ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS

K023100 · General Electric Medical Systems Information Techn · LLZ · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K023100
• Device Name: ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
• Applicant: General Electric Medical Systems Information Techn
• Product Code: LLZ · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AccuSketch LV HL is intended to aid the Cardiologist or trained technician in providing and documenting an objective quantification of a patient's Left Ventricular function. The AccuSketch STN HL is intended to aid the Cardiologist or trained technician in providing and documenting an objective quantification of coronary artery stenosis (the amount of vessel closure due to coronary artery disease). The Image Capture system provides image capture and printing.

Device Story

PC-based software system for cardiac catheterization labs; operated by cardiologists or trained technicians. Inputs: cardiac catheterization images. Functions: image viewing, capture, printing, annotation, and quantitative analysis of left ventricular function and coronary artery stenosis. Includes 'CardioTree' tool for electronic vessel anatomy annotation. Output: quantitative reports and annotated images. Used for clinical documentation and post-procedural status reporting. Benefits: provides objective measurements to aid clinical decision-making regarding coronary artery disease and ventricular function.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of module verification, system integration testing, and final validation testing to demonstrate safety and effectiveness equivalent to predicate devices.

Technological Characteristics

PC-based software system. Comprised of four individual programs. Includes CardioTree tool for vessel annotation. Connectivity: standalone or integrated into other GE cardiac image devices. Software-based analysis.

Indications for Use

Indicated for use under the direct supervision of a licensed healthcare practitioner or trained personnel to provide objective quantification of coronary artery stenosis and left ventricular function, and to digitize, store, annotate, and report cardiac images and patient status.

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

• CardioTrace (K912829)
• MUSE Cardiovascular Information System with Accusketch (K992937)

Submission Summary (Full Text)

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KO23100

# OCT 1 1 2002

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## Section 2 Summary and Certification

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... ... .. .. .. ... ... ... ... ... ... ... .......

| 510(k) Summary of Safety and Effectiveness | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date: | September 17, 2002 | |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223<br>USA | |
| Contact Person: | Lisa Lee Michels<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] | |
| Trade Name:<br>Device: | AccuSketch Cardiac Quantitative Analysis System w/ Advanced<br>Analysis Components | |
| Common/Usual Name: | Cardiac Image Analysis Station | |
| Classification Names: | System, Image Processing Radiological | |
| Predicate Devices: | CardioTrace K912829; *MUSE Cardiovascular Information System with<br>Accusketch K992937 | |
| | *NOTE: AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis<br>Components is being compared to AccuSketch, classification code LLZ, integrated into<br>MUSE in K#992637. MUSE classification codes of DQK Programmable Diagnostic<br>Computer (Class II) and DSI Detector & Alarm, Arrhythmia (Class III) are not applicable to<br>AccuSketch component of MUSE. | |
| Device Description: | The AccuSketch Cardiac Quantitative Analysis System w/ Advanced<br>Analysis Components is a PC based software system comprised of 4<br>individual programs used to view, capture/print, analyze and annotate<br>images from cardiac catheterization procedures. AccuSketch is offered<br>as a complete turn-key system or can be ported into other GE cardiac<br>image devices for image analysis. The AccuSketch is a Personal<br>Computer (PC) based software system designed to be permanently<br>installed in a hospital in or near the cardiac catheterization laboratory.<br>AccuSketch is comprised of four individual programs responsible for a<br>specific function. Their purpose is to view, capture/print, analyze and<br>annotate images from cardiac catheterization procedures. | |
| Intended Use: | The AccuSketch LV HL is intended to aid the Cardiologist or trained<br>technician in providing and documenting an objective quantification of a<br>patient's Left Ventricular function. The AccuSketch STN HL is intended<br>to aid the Cardiologist or trained technician in providing and<br>documenting an objective quantification of coronary artery stenosis (the<br>amount of vessel closure due to coronary artery disease). The Image<br>Capture system provides image capture and printing. | |

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The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.

- The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Technology: Analysis Components employs the same functional scientific technology as its predicate devices.
- The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Test Summary: Analysis Components complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components:
- Risk Analysis

.

- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) ●
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
- . Environmental testing
- The results of these measurements demonstrated that the AccuSketch Conclusion: Cardiac Quantitative Analysis System w/ Advanced Analysis Components is as safe, as effective, and performs as well as the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Lee Michels Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue MILWAUKEE WI 53223

#### Re: K023100

Trade/Device Name: AccuSketch Cardiac Quantitative Analysis System "/Advanced Analysis Components Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 17, 2002 Received: September 18, 2002

Dear Ms. Michels:

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 adultcration.

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.

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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Page 2

This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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Page 1 of 1

K D.23/00

510(k) Number (if known):

Haknown, 510(k) filed on September 17, 2002

AccuSketch Cardiac Quantitative Analysis System w/Advanced Analysis Device Name: Components.

Indications for Use:

AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number