(245 days)
Not Found
Yes
The device description explicitly states that the product analyzes cases using an "artificial intelligence algorithm".
No.
The device is a non-invasive post-processing software that evaluates calcified plaques and generates an estimated coronary artery calcium detection category for informational purposes, assisting radiologists in diagnosis, but it does not directly treat or alleviate a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "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." Furthermore, the "Device Description" states, "The device is intended for use by the radiologists as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment."
Yes
The device description explicitly states "HealthCCSng product is a software device" and describes its function as analyzing existing CT studies using an algorithm and providing output to a radiologist. There is no mention of accompanying hardware components.
Based on the provided information, the HealthCCSng 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.
- HealthCCSng's Function: The HealthCCSng device is a software that analyzes existing medical images (CT scans) of the coronary arteries. It does not involve the analysis of biological samples taken from the patient.
- Intended Use: The intended use clearly states it's a "non-invasive post-processing software" that evaluates calcified plaques in coronary arteries from CT studies. This is image analysis, not in vitro testing.
- Device Description: The description reinforces that it's a "software device" that analyzes CT scans.
While the device provides information related to a medical condition (coronary artery disease risk), it does so by processing medical images, not by performing tests on biological samples. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
No
The input text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The relevant text is "Not Found" for PCCP.
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
HealthCCSng product is a software device that automatically estimates the coronary artery 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:
- Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
Heart, coronary arteries
Indicated Patient Age Range
adult patients above the age of 30
Intended User / Care Setting
radiologist, in conjunction with additional patient information and professional judgment.
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
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 performance results were analyzed for 447 anonymized CT chest cases. Patient age ranged from 30-93 y.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) (15-966), KVP (100, 120, 130 and 140), and four (4) manufacturers of CT devices (GE, Philips, Siemens and Toshiba).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 performance results were analyzed for 447 anonymized CT chest cases.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement of 92.5% (95% CI: [89.7%, 95.5%)
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
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)
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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.
- 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.
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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 | Same |
| Compressed preview
image | Yes | No | Not applicable | Does not
introduce
questions of
safety and
effectiveness |
| Annotation of
detected calcium | Yes | Yes | Not applicable | Same |
| Visualization tools | Zooming, panning,
windowing | Zooming, panning | Not applicable | Similar, does not
introduce
questions of
safety and
effectiveness |
| Data reporting | | | | |
| Generate patient
report | Optional to copy
result to clipboard,
insert in report,
DICOM Secondary
Capture | Optional to copy
result to clipboard,
insert in report | Optional to insert
results in report | Similar, does not
introduce
questions of
safety and
effectiveness |
| Report of the calcium
score | Yes, Coronary
Calcium Detection
Category
3 categories:
0-99
100-399
=400 | Yes, Coronary
artery calcium risk
category
4 categories
0-10
11-100
101-400
400 | Not applicable | Both the subject
and primary
predicate device
provide calcium
detection and
category |
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Image /page/8/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 parallel lines that curve around each other. The words "zebra medical" are stacked on top of the word "VISION". The logo is black and white.
Comparison of Technological Characteristics
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Image /page/9/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 lines that are parallel to each other. The words "zebra medical VISION" are stacked on top of each other, with "zebra" on the top, "medical" in the middle, and "VISION" on the bottom.
Conclusion:
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, HealthCCSng device raises no new questions of safety and effectiveness and is substantially equivalent to the primary predicate device in terms of safety, efficacy and performance.
The results of the performance comparison study demonstrated that the HealthCCSng device performs as intended, in the specified use conditions, similarly to the predicate devices. The HealthCCSng device is therefore substantially equivalent to the primary predicate device.
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Image /page/10/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 letter "Z" is made up of several curved lines, and the words are stacked vertically.