(91 days)
The Alternans Processing System is intended for the 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 Alternans Processing 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 Alternans Processing 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.
The Cambridge Heart Alternans Processing System is intended for use with computerbased ECG systems which include the feature for the measurement and recording of T-Wave alternans at rest and during treadmill, ergometer, electrophysiological, and pharmacologic stress testing. The Alternans Processing System uses the Analytic Spectral Method which consists of several computational steps that combine to form a unique analytical process. The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death. The alternans levels reported in K983102 were measured using the Analytic Spectral Method.
The Alternans Processing System is embodied in software and can be incorporated into a device for the measurement of T-Wave alternans. The Cambridge Heart Alternans Processing System adds T-wave alternans diagnostic capabilities to standard stress test systems and ECG recording devices.
The Alternans Processing System is embodied in two legally marketed products, the Model CH2000 Cardiac Diaqnostic System (K983102) and the Heartwave Alternans Processing System (K001034). It is designed for use in conjunction with a host adapter/controller for ECG functions. The host may be any ECG recording or stress test system. In the case of the Model CH 2000 Cardiac Diagnostic System the host controller is an integral part of the device (K983102).
Attachment to the patient is through the Cambridge Heart patient module(s). Digitized signals from the patient module are used as inputs to the Alternans Processing System.
The Alternans test using the Alternans Processing System 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 beltworn Patient module, which provides digitized data to the Alternans Processor.
The Alternans Processing System uses interpretive Alternans Report Classifier software that provides an assessment of the alternans report data to assist the physician in diagnosis. The computerized assessment is printed at the bottom of the alternans report and indicates that the result is consistent with a Positive, Negative, or Indeterminate finding. This assessment should be considered preliminary and should be reviewed by a qualified physician. Alternans results should always be used as an adjunct to clinical history and the results of other non-invasive or invasive tests.
The provided text is a 510(k) summary for the Cambridge Heart Alternans Processing System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and technical description.
However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance sections of a 510(k) submission. The document emphasizes substantial equivalence to previously cleared devices (K983102 and K001034) that already utilize the Analytic Spectral Method for T-wave alternans measurement. Therefore, direct evidence of a new study with specific acceptance criteria is not presented here.
Based on the provided text, I can extract the following relevant information regarding performance and study details, though it does not fully address all points of your request for new acceptance criteria and a new study validation:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not specify new acceptance criteria or report performance against new criteria. Instead, it refers to the performance of the underlying Analytic Spectral Method, which was previously established and cleared.
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Definition of Microvolt T-wave Alternans (as per Indications for Use):(a) Measured from high-resolution multi-segment sensors.(b) Present in leads X, Y, Z, VM or two adjacent precordial leads.(c) At the level of 1.9 microvolts after signal optimization and subtraction of the background noise level.(d) At least three standard deviations greater than the background noise level.(e) Has an onset heart rate at or below 110 beats per minute.(f) Is sustained for all heart rates above the onset heart rate. | The Alternans Processing System uses the Analytic Spectral Method, which provides the Microvolt T-wave Alternans measurement. This method's output "has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death." The alternans levels reported in K983102 (a predicate device using the same method) were measured using the Analytic Spectral Method. |
| Performance Standards Met:- ANSI/AAMI EC11-1991- EN60601-1: 1988 (with A1, A2)- EN60601-1-1: 1993- EN60601-1-2: 1993- UL2601-1 (2000 Ed., with A1, A2)- CAN/CSA C22.2 No. 601.1-M90 (with C22.2 No. 601.1S1-94) | The Cambridge Heart HeartWave™ Alternans Processing System and the Cambridge Heart Model CH 2000 Cardiac Diagnostic System (which incorporate the Analytic Spectral Method) meet these listed performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a specific sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a new study. The submission relies on the established performance of the Analytic Spectral Method used in predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for a test set. The interpretive results are "preliminary and should be reviewed by a qualified physician," but this refers to the use of the device in practice, not its validation study.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not mentioned in the provided text. The device offers an "interpretive Alternans Report Classifier software that provides an assessment... to assist the physician in diagnosis," but there is no study comparing human reader performance with and without this assistance.
6. Standalone (Algorithm Only) Performance Study
The document implies standalone performance validation through its reference to the Analytic Spectral Method's established utility. It states, "The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death." This "shown to be useful" likely refers to prior studies that led to the clearance of predicate devices, implicitly validating the algorithm's standalone capability. However, no specific standalone study details (like metrics or dataset) are provided in this document.
