(176 days)
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.
The Optima CT660 and its associated configurations/packages is a multi-slice CT scanner system consisting of a gantry, patient table, operator console, power distribution unit (PDU), associated accessories, and connections/interfaces to accessories. The system includes image acquisition hardware, image acquisition & reconstruction software, associated accessories, and connections/interfaces to accessories. ASiR advanced reconstruction technology is also an option on this product and was cleared in K093581.
The Optima CT660 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 UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21 CFR Subchapter J. It has been developed under the same GE quality system and has completed all design controls, including risk management, verification and validation.
Here's an analysis of the provided text regarding the Optima CT660, addressing your questions about acceptance criteria and study details.
Important Note: The provided document is a 510(k) Premarket Notification Summary for a CT Scanner. It's a regulatory submission to demonstrate substantial equivalence to a predicate device, not typically a comprehensive clinical study report for a novel AI algorithm or diagnostic tool. Therefore, many of your questions, especially those related to specific performance metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies, are not directly addressed in this type of document because they are not usually required for a substantial equivalence claim for a CT scanner itself.
The focus here is on demonstrating that the new device meets established safety and performance standards equivalent to existing devices.
1. A table of acceptance criteria and the reported device performance
Since this is a CT scanner and not a device that produces a diagnostic output that would have metrics like sensitivity or specificity, the "acceptance criteria" are related to compliance with regulations and performance equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | The Optima CT660 employs the same fundamental scientific technology, basic operating principles, and indications for use as the predicate device (K082761 - LightSpeed VCT). It adheres to the same standards and has completed all design controls including risk management, verification, and validation, concluding it is "as safe, as effective, and performance is substantially equivalent to the predicate device." |
| Compliance with Regulatory Standards | - IEC 60601-1 and associated collateral and particular standards. - 21 CFR Subchapter J (for CT X-ray systems). - UL 60601-1. - Designed and manufactured under Quality System Regulations of 21 CFR 820 and ISO 13485. |
| Risk Mitigation (Electrical, Mechanical, Radiation Hazards) | Risks identified through risk management (hazard analysis) and controlled by: - System verification and validation. - Adherence and certification to industry and international standards. - Compliance to applicable CDRH 21CFR subchapter J requirements. |
| Image Acquisition and Reconstruction Capabilities | Intended to produce cross-sectional images via Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions, with or without contrast. Includes signal analysis, display, data/image processing for various planes (transaxial, reformatted, post-processed). |
| Intended Use (Head, Whole Body, Cardiac, Vascular X-ray CT) | The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. (Matches predicate and unmodified device). |
| Performance Testing | Completed "performance testing (Verification)" and "comparison testing to the unmodified device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a test set or data provenance in the context of diagnostic performance studies. The "testing" mentioned refers to engineering verification and validation against technical specifications and regulatory standards, not clinical data performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of information is not present as a clinical diagnostic performance study with expert-adjudicated ground truth was not performed or detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Optima CT660 is a CT scanner, not an AI-assisted diagnostic tool for interpretation. There is a mention of "ASiR advanced reconstruction technology" as an option which was cleared in K093581, but no details of an MRMC study for ASiR are provided here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a CT scanner, the "ground truth" would relate to its ability to accurately acquire and reconstruct images according to physical specifications, not clinical diagnostic outcomes. The document indicates verification against specifications and comparison to the predicate device.
8. The sample size for the training set
Not applicable. This document is for a CT scanner, not a machine learning model developed with training data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this submission type.
Summary of the document's relevance to your questions:
This 510(k) summary focuses on demonstrating that the Optima CT660 (a new CT scanner) is substantially equivalent to a legally marketed predicate CT scanner. This means it has the same indications for use, employs the same fundamental technology, and meets the same safety and performance standards. It details engineering verification, validation, and compliance with regulations rather than clinical performance studies typically associated with AI/CAD devices, which would involve test sets, expert ground truth, and specific performance metrics.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and connected, creating a unique and recognizable design.
GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660
JUL 2 0 2011
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).
