(259 days)
Yes
The document explicitly mentions the use of a "CNN-based probability threshold," where CNN stands for Convolutional Neural Network, a common type of deep learning model used in image processing.
No
The device is a software tool used for evaluating calcified plaques and generating risk categories based on existing CT scans. It provides information for physicians but does not directly treat, cure, mitigate, or prevent disease.
Yes
The device evaluates calcified plaques in coronary arteries to generate reports of total risk category, which physicians use for further analysis and treatment, indicating its role in diagnosis.
Yes
The device is described as a "non-invasive post-processing software" that analyzes pre-existing CT scans. The description focuses solely on the software's function of identifying, quantifying, and reporting calcification, without mentioning any associated hardware components that are part of the device itself.
Based on the provided information, the HealthCCS 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.
- HealthCCS Device Function: The HealthCCS Device analyzes pre-existing CT scans, which are medical images. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to evaluate calcified plaques in coronary arteries based on imaging data, not to perform a diagnostic test on a biological specimen.
Therefore, the HealthCCS Device falls under the category of medical imaging software or a medical device that processes imaging data, rather than an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is explicitly marked "Not Found".
Intended Use / Indications for Use
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 analyses pre-existing heart or chest ECG-Gated Triggered CT scans. The Device is indicated for use only on patients whose age at 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The HealthCCS Device is an automatic non-invasive post processing tool that uses cardiac CT images to identify and quantify calcification in the coronary arteries, known to be a risk factor for coronary disease. HealthCCS Device quantifies calcification on non-contrast cardiac computed tomography (CT) scans. HealthCCS Device calculates the amount of identified calcification and reports the risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The following quantification and data-reporting functionalities are provided by the HealthCCS Device: Quantification: - Calcification is automatically identified based on voxel density above a predefined threshold (130HU) - A CNN-based probability threshold is then applied to the identified calcification to determine the likelihood that the calcium is associated within the coronary arterial distribution. - Coronary Artery Calcium score is calculated for each study series using the Agatston method - If a single study contains more than one series for which Coronary Artery Calcium score is calculated, the results from these series are averaged to give a Agatston equivalent score for the study Data reporting: - Generate patients' reports with their respective calcium score category
Mentions image processing
Yes
Mentions AI, DNN, or ML
A CNN-based probability threshold is then applied to the identified calcification to determine the likelihood that the calcium is associated within the coronary arterial distribution.
Input Imaging Modality
CT
Anatomical Site
Coronary arteries (heart or chest ECG-Gated Triggered CT scans)
Indicated Patient Age Range
above 20 years old
Intended User / Care Setting
Physician / Not Found
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 performance of the HealthCCS device has been validated in a retrospective performance study (n=249 studies), where the agreement between the 4-level risk categorization of the Health CCS device has been compared to the ground truth (GT) categorization by 3 radiologists using the Kodak Carestream PACS device (K053347).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Retrospective performance study (n=249 studies). Adequate overall agreement of 0.89 (95% CI: [0.85, 0.92]) as well as adequate agreement per category were reported. The reproducibility was assessed on 150 studies that were read three times. All Agatston equivalent scores per study ID were found identical over all three readings. The performance validation study demonstrated that HealthCCS device, provides accurate calcium scoring as compared to a reference device that shares the same intended use and technological characteristics as the predicate device that is currently marketed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement of 0.89 (95% CI: [0.85, 0.92])
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.
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.
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Zebra Medical Vision Ltd. % Matan Neeman Director, Quality and Regulatory Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL
June 13, 2018
Re: K172983
Trade/Device Name: HealthCCS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 19, 2018 Received: May 22, 2018
Dear Matan Neeman:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172983
Device Name HealthCCS
Indications for Use (Describe)
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 analyses pre-existing heart or chest ECG-Gated Triggered CT scans. The Device is indicated for use only on patients whose age at 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510 (k) Summary
510(K) Summary - HealthCCS Zebra Medical Vision Ltd.
510(k) Number K172983
| 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: 06 June 2018
- Trade Name: HealthCCS
Classification Name:
JAK - Computed tomography x-ray system
Classification:
Class II, Radiology
Predicate Device:
The HealthCCS device is substantially equivalent to the following device:
| Proprietary Name | CSCS-001A Calcium Scoring Package |
|---|---|
| Premarket Notification | K072737 (5 Oct. 2007) |
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 21 CFR 892.1750 |
| Product Code | JAK |
| Regulatory Class | II |
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Reference Device:
| Proprietary Name | Kodak Carestream PACS |
|---|---|
| Premarket Notification | K053347 |
| Classification Name | Picture archiving and communications system |
| Regulation Number | 892.2050 |
| Product Code | LLZ |
| 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.
Indication for Use:
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 analyses 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.
Device Description:
The HealthCCS Device is an automatic non-invasive post processing tool that uses cardiac CT images to identify and quantify calcification in the coronary arteries, known to be a risk factor for coronary disease.