7. Type of Ground Truth Used
For the underlying Analytic Spectral Method, the "usefulness" is cited in terms of predicting ventricular tachyarrhythmias and sudden cardiac death (outcomes data). However, for this specific 510(k) submission, the primary "ground truth" for showing equivalence seems to be alignment with the performance of previously cleared devices using the same Analytic Spectral Method. No new specific type of ground truth for a new validation study is mentioned.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for a training set. As this is a 510(k) relying on substantial equivalence of an existing method, new training details are not typically required if the underlying algorithm is unchanged.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how ground truth for a training set was established.
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012206
510(k) Summary
Submitter: Cambridge Heart, Inc 1 Oak Park Bedford, Ma 01730 (781) 271-1200 (781) 275-8431
Contact: David Chazanovitz
510(k) Numbers and Product Codes of equivalent devices.
Cambridge Heart, Inc.; Model CH 2000 Cardiac Diagnostic System
510(k) Number: #K983102
Product Code: 74 DPS
CFR Section: 870.2340
Spacelabs/Burdick, Inc.; Quest Exercise Stress system
510(k) Number: #K952417
Product Code: 74 DSI
CFR Section: 870.1025
Indications for Use and Intended Population
Indications for use
The Alternans Processing System is intended for the 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 Alternans Processing 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 Alternans Processing 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
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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.
Description of Device
The Cambridge Heart Alternans Processing System is intended for use with computerbased ECG systems which include the feature for the measurement and recording of T-Wave alternans at rest and during treadmill, ergometer, electrophysiological, and pharmacologic stress testing. The Alternans Processing System uses the Analytic Spectral Method which consists of several computational steps that combine to form a unique analytical process. The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death. The alternans levels reported in K983102 were measured using the Analytic Spectral Method.
The Alternans Processing System is embodied in software and can be incorporated into a device for the measurement of T-Wave alternans. The Cambridge Heart Alternans Processing System adds T-wave alternans diagnostic capabilities to standard stress test systems and ECG recording devices.
The Alternans Processing System is embodied in two legally marketed products, the Model CH2000 Cardiac Diaqnostic System (K983102) and the Heartwave Alternans Processing System (K001034). It is designed for use in conjunction with a host adapter/controller for ECG functions. The host may be any ECG recording or stress test system. In the case of the Model CH 2000 Cardiac Diagnostic System the host controller is an integral part of the device (K983102).
Attachment to the patient is through the Cambridge Heart patient module(s). Digitized signals from the patient module are used as inputs to the Alternans Processing System.
The Alternans test using the Alternans Processing System 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 beltworn Patient module, which provides digitized data to the Alternans Processor.
The Alternans Processing System uses interpretive Alternans Report Classifier software that provides an assessment of the alternans report data to assist the physician in diagnosis. The computerized assessment is printed at the bottom of the alternans report and indicates that the result is consistent with a Positive, Negative, or Indeterminate finding. This assessment should be considered preliminary and should be reviewed by a qualified physician. Alternans results should always be used as an adjunct to clinical history and the results of other non-invasive or invasive tests.
Patient Electrodes:
Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with Alternans Processing Systems.
Cambridge Heart Alternans Processing System 510(k) Premarket Submission 510(k) Summary page 2
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Measurement of alternating beat to beat T-wave amplitude (alternans) requires the use of the Cambridge Heart Hi-Res Electrode (Ref: # K962115) or 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 Analytic Spectral Method of Alternans Processing is incorporated into the Cambridge Heart HeartWave™ Alternans Processing System and the Cambridge Heart Model CH 2000 Cardiac Diagnostic System which meet 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 svstems"
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" 200 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)
Conclusion
There are more similarities than differences between the predicate device and the Alternans Processing System. The predicate devices use the Analytic Spectral Method of Alternans Processing and/or an interpretive algorithm for assessing ECG data. When used in accordance with the directions for use, by qualified personnel, the Alternans Processing System is safe and effective, as indicated, for its intended use.
Cambridge Heart Alternans Processing System 510(k) Premarket Submission 510(k) Summary page 3
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2001
Cambridge Heart, Inc. c/o Mr. John D. Greenbaum Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332
Re: K012206
Trade Name: Cambridge Heart Alternans Processing System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 6, 2001 Received: July 13, 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.
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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,
Deeth Till
James F. Dillard III
Director Division of Cardiovascular and Respiratory 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): K012206
Device Name: Alternans Processing System
Indications For Use:
The Alternans Processing System is intended for the 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 Alternans Processing 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 Alternans Processing 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-seqment 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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012206
§ 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).