Date:
May 3, 2011
Submitter:
GE Healthcare (GE Medical Systems, LLC) 3000 N. Grandview Blvd., W-1140 Waukesha, WI 53188
Primary Contact:
John Jaeckle Requlatory Affairs Manager MI & CT GE Healthcare (GE Medical Systems, LLC) Tel: 262-312-7358 e-mail: john.jaeckle@ge.com
Secondary Contact:
Tracey Ortiz Requlatory Affairs Leader MI & CT GE Healthcare (GE Medical Systems, LLC) Tel: 262-544-3026 Fax: 414-918-1609 e-mail: tracey.ortiz@ge.com
Product Identification
Device Trade Name:
Common/Usual Name:
Computed Tomography X-ray System
Optima CT660
90-JAK
Classification Name:
Product Code:
Manufacturer: /Design Location: GE Healthcare Japan Corporation 7-127 Asahigaoka, 4-chome, Hino-shi Tokyo, 191-8503, Japan
Computed Tomography X-ray System per 21CFR 892.1750
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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame has a swirling, decorative pattern around the letters. The logo is black and white.
GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660
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
Distributor:
GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188
Marketed Devices:
The Optima CT660 is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomograhpy X-ray Systems that comply with the same standards. In addition, the system has similar indications for use as other GE Computed Tomograhpy X-ray Systems and identical indications as the unmodified device. The system is labeled as the Optima CT660 however the commercial names used for the configurations are Optima CT660 or Optima CT660 s.
Predicate Device:
K082761 - LightSpeed VCT (GE LightSpeed 7.2 CT Scanner System)
Device Description:
The Optima CT660 and its associated configurations/packages is a multi-slice CT scanner system consisting of a gantry, patient table, operator console, power distribution unit (PDU), associated accessories, and connections/interfaces to accessories. The system includes image acquisition hardware, imaqe acquisition & reconstruction software, associated accessories, and connections/interfaces to accessories. ASiR advanced reconstruction technology is also an option on this product and was cleared in K093581.
The Optima CT660 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 UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21 CFR Subchapter J. It has been developed under the same GE quality system and has completed all design controls, including risk management, verification and validation.
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Image /page/2/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 and the inner part of the circle are white, while the background is black.
GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660
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.
Technology:
The Optima CT660 employs the same fundamental scientific technology as its predicate device.
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 . Requlations, and user requirements.
- Adherence and certification to industry and international standards. (UL/CSA and IEC). .
- Compliance to applicable CDRH 21CFR subchapter J requirements. .
The device is designed and manufactured under the Quality System Regulations of 21CFR820.
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are decorative swirls or flourishes around the outer edge of the circle, adding a touch of elegance to the design. The logo is presented in black and white.
GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660
Determination of Substantial Equivalence:
The Optima CT660 has completed testing and is in compliance IEC 60601-1 and associated collateral and particular standards, and 21 CFR Subchapter J. The device has completed all testing per our quality system as well as comparison testing to the unmodified device. It was designed and is manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:
- Risk Analvsis .
- Requirement Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
Conclusion:
The Optima CT660 does not raise in any new potential safety risks and performs as well as devices currently on the market. The Optima CT660 CT system has been certified in accordance with the same standards as the predicate device. GE Healthcare considers the Optima CT660 to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracey Ortiz Regualtory Affairs Lead Engineer-MI & CT GE Healthcare, GE Medical Systems, LLC 3000 N. Grandview Blvd. W-1140 WAUKESHA WI 53188
Re: K110227
JUL 20 2011
Trade/Device Name: Optima CT660 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 3, 2011 Received: May 5, 2011
Dear Ms. Ortiz:
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 indictions for use stated in the enclosure) to legally marketed predicate devices market 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, Drig 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device or your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 tolli inte (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/6/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 letters are stylized and connected, creating a distinctive and recognizable mark. The logo is black and white.
GE Healthcare / GE Medical Systems, LLC 510(k) Premarket Notification Submission Product Name: Optima CT660
. Indications for Use
510(k) Number (if known): K110227
Device Name: Optima CT660
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, quiding, and monitoring therapy.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K
§ 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.