(221 days)
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No
The description focuses on standard ECG analysis techniques and hardware features, with no mention of AI or ML.
No
The device is described as a "Cardiac Diagnostic System" intended for measurement, recording, and computation of cardiac data. Its purpose is to predict the risk of a cardiac event, not to treat it. The "Intended Use" explicitly states it should be used only as an "adjunct to clinical history and the results of other non-invasive and/or invasive tests," highlighting its diagnostic rather than therapeutic role.
Yes
The device is intended for the measurement of T-wave alternans, which predicts increased risk of a cardiac event, and records electrocardiograms and vector cardiograms. It's described as a "Cardiac Diagnostic System." All these functions are integral to diagnosing cardiac conditions and assessing risk.
No
The device description explicitly states it is a "computer-based ECG exercise tolerance test system" and lists several hardware components and functionalities beyond just software, such as a high-resolution printer/recorder, CRT display, and filters.
Based on the provided information, the CH 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CH 2000 Function: The CH 2000 measures T-wave alternans and records electrocardiograms and vector cardiograms. These are non-invasive measurements taken directly from the patient's body using electrodes on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as being used for "measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing." This aligns with a non-invasive diagnostic device, not an IVD.
Therefore, the CH 2000 falls under the category of a non-invasive diagnostic device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CH 2000 is intended for the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.
Product codes
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Device Description
The Cambridge Heart CH 2000 Cardiac Diagnostic System is a computer-based ECG exercise tolerance test system designed for use in hospitals, offices and clinical cardiology laboratories.
The CH 2000 incorporates the following features:
- Recording of electrocardiograms and vector cardiograms with high-resolution laser printer or thermal recorder output.
- Measurement of T-wave alternans.
- Controlling resting and exercise stages of treadmill and bicycle ergometer stress tests based on standard and user-customized protocols.
- Computation of ST-level and slope, plus supplemental measurements including ST-integral and ST-index.
- Diagnostic-quality color CRT display on a swivel-tilt mounting.
- Baseline and artifact filters to remove artifact without ST-segment distortion.
- Detection of pacemaker functioning and visible pacemaker spikes displayed on the ECG.
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
Not Found
Intended User / Care Setting
Used by a physician, or under the direction of the physician, in hospitals, offices and clinical cardiology laboratories.
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
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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)
Reference Device(s)
Not Found
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
4/12/99
Appendix IV
Model GH 2000 Cardiac Diagnos of Safety and Effectiveness Infor Substantially Equivalent Determ
The following information as presented in the 510(k) Supplement to expand the Intended Use. Indications For Use and Promotional Claims for the Cambridge Heart CH 2000 Cardiac Diagnostic System. The CH 2000 (K950018) and Zymed Model 2010 Holter Scanner (Zymed, Inc.) (K955015) contain data supporting a Substantial Equivalence determination.
1. General
The Cambridge Heart CH 2000 with Alternans Option is a computer (PC) based diagnostic electrocardiograph (ECG) designed for the measurement of T-wave alternans and the recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. It is substantially equivalent to:
-
Cambridge Heart Model CH 2000 (Cambridge Heart, Inc. . Bedford, Mass), Premarket Notification K981697
In addition the alternans option is equivalent to: -
Zymed Model 2010 Holter Scanner ( Zymed, Inc.) Pre-market . Notification K955015
2. Indications for Use
The CH 2000 is intended for the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.
1
3. Device Description
The Cambridge Heart CH 2000 Cardiac Diagnostic System is a computer-based ECG exercise tolerance test system designed for use in hospitals, offices and clinical cardiology laboratories.
The CH 2000 incorporates the following features:
- Recording of electrocardiograms and vector cardiograms with high-. resolution laser printer or thermal recorder output.
- Measurement of T-wave alternans. .
- Controlling resting and exercise stages of treadmill and bicycle ergometer ● stress tests based on standard and user-customized protocols.
- . Computation of ST-level and slope, plus supplemental measurements including ST-integral and ST-index.
- Diagnostic-quality color CRT display on a swivel-tilt mounting.
