(61 days)
Not Found
No
The description mentions "semi-automatic detection" and manual selection tools, but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The focus is on image analysis and quantification using established methods like the Agatston score.
No
The device is an image analysis software designed to assist in the identification and quantification of coronary calcified plaques, not to treat or diagnose conditions.
Yes
Explanation: The device is intended to assist clinicians in the "identification and quantification of coronary calcified plaques" and for "evaluation of the progression or regression of calcified plaques." This involves analyzing image data to assess a patient's medical condition, which is a diagnostic function.
Yes
The device is explicitly described as a "PC-based, stand-alone, non-invasive, image analysis software application" and a "software tool." There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, MedicHeart 1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MedicHeart 1's Function: MedicHeart 1 analyzes CT image data of the coronary arteries. This is image analysis of the body itself, not analysis of a specimen taken from the body.
Therefore, MedicHeart 1 falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT image data
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and other clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test data are provided to validate the performance of the system and its substantial equivalence to the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
032823
Image /page/0/Picture/1 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 smaller squares, some of which are filled in with black. The word "medicsight" is written in lowercase letters below the grid.
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:
| Name: | Medicsight PLC. |
|---|---|
| Address: | 46 Berkeley Square |
| London W1J 5AT | |
| 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 |
1
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.
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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