(14 days)
No
The description focuses on signal processing and classification software based on defined parameters, not on learning from data. The modification is a parameter change in existing software.
No.
The device is for diagnostic purposes, specifically for recording electrocardiograms, vector cardiograms, and measuring Microvolt T-Wave Alternans to predict the risk of cardiac events. It does not provide treatment.
Yes
The device is explicitly named "Model CH 2000 Cardiac Diagnostic System" and its intended use is to aid in the diagnosis and prediction of cardiac events such as ventricular tachyarrhythmia and sudden death by measuring Microvolt T-Wave Alternans.
No
The device description explicitly mentions hardware components like "seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors," a "leadwire set," and a "belt-worn patient module." While software is a key part of the system, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Model CH 2000 Cardiac Diagnostic System records electrocardiograms, vector cardiograms, and measures Microvolt T-Wave Alternans. These are measurements taken directly from the patient's body using electrodes and sensors attached to the skin.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples (blood, urine, tissue, etc.). The device is directly measuring electrical activity of the heart.
Therefore, the device falls under the category of a medical device used for physiological measurement and diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model CH 2000 Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.
The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Model CH2000 Cardiac Diagnostic System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The Model CH2000 Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.
The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.
*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.
Product codes
DPS, DQK
Device Description
The Model CH2000 Cardiac Diagnostic System is intended for the measurement and recording of T-Wave alternans. The modification which is the subject of this pre-market submission is the modification of a parameter in Alternans Report Classifier software which was cleared for marketing on November 17, 2001 (K013565). Classification software provides the clinician with an indication of positive, negative, or indeterminate result for the Alternans Trend Reports. The results remain subject to the final review of a qualified medical practitioner. Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.
The Model CH2000 Cardiac Diagnostic System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing. The Alternans Report Classifier provides input to the physician on interpreting the Alternans trend reports.
The alternans test using the Analytic Spectral Method of Alternans Processing is performed with seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors. The electrodes and sensors are attached through a leadwire set to the belt-worn patient module, which provides digitized data to the CH2000.
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
qualified physician, standard stress labs
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)
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).
0
JUL 1 6 2002
510(k) Summary
June 30. 2002
Submitter: Cambridge Heart, Inc 1 Oak Park Drive Bedford, Ma 01730 (781) 271-1200 (781) 275-8431 (Fax)
Contact: David Chazanovitz
510(k) Numbers and Product Codes of equivalent devices.
Cambridge Heart Model CH 2000 Cardiac Diagnostic System 510K Number; #K013565 Product Code: 74 DPS CFR Section: 870.2340
Indications for Use and Intended Population
The Model CH 2000 Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.
The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Model CH2000 Cardiac Diagnostic System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The Model CH2000 Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.
The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.
*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.
Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 1
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K022149
page 2 of 4
Device Description
The Model CH2000 Cardiac Diagnostic System is intended for the measurement and recording of T-Wave alternans. The modification which is the subject of this pre-market submission is the modification of a parameter in Alternans Report Classifier software which was cleared for marketing on November 17, 2001 (K013565). Classification software provides the clinician with an indication of positive, negative, or indeterminate result for the Alternans Trend Reports. The results remain subject to the final review of a qualified medical practitioner. Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.
The Model CH2000 Cardiac Diagnostic System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing. The Alternans Report Classifier provides input to the physician on interpreting the Alternans trend reports.
The alternans test using the Analytic Spectral Method of Alternans Processing is performed with seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors. The electrodes and sensors are attached through a leadwire set to the belt-worn patient module, which provides digitized data to the CH2000.