- Baseline and artifact filters to remove artifact without ST-seqment distortion. ●
- Detection of pacemaker functioning and visible pacemaker spikes displayed . on the ECG.
| Exercise Equipment: | The CH 2000 has been designed and tested for use
with the Trackmaster TM-400 and TM-425 treadmills,
manufactured by Patex International, Inc. and the
Lode Corival 400 bicycle ergometer, distributed by the
Quinton Instrument Company and other treadmills
and bicycle ergometers cleared for use for exercise
stress testing. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display: | 15-inch color monitor on swivel/tilt bracket. |
| ECG Amplifier | The ECG Amplifier is embodied in the PM-2 (PM-1 optional) patient module. 12 leads/10 electrodes. Plugs into computer. |
| Printer: | Windows 95 compatible printers, Strip Chart Recorder. |
| Serial Treadmill Interface: | Standard RS-232 interface allows computer control of speed and incline. Works with Trackmaster TM-400 & TM-425 treadmills. (Requires optional RS-232 interface cable.) |
| Serial Bicycle Interface: | Standard RS-232 interface allows computer control of resistance and measurement of RPM for compatible serial ergometers. (Requires optional RS-232 interface cable). |
| Software: | System and diagnostic software is provided on floppy disk. |
| Shipping Containers: | Cart, Computer and Display are shipped in a single container. |
| Standard Hardware Accessories | |
| Patient Cable: | Set of 10 separately detachable lead wires which meet the requirements of 21CFR 898.12 and comply with IEC-601-1; 56.3c part 1.1, General Requirements for Safety
Individual patient leads are either not detachable, or user detachable with female socket connections such that no conductive surface is exposed when unconnected. |
| User Manuals: | Operators manual supplied with every system. Service manual supplied upon request. Physicians Guide to T-Wave Alternans Processing supplied with alternans option. T-Wave Alternans Reader Training Course manual supplied in conjunction with training course. |
| Optional Hardware Components | |
| Alternans Option: | Patient Module (PM-1), Tachometer Display Module (TM-1), Digital Signal Processor (DSP), High Resolution Electrode Patient Leads High |
| | |
| | High Resolution electrodes, alternans software, ergometer and interface cable are required for T-wave alternans measurement and are purchased in addition to the basic CH 2000. |
| Analog Interface Option: | Provides interface to the following devices: |
| | Quinton Q Series and 90 Series Treadmills. |
| | Marquette 1800 Series Analog Treadmills. |
| | Lode Corival Ergometer. |
| | The analog interface option also provides analog ECG and TTL R-Wave trigger outputs. Requires the use of optional interface cables for each application. |
| Serial interface cable: | RS-232 cable for connection to compatible bicycles and treadmills. |
| Serial bicycle: | Seca Cardiotest 100. |
| Optical disk: | 640 megabyte read/write optical disk |
- Patient Electrodes: Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with the CH 2000.
Measurement of alternating beat to beat T-wave amplitude (alternans) requires the use of the Cambridge Heart Hi-Res Electrode (Ref: # K962115) in conjunction with other patient electrodes designed and approved specifically for use during exercise stress testing.
Standard Hardware Components 4.
System Cart: Mounts computer, display, keyboard, and output devices. Dimensions assembled (approximate); 58 x 25.75 x 27 in.
Computer and Keyboard: IBM compatible, including hard disk, floppy disk and interface cards.
2
Resolution Electrodes (package of 7).
3
7. Software
The Cambridge Heart CH 2000 software is designed to :
- Input a standard 12 lead, or 12 lead + XYZ ECG lead configuration .
- Display ECG traces on a CRT monitor .
- Record ECG traces on a printer .
- Detect QRS complexes and compute heart rate .
- Compute ECG median beats .
- Detect fiducial points on the ECG median beats .
- Compute ST and T wave measures (alternans) .
- Execute standard exercise protocols with specified stages and stage . times.
Principles of Operation 8.
The CH 2000 is a computer-controlled system for performing cardiac stress and T-Wave alternans tests. ECG signals are acquired from a patient using 10-lead and 14-lead connections for standard stress and T-wave alternans
4
measurements respectively. Within a patient-attached module, signals are digitized with 22-bits resolution, allowing capture of signals over the full offset range according to ANSI/AAMI EC11. Digitized signals are coupled through an optical isolation barrier and sent serially through a cable to the computer. The patient-attached module is powered through a small transformer, assuring that leakage and withstand requirements per ANSI/AAMI and IEC standards are met.
