CAMBRIDGE HEART OEM

K100362 · Cambridge Heart, Inc. · DQK · Apr 14, 2010 · Cardiovascular

Device Facts

• Record ID: K100362
• Device Name: CAMBRIDGE HEART OEM
• Applicant: Cambridge Heart, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Cambridge Heart MTWA OEM Module 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 MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The MTWA OEM Module 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 MTWA OEM Module 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.

Device Story

MTWA OEM Module records ECGs and vector cardiograms; measures Microvolt T-Wave Alternans (MTWA) at rest and during stress testing (treadmill, ergometer, pharmacologic). System uses seven standard electrodes and seven proprietary multi-segment Micro-V Alternans sensors; data digitized by belt-worn patient module; processed by PC-based software. Analytic Spectral Method identifies beat-to-beat T-wave amplitude variations. Used in clinical stress labs by qualified personnel; output reviewed by physician to assess cardiac event risk. Serves as adjunct to clinical history and other diagnostic tests. Enables integration of MTWA diagnostic capabilities into compatible third-party electrocardiograph systems.

Clinical Evidence

Bench testing only. Validation conducted by integrating the OEM module into the Cardiac Science Q-Stress System. Parameters verified included data management, main application/processing screens, printing, system setup/configuration, MTWA algorithm, ECG processing, and overall system performance. No new clinical studies were required as the core technology and algorithm are identical to the predicate.

Technological Characteristics

PC-based software module; uses Analytic Spectral Method for signal processing. Compatible with standard stress test electrodes and proprietary multi-segment Micro-V Alternans sensors. Complies with AAMI/ANSI EC11, EC13, EC53, and IEC 60601-1/1-1/1-2/1-4/2-25 standards. Connectivity via leadwire set to belt-worn patient module (PM3).

Indications for Use

Indicated for patients with known, suspected, or at risk of ventricular tachyarrhythmia to predict risk of cardiac events (ventricular tachyarrhythmia or sudden death). Contraindicated in patients with active, untreated ischemia.

Regulatory Classification

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.

Predicate Devices

• HearTwave II Cardiac Diagnostic System (K050225)

Reference Devices

• Cardiac Science Q-Stress System (K082173)
• K983012
• K001034
• K003492
• K022149
• Cambridge Heart Hi-Res Electrode (K962115)
• Cambridge Heart Micro-V Alternans Sensor (K002230)

Submission Summary (Full Text)

{0}------------------------------------------------

#### Attachment I - Revised 510k Summary MTWA OEM Module

# APR 1 4 2010

#### 5. 510K Summary

#### Submitter: Cambridge Heart, Inc 100 Ames Pond Tewksbury MA. [phone] [phone]

Contact: Ali Haqhighi-Mood

#### 510(k) Numbers and Product Codes of equivalent devices:

Cambridge Heart, Inc .; HearTwave II Cardiac Diagnostic System 510(k) Number: # K050225 Product Code: 74 DPS CFR Section: 870.2340

#### Indications for Use and Intended Population

The MTWA QEM Module 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 MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The MTWA OEM Module 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 MTWA OEM Module 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.

## Device Description

{1}------------------------------------------------

The MTWA OEM Module consist of a patient module and an analysis software operating on a PC platform meeting the technical requirement specified in Product Requirement Document (PRD) for the module. The MTWA OEM Module is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The alternans levels reported in K983012, K001034, K003492 and K022149, K050225 were measured using the Analytic Spectral Method. This method 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 Cambridge Heart MTWA OEM Module provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the Cambridge Heart MTWEA OEM Module is intended for the measurement of microvolt T-Wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing.

The Alternans test using the Cambridge Heart MTWA OEM Module 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 MTWA OEM Module.

#### Patient Electrodes:

Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with the Cambridge Heart MTWA OEM Module.