Standard Hardware Components
| System Cart: | Mounts computer, display, keyboard, and output devices. |
|---|---|
| Computer and Keyboard: | IBM compatible, including hard disk floppy disk and interface cards. |
| Display: | 15 inch color monitor on swivel tilt bracket. |
| ECG amplifier: | The ECG amplifier is embodied in the PM-3(PM2 optional) patient module. |
| Printer: | Windows © compatible printers, strip chart recorder. |
| Serial Treadmill Interface: | Standard RS-232 interface allows computer control of speed and incline. (requires optional RS-232 interface cable) |
| Serial Bicycle Interface: | Analog interface allows computer control of resistance and measurement of RPM for Lode Corival ergometer. (requires optional analog cable) |
| Software: | System and diagnostic software is provided on floppy disk. |
Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 2
2
K022149
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Shipping Container: Cart, computer and display are shipped in a single container.
Standard Hardware Accessories
Set of 10 or 14 lead wires which meet the Patient Cable: 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 standard with every system. Service manual supplied upon request. Physician Guide to T-wave Alternans processing supplied with T-wave Alternans option. Training manual supplied in conjunction with training course.
- Patient Electrodes: Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with the Model CH2000 Cardiac Diagnostic System.
Measurement of alternating beat to beat T-wave amplitude (alternans) requires the use of the Cambridge Heart Micro-V Alternans Sensor (Ref: #K002230) in conjunction with other patient electrodes designed and approved specifically for use during exercise stress testing.
Performance Standards
The Cambridge Heart Model CH2000 Cardiac Diagnostic System meets the following Performance Standards:
- ANSI/AAMI EC11-1991
- EN60601-1: 1988, "Medical Electrical Equipment, Part 1: General . Requirements for Safety" including Amendments A1 and A2
- EN60601-1-1: 1993, "Medical Electrical Equipment, Part 1: General . Requirements for Safety - Section 1.1 Collateral standard: Safety requirements for medical electrical systems"
- EN60601-1-2: 1993, "Medical Electrical Equipment, Part 2: Collateral .
Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 3
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K022149
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Standard: Electromagnetic Compatibility - Requirements and Tests"
- UL2601-1, "Medical Electrical Equipment, Part 1: General Requirements for . Safety" 2nd Edition, including Amendments A1 and A2
- CAN/CSA C22.2 No. 601.1-M90, "Medical Electrical Equipment, Part 1: . General Requirements for Safety" including C22.2 No. 601.1S1-94 (IEC 601-1. Amendment 1:1991)
Similarities and Differences to Predicates
The Model CH2000 Cardiac Diagnostic System (new) is the same device as in K013565 with the exception of the modification described in this pre-market submission. The Model CH 2000 Cardiac Diagnostic System uses the same Analytic Spectral Method as the predicate CH2000 for measuring T-Wave Alternans.
Conclusion
There are more similarities than differences between the predicate device and the Cambridge Heart Model CH2000 Cardiac Diagnostic System. Both devices use the Analytic Spectral Method. When used by qualified personnel in accordance with the directions for use, the Model CH2000 Cardiac Diagnostic System with Alternans Report Classifier is safe and effective, as indicated, for its intended use.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850
JUL 1 6 2002
Cambridge Heart, Inc. c/o Mr. John D. Greenbaum Consultant Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332
Re: K022149
Trade Name: Model CH2000 Cardiac Diagnostic System Regulation Number: 21 CFR 870.2340 and 870.1425 Regulation Name: Electrocardiograph and Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DPS and DQK Dated: June 30, 2002 Received: July 2, 2002
Dear Mr. Greenbaum:
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.
5
Page 2 - Mr. John D. Greenbaum
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 (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.
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 your 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,
N. O'Keeffe
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number(if known):______________________________________________________________________________________________________________________________________________________
Device Name: Model CH2000 Cardiac Diagnostic System
Indications For Use:
The Model CH 2000 Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.
The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Model CH2000 Cardiac Diagnostic System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The Model CH2000 Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.
The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.
*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use_X_
| (Per 21 CRF 801.109) | Over-The-Counter Use____ |
|---|---|
| --------------------------------------------- | -------------------------- |
(Division Sign-Off) (Optional Format 1-2-96)
Division of Cardiovascular
and Respiratory Devices
| 510(k) Number | K022149 |
|---|---|
| --------------- | --------- |
000009