(91 days)
K110227 - Optima CT660
Not Found
No
The document mentions "image processing" and "post processing" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of the changes focuses on hardware modifications for regulatory compliance and cost reduction, and software updates for bug fixes and new features, none of which are described as AI/ML-driven. The performance studies focus on traditional image quality metrics and clinical assessment by radiologists, not on the performance of an AI/ML algorithm.
No
The "Intended Use" section states that the device output is a valuable medical tool for the "diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy", indicating a diagnostic rather than a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy." This directly indicates its use for diagnostic purposes.
No
The device description explicitly states it is composed of hardware components including a gantry, patient table, operator console, computer, power distribution unit, and interconnecting cables, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the Optima CT660 produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is for producing images for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. This is consistent with an imaging device, not an IVD.
- Device Description: The components listed (gantry, patient table, operator console, etc.) are typical of a CT scanner, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Optima CT660 is a medical imaging device, specifically a CT scanner, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Product codes
90-JAK
Device Description
The Optima CT660 v2 CT system is composed of a gantry, patient table, operator console, computer, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition, reconstruction software, associated accessories, and connections/interfaces to accessories.
The current system configuration/package names are: Optima CT660, Optima CT660 Pro, Optima CT660 s, Optima CT660 sPro, Optima CT660SE, Optima CT660 FREEdom.
The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.35 seconds per rotation, and can acquire up to 64 slices/rows of data per rotation with a maximum total collimation coverage of 40mm in the z direction. The system can be operated in Axial, Cine, Helical, Cardiac and Gated acquisition modes.
The system is designed as an evolutionary modification to the Optima CT660 CT Scanner System (K110227). Most of hardware is identical to the predicate system, however some has undergone changes due to the need to meet IEC60601-1 Ed. 3 and RoHS regulation and also for reducing costs while maintaining performance, compliance, and specifications. The software has been updated in accordance with GE's quality management system procedures that incorporate the software development life cvcle to introduce the new features discussed in this submittal. Software updates were also made for quality (bug) fixes and to meet the new requirements of IEC 60601-2-44 Ed. 3.0.
The Optima CT660 v2 uses virtually the same materials and identical operating principle as our existing marketed product, except in the case of using the compensatory ROHS compliant materials. The image chain components (tube, collimator, detector, DAS) are virtually identical to the predicate device.
The changes do not affect the intended use, the indications for use, patient population nor fundamental operating principles of the currently commercially available predicate system and are the identical or similar to other GE CT systems and features previously cleared.
The Optima CT660 v2 CT system is intended to be a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. Materials and construction are equivalent to our existing marketed products which are compliant with ES 60601-1. IEC 60601-1 and associated collateral and particular standards, 21 CFR Subchapter J, and NEMA XR-25. The accompanying documents also contain the information in support if IEC61223-3-5 and IEC61223-2-6 for acceptance and constancy testing. All changes have been tested and certified by a NRTL and continue to meet all applicable IEC/UL safety standards.
Mentions image processing
This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
head, whole body, cardiac and vascular
Indicated Patient Age Range
patients of all ages
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Tests on phantoms confirmed that ODM enables reducing radiation dose in the superficial tissues while maintaining diagnostic image quality. Tests were also conducted on phantoms that confirmed the ODM enables equivalent mean CT number accuracy and uniformity.
For Ultra Kernel, phantoms were used to test and demonstrate that Ultra kernel improves visual spatial resolution while maintaining pixel noise standard deviation and level of image artifacts.
For High Helical Pitch, performance tests on phantoms were conducted and demonstrated that the helical pitch 1.531 meets GE's image quality specifications for lower pitch acquisitions.
Sample Clinical Images:
47 subject clinical exams representing various acquisition modes and body regions were collected and reviewed.
An assessment of diagnostic quality using a 5 point Likert scale was performed by two independent radiologists.
The image quality assessment on the sample clinical CT exam images obtained on the GE Healthcare Optima CT660 2.0 scanner with the three new features demonstrated that diagnostic results (and actual diagnoses) were obtained for all 47 subject exams. This sample data was representative of a wide range of anatomical coverage and patient indications and serves to help demonstrate the modified Optima CT660 2.0 scanner with the new features continues to perform as intended and in the substantially equivalent manner to the unmodified predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110227 - Optima CT660
Reference Device(s)
Not Found
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.
