(87 days)
Yes
The document explicitly states that "Auto Positioning uses Deep Learning CNNs to determine the scout's landmark location and the patient orientation". Deep Learning CNNs are a type of Artificial Intelligence/Machine Learning.
No.
The device is described as an optional feature for GE CT systems, intended to streamline workflow, enhance safety checks, and optimize patient positioning for imaging, not to provide therapy.
No
The device is an "optional feature developed for use with GE CT systems" and its "purpose... is to provide both a streamlined workflow and enhanced quality and safety checks during the exam setup process up to the initiation of the first scout scan." It does not produce diagnostic images or provide diagnostic evaluations.
No
The device description explicitly states that Auto Positioning uses a "fixed, ceiling mounted, off the shelf, 2D/3D video camera" as a component, indicating it includes hardware beyond just software.
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 Auto Positioning feature described here is a workflow and safety tool for setting up CT scans. It uses a camera and software to position the patient correctly for imaging. It does not analyze biological samples from the patient.
- Intended Use: The intended use is to improve the efficiency and safety of the CT exam setup process, not to diagnose or monitor a disease or condition based on in vitro analysis.
- Device Description: The description focuses on the camera, software, and how it interacts with the CT system and patient positioning. There is no mention of analyzing biological samples.
Therefore, the Auto Positioning feature is a component of a medical imaging system (CT scanner) that assists in the imaging process, but it is not 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.
Intended Use / Indications for Use
The Auto Positioning feature provides an alternate, streamlined and efficient workflow and safety checks for the CT technologist in setting up CT examinations of the initiation of the first scout scan.
Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout's start and end locations. Concurrently it checks for proper patient orientation, determines the table height for optimum patient centering, and checks for potential contact between the patient and the gantry. Upon acceptance by the technologist the patient is automatically moved to the correct scout start location.
Use of Auto Positioning is intended to provide consistent patient positioning for optimal image quality and automatic exposure control.
Product codes
JAK
Device Description
Auto Positioning is an optional feature developed for use with GE CT systems. The purpose of this feature is to provide both a streamlined workflow and enhanced quality and safety checks during the exam setup process up to the initiation of the first scout scan. Incorporation of this optional feature does not preclude the technologist from preforming the existing manual workflow on the CT system, if desired.
Auto Positioning uses a fixed, ceiling mounted, off the shelf, 2D/3D video camera that is capable of determining distances to points in its field of view. It displays standard RGB video images on the CT system's existing gantry-mounted touchscreens. Information from the standard output of the camera, precise spatial information of the individual CT system's gantry and table installation geometry, and information contained in the user-selected protocol is used to determine the anatomical landmark location and the start and end locations for the scout scan(s).
Addition functionality of Auto Positioning includes performing safety checks for patient orientation and the potential for the patient to come into contact with the gantry while the patient is placed into the gantry and during scanning.
Mentions image processing
Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout's start and end locations.
Mentions AI, DNN, or ML
Auto Positioning uses Deep Learning CNNs to determine the scout's landmark location and the patient orientation based on the standard outputs from the 2D/3D camera and the information in the user selected protocol.
Input Imaging Modality
2D/3D video camera
Anatomical Site
Not Found
Indicated Patient Age Range
All ages
Intended User / Care Setting
CT technologist / Hospitals, outpatient clinics, research institutions, and other clinical facilities.
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
Not Found
Summary of Performance Studies
Non-Clinical Testing: This testing included evaluation of the landmark location and the scout scan's start and end location. All testing met its predefined acceptance criteria.
Clinical Testing: The Auto Positioning can be fully tested on the engineering bench thus no additional clinical testing was required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Hangwei Medical Systems, Co., Ltd. % Yonghui Han Regulatory Affairs Leader West Area of Building No.3, No.1 Yongchang North Road Beijing, 100176 CHINA
January 16, 2020
Re: K192956
Trade/Device Name: Auto Positioning Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 18, 2019 Received: October 21, 2019
Dear Yonghui Han:
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
1
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
Section 4: Indications for Use Statement
Auto Positioning
3
Indications for Use
510(k) Number (if known) K192956
Device Name Auto Positioning
Indications for Use (Describe)
The Auto Positioning feature provides an alternate, streamlined and efficient workflow and safety checks for the CT technologist in setting up CT examinations of the initiation of the first scout scan.
Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout's start and end locations. Concurrently it checks for proper patient orientation, determines the table height for optimum patient centering, and checks for potential contact between the patient and the gantry. Upon acceptance by the technologist the patient is automatically moved to the correct scout start location.
Use of Auto Positioning is intended to provide consistent patient positioning for optimal image quality and automatic exposure control.
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."
4-2
4
Image /page/4/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 has a swirling pattern around the letters, giving the impression of movement or energy.
GE Healthcare 510(k) Premarket Notification Submission for Auto Positioning
510(k) Summary
Auto Positioning
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is blue and white.
510(k) Premarket Notification Submission for Auto Positioning
510(k) Summary
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 19, 2019 |
|---|---|
| Submitter: | GE Hangwei Medical System Co.,Ltd |
| West Area of Building No.3, No.1 Yongchang North | |
| Road, Beijing Economic and Technological | |
| Development Area, BEIJING 100176 CHINA | |
| Primary Contact Person: | Mr. Yonghui Han |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone Number: (86)-10-57083350 | |
| e-mail: yonghui.han@ge.com | |
| Secondary Contact Persons: | John Jaeckle |
| Chief Regulatory Affairs Engineer and Strategist | |
| GE Healthcare | |
| Phone Number: 262-424-9547 | |
| e-mail: John.Jaeckle.com |
Helen Peng
Sr Regulatory Affairs Director
GE Healthcare
Phone Number: 262-4248222
e-mail: hong.peng@ge.com |
| Product Identification | Auto Positioning |
| Device Trade Name: | Auto Positioning |
| Classification Names: | Computed Tomography X-ray System,
21CFR892.1750 (Class II) |
| Product Code: | 90-JAK |
| Manufacturer | GE Hangwei Medical System Co., Ltd
West Area of Building No.3, No.1 Yongchang North
Road, Beijing Economic and Technological
Development Area BEIJING 100176 CHINA |
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive. The blue circle provides a distinct border and background for the letters.
510(k) Premarket Notification Submission for Auto Positioning
Predict Device:
| Device Name | GE's Optima CT660 |
|---|---|
| 510 (K) number | K131576 |
| Regulation Number/Classification | Computed Tomography X-ray System, 21 CFR 892.1750 / |
| Class II | |
| Product Code | 90-JAK |
Reference Device:
| Device Name | Siemens SOMATOM CT family |
|---|---|
| 510 (K) number | K173630 |
| Regulation Number/ | Computed Tomography X-ray System, 21 CFR 892.1750 / |
| Classification | Class II |
| Product Code | 90-JAK |
Reference Device:
| Device Name | GE's Revolution Maxima |
|---|---|
| 510 (K) number | K192686 |
| Regulation Number/ | Computed Tomography X-ray System, 21 CFR 892.1750 / |
| Classification | Class II |
| Product Code | 90-JAK |
Marketed Devices:
Auto Positioning provides both a streamlined workflow and enhanced quality and safety checks during the exam set up process up to the initiation of the first scout scan. Auto Positioning is built upon the existing workflow of the predicate device, GE Healthcare' s currently marketed Computed Tomography X-ray System Optima CT660 (K131576). It is of comparable type and substantially equivalent to Optima CT660 and the Siemens Reference device.
Auto Positioning is a patient positioning workflow enhancement tool and intended to work together with a GE CT System. It doesn't change the Intended Use or the Indications for Use of
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle and the letters are both in a light blue color.
510(k) Premarket Notification Submission for Auto Positioning
the CT system it is used with. Auto Positioning's Intended Use aligns and correspond with the predicates device's Intended Use.
Device Description:
Auto Positioning is an optional feature developed for use with GE CT systems. The purpose of this feature is to provide both a streamlined workflow and enhanced quality and safety checks during the exam setup process up to the initiation of the first scout scan. Incorporation of this optional feature does not preclude the technologist from preforming the existing manual workflow on the CT system, if desired.
