(26 days)
No
The document describes a system for measuring Microvolt T-wave Alternans using an "Analytic Spectral Method" and a "Report Classifier". While the classifier provides an "indication of positive, negative, or indeterminate", there is no mention of AI, ML, or any learning-based approach. The methods described appear to be based on signal processing and predefined criteria rather than learned patterns.
No.
The device is a diagnostic tool intended for recording electrocardiograms, vector cardiograms, and measuring Microvolt T-Wave Alternans to predict the risk of cardiac events. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is for "the recording of electrocardiograms, vector cardiograms, and measurement of Microvolt T-Wave Alternans" and that the presence of Microvolt T-wave Alternans "predicts increased risk of a cardiac event," directly indicating its role in diagnosis and risk assessment.
No
The device description explicitly mentions hardware components like "high-resolution multi-segment sensors," "electrodes," "seven proprietary sensors," and a "belt-worn patient module" that provides digitized data to the system. While software is a key component ("Alternans Report Classifier software"), the system relies on these physical components for data acquisition.
Based on the provided text, the Model CH 2000 Cardiac Diagnostic System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The description of the Model CH 2000 clearly states it records electrocardiograms and vector cardiograms, and measures Microvolt T-Wave Alternans using electrodes and sensors placed on the patient's body. It's a non-invasive diagnostic tool that analyzes electrical signals from the heart.
- The intended use and device description focus on analyzing physiological signals directly from the patient. There is no mention of collecting or analyzing biological samples.
Therefore, the Model CH 2000 Cardiac Diagnostic System falls under the category of a medical device that performs physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Model CH 2000 Cardiac Diagnostic System is intended for the The Modor 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 measured from high roosadiacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the 1.5 millerovolis - and - Signal - Signal - Signal - Standard deviations greater background noise lovel, (a) is all (e) has an onset heart rate at or below than the buongrounde, and (f) is sustained for all heart rates above the onset heart rate.
Product codes (comma separated list FDA assigned to the subject device)
DPS, DQK
Device Description
The Model CH2000 Cardiac Diagnostic System is intended for the measurement The Model Of I2000 Ourdial Diagnoction of over in the subject of this and rooverally of the inclusion of the Alternans Report Classifier pre manter submission is the or marketing on October 11, 2001 (K012206). SUltware which was olourou for manages the clinician with an indication of positive, Olassinoution soltware promate for the Alternans Trend Reports. The results negative, of indotominate review of a qualified medical practitioner. Microvolt Twave 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 The Model Of ILOGO Caralde Blagf stress labs. The Analytic Spectral Method of diagnostic capabilities to clain the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and Microvon' I wave allemans 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 The allorhand tool as a long the relectrodes and seven proprietary portumou with 65%-V Alternans™ Sensors. The electrodes and sensors are maill sogmont Misro · Ailematter 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
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.
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
NOV 21 2001
510(k) Summary
October, 22, 2001
KU13565
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 Heartwave™ Alternans Processing System
510K Number; #K010758 Product Code: 74 DPS CFR Section: 870.2340
Cambridge Heart Model CH 2000 Cardiac Diagnostic System
510K Number; #K010756 Product Code: 74 DPS CFR Section: 870.2340
Cambridge Heart Alternans Processing System
510K Number; #K012206 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 The Modor 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
1
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 measured from high roosadiacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the 1.5 millerovolis - and - Signal - Signal - Signal - Standard deviations greater background noise lovel, (a) is all (e) has an onset heart rate at or below than the buongrounde, and (f) is sustained for all heart rates above the onset heart rate.
Device Description
The Model CH2000 Cardiac Diagnostic System is intended for the measurement The Model Of I2000 Ourdial Diagnoction of over in the subject of this and rooverally of the inclusion of the Alternans Report Classifier pre manter submission is the or marketing on October 11, 2001 (K012206). SUltware which was olourou for manages the clinician with an indication of positive, Olassinoution soltware promate for the Alternans Trend Reports. The results negative, of indotominate review of a qualified medical practitioner. Microvolt Twave 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 The Model Of ILOGO Caralde Blagf stress labs. The Analytic Spectral Method of diagnostic capabilities to clain the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and Microvon' I wave allemans 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 The allorhand tool as a long the relectrodes and seven proprietary portumou with 65%-V Alternans™ Sensors. The electrodes and sensors are maill sogmont Misro · Ailematter the belt-worn patient module, which provides digitized data to the CH2000.
2
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. |
| Shipping Container: | Cart, computer and display are shipped in a single container. |
| Standard Hardware Accessories | |
| Patient Cable: | Set of 10 or 14 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 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. |
3
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 . 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 K010756 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 Heartwave™ for measuring T-Wave Alternans, but also includes standard exercise stress test capability. The Alternans Report Classifier to be used with the CH2000 was cleared for marketing on October 11, 2001 (K012206).
Conclusion
There are more similarities than differences between the predicate devices and the Cambridge Heart Model CH2000 Cardiac Diagnostic System. All predicate devices use the Analytic Spectral Method. When used by qualified personnel in accordance
4
with the directions for use, the Model CH2000 Cardiac Diagnostic System with with the directions for aco, the model offective, as indicated, for its intended use.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2001
Cambridge Heart, Inc. c/o Mr. John D. Greenbaum Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332
Re: K013565
Trade Name: Cambridge Heart 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: October 22, 2001 Received: October 26, 2001
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.
6
Page 2 - Mr. John D. Greenbaum
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dri 3 issuaires over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I odetar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 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) This letter will anow you've ought and ing of substantial equivalence of your device to a legally prematics notification. The stars 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 11 you desire operies arra 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 31 - 50 - 4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-661 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 Oiner general intermation turers, 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
NOV 21 2001
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 The Model CTT2000 Ourdiao Blagnooths and measurement
recording of electrocardiograms, vector cardiograms, vector construction recording or clecurelogians, at rest and during ECG stress testing.
The presence of Microvolt T-wave Alternans as measured by the The prosence of Microver of the Model CH2000 Cardiac Diagnostic Andlytic Opentral mothou of suspected or at risk of ventricular System in patients with known, sed risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The Model CH2000 Cardiac Diagnostic System should be used only as The Model Orizooo Ourdiate Blaghoeins of other non-invasive and/or an adjuriot to oliniour more of the Alternans Processing System should be reviewed by a qualified physician.
The predictive value of T-wave Alternans for cardiac events has not The prodiolished 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 (a) is measured from high roomwonent precordial leads, (c) is proboth wel of 1.9 microvolts after signal optimization and at the lover 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 (1) is has an onest no 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_
(Optional Format 1-2-96) |
| --------------------------------------------- | --------------------------------------------------- |
|---|
OR
Division of Cardiovascular & Respiratory Devices