K Number
K013564
Device Name
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Date Cleared
2001-11-21

(26 days)

Product Code
Regulation Number
870.2340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Heartwave™ 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 Heartwave™ 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 Heartwave™ 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 modour. The first fight 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 than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.
Device Description
The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). 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. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death. The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and nharmacologic 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 Alternans Processor.
More Information

No
The document describes a "Classification software" which provides an indication of positive, negative, or indeterminate results. While classification is a common task for AI/ML, the description does not explicitly mention AI, ML, or any related technologies (like DNNs). The software was cleared in 2001 (K012206), which predates the widespread adoption of AI/ML in medical devices. The description focuses on signal processing and measurement techniques (Analytic Spectral Method) rather than learning algorithms.

No
The device is described as an "Alternans Processing System" used for measurement and diagnosis, specifically to predict risk, not to treat or alleviate a medical condition.

Yes

The device description explicitly states, "The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs." Additionally, its intended use is to predict increased risk of a cardiac event, which is a diagnostic purpose.

No

The device description explicitly mentions "seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors" and a "belt-worn patient module" which are hardware components.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Heartwave™ Alternans Processing System measures electrical signals from the heart through electrodes and sensors attached to the patient's skin. It does not analyze biological specimens.
  • The device description focuses on processing and analyzing ECG signals. It describes the use of electrodes and sensors to capture electrical activity and the software used to process this data.
  • The intended use is to measure Microvolt T-Wave Alternans directly from the patient. This is a physiological measurement, not an in vitro test.

Therefore, the Heartwave™ Alternans Processing System falls under the category of a medical device that performs a physiological measurement, rather than an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Heartwave™ 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 Heartwave™ 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 Heartwave™ 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 modour. The first fight 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 than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.

Product codes

74 DPS, DQK

Device Description

The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). 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. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and nharmacologic 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 Alternans Processor.

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)

K010758, K010756, K012206

Reference Device(s)

K002230

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

K013564

510(k) Summary

October, 22, 2001

Submitter: Cambridge Heart, Inc 1 Oak Park Drive Bedford, Ma 01730 (781) 271-1200 (781) 275-8431 (Fax)

NOV 21 2001

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 Heartwave™ 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 Heartwave™ 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 Heartwave™ Alternans Processing 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 modour. The first fight 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 than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.

Device Description

The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). 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. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and nharmacologic 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 Alternans Processor.

2

Standard Hardware Components

Alternans Processor:Configured for English language and U.S. lead designations
Power Supply:Modular medical-grade, in-line power supply with universal power input for Alternans Processor
PM-3 w/ Hi-Res™ Leads:With U.S. lead designations
Printer, w/ data cable:Inkjet Printer w/data cable & power cord
Line Cords:IEC 320 line cord with NEMA 5-15P hospital grade plug for Alternans Processor; printer line cord supplied with printer.
Documentation:Domestic Operator's Manual, Physicians Guide, and TWA Training Program
Shipping Containers:Mobile pole, Processor unit and Display are shipped in a single container.

Standard Hardware Accessories

| Patient Cable: | Set of 14 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 standard with every
system. 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 Heartwave™ Alternans
Processing 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. |

3

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: K013564

Trade Name: HeartWave™ Alternans Processing 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.

4

Page 2 - Mr. John D. Greenbaum

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act tires - 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 Of It rat 0017, accems (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 promated 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,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

NOV 21 2001

Page 1 of 1

510(k) Number(if known):______________________________________________________________________________________________________________________________________________________

Device Name: Heartwave™ Alternans Processing System

Indications For Use:

The Heartwave™ Alternans Processing System is intended for the The Hourthave - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " stress testing.

The presence of Microvolt T-wave Alternans as measured by the The prosented of Microrof the Heartwave™ Alternans Processing Amaryan in patients with known, suspected or at risk of ventricular Oystem in padonto will a increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The Heartwave™ Alternans Processing System should be used only as The Heartwave - Anomans in the results of other non-invasive and/or an adjariot to cliffic 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 (c) is modeleds 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) NumberK013564