Auto Positioning uses a fixed, ceiling mounted, off the shelf, 2D/3D video camera that is capable of determining distances to points in its field of view. It displays standard RGB video images on the CT system's existing gantry-mounted touchscreens. Information from the standard output of the camera, precise spatial information of the individual CT system's gantry and table installation geometry, and information contained in the user-selected protocol is used to determine the anatomical landmark location and the start and end locations for the scout scan(s).
Information from the standard output of the camera, precise spatial information of the individual CT system's gantry and table installation geometry, and information contained in the userselected protocol is used to determine the anatomical landmark location and the start and end locations for the scout scan(s).
Addition functionality of Auto Positioning includes performing safety checks for patient orientation and the potential for the patient to come into contact with the gantry while the patient is placed into the gantry and during scanning.
Intended Use:
Auto Positioning is intended for use with head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Indications for Use:
The Auto Positioning feature provides an alternate, streamlined and efficient workflow and performs quality and safety checks for the CT technologist in setting up CT examinations up to the initiation of the first scout scan.
Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout's start and end locations. Concurrently it checks for proper patient orientation, determines the table height for optimum patient centering, and checks for potential contact between the patient and the gantry. Upon acceptance by the technologist the patient is automatically moved to the correct scout start location.
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive. The blue circle provides a border around the letters, making the logo easily recognizable.
510(k) Premarket Notification Submission for Auto Positioning
Use of Auto Positioning is intended to provide consistent positioning for optimal image quality and automatic exposure control.
Technology Comparison:
Auto Positioning's functionality in setting up CT examinations is an automated version of the existing steps in the predicate's (and other GE CTs') current manual workflow and does not change the underlying principles. In addition, Auto Positioning introduces enhanced quality and safety checks during the exam setup. At any time during the use of Auto Positioning the operator can switch back to manual positioning.
The Auto Positioning feature can only be used with a host CT system that has a compatible gantry touchscreen(s) and the Auto Positioning-specific software integrated onto the CT system's host computer. Auto Positioning's major components consists of the ceiling mounted camera, Auto Positioning software, calibration tools, and compatible gantry touchscreen(s).
Auto Positioning was first integrated on the GE Revolution Maxima (K192686) CT System. Auto Positioning shares very similar technology, hardware, and functions with the corresponding functionality of the reference device, Siemens SOMATOM CT family with FAST Integrated Workflow (K173630).
| The table below summarizes the substantive feature/technological differences between the | ||||||
|---|---|---|---|---|---|---|
| predicate device and the proposed device: | ||||||
| . |
| Attribute | Predicate Device | Proposed Device |
|---|---|---|
| Optima CT660 (K131576) | Auto Positioning | |
| Exam Setup | ||
| Workflow | Manual workflow to set the landmark, | |
| patient centering, the scout's start and | ||
| end locations, and the scout's start | ||
| table position. | Automated workflow to set the | |
| landmark, patient centering, the scout's | ||
| start and end locations, and the scout's | ||
| start table position. | ||
| Additional, automatic safety checks for | ||
| patient orientation and patient/gantry | ||
| collision. | ||
| Use of Deep | ||
| Learning for | ||
| exam set up | The manual workflow for exam setup | |
| does not utilize deep learning. | Auto Positioning uses Deep Learning | |
| CNNs to determine the scout's landmark | ||
| location and the patient orientation | ||
| based on the standard outputs from the | ||
| 2D/3D camera and the information in the | ||
| user selected protocol. | ||
| Hardware | ||
| Needed to | ||
| Support the | Manual patient positioning does not | |
| require any unique hardware beyond | ||
| the what are on the CT system. | The Auto Positioning feature requires a | |
| ceiling mounted, off the shelf 2D/3D | ||
| camera and requires a compatible gantry |
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. Three curved arrows surround the circle, suggesting motion or energy.
510(k) Premarket Notification Submission for Auto Positioning
| Patient
Positioning | The hardware used for manual
positioning includes: gantry alignment
lasers, table motion control switches on
the gantry, table, and operator console. | touchscreen
In corporation of the Auto Positinoing
feature does not remove or disable any
of the functionalities for manual patient
positioning. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Population | All ages | All ages |
| Environment
of Use | Hospitals, outpatient clinics, research
institutions, and other clinical facilities. | Hospitals, outpatient clinics, research
institutions, and other clinical facilities. |
Risk Analysis:
Potential electrical and mechanical hazards are identified in risk management including hazard analysis and controlled by:
- System verification and validation to ensure performance to specifications, Federal । Regulations, and user requirements.