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510(k) Summary of Safety and Effectiveness
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: | May 30, 2013 |
|---|---|
| Submitter: | GE Healthcare GE Healthcare (GE Medical Systems, LLC) |
| 3000 N. Grandview Blvd., W-1140 Waukesha, WI 53188 | |
| Primary Contact Person: | Tomohiro Ito |
| Regulatory Affairs Leader, MI&CT | |
| GE Healthcare (GE Healthcare Japan Corporation) | |
| Tel: +81-42-585-5383 | |
| e-mail: tomohiro.ito@ge.com | |
| Secondary Contact | |
| Persons: | Helen Peng |
| Regulatory Affairs Manager, MI&CT | |
| GE Healthcare (GE Medical Systems, LLC) | |
| Tel: 262-548-5091 | |
| Fax: 262-364-2506 | |
| e-mail: hong.peng@ge.com | |
| AUG 3 0 2013 | |
| John Jaeckle | |
| Chief Regulatory Affairs Strategist | |
| GE Healthcare | |
| Tel: 262-424-9547 | |
| Fax: 262-364-2506 | |
| e-mail: John.Jaeckle@ge.com | |
| Product Identification: | Optima CT660 |
| Device Trade Name: | Optima CT660 |
| Common/Usual Name: | Computed Tomography X-ray System |
| Classification Names: | Computed Tomography X-ray System per 21CFR 892.1750 |
| Product Code: | 90-JAK |
:
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, giving the logo a classic and recognizable appearance. The logo is in black and white.
| Predicate Device | K110227 - Optima CT660 |
|---|---|
| Manufacturer: | |
| /Design Location: | GE Healthcare Japan Corporation |
| 7-127 Asahigaoka, 4-chome, Hino-shi Tokyo, 191-8503, | |
| Japan | |
| Manufacturing location | |
| (s): | GE Healthcare Japan Corporation |
| 7-127 Asahigaoka, 4-chome, Hino-shi Tokyo, 191-8503, | |
| Japan | |
| GE Medical Systems, LLC | |
| 3000 N. Grandview Blvd. Waukesha, WI 53188, USA | |
| GE Hangwei Medical Systems, Co, Ltd | |
| No.1, YongChang Street, Beijing Economic & Technical | |
| Development Area, Beijing PR, Beijing, 100176, China | |
| Distributor: | GE Medical Systems, LLC |
| 3000 N. Grandview Blvd. Waukesha, WI 53188, USA |
Marketed Devices:
The Optima CT660 v2 is of comparable type and substantially equivalent to its predicate device, GE Healthcare's currently marketed Computed Tomography X-ray System Optima CT660 (K110227). In addition, the system has similar indications for use as other GE Computed Tomography X-ray Systems and identical intended use and indications as the predicate device. The system is labeled as Optima CT660. The system has completed all design controls activities including risk management, verification and validation testing per GE's quality management system and complies with the same standards as the predicate device.
Device Description:
The Optima CT660 v2 CT system is composed of a gantry, patient table, operator console, computer, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition, reconstruction software, associated accessories, and connections/interfaces to accessories.
The current system configuration/package names are: Optima CT660, Optima CT660 Pro, Optima CT660 s, Optima CT660 sPro, Optima CT660SE, Optima CT660 FREEdom.
The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.35 seconds per rotation, and can acquire up to 64 slices/rows of data per rotation with a
2
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The design is simple and recognizable, representing the company's brand identity.
maximum total collimation coverage of 40mm in the z direction. The system can be operated in Axial, Cine, Helical, Cardiac and Gated acquisition modes.
The system is designed as an evolutionary modification to the Optima CT660 CT Scanner System (K110227). Most of hardware is identical to the predicate system, however some has undergone changes due to the need to meet IEC60601-1 Ed. 3 and RoHS regulation and also for reducing costs while maintaining performance, compliance, and specifications. The software has been updated in accordance with GE's quality management system procedures that incorporate the software development life cvcle to introduce the new features discussed in this submittal. Software updates were also made for quality (bug) fixes and to meet the new requirements of IEC 60601-2-44 Ed. 3.0.
The Optima CT660 v2 uses virtually the same materials and identical operating principle as our existing marketed product, except in the case of using the compensatory ROHS compliant materials. The image chain components (tube, collimator, detector, DAS) are virtually identical to the predicate device.
The changes do not affect the intended use, the indications for use, patient population nor fundamental operating principles of the currently commercially available predicate system and are the identical or similar to other GE CT systems and features previously cleared.
The Optima CT660 v2 CT system is intended to be a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. Materials and construction are equivalent to our existing marketed products which are compliant with ES 60601-1. IEC 60601-1 and associated collateral and particular standards, 21 CFR Subchapter J, and NEMA XR-25. The accompanying documents also contain the information in support if IEC61223-3-5 and IEC61223-2-6 for acceptance and constancy testing. All changes have been tested and certified by a NRTL and continue to meet all applicable IEC/UL safety standards.
The modified system has been developed under the same GE quality system and has completed all design controls, including risk management, verification and validation.
Intended Use:
The system is intended to be used for head, whole body Computed Tomography applications.
Indications for Use:
The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal
3
Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic, giving the logo a classic and recognizable look.
analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Technology:
The Optima CT660 v2 employs the same fundamental scientific technology as its predicate device and other marketed CT systems.
