353656864100 Fax: +353656829289.
- 2. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
- 3. Date prepared: 2nd July 2014.
- 4. Device Trade Name: Vitalograph Model 7000 Spirotrac
- 5. Common / Usual name: Vitalograph Spirotrac,
- 6. Classification number:
Class 2 Spirometer as classified per 21 CFR 868.1840. Product Code BZG.
- 7. Predicate Device:
| Manufacturer | : Welch Allyn |
|--------------|--------------------------------------|
| Device Name | : CardioPerfect Workstation Software |
| 510(k) No | : K082478, Class 2, Product Code BZG |
| | |
| Manufacturer | : MIR |
| Device Name | : Spirodoc |
| 510(k) No | : K103530, Class 2, Product Code BZG |
- 8. Description of Device:
Spirotrac shall provide 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
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Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.
Its primary functions are:
- 1. 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 it's 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).
- 2. 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.
- 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.
## 9. Indications for Use:
The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is 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.
- 10. Technological Characteristics
The primary difference between the revised Vitalograph Model 7000 Spirotrac and the predicate devices is the inclusion of the weighing scales as a compatible third party devices. The predicates all measure spirometry with optional ECG, Blood Pressure, Weight and Pulse Oximetry connectivity.
The connectivity to other compatible devices is to allow data to be downloaded from the other devices via a cable or wireless connection, in lieu of manual data entry which can still be performed within Spirotrac.
Connectivity includes a wired / wireless connection to devices to allow downloading of data into the Spirotrac database. Risks have been evaluated and the connectivity / communication with other devices have been validated with the Vitalograph Model 7000 Spirotrac software. This validation is on file for all devices.
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| | Welch Allyn<br>CardioPerfect<br>Workstation | Spirotrac Model<br>7000 | MIR Spirodoc,<br>K103530 |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software,<br>K082478 | | |
| Spirometry -<br>acquire, view, store<br>and print<br>measures and<br>waveforms of<br>pulmonary function | Yes | Yes | Yes |
| ECG waveforms -<br>view, store, print | Yes | Yes | No |
| ECG waveforms -<br>acquire | Yes | Yes, From<br>compatible device. | No |
| ECG waveform-<br>view, store, print | Yes | Yes | No |
| ECG Interpretation<br>via algorithms | Yes | Yes | No |
| Ambulatory Blood<br>Pressure - retrieve,<br>view, store and print<br>patient ambulatory<br>blood pressure<br>history | Yes | Yes, from<br>compatible device. | No |
| Spot Oximetry<br>download, view. | No | Yes, From<br>compatible device. | Yes |
| Weight | Manual entry | Manual entry or<br>download via<br>connection to<br>compatible device | No |
| Microsoft windows<br>Operating Systems<br>Supported: | Yes | Yes | Yes |
| Database: | MS SQL Server | MS SQL Server | MS SQL Server |
| Where used | Hospital, Clinic | Hospital, Health<br>centre, primary<br>care practices and<br>clinics | Physician or patient<br>under prescribed us<br>of a physician |
| Networked<br>operation | Yes | Yes | Yes |
| Subject<br>Management:<br>Demographic Entry,<br>Maintenance and<br>Deletion | Yes | Yes | Yes |
| Report Printing | Yes | Yes | Yes |
| Spirometry testing | Yes | Yes | Yes |
| Trending Graphs for<br>Spirometry Results | Yes | Yes | Yes |
| Spirometry<br>Predicted Value<br>Equations | Yes | Yes | Yes |
| Population Group<br>Management | Yes | Yes | Yes |
| Data Import/Export | Yes | Yes | Yes |
| Subject and<br>Spirometry Data<br>Export | Yes | Yes | Yes |
| Manual data entry<br>of results | Yes | Yes | Yes |
| Data export via<br>Email | Yes | Yes | Yes |
| Database<br>Management | Yes | Yes | Yes |
| Colour Display | Yes | Yes | Yes |
| Population groups | Adult, Paediatric<br>Adult & Paediatric | Adult, Paediatric | Yes<br>Spirometry - Adult &<br>paediatric |
| Target Population | | Adult & Paediatric | Oximetry - All ages |
| Communication | Wireless, USB,<br>Serial,<br>Dependent on<br>storage media | Bluetooth, USB,<br>Dependent on<br>storage media | Bluetooth, USB |
| Storage | | | |
| Sterile | No | No | No |