The CH 2000 computer is a Pentium PC running a Windows™ operating system. Running the CH 2000 application software, it is used to process digitized ECG data, display standard stress-test measures, and print standardstress and T-wave alternans reports. The application software also controls exercise treadmills and ergometers via the computer serial ports.
The application software performs heart rate and ST-T computations, QRS detection and Median Beat calculations. Alternans measures are computed using the Spectral Method (reference Smith, JM et al. Circulation 1988; 77:110-21).
9. Similarities and Differences
A. Product Labeling
The comparison table for the Cambridge Heart CH 2000 and the Zymed 2010 was generated from the referenced pre-market notifications and product brochures supplied by the manufacturers for each of the devices. The comparison clearly illustrates that the systems are very similar regarding intended use, physical characteristics, target population, and safety characteristics.
B. Indications for Use/ Intended Use
The Cambridge Heart CH 2000 and the Zymed 2010 are intended for patients for whom the recording of electrocardiograms and vector cardiograms by a physician are indicated for the diagnostic and prognostic evaluation of patients with known, suspected or at risk of cardiovascular disease.
Both the CH 2000 alternans option and the Zymed 2010 are used to analyze recorded ECG data to aid in the diagnosis of risk of arrhythmia.
Copies of the labeling for the equivalent devices are provided at the end of this section.
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C. Physical Characteristics
All three devices have very similar physical and technical characteristics. No changes of physical characteristics have been made to the Cambridge Heart CH 2000 which are the subject of this submission.
D. Target Population
All three devices are used specifically for the evaluation of patients with known or suspected cardiovascular disease.
E. Safety Characteristics
All three devices meet the requirements of IEC 60601-1
10. Labeling and Description of Substantially Equivalent Devices
(Please refer to following pages)
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1. Comparison Table
| Cambridge Heart, Inc. | Cambridge Heart, Inc. | Zymed, Inc. | |
|---|---|---|---|
| CH 2000 | CH 2000 | Model 2010 | |
| (new) | K950018 | K955015 | |
| Device | |||
| Description | Computerized system to record and | ||
| measure electrocardiographic (ECG) | |||
| data at rest and during exercise | |||
| stress test. |
Computes measurements of ST
segment level and slope at rest and
during physiological stress.
Analyzes recorded ECG data to
measure T-wave alternans at rest
and during exercise for diagnosis of
risk of arrhythmia. | Computerized system to record and
measure electrocardiographic (ECG)
data at rest and during exercise
stress test.
Computes measurements of ST
segment level and slope at rest and
during physiological stress.
Analyzes recorded ECG data to
measure T-wave alternans at rest and
during exercise. | Computerized system to measure
and analyze recorded
electrocardiographic (ECG) data.
Computes ST segment level and
slope.
Analyzes recorded ECG data for
measuring ectopic rates and other
parameters for diagnosis of risk of
arrhythmia. |
| Intended Use | The CH 2000 is intended for the
measurement of T-wave alternans
and recording of electrocardiograms
and vector cardiograms at rest and
during ECG stress testing.
The presence of T-wave alternans in
patients with known, suspected or at
risk of ventricular tachyarrhythmia
predicts increased risk of a cardiac
event (ventricular tachyarrhythmia or
sudden death). The CH 2000 should
be used only as an adjunct to clinical
history and the results of other non-
invasive and/or invasive tests. | For the recording of
electrocardiograms and vector
cardiograms by a physician, or under
the direction of the physician, at rest
and during ECG stress testing.
The correlation of the alternans
results with a specific clinical
diagnosis or prognosis, when the
alternans are not visually apparent on
the standard ECG has not been
clinically established. | For the analysis of recorded
electrocardiogram data. Three
channels of recorded patient ECGs
are utilized by the sophisticated
arrhythmia analysis program to
detect abnormalities. |
| Safety | IEC 60601 | IEC 60601 | IEC 60601 |
| Analysis
Software | Multichannel QRS detection, ST-
segment analysis, morphology
analysis. T-wave alternans analysis | Multichannel QRS detection, ST-
segment analysis, morphology
analysis. T-wave alternans analysis | Multichannel QRS detection, ST-
segment analysis, morphology
analysis, arrhythmia analysis |