Who is the manufacturer of HealthCCSng?

Zebra Medical Vision, Ltd. filed the 510(k) submission for HealthCCSng (K210085).

What is the FDA product code for HealthCCSng?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HealthCCSng?

510(k) clearance (submission type: Traditional).

Does HealthCCSng use AI or machine learning?

Yes. HealthCCSng (K210085) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for HealthCCSng?

HealthCCS (K172983); AI-Rad Companion (K183268).

Who can help prepare an FDA 510(k) submission like HealthCCSng?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like HealthCCSng get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

HealthCCSng

K210085 · Zebra Medical Vision, Ltd. · JAK · Sep 15, 2021 · Radiology

Device Facts

Record ID	K210085
Device Name	HealthCCSng
Applicant	Zebra Medical Vision, Ltd.
Product Code	JAK · Radiology
Decision Date	Sep 15, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.

Device Story

HealthCCSng is non-invasive post-processing software for opportunistic coronary artery calcium (CAC) detection in non-cardiac-gated adult CT scans. Input: DICOM CT studies (slice thickness up to 3mm). Operation: AI algorithm validates input data, analyzes heart region, detects calcifications (threshold ≥130 HU), and quantifies calcium into three categories (Low: 0-99, Medium: 100-399, High: ≥400). Output: Estimated CAC category and preview axial images with annotations. Usage: Integrated into radiologist's standard workflow via Zebra's Imaging Analytics Platform (IMA). The radiologist reviews software output alongside original images to inform clinical assessment. Benefits: Enables automated, opportunistic screening for coronary artery disease risk during routine CT scans without requiring dedicated cardiac-gated protocols.

Clinical Evidence

Bench-only validation using a retrospective dataset of 447 anonymized chest CT scans from two institutions. Ground truth established by majority agreement of three radiologists. Primary endpoint: overall agreement with ground truth. Results: 92.5% overall agreement (95% CI: 89.7%-95.5%), exceeding the 85% performance goal. Data included diverse imaging parameters (slice thickness 0.625-3mm, KVP 100-140, various manufacturers).

Technological Characteristics

Software-only device; DICOM input; non-contrast CT; threshold-based detection (130 HU); AI-based analysis; standalone/networked integration via Imaging Analytics Platform (IMA); no hardware components.

Indications for Use

Indicated for adult patients >30 years old undergoing non-cardiac-gated CT scans of the chest/heart to evaluate calcified plaques in coronary arteries.

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

HealthCCS (K172983)
AI-Rad Companion (K183268)

