CARDIAC SCORING FOR CT SCANNERS

K970980 · Elscint, Inc. · JAK · May 29, 1997 · Radiology

Device Facts

• Record ID: K970980
• Device Name: CARDIAC SCORING FOR CT SCANNERS
• Applicant: Elscint, Inc.
• Product Code: JAK · Radiology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Cardiac scoring from whole body computed tomography derived measurements

Device Story

Cardiac Scoring option is a software feature for CT scanners; utilizes Agaston scoring method to quantify high-density structures, specifically calcified tissues in coronary arteries. Input consists of CT image data; software transforms these inputs by calculating weighted scores for calcifications, replacing manual area-density product calculations. Used in clinical settings by radiology staff; output provides automated quantification of coronary calcification to assist clinicians in assessing cardiovascular health. Benefits include improved ease of use and efficiency compared to manual measurement methods.

Clinical Evidence

Bench testing only. Verification and validation results demonstrate that the software option meets all functional requirements and specifications.

Technological Characteristics

Software-based image processing option for CT scanners. Implements Agaston scoring algorithm for quantification of calcified tissues. Operates as an integrated software module within the CT system environment.

Indications for Use

Indicated for cardiac scoring from whole body computed tomography derived measurements.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• CT Twin flash (K945512)

Submission Summary (Full Text)

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K970980

# Summary of Safety and Effectiveness

## 1. Device Name

Cardiac Scoring option

MAY 29 1997

## 2. Submitter

Elscint Inc.,
505 Main Str.
Hackensack, NJ 07601.

## 3. Description of Main Features

The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

## 4. Predicate Devices

CT Twin flash, K945512,

## 5. Safety

The Level of Concern of the Cardiac Scoring was determined to be minor.

The safety of this software option is assured by the company procedures that conform to accepted practices. The key process stages are:

- Definition of Requirements
- Design
- Implementation
- Verification and Validation

Good quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

## 6. Effectiveness

The Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use.

## 7. Substantial Equivalency Statement

Based on the above considerations, it is Elscint’s opinion that the Cardiac Scoring option is substantially equivalent in safety and effectiveness to the Histogram and ROI functions of the predicate device, CT Twin flash, K945512.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Thomas J. Spackman, M.D., F.A.C.R.
President and Chief Executive Officer
Elscint, Inc.
86 Orchard Street
Hackensack, NJ 07601

Re: K970980
Cardiac Scoring for CT Scanners
Dated: March 11, 1997
Received: March 18, 1997
Regulatory Class: II
21 CFR 892.1750/Procode: 90 JAK

Dear Dr. Spackman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K970980

Device Name: Cardiac Scoring for CT Scanners

Indications For Use: Cardiac scoring from whole body computed tomography derived measurements

(Please do not write below this line-continue on another page if needed)

(Concurrence of CDRH, Office of Device Evaluation(ODE)

David H. Segarn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970980

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

7704

ONI INSTITUOYI CIIH 1C-77-1WU