(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the algorithm as "based on the same fundamental algorithm as the predicate product". There is no mention of training data or machine learning techniques.
No
The device is a post-processing software that reduces motion artifacts in cardiac CT images, which aids in diagnosis rather than providing direct therapy.
No
The device is described as a post-processing software that reduces motion artifacts in cardiac CT images, producing a new image series. While the performance studies mention that the assessment "demonstrated the diagnostic capability of the motion corrected images," the device itself is not presented as diagnosing a disease, but rather as improving the quality of images used for diagnosis by clinicians. The primary function described is image enhancement, not diagnosis.
Yes
The device is described as "post processing software" delivered on "general purpose computing platforms" and its function is an "automated motion correction algorithm." There is no mention of any dedicated hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that SnapShot Freeze 2 is a post-processing software that works on image data from a CT scanner. It processes images of the heart to reduce motion artifacts.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is solely focused on manipulating and improving medical images.
Therefore, SnapShot Freeze 2 falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
SnapShot Freeze 2 (SSF 2) is a post processing software, which can be delivered on general purpose computing platforms. SnapShot Freeze 2 is an automated motion correction algorithm designed for use with gated cardiac acquisitions from GE CT scanners to reduce cardiac induced motion artifacts in the whole heart. It is based on the same fundamental algorithm as the predicate product commercially marketed under the name CardIQ Xpress 2.0 with SnapShot Freeze Option (K120910, AKA SSF 1). Same as its predicate device the SSF 2 algorithm works on multi-phase, gated cardiac CT DICOM compatible image data and produces a new image series in which motion artifact is reduced.
The device is marketed as SnapShot Freeze 2
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
cardiac, whole heart, coronary vessels, coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
A representative clinical sample image set of 60 CT cardiac cases, focused on patient populations with elevated heart rate were assessed by three board certified radiologists using 5point Likert scale. This data is representative of routine clinical imaging from a cardiac acquisition perspective, but intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases, in which such an algorithm is most likely to be utilized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering bench testing was performed to support substantial equivalence and the product performance claims. The testing used a commercially available cardiac motion phantom with linear motion of variable velocity for modeling of the coronary vessels and the whole heart. The testing also used a mathematical phantom to demonstrate effective temporal resolution, coronary motion and whole heart motion correction. The combination of both analyses (from physical and mathematical motion phantoms) is intended to provide further confidence in the capabilities and full extent of the Snapshot Freeze 2 whole heart motion correction.
A representative clinical sample image set of 60 CT cardiac cases, focused on patient populations with elevated heart rate were assessed by three board certified radiologists using 5point Likert scale. This data is representative of routine clinical imaging from a cardiac acquisition perspective, but intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases, in which such an algorithm is most likely to be utilized. The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Effective temporal resolution of 29 ms for 0.35 sec/rot gantry speed. Effective temporal resolution of 24 ms for 0.28sec/rot gantry.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems, LLC. % Ms. Laura Turner Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188
February 13, 2019
Re: K183161
Trade/Device Name: SnapShot Freeze 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: November 13, 2018 Received: November 15, 2018
Dear Ms. Turner:
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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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
2
Indications for Use
510(k) Number (if known)
Device Name SnapShot Freeze 2
Indications for Use (Describe)
SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2
510(k) Summary
SnapShot Freeze 2
4
GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2
Image /page/4/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a stylized, swirling design around the letters, giving it a dynamic and recognizable appearance.
510(k) SUMMARY OF SAFETY AND EFFECTIVNESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):
| Date: | 2/4/2019 | Primary Contact: | Laura Turner |
|---|---|---|---|
| Submitter: | GE Medical Systems, LLC | ||
| 3000 North Grandview Blvd | |||
| Waukesha, WI 53188 | Regulatory Affairs Leader | ||
| Primary Contact: | Laura Turner | Phone 262-548-4588 | |
| Email: laura.turner@ge.com |
| Secondary Contacts: | Helen Peng |
|---|---|
| Regulatory Affairs Director | |
| GE Healthcare | |
| Tel: 262-424-8222 | |
| Email: hong.peng@meg.ge.com |
PRODUCT IDENTIFICTION
| Device Name: | SnapShot Freeze 2 |
|---|---|
| Regulation number/ | |
| Product Code | 21 CFR 892.1750 Computed tomography x-ray system / |
| JAK | |
| Secondary Regulation | |
| number/Product Code | 21 CFR 892.2050 Picture archiving and communications system/ LLZ |
| Device Classification | Class II |
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of curved, teardrop-shaped elements, also in blue, that give the impression of motion or energy emanating from the central letters. The logo is simple, recognizable, and associated with a large, multinational corporation.
