ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM

K050858 · Heartlab, Inc. · DPS · Jun 29, 2005 · Cardiovascular

Device Facts

• Record ID: K050858
• Device Name: ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
• Applicant: Heartlab, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

Device Story

HeartStation™ is a centralized ECG management system for healthcare enterprises. It ingests standard 12-lead ECG data from various third-party cardiographs and patient monitors; normalizes data to a common format; performs automated measurements and interpretations using the Glasgow Interpretive ECG Program; and enables serial comparison with historical records. The system provides a web-based GUI for physicians to review, edit, and electronically sign diagnostic reports. Final reports are distributed via print, fax, email, or export to EMRs. Used in clinical settings, including remote access via web-enabled PCs. Benefits include workflow automation, centralized cardiology record integration, and improved diagnostic efficiency for clinicians.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design control activities, risk analysis, module verification, system integration testing, and final validation testing.

Technological Characteristics

System utilizes off-the-shelf PC hardware running Windows 2000/XP. Connectivity via network/web-enabled interface. Software includes the Glasgow Interpretive ECG Program and Datamed Format Translator. Complies with U.L. 544 and 1950, 21 CFR 1020.10, 21 CFR 1040.10, SMPTE, and ACR/NEMA standards.

Indications for Use

Indicated for use by clinicians for the management, processing, storage, and display of 12-lead ECG data for adult and pediatric patients with heart disease within a healthcare enterprise.

Regulatory Classification

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.

Predicate Devices

• Infinity MegaCare (K031970)
• Eclipse ECG (K946281)
• Tracemaster ECG Management System (K032103)
• Pyramis ECG Management System (K032038)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in a large, bold, sans-serif font, with the letters in white against a black background. Below "Heartlab" is the phrase "CARDIAC SOLUTIONS" in a smaller, sans-serif font, also in white against a black background. The logo is simple and modern, with a focus on clarity and readability.

JUN 2 9 2005

#### Abbreviated 510(K) Summary

This is a summary of 510(k) safety and effectiveness information, submitted in accordance with the SMDA 1990 and 21 CFR 807.92.

March 31, 2005 DATE:

#### SUBMITTER:

Heartlab Inc. One Crosswind Road Westerly, RI 02891 Phone: [phone] Fax: [phone]

#### OFFICIAL CONTACT PERSON:

Richard Petrocelli, President Tel No: [phone]

## 510(k) SUBMITTAL CONTACT PERSON:

Lori Kahler, Director of Quality & Regulatory Affairs Tel No: [phone]

#### IDENTIFICATION OF THE PRODUCT

| TRADE NAME: | Ascentia HeartStation™ ECG Management System |
|----------------------|-----------------------------------------------------------|
| COMMON NAME: | Ascentia HeartStation™ |
| CLASSIFICATION NAME: | System, ECG Analysis<br>Product Code LOS, 21 CFR 870.2340 |

Computer, Diagnostic, Programmable Product Code DQK, 21 CFR 870.1425

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Image /page/1/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, bold, white letters on a black background. Below that, "CARDIAC SOLUTIONS" is in smaller, white letters on a black background.

## DEVICE DESCRIPTION / INTENDED USE:

The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports

Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.

A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.

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Image /page/2/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, white, bold letters against a black background. Below "Heartlab" are the words "CARDIAC SOLUTIONS" in smaller, white, bold letters against a black background.

## SUBSTANTIAL EQUIVALENCE INFORMATION:

Ascentia HeartStation™ is considered comparable and substantially equivalent to the following predicate devices currently in commercial distribution:

| Model | Manufacturer |
|---------------------------------------------|----------------|
| Infinity MegaCare (k031970) | Dräger-Siemens |
| Eclipse ECG (k946281) | Burdick |
| Tracemaster ECG Management System (k032103) | Philips |
| Pyramis ECG Management System (k032038) | Quinton |