The modification for this 510(k) review is the introduction of the three new optional
features: Organ Dose Modulation (ODM); Ultra Kernel (UK); and High Pitch Helical (HPH).
Organ Dose Modulation
This feature enables prescription of X-Ray tube current modulation to control radiation dose to the anterior body surface where some sensitive organs such as breasts. thyroids, or eyes are located creating a virtual shield. It is a modification to our existing Automatic Exposure Control (AutomA/SmartmA) where the mA modulation now can be reduced over the user prescribed section of the rotations in consideration of more radiosensitive superficial organs/tissues ..
High Pitch Helical
Enables scanning at 30.62mm/rotation or 61.25mm/rotation for 20 and 40mm collimation respectively. This feature introduces a new higher pitch helical scan acquisition parameter that meets GE's existing helical image quality specifications.
Ultra Kernel
This is a new reconstruction kernel for filtered back projection that is designed for applications where improved detail is desired.
Potential Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management including hazard analysis and controlled by:
System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
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GE Healthcare
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. The letters and the circle are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.
510/k} Premarket Notification Submission for Optima CT660 v2
Adherence and certification to industry and international standards. (UL/CSA and . IEC).
- Compliance to applicable CDRH 21CFR subchapter J requirements. .
- Compliance to NEMA XR-25 .
The device is designed and manufactured under the Quality System Regulations of 21CFR820.
Determination of Substantial Equivalence:
The Optima CT660 v2 is a modified device based on the hardware and software platform of the predicate device. It was designed and is manufactured under GE's quality system that meet the Quality System Regulations of 21CFR 820 and ISO 13485. All the changes were fully verified and validated to the acceptance criteria per GE Healthcare's design control procedures under our quality system before the modified device was commercially introduced in applicable countries. In addition the Optima CT660 v2 has been successfully tested to demonstrate compliance with IEC 60601-1 (edition 3) and its associated collateral and particular standards. 21CFR Subchapter J. and NEMR XR-25. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Required Reviews .
- . Design Reviews
- . Testing on unit level (Module Verification)
- Integration testing (System Verification) .
- . Performance testing (Verification)
- . Safety testing (Verification)
- . Simulated use testing (Validation)
All changes were verified and validated on the bench, and the testing did not reveal any new questions of safety or effectiveness. GE believes the Optima CT660 v2 is of comparable type and substantially equivalent to our currently marketed system: Optima CT660 (K110227). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Summary of Additional Testing
- Non-Clinical Testing
In addition to the verification and validation testing successfully completed as required by GE Healthcare's quality system, additional engineering testing was performed to provide the requisite data to substantiate performance claims, safety and efficacy, and ultimately substantial equivalence.
These tests include the objective image quality acceptance testing conducted using phantoms and performed in accordance IEC 61223-3-5 as well as the following specific tests performed on the new features:
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KB1576
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For Organ Dose Modulation, tests on phantoms confirmed that ODM enables reducing radiation dose in the superficial tissues while maintaining diagnostic image quality. . Tests were also conducted on phantoms that confirmed the ODM enables equivalent mean CT number accuracy and uniformity.
For Ultra Kernel, phantoms were used to test and demonstrate that Ultra kernel improves visual spatial resolution while maintaining pixel noise standard deviation and level of image artifacts.
For High Helical Pitch, performance tests on phantoms were conducted and demonstrated that the helical pitch 1.531 meets GE's image quality specifications for lower pitch acquisitions.
Sample Clinical Images
47 subject clinical exams representing various acquisition modes and body regions were collected and reviewed. The exams acquired used either one or more of the 3 new features or were acquired using the system without the new features at the physician's discretion. An assessment of diagnostic quality using a 5 point Likert scale was performed by two independent radiologists.
The image quality assessment on the sample clinical CT exam images obtained on the GE Healthcare Optima CT660 2.0 scanner with the three new features demonstrated that diagnostic results (and actual diagnoses) were obtained for all 47 subject exams. This sample data was representative of a wide range of anatomical coverage and patient indications and serves to help demonstrate the modified Optima CT660 2.0 scanner with the new features continues to perform as intended and in the substantially equivalent manner to the unmodified predicate device.
Conclusion:
The Optima CT660 v2 does not raise any new potential safety risks and performs as well as devices currently on the market. Based on the conformance to standards, development under our quality system, engineering testing, and sample clinical images provided, GE Healthcare believes that the Optima CT660 v2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device, Optima CT600 (K110227).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
GE Medical Systems, LLC % Ms. Helen Peng Regulatory Affairs Manager 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K131576 Trade/Device Name: Optima CT660 V2 Regulation Number: 21 CFR 892.1750 Regulation Name: Commuter Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: August 16, 2013 Received: August 19, 2013
Dear Ms. Peng:
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 cither 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
7
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris 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):
Device Name: Optima CT660 V2
Indications for Use:
The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
$m_{h,p}$).
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K131576
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