HealthCCS Device quantifies calcification on non-contrast cardiac computed tomography (CT) scans. HealthCCS Device calculates the amount of identified calcification and
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Image /page/5/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white zebra-like symbol. To the right of the symbol is the word "zebra" in black, with the words "MEDICAL.VISION" in smaller font below it.
reports the risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment.
The following quantification and data-reporting functionalities are provided by the HealthCCS Device:
Quantification:
- Calcification is automatically identified based on voxel density above a predefined threshold (130HU)
- । A CNN-based probability threshold is then applied to the identified calcification to determine the likelihood that the calcium is associated within the coronary arterial distribution.
- Coronary Artery Calcium score is calculated for each study series using the । Agatston method
- । If a single study contains more than one series for which Coronary Artery Calcium score is calculated, the results from these series are averaged to give a Agatston equivalent score for the study
Data reporting:
- Generate patients' reports with their respective calcium score category
Performance Data:
Safety and performance of HealthCCS device has been evaluated and verified in accordance with software specifications and applicable performance standards. Software Development and Validation & Verification Processes have been implemented to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance document: "General Principles of Software Validation".
The performance of the HealthCCS device has been validated in a retrospective performance study (n=249 studies), where the agreement between the 4-level risk categorization of the Health CCS device has been compared to the ground truth (GT) categorization by 3 radiologists using the Kodak Carestream PACS device (K053347). Adequate overall agreement of 0.89 (95% CI: [0.85, 0.92]) as well as adequate agreement per category were reported. The reproducibility was assessed on 150 studies that were
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Image /page/6/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white zebra head, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller black letters below it. The logo is simple and modern, and it is likely used to represent a company that specializes in medical imaging or related technologies.
read three times. All Agatston equivalent scores per study ID were found identical over all three readings.
With respect to the specified requirements of accuracy, precision, and reproducibility, the obtained results have been found to be acceptable. The performance validation study demonstrated that HealthCCS device, provides accurate calcium scoring as compared to a reference device that shares the same intended use and technological characteristics as the predicate device that is currently marketed.
Technological Characteristics Compared to Predicate Device:
The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the HealthCCS device are substantially equivalent to the predicate device cited above.
A comparison of the technological characteristics with the predicate and reference devices is summarized below.
| Technological
Characteristics | Proposed
Device:
HealthCCS
software tool | Predicate Device:
CSCS-001A,
Calcium Scoring
Package (K072737) | Reference Device
Kodak Carestream
PACS (K053347) | Summary |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------|
| General | | | | |
| Modality | CT | CT | CT | Same |
| Image format | DICOM | DICOM | DICOM | Same |
| Supported
Computed
Tomography
(CT) scan - body
part | Heart/Chest | Heart/Chest | Heart/Chest | Same |
| Supported
Computed
Tomography
(CT) scan - dose | Typically Normal
Dose | Typically Normal
Dose | Typically Normal
Dose | Same |
| Supported
Computed
Tomography
(CT) scan - Use
of IV contrast | No | No | No | Same |
| Supported
Computed
Tomography
(CT) scan – ECG
Gating/Triggering | ECG-Gated | ECG-Gated | ECG-Gated | Same |
| Quantification | | | | |
| Calcification
location marking | Automatic | Semi-automatic,
Manual | Semi-automatic,
Manual | Substantially
equivalent |
| Selection of a
calcified plaques
based on voxel
identification
above a known
threshold | Yes | Yes | Yes | Same |
| Default threshold
of Calcium | 130 HU
(Hounsfield
Units) | 130 HU (Hounsfield
Units) | 130 HU (Hounsfield
Units) | Same |
| Spatial threshold | 1.5 mm² | 1 mm² | 1 mm² | Substantially
equivalent |
| Coronary
Calcification
calculation
method | Agatston
equivalent score
based on the
Agatston method | – Agatston score
– Mass score
– Volume score | – Agatston score
– Mass score
– Volume score | Substantially
equivalent |
| Computed
calcium scoring | Total calcium
score | Total calcium score,
and per-artery
calcium score | Total calcium score,
and per-artery
calcium score | Substantially
equivalent |
| Data reporting | | | | |
| Generate patient
report | Yes | Yes | Yes | Same |
| Printable hard
copy reports | No | Yes | Yes | Substantially
equivalent |
| Maintain a
patient database
for future
reference | No | Yes | Yes | Substantially
equivalent |
| Report of the
calcium score
category | Yes | Yes | Yes | Substantially
equivalent |
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Image /page/7/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a stylized "Z" symbol on the left and the word "zebra" in lowercase letters on the right. Below the word "zebra" is the text "MEDICAL.VISION" in smaller letters. The logo is black and white.
Substantial Equivalence:
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, HealthCCS
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Image /page/8/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line, a stylized black and white "Z" symbol, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller font below it. The logo is simple and modern, and it is likely used to represent a company that specializes in medical imaging or related technologies.
device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.
The results of the performance comparison study demonstrated that the HealthCCS device performs as intended, in the specified use conditions, similarly to the reference device. The HealthCCS device is therefore substantially equivalent to the predicate device as the reference device and the predicate device share the same intended use and equivalent technological characteristics.