## Predicate device specifications comparison:

| | Principal<br>Device –<br>Heartlab<br>Ascentia<br>HeartStationTM | Predicate<br>Device –<br>Dräger-<br>Siemens<br>Infinity<br>MegaCare | Predicate<br>Device –<br>Burdick<br>Eclipse ECG | Predicate<br>Device –<br>Philips<br>Tracemaster<br>ECG Mgmt.<br>System | Predicate<br>Device –<br>Quinton<br>Pyramis ECG<br>Mgmt.<br>System |
|----------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Product<br>description | ECG<br>information<br>management | ECG<br>information<br>management | ECG cart with<br>software | ECG<br>information<br>management | ECG<br>information<br>management |
| User Interface | Off-the-shelf<br>Personal<br>Computer | Off-the-shelf<br>Personal<br>Computer | NA | Compaq<br>Proliant ML<br>370 G3 server | Off-the-shelf<br>Personal<br>Computer |
| Operating<br>System | Windows<br>2000/XP | Windows 2000 | NA | Windows<br>Server 2003 | Windows 2000 |
| Record export<br>interface | TIFF, XML,<br>PDF or HL-7 | HL-7 | NA | TIFF, XML,<br>HL-7 | HL-7 |
| Display | 17" (19"<br>recommended)<br>SVGA display,<br>1280 x 1024<br>min. resolution | Minimum<br>resolution<br>1280 x 1024 | NA | 17" SVGA | Not specified |
| Web software | Microsoft<br>Internet<br>Explorer 6.0 | Microsoft<br>Internet<br>Explorer 6.0 | NA | Microsoft<br>Internet<br>Explorer 6.0 | NA |
| Measurement<br>model | Glasgow<br>Interpretive<br>ECG Program | Glasgow<br>Interpretive<br>ECG Program | Glasgow<br>Interpretive<br>ECG Program | Philips 12-lead<br>algorithm | NA |
| Format<br>translator | Datamed<br>Format<br>Translator<br>(Engineering<br>Solutions,<br>Inc.) | Datamed<br>Format<br>Translator<br>(Engineering<br>Solutions,<br>Inc.) | NA | Datamed<br>Format<br>Translator<br>(Engineering<br>Solutions,<br>Inc.) | Datamed<br>Format<br>Translator<br>(Engineering<br>Solutions,<br>Inc.) |

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Image /page/3/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, white, bold letters on a black background. Below that, "CARDIAC SOLUTIONS" is in smaller, white letters on a black background.

The similar predicate systems above provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease.

The differences in the hardware platforms and off the shelf software used to operate the proposed device are considered to be improvements in the "state of the art" as compared to the predicate devices, and offer no affect to the safety or efficacy of the product.

## STANDARDS:

Ascentia HeartStation™ is designed in accordance with product safety and performance requirements set forth in the following standards:

- 1. 21 CFR 1020.10 Video Monitor Performance Requirements
- 2. 21 CFR 1040.10 Fiberoptic Communications Performance
- 3. Society of Motion Picture and Television Engineers (SMPTE)
- 4. ACR/NEMA Data Compression Standard
- 5. Underwriters Laboratories (U.L.) Standard No. 544 for Medical and Dental Equipment
- 6. Underwriters Laboratories (U.L.) Standard No. 1950 Safety Standards

### SUMMARY OF DESIGN CONTROL ACTIVITIES:

The software utilized was designed, developed, tested according to written Design Control procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance. Potential hazards have been studied and controlled by a Risk Management Plan.

The following quality assurance design control measures were applied to the development of the Ascentia HeartStation™ product:

- 1. Risk Analysis
- 2. Requirement Reviews
- 3. Design Reviews
- 4. Testing on unit level (Module verification)
- 5. Integration testing (System verification)
- 6. Final acceptance testing (Validation)
- 7. Performance testing

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular pattern.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2005

Heartlab Inc. c/o Ms. Lori Kahler Director of Quality & Regulatory Affairs One Crosswind Road Westerly, RI 02891

Re: K050858

Trade Name: Ascentia HeartStation™ ECG Management System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 13, 2005 Received: June 14, 2005

Dear Ms. Kahler:

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 - Ms. Lori Kahler

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), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bzimtuma for

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

Enclosure

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# Indications for Use

510(k) Number (if known): K050858

Device Name: Heartlab Ascentia HeartStation™ ECG Management System

#### Indications For Use:

The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

| Prescription Use | |
|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF |
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| NEEDED) |

| Richard Petrocelli, President | Date: 6/22/05 |
|---------------------------------|---------------|
| All State Address of the States | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Mamma

Divison Sign-Off) Division of Cardlovascular Devices , 10(k) Number

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