Predicate Device Information :
| Device Name | CardIQ Xpress 2.0 with SnopShot Freeze Option |
|---|---|
| Manufacturer | GE Medical System SCS (d.b.a GE Healthcare) |
| 510(k) number | K120910 cleared on June 18, 2012 |
| Regulation number | |
| /product Code | 21 CFR 892.1750 Computed tomography x-ray system, |
| JAK |
Device Description
SnapShot Freeze 2 (SSF 2) is a post processing software, which can be delivered on general purpose computing platforms. SnapShot Freeze 2 is an automated motion correction algorithm designed for use with gated cardiac acquisitions from GE CT scanners to reduce cardiac induced motion artifacts in the whole heart. It is based on the same fundamental algorithm as the predicate product commercially marketed under the name CardIQ Xpress 2.0 with SnapShot Freeze Option (K120910, AKA SSF 1). Same as its predicate device the SSF 2 algorithm works on multi-phase, gated cardiac CT DICOM compatible image data and produces a new image series in which motion artifact is reduced.
The device is marketed as SnapShot Freeze 2
Intended Use
SnapShot Freeze 2 is intended to be used for motion correction of gated cardiac image series
Indications for Use
SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
Technological Characteristic
SSF 2 employs the same fundamentally technology as that of the predicate. The motion correction algorithm fundamentally remains the same, taking the multi-phase temporal enhanced cardiac gated DICOM series, applying motion correction and producing the dramatically motion reduced DICOM dataset. The difference is that the SSF2 extends the motion correction capability to the whole heart beyond the coronary vessels as offered in the predicate.
Comparisons
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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are swirling shapes around the letters. The logo is simple and recognizable, and it is associated with a large and well-known company.
The most notable change in SSF 2 as compared to SSF1 is the ability to extend motion correction capability to the whole heart compared with only coronary vessel motion artifact reduction. This may enable new applications in assessing other structures of the heart that are impacted by motion artifacts.
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Specification/
Attribute | Predicate Device
CardIQ Xpress 2.0 with SnapShot
Freeze Option (K120910) | Proposed Device
SnapShot Freeze 2 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population | Patients referred for a CT
cardiovascular examination | Same |
| Contraindications | None | Same |
| Platforms | AW workstation, AW Server & CT
Console | AW workstation, AW Server, CT
Console & other platforms
including cloud-based computing
and image processing platforms |
| Input | 3-phase temporal cardiac image
series | Same |
| Output | Motion corrected target phase
image series | Same |
| Motion Correction
of coronary vessels | Yes – SSF algorithm is capable of
coronary vessel motion correction | Same |
| Whole heart motion
correction | Not Available | Yes, enchantment to the
algorithm demonstrates whole
heart motion correction |
| Effective Temporal
Resolution* | 6x improvement in reducing
blurring artifacts of the coronary
arteries due to cardiac motion.
Effective temporal resolution of
29 ms for 0.35 sec/rot gantry
speed. | 6x improvement in reducing
blurring artifacts of the coronary
arteries due to cardiac motion.
Effective temporal resolution of
29 ms for 0.35 sec/rot gantry
speed.
Effective temporal resolution of
24 ms for 0.28sec/rot gantry. |
*As demonstrated in mechanical and mathematical cardiac phantom testing.
7
SnapShot Freeze 2 does not introduce any new risks/hazards, warnings, or limitations.
Determination of Substantial Equivalence
Engineering bench testing was performed to support substantial equivalence and the product performance claims. The testing used a commercially available cardiac motion phantom with linear motion of variable velocity for modeling of the coronary vessels and the whole heart. The testing also used a mathematical phantom to demonstrate effective temporal resolution, coronary motion and whole heart motion correction. The combination of both analyses (from physical and mathematical motion phantoms) is intended to provide further confidence in the capabilities and full extent of the Snapshot Freeze 2 whole heart motion correction.
A representative clinical sample image set of 60 CT cardiac cases, focused on patient populations with elevated heart rate were assessed by three board certified radiologists using 5point Likert scale. This data is representative of routine clinical imaging from a cardiac acquisition perspective, but intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases, in which such an algorithm is most likely to be utilized. The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2.
SnapShot Freeze 2 has successfully completed the required design control testing per GE's quality system. No new hazards were identified, and no unexpected test results were obtained. SnapShot Freeze 2 was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the system:
- Risk Analysis
- Required Reviews
- Design Reviews
- Software Development Lifecycle
- Testing on unit level (Module verification)
- . Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The testing and results did not raise different questions of safety and effectiveness than associated with predicate device using device-based respiratory gating.
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Conclusion:
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Based on the conformance to standards, development under our quality system, and the engineering and clinical testing provided, GE Medical Systems believes that the SnapShot Freeze 2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnopShot Freeze Option.