- । Adherence and certification to industry and international standards. (UL/CSA and IEC60601-1 Ed.3.1 and associated collateral and particular standards for CT).
The device is designed and manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485.
Testing Summary:
The Auto Positioning feature is developed and tested under the same design controls processes, software development life cycle, risk management, and GE quality system as the predicate. Additional engineering bench testing in support of this submission. All testing was successfully completed without unexpected results.
Subsystem verification, system verification testing including hazard mitigation has been performed with their results demonstrating the Auto Positioning feature meets its design inputs and user needs. Auto Positioning meets the requirements IEC60601-1 Ed. 3.1 and its associated collateral and particular standards.
No new hazards were identified. New causes and mitigations were identified, and their impacts were fully tested without unexpected results. Auto Positioning 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
10
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in a blue color.
510(k) Premarket Notification Submission for Auto Positioning
- Software Development Lifecycle ●
- Testing on unit level (Module verification)
- Integration testing (System verification)
- . Performance testing (Verification)
- o Safety testing (Verification)
- . Simulated use testing (Validation)
GE believes the Auto Positioning system is of comparable type and substantially equivalent to currently marketed system GE Optima CT660(K131576).
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Summary of Additional Testing
Non-Clinical Testing:
The verification and validation testing have been successfully completed as required by design control procedures under GE Healthcare's quality system. This includes risk management and, software verification and validation testing.
Because Auto Postioning is for the exam setup process up to the initiation of the first scout scan, and does not involve diagnostic imaging or diagnostic evaluation, non-clinical bench testing is appropriate. This testing included evaluation of the landmark location and the scout scan's start and end location. All testing met its predefined acceptance criteria.
Clinical Testing:
The Auto Positioning can be fully tested on the engineering bench thus no additional clinical testing was required.
Determination of Substantial Equivalence
The Substantial Equivalence of the proposed device has been demonstrated by:
- 트 Review of the proposed Indications for Use shows that it is substantially equivalent to the predicate. Auto Positioning's Indications for Use do not create a new Intended Use.
- 그 The device description and the comparison of device characteristics show that Auto Positioning does not alter energy type, operating primary control mechanisms as compared to the predicate device.
- The bench testing demonstrates the effectivity of Auto Positioning for its use as a streamlined, alternate CT exam setup workflow.
11
Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized, cursive font. The letters are enclosed within a blue circle, and there are swirling, wave-like shapes surrounding the letters within the circle, giving the logo a dynamic and recognizable appearance.
510(k) Premarket Notification Submission for Auto Positioning
- The integration of Auto Positioning does not change the IEC standards or 21CFR1020.30 & .33 compliance of the host CT system. The unmodified host CT system's alignment lasers remain available with the Auto Positioning feature.
- The different technological characteristics do not raise new or different questions of safety and effectiveness. The proposed device is as safe and effective as the legally marketed predicate device as demonstrated by the:
- software verification and validation without unexpected results; O
- o development under GE's quality management system, design control activities including risk management
- device labeling ; and o
- engineering bench testing without unexpected results. o
Substantial Equivalence Conclusion:
Auto Positioning's Indications for Use do not create a new Intended Use. Auto Positioning has identical or equivalent technological characteristics as its predicate device and the Siemens' reference device. There is no impact on energy type, operating principles, or primary control mechanisms.
The Auto Positioning was developed under GE Healthcare's quality system. Design verification, along with bench testing included demonstrate that Auto Positioning is substantially equivalent and hence as safe and as effective as the legally marketed predicate and reference devices. GE's quality system's design, verification, and risk management processes did not identify any new hazards, unexpected results, or adverse effects stemming from the changes to the predicate.
Based on development under GE Healthcare's quality system, the successful verification testing and engineering bench testing, GE Healthcare believes that Auto Positioning is substantially equivalent to the predicate device (K131576) and the similar functionality on the Siemens reference device (K173630), and hence is safe and effective for its intended use.