Related Devices

K172983 — HealthCCS · Zebra Medical Vision, Ltd. · Jun 13, 2018
K241440 — HealthCCSng · Nano-X AI , Ltd. · Aug 19, 2024
K221219 — syngo.CT CaScoring · Siemens Medical Solutions USA, Inc. · May 17, 2022
K233211 — AVIEW CAC · Coreline Soft Co., Ltd. · Mar 29, 2024
K242188 — ClearRead CT CAC · Riverain Technologies, Inc. · Dec 3, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ September 15, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Zebra Medical Vision Ltd. % Shlomit Cymbalista Regulatory Affairs Lead Shefayim Commercial Center, PO Box 25 Shefavim. 6099000 ISRAEL Re: K210085 Trade/Device Name: HealthCCSng Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 4, 2021 Received: August 9, 2021 #### Dear Shlomit Cymbalista: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, , for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210085 Device Name HealthCCSng Indications for Use (Describe) The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the words "zebra medical VISION" on the right. The letter Z is made up of three curved lines that are stacked on top of each other. The words "zebra medical" are stacked on top of the word "VISION". ## 510(K) Summary - HealthCCSng Zebra Medical Vision Ltd. #### 510(k) Number – K210085 | Applicant's Name: | Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL Telephone: +972-9-8827795 Fax: +972-9-8827795 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | September 14, 2021 | #### Trade Name: HealthCCSng #### Classification Name: JAK - Computed tomography x-ray system # Regulation Number: 21 CFR 892.1750 ## Classification: Class II, Radiology ### Predicate Device: The HealthCCSng device is substantially equivalent to the following Primary Predicate Device: | Proprietary Name | HealthCCS | |------------------------|-----------------------------------| | Premarket Notification | K172983 | | Classification Name | Computed tomography x-ray system. | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Regulatory Class | II | ### Secondary Predicate Device: | Proprietary Name | AI-Rad Companion | |------------------------|-----------------------------------| | Premarket Notification | K183268 | | Classification Name | Computed tomography x-ray system. | | Regulation Number | 21 CFR 892.1750 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the words "zebra medical VISION" on the right. The letter Z is made up of three curved lines that are stacked on top of each other. The words "zebra medical VISION" are written in a sans-serif font, with "zebra" on the top line, "medical" on the second line, and "VISION" on the third line. | Product Code | JAK | |------------------|-----| | Regulatory Class | II | #### Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food. Drug. and Cosmetic Act. #### Intended Use/Indication for Use: The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. #### Device Description: HealthCCSng product is a software device that automatically estimates the coronary arterv calcium category from non-cardiac-gated adult CT scans. The product is aimed to leverage the high utilization of CT scans in the medical care environment (both inpatient and outpatient), including lung cancer screening programs, in order to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. Zebra's HealthCCSng product analyzes cases using an artificial intelligence algorithm for the automated detection and estimation of coronary calcium and outputs a result for review by the radiologist. The device works in parallel to and in conjunction with the standard of care workflow. The final diagnosis is made by the radiologist after reviewing the scan independently of the software. The device is intended for use by the radiologists as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment. HealthCCSng receives a non-cardiac-gated CT study from the storage application, Zebra's Imaging Analytics Platform (IMA). For each CT study received, the software shall validate there is at least one compliant series in which the entire heart is present, and perform an analysis. For each compliant study, the software shall output: 1.Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the words "zebra medical VISION" on the right. The letter Z is made up of three nested Z shapes, creating a layered effect. The text is in a simple, sans-serif font, with "zebra" and "medical" stacked on top of each other and "VISION" below them. 2. A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurement. The software output will include the following calcium categories: | Estimated Coronary Calcium Detection | Corresponding Estimated Coronary Calcium Detection Category | |-----------------------------------------|----------------------------------------------------------------| | 0-99 | Low | | 100-399 | Medium | | ≥400 | High | For patients in which calcium was detected, the user will be presented with representative images - all the slices containing the measured coronary calcifications (130 HU and above). On these images, the calcified areas will be annotated (with an option for the user to toggle on and off the annotation). The following modules compose the HealthCCSng software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system. ## Performance Data: Safety and performance of HealthCCSng has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Zebra Medical Vision. The logo consists of a stylized letter "Z" on the left and the words "zebra medical VISION" on the right. The "Z" is made up of three curved lines that overlap each other. The words "zebra medical" are stacked on top of each other, and the word "VISION" is below them. The HealthCCSng software device performance was validated in a stand-alone retrospective study for its overall agreement compared to the established ground truth and respective to the predicate device. The validation data-set consisted of anonymized CT scans of the chest from two healthcare institutions composed of multiple clinical sites. The sample included representation of each coronary calcium detection category. Ground truth category was determined by the majority agreement of two of three radiologists. The objective of the study was to establish the safety, effectiveness and substantial equivalence of the HealthCCSng software as compared to the predicate device (HealthCCS, K172983). The HealthCCSng overall agreement was determined by comparing the device output coronary calcium detection category, to the ground truth coronary calcium detection category. For overall agreement to be considered successful it had to be equal or superior to the 85% performance goals defined by the predicate device. The performance results were analyzed for 447 anonymized CT chest cases. Patient age ranged from 30-93 v.o (mean age of 62.6 years: SD=14.4) and 57.7% (258) were male. The validation data-set represented the following imaging parameters: Modality (CT), Slice Thickness (0.625, 1, 1.25, 1.5, 2, 2.5 and 3 mm), Slice Increment (0.625, 1, 1.25, 1.5, 2, 2.5 and 3 mm), Exposure in mAs (Radiation Dose) i(15-966), KVP (100, 120, 130 and 140), and four (4) manufacturers of CT devices (GE, Philips, Siemens and Toshiba). The HealthCCSng device demonstrated an overall agreement of 92.5% (95% CI: [89.7%, 95.5%) exceeding the stated performance goal and the predicate performance. All CT data across, slice thickness, slice increment, exposure, KVP, manufacturers and reconstruction type were well supported by the HealthCCSng device. In conclusion, this study demonstrated the HealthCCSng overall agreement with the ground truth coronary calcium detection category and establishes its substantial equivalence to the predicate device. It also validated the performance of the HealthCCSng across important cohorts, and applicable subsets of imaging acquisition characteristics. ## Technological Characteristics Compared to Predicate Device: Zebra Medical Vision believes that the HealthCCSng device is substantially equivalent to the HealthCCSng Device K172983 (primary predicate) and the AI-Rad Companion (Cardiovascular) K183268 (secondary predicate). The two predicate devices listed (K172983 and K183268) have the same intended use as the predicate device, namely, coronary calcium detection and quantification, and support substantial equivalence with respect to technological characteristics. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the words "zebra medical VISION" on the right. The letter Z is made up of three curved black lines that are stacked on top of each other. The words "zebra medical" are stacked on top of the word "VISION". | | Proposed Device: HealthCCSng | Primary Predicate Device: HealthCCS Device v3.0 (K172983) | Secondary Predicate Device: AI-Rad Companion (K183268) | | |-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. | The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyzes pre-existing heart or chest ECG-Gated/Triggered CT scans. The Device is indicated for use only on patients whose age at the time, when the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician's own judgment. It may require further testing to evaluate the appropriate clinical management. | AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: • Segmentation and volume measurement of the heart • Quantification of the total calcium volume in the coronary arteries • Segmentation of the aorta • Measurement of maximum diameters of the aorta at typical landmarks •Threshold-based highlighting of enlarged diameters The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input. | | | Technological Characteristics | Proposed Device: HealthCCSng Device v1.0 | Primary Predicate Device: HealthCCS Device v3.0 (K172983) | Secondary Predicate Device: AI-Rad Companion (K183268) | Summary | | Regulation | | | | | | Product Code | JAK | JAK | JAK | Same | | Regulation Number | 21 CFR §892.1750 | 21 CFR §892.1750 | 21 CFR §892.1750 | Same | | General | | | | | | Modality | CT | CT | CT | Same | | Image format | DICOM | DICOM | DICOM | Same | | Contrast | Non-contrast | Non-contrast | Non-contrast | Same | | Supported CT scan | Non-cardiac-gated CT scan | Cardiac-gated CT scan | Non-cardiac-gated CT scan | Different supported CT scans by the subject device and primary predicate device. | | Slice thickness | Up to 3mm | Up to 3mm | Up to 3mm | Same | | Quantification | | | | | | Calcification detection | Automatic | Automatic | Automatic | Same | | Default threshold of calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | Same | | Coronary artery calcification quantification method | CAC detection category | Agatston equivalent CAC risk category, based on the Agatston method | Calcium volume | Similar, provide detected calcium for assessment. | | Display and Visualization | | | | | | Main Image Quality | DICOM | DICOM | Not applicable…