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 Cambridge Heart MTWA OEM Module is designed to work with FDA cleared computerized electrocardiographic devices that meet the following or equivalent voluntary Performance Standards:

- AAMI/ANSI EC11 1991(R)2007 "Diagnostic electrocardiographic . devices" (Cardiovascular)
- . AAMI/ANSI EC 13 - 2002/(R)2007 -- "Cardiac monitors, heartrate meters, and alarms (Cardiovascular)"

{2}------------------------------------------------

- . AAMI EC53 - 2001 - "ECG Cables and Leadwires"
- . IEC 60601-1: , "Medical Electrical Equipment, Part 1: General Requirements for Safety, 1998; Amendment 2. 1995. (general)"
- IEC60601-1-1: 2000, "Medical Electrical Equipment, Part 1: General . Requirements for Safety - Collateral standard: Safety requirements for medical electrical systems"
- IEC60601-1-2: 2001, "Medical Electrical Equipment, Part 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests"
- · IEC60601-1-4: edition 1.1 2000, "Medical Electrical Equipment Part 1-4: General Requirement for Safety - Collateral Standard, Programmable Electrical Medical Systems"
- . IEC 60601-2-25: 1999, ""Medical Electrical Equipment, Part 2: Particular requirements for the safety of electrocardiographs (Cardiovascular"
- . FDA Diagnostic ECG Guidance: 1998, Version 1.0
- FDA Electrocardiograph Lead Switching Adaptor Guidance: 1997, . Version 1.0
- . FDA Guidance For Industry: 2000 * General Principles of Software Validation"
- FDA Guidance For Industry: 1999 " Guidance for Off-The -Shelf � Software for use in Medical Devices"
- . ISO 14971: 2007 " Application of risk management to medical devices"

#### Similarities and Differences to Predicates

The MTWA OEM Module (new) is essentially the same device as in K050225 with the exception of the modification described in this pre-market submission. which essentially allows a user to apply the module as a "plug in" to a compatible electrocardiograph or similar device. The MTWA QEM Module uses the same patient interface, the same data acquisition module (PM3), and the same application software and analysis method (Analytic Spectral Method)as the HearTwave II Cardiac Diagnostic System (K050225) for measuring T-Wave Alternans. The MTWA OEM Module and the predicate device have the same indications for use and utilize the same software to process analytical results.

The Cambridge Heart MTWA OEM Module was validated for specific use with the Cardiac Science Q-Stress System (K082173). Both design and process validations were conducted using the OEM Module incorporated into the Qstress system. Validation parameters verified that all compatibility requirements are met and that the performance of the Cambridge Heart TWA OEM module is identical to its predicate device, HearTwave II Cardiac Diagnostic System (K050025), Validations and compatibility testing of the OEM Module included. but were not limited to: Data Management, Main Application and Processing

{3}------------------------------------------------

Screens, Printing, System Setup,& Configuration, MTWA Algorithm, ECG Processing and Overall System Performance.

#### Conclusion

There are more similarities than differences between the predicate device and the Cambridge Heart MTWA OEM Module. Both devices use the same patient interface the Analytic Spectral Method of Alternans Processing. When used in accordance with the directions for use, by qualified personnel, the Cambridge Heart MTWA OEM Module is safe and effective, as indicated, for its intended use.

{4}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with its wings spread and head turned to the right. The eagle is depicted in a stylized manner, with flowing lines suggesting feathers.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 1 4 2010

Cambridge Heart, Inc. c/o Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Ft. Lauderdale, FL 33332

Re: K100362

Device Name: MWTA OEM Module Regulation Number: 21 CFR 870.2340 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DQK Dated: March 12, 2010 Received: March 17, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Page 1 of 1

510(k) Number(if known):_Kloo36Z

Device Name: MTWA OEM Module

Indications For Use:

The Cambridge Heart MTWA OEM Module is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvott T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Atternans as measured by the Analytic Spectral Method of the MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The MTWA OEM Module 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 MTWA OEM Module 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 highresolution 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 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 Sign-Off)
Division of Cardiovascular Devices

510(k) Number K100362

Proprietary and Confidential Information