AGFA HEARTLAB CARDIOVASCULAR

K050228 · Heartlab, Inc. · LLZ · Feb 18, 2005 · Radiology

Device Facts

• Record ID: K050228
• Device Name: AGFA HEARTLAB CARDIOVASCULAR
• Applicant: Heartlab, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Ascentia™ (formally Encompass™) is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Ascentia™ is software comprised of modular software programs that run on standard “off-the-shelf” personal computers and servers running the Windows 2000/2003/XP operating system. Ascentia™ is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Ascentia™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Device Story

Ascentia is a networked cardiovascular information management system (PACS) operating on standard Windows-based PCs and servers. It ingests DICOM-compliant image data from various OEM cardiovascular imaging equipment. The system consolidates these images into a central digital archive, allowing clinicians to view images, perform digital subtraction, generate graphical representations of coronary arteries, and conduct quantitative measurements on cath and ultrasound images. It includes reporting tools for entering clinical findings and generating patient reports. Used in clinical environments, the system supports scalable deployment from small departments to large hospital networks. By centralizing image access and providing integrated analysis and reporting tools, the device assists healthcare providers in cardiovascular diagnostic workflows and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Software-based PACS running on Windows 2000/2003/XP. Inputs: DICOM-compliant imaging data. Features: Image consolidation, digital subtraction, coronary artery graphical representation, quantitative measurement/analysis tools for cath and ultrasound, and report generation. Connectivity: Networked architecture for multi-user access. Scalable deployment on off-the-shelf PC/server hardware.

Indications for Use

Indicated for use as a cardiovascular information management system for the storage, display, and analysis of DICOM-compliant cardiac imaging data in clinical settings ranging from small departments to large hospital networks.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Impax (K022292)
• Inturis Suite (K994210)

Submission Summary (Full Text)

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Special 510(k) Ascentia (formally Encompass)

FEB 18 2005

K050218

# Special 510(K) Summary

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

## DATE:

31 January 2005

## SUBMITTER:

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

## CONTACT PERSON:

Richard Petrocelli
Tel No: [phone]

## IDENTIFICATION OF THE PRODUCT

**TRADE NAME:** Ascentia™
**COMMON NAME:** Encompass Cardiac Network
**CLASSIFICATION NAME:** Image Processing System, LLZ CFR 892.2050

## SUBSTANTIAL EQUIVALENCE INFORMATION

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

**Model** Manufacturer
Impax (k022292) Agfa Corp.
Inturis Suite (k994210) Philips Medical Systems

ONE CROSSWIND ROAD • WESTERLY, RI • 02891
PHONE: [phone] • FAX: [phone]

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Special 510(k) Ascentia (formally Encompass)

# Predicate Technical Characteristics

| Feature | Heartlab, Inc. Ascentia (formally Encompass) | Agfa Corp. Impax | Philips Inturis Suite |
| --- | --- | --- | --- |
| Operating System | Windows NT / 2000 / 2003 / XP | Windows NT | Windows NT |
| Image Source | DICOM | DICOM | DICOM |
| Display Rate | Over 30 fps | Up to 30 fps | Up to 30 fps |
| Multiple Windows | Yes | Yes | Yes |
| Image Export | bmp, jpg, mpg | bmp, jpg, mpg | bmp, jpg, avi |
| Network Access | Yes | Yes | Yes |
| Analysis | Yes | Yes | Yes |
| Reporting | Yes | Yes | Yes |

Very little difference can be found between Heartlab, Inc. Ascentia™ and the predicate devices noted above. Both systems take DICOM images from DICOM compliant imaging systems. Both systems archive this data in the DICOM format and provide a retrieval function for review, analysis and reporting.

For the acquisition of images from DICOM compliant imaging systems and the conversion of these images for distribution over a network; the Heartlab, Inc. system, and both the Agfa and Philips systems use similar techniques and offer the same functionality. Thus, for DICOM compliant image distribution over a network, the Heartlab, Inc. Ascentia™ device is substantially equivalent to the predicate devices noted above.

ONE CROSSWIND ROAD • WESTERLY, RI • 02891
PHONE: [phone] • FAX: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 18 2005

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Richard Petrocelli
President
Heartlab Cardiac Solutions
One Crosswind Road
WESTERLY RI 02891

Re: K050228
Trade/Device Name: Ascentia®
(formally Encompass®)
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and
Communications system
Regulatory Class: II
Product Code: 90 LLZ
Dated: January 31, 2005
Received: February 1, 2005

Dear Mr. Petrocelli:

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 (Premarket Approval), 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.

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.

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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
| --- | --- | --- |
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Special 510(k) Ascentia (formally Encompass)

Heartlab
CARDIAC SOLUTIONS

# Attachment A

510(k) Number: K050228
Device Name: Ascentia™ (formally Encompass™)

## Indications For Use:

Ascentia™ (formally Encompass™) is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Ascentia™ is software comprised of modular software programs that run on standard “off-the-shelf” personal computers and servers running the Windows 2000/2003/XP operating system. Ascentia™ is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Ascentia™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Prescription Use ☑

David B. Lippman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050228

ONE CROSSWIND ROAD • WESTERLY, RI • 02891
PHONE: [phone] • FAX: [phone]