(92 days)
No
The summary does not mention AI, ML, or related terms, and the described functionalities (ECG analysis, risk scoring via recognized protocols, automatic interpretation) are typically achieved through traditional algorithms and signal processing techniques in stress testing devices.
No
The device is described as a "diagnostic device" for acquiring and analyzing electrocardiographic data during stress testing, and it explicitly states, "The device is not intended to be used as a vital signs physiological monitor." Its purpose is to provide data for diagnosis rather than to treat or provide therapy.
Yes
The "Device Description" section explicitly states: "The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection..."
No
The device description explicitly mentions wired and wireless acquisition modules, a touch screen interface, keyboard/mouse interface, and a wired remote control unit, indicating the presence of hardware components beyond just software.
Based on the provided information, the XScribe/Q-Stress device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- XScribe/Q-Stress Function: The description clearly states that the device "acquire[s], process[es], record[s], archive[s], analyze[s], and output[s] electrocardiographic data during physiologic stress testing." This involves measuring electrical activity of the heart directly from the patient's body, not from a specimen taken from the body.
- Lack of Specimen Handling: There is no mention of the device handling or analyzing any biological specimens.
Therefore, the XScribe/Q-Stress device falls under the category of a diagnostic device that performs measurements directly on the patient, rather than an in vitro diagnostic device that analyzes specimens.
N/A
Intended Use / Indications for Use
The XScribe/Q-Stress device is intended to acquire, process, record, archive, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.
The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.
The device is not intended to be used as a vital signs physiological monitor.
Product codes
DPS, DOK
Device Description
The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. The device is able to generate risk scoring via recognized protocols. The device is capable of obtaining a resting ECG with automatic interpretation. The device can interface with equipment for pulmonary evaluation. The device has several built in exercise protocols for connection and control of exercise equipment such as treadmills and ergometers. The device supports measurement of non-invasive blood pressure. The device can output analog ECG signals or digital QRS trigger signals for synchronizing an external device. The device supports a touch screen interface as well as a keyboard / mouse interface and a wired remote control unit. The device will store a complete record of diagnostic quality test data from which the user can generate and review stress test reports. The device can function as standalone workstation or can connect via network to a database server allowing for remote review capabilities. The device can communicate with electronic record keeping systems to obtain work lists and patient data, and to provide test result reports.
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
adult, adolescent, and children patient populations
Intended User / Care Setting
clinical setting by trained personnel under the supervision of a licensed physician.
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 non-clinical data that supports the safety of this device as well as the hardware and software verification and validation that have been completed at the time of this submission demonstrate that XScribe/Q-Stress performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Mortara Instrument, Inc. Ms. Eleanore Dias Regulatory Affairs Specialist 7865 North 86th Street Milwaukee, Wisconsin 53224
Re: K152944
Trade/Device Name: Xscribe Stress Exercise Testing Systems, O-stress Stress Exercise Testing Systems Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DOK Dated: December 11, 2015 Received: December 14, 2015
Dear Ms. Dias:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education 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. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
XScribe and Q-Stress Stress Exercise Testing System
Indications for Use (Describe)
The XScribe/Q-Stress device is intended to acquire, process, record, archive, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.
The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.
The device is not intended to be used as a vital signs physiological monitor.
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5
510(k) Summary Statement
1. Submitter
| Mortara Instrument, Inc.
