← Product Code [JAK](/productcode/JAK) · K040782 # N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX (K040782) _Image Analysis, Inc. · JAK · Jul 13, 2004 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K040782 ## Device Facts - **Applicant:** Image Analysis, Inc. - **Product Code:** [JAK](/productcode/JAK.md) - **Decision Date:** Jul 13, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## 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. ## Device Story N-Vivo Calcium Score is a PC-based software package for non-invasive measurement of vascular calcified plaques. Input: Phantom-calibrated CT images. Operation: Hybrid calibration using external phantom and in-vivo blood pool reference; artery tracing to segment coronary arteries and aorta; statistical and calibrated thresholding for calcium mass measurement. Output: Agaston, Volume, and Mass scores; DICOM reports; serial graphs. Used in clinical settings by trained physicians to monitor calcium progression; aids in cardiovascular disease prognosis. System includes database, QA module, and web-browser interface. ## Clinical Evidence No clinical data provided. The device was developed and validated according to industry and FDA standards for software-based image analysis. Bench testing confirmed the performance of the calibration and software analysis for calcium measurements. ## Technological Characteristics Software-based image analysis package; operates on off-the-shelf PC hardware. Features hybrid calibration (external phantom and in-vivo blood pool reference). Includes artery tracing, automated identification, quantification, and scoring algorithms. Connectivity via web-browser interface; supports DICOM reporting. No specific material standards or energy sources applicable as it is a software accessory to CT imaging systems. ## Regulatory 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 - UltraAccess Workstation with Cardiac Score ([K972903](/device/K972903.md)) - AccuView with AccuScore ([K990241](/device/K990241.md)) - QCT-Lung nodule analysis ([K891931](/device/K891931.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## JUL 1 3 2004 K040782 ## 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 {2}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 --- **Source:** [https://fda-staging.innolitics.com/device/K040782](https://fda-staging.innolitics.com/device/K040782) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com