(109 days)
No
The summary describes image processing and automated quantification but does not mention AI, ML, or related terms like neural networks or deep learning. The features listed are consistent with traditional image analysis techniques.
No
The device is described as software for quantifying calcium in coronary arteries and aorta, intended for monitoring progression useful in prognosis, which are diagnostic rather than therapeutic functions.
Yes
The device provides quantitative measures of calcium content in coronary arteries and aorta from CT images, which is used to monitor progression of vascular calcium and aid in the prognosis of cardiovascular disease. This process of identifying and quantifying a condition (calcium content and its progression) to inform prognosis fits the definition of a diagnostic device.
Yes
The device is described as a "software package operating on a PC" and its functions are entirely software-based (image processing, database, reporting, scoring). While it requires a standard PC to run, the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device analyzes CT images, which are generated from outside the body (in vivo imaging). It does not process biological samples.
- Intended Use: The intended use is to analyze medical images for calcium scoring, which is a diagnostic process based on imaging data, not laboratory testing of biological samples.
Therefore, while this device is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Calcium scoring of calibrated CT images to provide quantitative measures of calcium content in the coronary arteries and aorta. The software is intended to be used under the supervision of trained physicians to monitor progression of vascular calcium which may be useful in the prognosis of Cardiovascular disease.
N-Vivo™ Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions.
N-Vivo™ may be used to monitor progression of calcium which may be useful in the prognosis of cardiovascular disease.
Product codes
90 JAK
Device Description
A software package operating on a PC which facilitates non-invasive measurements of vascular calcified plaques. The device provides Agaston, Volume and Mass Scores using Phantom Calibrated CT images.
The key features include:
- Hybrid calibration with external phantom and invivo blood pool reference. .
- 사 Plaque definition which include statistical and calibrated thresholds for a calcium mass measurement.
- . Artery trace which segments regions of the heart that include the coronary arteries and aorta.
- . Automated identification, quantification, and scoring of vascular calcium.
- 내 PC workstation with web browser based interface which includes database, Dicom reports, Serial graphs and QA module.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
coronary arteries and aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under the supervision of trained physicians
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
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 3 2004
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Submitted in accordance with the requirements of 21 CFR 807.3)
| Contact information: | Ben Arnold, Ph.D. Image Analysis, Inc. 1380 Burkesville Street Columbia, KY 42728 PH: 270-384-6400 FAX: 270-384-6405 Email: info@image-analysis.com |
|---|---|
| Date: | March 22, 2004 |
| Device/Trade Name: | N-Vivo Calcium Score |
| Common/Usual Name: | CT Calcium Scoring Software |
| Classification Name: | No Classification has specifically been issued for calcium scoring, however it may be classified as an accessory to an imaging device. 21CFR892.1750 |
| Marketed Devices: | N-Vivo™ Calcium Score operating on the IA Chassis is substantially equivalent to currently marketed devices including: K972903 |
ly equivalent to currently marketed devices including: K972903 UltraAccess Workstation with Cardiac Score, K990241 AccuView with AccuScore, K891931 QCT-Lung nodule analysis.
Device Description:
A software package operating on a PC which facilitates non-invasive measurements of vascular calcified plaques. The device provides Agaston, Volume and Mass Scores using Phantom Calibrated CT images.
The key features include:
- Hybrid calibration with external phantom and invivo blood pool reference. .
- 사 Plaque definition which include statistical and calibrated thresholds for a calcium mass measurement.
- . Artery trace which segments regions of the heart that include the coronary arteries and aorta.
- . Automated identification, quantification, and scoring of vascular calcium.
- 내 PC workstation with web browser based interface which includes database, Dicom reports, Serial graphs and QA module.
Indications for Use:
Calcium scoring of calibrated CT images to provide quantitative measures of calcium content in the coronary arteries and aorta. The software is intended to be used under the supervision
1
of trained physicians to monitor progression of vascular calcium which may be useful in the prognosis of Cardiovascular disease.
Adverse Effects on Health:
Neither the software package nor the presence of the phantom during CT scanning will have any adverse effects on health. The calibration and software analysis improves the performance of calcium measurements from reconstructed CT images. Any potential safety risks associated with this product are not materially different form those of currently marketed devices for post processing image analysis. The PC hardware is "off-the-shelf" and complies with applicable safety standards for PC hardware and peripherals.
Conclusions:
The N-Vivo™ Calcium Score software operating on the IA chassis has been developed and validated by acceptable standards for the industry and these required by the FDA. It is substantially equivalent to calcium scoring products currently in the market.
Signature
Ben Arnold
esident
Title
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IUL 1 3 2004
Ben A. Arnold, Ph.D. President Image Analysis, Inc. 1380 Burkesville Street COLUMBIA KY 42728 Re: K040782
Trade/Device Name: N-Vivo™ Calcium Score on Image Analysis Chassis PC Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK Dated: June 22, 2004 Received: June 24, 2004
Dear Dr. Arnold:
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. Brydon
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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Statement of Indications for Use
510(k) Number:
Device Name: N-Vivo™ Calcium Score on Image Analysis Chassis PC
Indications for Use:
N-Vivo™ Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions.
N-Vivo™ may be used to monitor progression of calcium which may be useful in the prognosis of cardiovascular disease.
Prescription Use
Nancy C. bradom