| Regulatory (USA): | FDA - 510(k)<br>Class 2 { K082478} | FDA - 510(k) Class<br>2 | FDA - 510(k) Class 2<br>{K103530} |
| Indications for Use | The CardioPerfect<br>Workstation software<br>and associated<br>accessories are<br>indicated for the<br>acquisition, analysis,<br>formatting, display,<br>printing and storage of<br>certain physiologic<br>signals, as identified<br>below, for the purpose<br>of assisting the<br>clinician in the<br>diagnosis and<br>monitoring of various<br>diseases and/or<br>treatment regimens.<br>The CardioPerfect<br>Workstation software<br>also provides non-<br>diagnostic functions<br>such as patient<br>management, data<br>security, search tools<br>for patient and/or test<br>records and support<br>for exporting data to<br>Electronic Medical | The Vitalograph Model<br>7000 Spirotrac is<br>intended for use by or<br>on the order of a<br>physician in a hospital<br>or clinic setting. The<br>product is designed for<br>use on both adult and<br>pediatric patients. The<br>device is a PC based<br>software application<br>which is intended to be<br>used as a spirometer or<br>connect to compatible<br>Vitalograph or third<br>party devices to acquire,<br>view, store and print the<br>device output. | The Spirodoc Spirometer<br>and pulse oximeter is<br>intended to be used by<br>a physician or by a<br>patient under the<br>prescribed use of a<br>physician.<br>The device is intended to<br>test lung function and can<br>perform spirometry<br>testing in adult and<br>pediatric patients,<br>excluding infants and<br>neonates, and oximetry<br>readings in patients of all<br>ages. |
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| The CardioPerfect<br>Workstation and<br>associated accessories<br>are intended for use<br>by or on the order of a<br>physician in a hospital<br>or clinic setting. The<br>product is designed for<br>use on both adult and<br>pediatric patients,<br>subject to any specific<br>contraindications<br>identified below. | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--|--|--|
| <b>Stress<br/>Electrocardiograph -<br/>Intended Use</b><br>Using the optional ECG<br>module and<br>associated accessories<br>the user can acquire,<br>view, store and print<br>ECG waveforms. | | | | |
| <b>Resting<br/>Electrocardiograph -<br/>Intended Use</b><br>The same as defined<br>for stress ECG plus the<br>ability to use optional<br>algorithms (MEANS) to<br>generate<br>measurements, data<br>presentations,<br>graphical<br>presentations and<br>interpretive<br>statements on an<br>advisory basis. These<br>are presented for<br>review and<br>interpretation by the<br>clinician. | | | | |
| <b>Spirometry - Intended<br/>Use</b><br>Using the optional<br>spirometry module<br>and associated<br>accessories to acquire,<br>view, store and print<br>measures and<br>waveforms of<br>pulmonary function.<br>The spirometer should | only be used with<br>patients able to<br>understand the<br>instructions for<br>performing the test. | | | |
| Ambulatory Blood<br>Pressure - Intended | | | | |
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| Use | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Using the optional ABP<br>module and<br>associated accessories<br>the user can acquire,<br>retrieve, view, store<br>and print patient<br>ambulatory blood<br>pressure history. | | |
The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as
- ISO 26782{ Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans},
- . ATS/ERS 2005 { ATS/ERS Task Force: Standardisation of Lung Function Testing} and
- ISO 23747 { Anaesthetic and respiratory equipment -- Peak expiratory flow . meters for the assessment of pulmonary function in spontaneously breathing humans}.
Validation of the interfaces with compatible third party devices is to ensure the integrity of the information is maintained and that the information on the third party devices may be successfully downloaded and stored within the Spirotrac database.
All tests and validations demonstrated satisfactory results. Evidence of successful completion of tests and validations has been provided with this submission.
## 11. Conclusion:
The characteristics of the Model 7000 Spirotrac are similar to those of the predicate devices listed.
Based on the above, including the successful completion of all device testing Vitalograph conclude that this device is as safe and as effective as the predicate devices. No new issues of safety or effectiveness have been introduced as a result.
