MEDICHEART, MODEL RELEASE 1

K032823 · Medicsight · JAK · Nov 10, 2003 · Radiology

Device Facts

• Record ID: K032823
• Device Name: MEDICHEART, MODEL RELEASE 1
• Applicant: Medicsight
• Product Code: JAK · Radiology
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.

Device Story

MedicHeart Release 1 is a PC-based, stand-alone software tool for CT image analysis. It assists radiologists and clinicians in identifying and quantifying coronary artery calcification. Input consists of CT image data. Users manually select Regions of Interest (ROI) via single-click or drawing tools, followed by semi-automatic detection. The software calculates calcium scores using the Agatston method and measures volume and mass of calcified plaques. Output is provided to the clinician for evaluation of plaque progression or regression over time. Used in clinical settings to support diagnostic decision-making regarding coronary artery disease.

Clinical Evidence

Bench testing only. Performance of the system was validated through test data demonstrating substantial equivalence to predicate devices.

Technological Characteristics

PC-based, stand-alone, non-invasive image analysis software. Operates on CT image data. Features manual ROI selection and semi-automatic detection. Implements Agatston scoring method and plaque volume/mass quantification.

Indications for Use

Indicated for radiologists and clinicians to identify and quantify coronary artery calcified plaques using CT image data to evaluate plaque progression or regression over time.

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

• GE Medical Systems SMARTSCORE 3.5; 4.0; 4.5 (K020929)
• VIATRONIX V3D CALCIUM SCORING (K013146)
• VOXAR CALCIUM SCORING PRODUCT (K020140)

Submission Summary (Full Text)

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032823

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NOV 1 0 2003

Appendix E

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92( c ).

| Submitted by:<br>Name: | Medicsight PLC. |
|------------------------|--------------------------------------------|
| Address: | 46 Berkeley Square<br>London W1J 5AT<br>UK |
| Telephone: | 44 (0) 207 598 4070 |
| Facsimile: | 44 (0) 207 598 4071 |
| Contact: | Carol MacDonald, RA QA Manager |
| Date of summary: | 02 September 2003 |

#### Device Information:

| Trade Name: | MedicHeart™ Release 1 |
|----------------------|---------------------------------------------|
| Common Name: | Medical imaging software for CT scanners |
| Classification Name: | Computed Tomography X-Ray System, Accessory |
| Regulation Number: | 892.1750 |

#### Predicate Device:

Medicsight MedicHeart 1 is substantially equivalent to the following devices:

| Manufacturer | Device | 510(k) No. |
|--------------------|--------------------------|------------|
| GE Medical Systems | SMARTSCORE 3.5; 4.0; 4.5 | K020929 |
| VIATRONIX | V3D CALCIUM SCORING | K013146 |
| VOXAR | CALCIUM SCORING PRODUCT | K020140 |

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Image /page/1/Picture/0 description: The image shows a logo for a company called "medicsight". The logo consists of a square grid with a circle in the center. The grid is made up of nine squares, with the four corner squares and the center square being black. The circle in the center is white. The text "medicsight" is written in a small, sans-serif font below the grid.

#### Device Description:

MedicHeart™ is a software tool designed to assist radiologists and other clinicians in the identification and quantification of coronary artery calcification. The software allows the user to manually select Regions of Interest by a single click or a drawing tool followed by semi-automatic detection. It provides calculation of calcium score using the traditional Agatston method, as well as measurement of the volume and mass of calcified plaques.

#### Intended Use:

MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.

#### Comparison to Predicate Device:

As in the predicate devices, GE SmartScore, Viatronix V3D and Voxar Calcium Scoring, MedicHeart 1 evaluates CT images for the identification and quantification of coronary artery calcified plaques.

Test data are provided to validate the performance of the system and its substantial equivalence to the predicate devices. The functional features and the intended use of MedicHeart 1 are substantially equivalent to the predicate devices.

#### Safety:

A comprehensive hazard analysis was carried out on MedicHeart 1, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system.

#### Conclusion:

MedicHeart 1 does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. MedicHeart 1 is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 0 2003

Ms. Carol MacDonald Regulatory & Quality Manager Medicsight 46 Berkeley Square W1J5AT, London UNITED KINGDOM

Re: K032823 Trade/Device Name: Medicsight Medic-Heart Release 1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: September 8, 2003 Received: September 10, 2003

Dear Ms. MacDonald:

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.

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 (OS) 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 the 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" (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.

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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APPENDIX A

Page __ of_

# 510(k) Number (if known): K032883

Medicsight MedicHeart Release 1 Device Name:

Indications for Use:

MedicHeart 1is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032823

*Prescription Use*