(30 days)
K900720, K 001492
No
The summary describes standard ECG data acquisition, processing, and reporting. There is no mention of AI, ML, or any advanced analytical techniques beyond typical signal processing for ECG data. The decision-making is explicitly stated to be made by trained medical personnel.
No
Explanation: The device is described as a "diagnostic tool" intended to acquire, process, and store ECG data to "assist in the diagnosis" of patient conditions, and it is explicitly stated that it is "not intended to be the sole basis of diagnosis." It processes data to assist in diagnosis, which is distinct from providing therapy directly.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "PC based diagnostic tool" and that the data it provides is "reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis." It also notes that the device "captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician."
No
The device description explicitly states that the device consists of hardware components including a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector, in addition to the software application.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing." It also mentions that the data is "reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing." While it's not the sole basis of diagnosis, it provides data used in the diagnostic process.
- Nature of the Data: The device processes and analyzes physiological data (ECG, heart rate, ST data) obtained from the patient. This type of data, when used to assist in diagnosis, falls under the scope of IVDs.
- Clinical Setting and User: The device is intended for use in a clinical setting by trained medical personnel, which is typical for diagnostic devices.
While the device doesn't analyze samples in vitro in the traditional sense (like blood or tissue), the regulatory definition of an IVD can encompass devices that analyze physiological data from the body to provide information for diagnostic purposes. The key is that the device provides information used in the diagnostic process.
Therefore, based on the intended use and the nature of the data processed for diagnostic assistance, this device fits the description of an IVD.
N/A
Intended Use / Indications for Use
The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.
The device captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of adult patients with various rhythm patterns.
The device is not intended to be the sole basis of diagnosis.
The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.
The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic tool consisting of an ECG analysis software application running on a commercial PC using Windows operating system. Electrocardiographic data is obtained by means of a compatible device, such as the Mortara X-12 (K974149) or the Mortara direct connect patient cable, and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The device consists of a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector. The device may interface with external devices, including a treadmill or erqometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment.
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 populations
Intended User / Care Setting
Clinical setting by a physician, or trained personnel who are acting on the orders 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)
Not Found
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.
K900720, K 001492
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
§ 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).
0
510(k) Summary
6 2002 SEP
Submitter:
| Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs | |
|---|---|
| Mortara Instrument, Inc. | |
| 7865 N. 86th Street | |
| Milwaukee, WI 53224 | |
| Fax: | (414) 354-4760 |
| Phone: | (414) 354-1600 |
| Contact: | Harlan Van Matre (see above) |
| Trade Name: | X-Scribe II |
| Common Name: | Stress Exercise Testing System |
| Classification Name: | Programmable Diagnostic Computer (Class II Per 21 CFR § 870.1425) |
| Electrocardiograph (Class II Per 21 CFR § 870.2340) | |
| Legally marketed devices to which S.E. is claimed | |
| Mortara X-Scribe Stress Exercise System - 510(k) K900720 | |
| Quinton Q-Stress – 510(k) K 001492 |
Description:
The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic tool consisting of an ECG analysis software application running on a commercial PC using Windows operating system. Electrocardiographic data is obtained by means of a compatible device, such as the Mortara X-12 (K974149) or the Mortara direct connect patient cable, and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The device consists of a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector. The device may interface with external devices, including a treadmill or erqometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment.
Intended use:
The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.
Indications for use:
The device captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of adult patients with various rhythm patterns.
The device is not intended to be the sole basis of diagnosis.
The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.
The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002
Mortara Instrument, Inc. c/o Mr. Harlan L. Van Matre Manager of Ouality Assurance and Regulatory Affairs 7865 North 86th Street Milwaukee, WI 53224-3431
Re: K022618
Trade Name: Mortara X-Scribe II Stress Exercise Testing System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: May 3, 2002 Received: August 7, 2002
Dear Mr. Van Matre:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Harlan L. Van Matre
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Device Name:
Mortara X-Scribe II Stress Exercise Testing System
The X-Scribe II is a PC based diagnostic tool intended to acquire, process, record. analyze, archive and output electrocardiographic data obtained during physiologic stress testing.
Intended use:
The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.
Indications for use:
- The device is indicated for use to acquire, process, record, archive, analyze, and . output electrocardiographic data obtained during physiologic stress exercise testing.
- . The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The device is indicated for use on adult populations, typically symptomatic.
- The device is not intended to be used as a vital signs physiological monitor. ●
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K022618 |
| Prescription Use
| (Per 21CFR801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ---------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)