7865 North 86th Street
| Milwaukee, WI 53224 | Primary Contact |
|---|---|
| Telephone 414-354-1600 | |
| Fax 414-354-4760 | Eleanore Dias |
| Regulatory Affairs Specialist | |
| eleanore.dias@mortara.com | |
| Secondary Contact | |
| Margaret Mucha | |
| Director of Global Regulatory | |
| Affairs | |
| meg.mucha@mortara.com |
2. Product Names
Device Trade Name
Common/ Usual Name
Classification
XScribe and Q-Stress
Stress Exercise Testing System
Programmable Diagnostic Computer
870.1425 DQK Cardiovascular
Electrocardiograph 870.2340 DPS Cardiovascular
Note: There are no previous submissions for this device
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3. Predicate Device to which this is Substantially Equivalent
XScribe II
This predicate device has not been subject to a design-related recall
4. Device Description
The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. The device is able to generate risk scoring via recognized protocols. The device is capable of obtaining a resting ECG with automatic interpretation. The device can interface with equipment for pulmonary evaluation. The device has several built in exercise protocols for connection and control of exercise equipment such as treadmills and ergometers. The device supports measurement of non-invasive blood pressure. The device can output analog ECG signals or digital QRS trigger signals for synchronizing an external device. The device supports a touch screen interface as well as a keyboard / mouse interface and a wired remote control unit. The device will store a complete record of diagnostic quality test data from which the user can generate and review stress test reports. The device can function as standalone workstation or can connect via network to a database server allowing for remote review capabilities. The device can communicate with electronic record keeping systems to obtain work lists and patient data, and to provide test result reports.
5. Intended Use
The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.
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Image /page/5/Picture/1 description: The image shows a white heart shape inside of a blue square. The heart shape is centered within the square, and the blue square provides a contrasting background that makes the heart shape stand out. The heart is symmetrical and has a smooth, rounded appearance. The blue square is a solid color and has sharp, defined edges.
Traditional 510(k) Notification
The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.
The device is not intended to be used as a vital signs physiological monitor.
6. Technological characteristics
The XScribe and Q-Stress Stress Exercise Testing System employs the same functional scientific technology as its predicate device XScribe II (K022618). At a high level, both devices employ a Windows based tool to acquire, process, record, archive analyze and record electrocardiographic data during physiologic stress testing. Both devices connect to treadmills, NIBP monitors, and ergometers.
XScribe/ Q-Stress was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. XScribe/Q-Stress is substantially equivalent to X-Scribe II (Predicate K022618) with the following technological differences:
- Added Cardiopulmonary function ●
- Added third party interface options through USB and serial ports for ● NIBP and SPO2
- Updated operating system to Windows 7
- Added Quinton Burdick treadmill compatibility ●
- Updated front end acquisition device to support the Wireless ● Acquisition Module (WAM) (K142105)
- Increased front end sampling rate
- Added report customization option ●
- Added DICOM communication protocol ●
- Added audit trails ●
- Added ability to import orders from EMR system ●
- Updated hardware to conform with EU Restriction of Hazardous Substances Directive
- Added remote keypad control of some features ●
- Added demonstration mode for training of clinicians ●
- Added ability for clinician to document drugs used during protocols ●
- Added Q-Stress user interface to XScribe software ●
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Image /page/6/Picture/1 description: The image shows a white heart shape inside of a blue square. The heart is centered within the square, and the blue square provides a contrasting background that makes the heart shape stand out. The heart is simple and stylized, with smooth curves and a symmetrical design.
Traditional 510(k) Notification
A full comparison matrix of functionality is located in Section 12. Substantial Equivalence Discussion.
7. Determination of Substantial Equivalence – Non-clinical
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content fo Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices."
XScribe/Q-Stress was designed and tested for compliance with the applicable clauses of the following standards:
- ANSI/AAMI ES60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005 + C1:09 + A2:10)
- 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-● 2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
- IEC 60601-2-25 Medical electrical equipment part 2-25: Edition 2.0 ● 2011-10, particular requirements for the basic safety and essential performance of electrocardiographs. (Cardiovascular)
8. Determination of Substantial Equivalence – Clinical
The subject of this premarket notification did not require clinical data to support substantial equivalence.
9. Conclusion
The non-clinical data that supports the safety of this device as well as the hardware and software verification and validation that have been completed at the time of this submission demonstrate that XScribe/Q-Stress performs as intended. As a result of completed verification and validation activities to date, Mortara has determined the XScribe/Q- is substantially equivalent to the predicate device.