(92 days)
No
The summary mentions "computer reconstruction" and "data and image processing," which are standard techniques in CT imaging and do not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or related terms.
No
Explanation: The device is indicated for imaging and diagnosis, and for planning, guiding, and monitoring therapy, but it does not directly provide therapy itself.
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 indicates its role in diagnosis.
No
The device description explicitly states it is a "head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables," indicating it includes significant hardware components 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device produces cross-sectional images of the body using X-ray transmission data. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from it.
- Intended Use: The intended use is for generating images for diagnosis, planning, guiding, and monitoring therapy based on these images of the body.
- Input Data: The input is X-ray transmission data, which is acquired directly from the patient's body.
Therefore, this device falls under the category of medical imaging devices, specifically a Computed Tomography (CT) system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The system 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 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 trans-axial and reformatted planes. Further the image can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac 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
JAK
Device Description
The proposed device Revolution Ascend Sliding is a head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections.
Revolution Ascend Sliding generates cross-sectional images of the body by computer reconstruction of xray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.
CT is routinely used in interventional radiology (IR) and radiation oncology because it can provide outstanding spatial resolution and valuable geometric structure information for determining the treatment plan before a treatment procedure takes out place. In some clinical scenarios in radiation oncology and/or IR, it is not optimal to transport a patient to a separate room and/or a separate table to get a diagnostic CT image. To simplify the clinical workflow, some hospitals desire to have the treatment procedure to be done in the CT suite where the clinicians can do CT imaging and the treatment procedure in the same room without moving the patient between rooms. To support such improved clinical workflow, we have modified predicate device Revolution Ascend (K213938) by mounting the gantry to a transporter which allows the gantry linear movement on rails in longitude direction to scan the desired region of interest instead of having the patient on a traditional CT tabletop (a.k.a. Cradle) that moves in and out of the gantry bore in the predicate device.
Revolution Ascend Sliding includes all the available features on predicate device (K213938) and maintains the identical/equivalent performance and image quality specifications. Its Intended Use and indications for use remain identical to those of the unmodified predicate device. Revolution Ascend Sliding remains compliant with IEC 60601-1 Ed. 3.2 and associated collateral and particular standards, NEMA XR25, XR26, XR28, and 21CFR Subchapter J performance standards.
Mentions image processing
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the image 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 / X-ray Computed Tomography
Anatomical Site
head, whole body, cardiac
Indicated Patient Age Range
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: 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, software verification and validation testing as well as dose specifications and image quality testing in accordance with IEC 61223-3-5 ed.2 to demonstrate the overall system performance in a standardized and referenceable manner. Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device.
Clinical Testing: The Revolution Ascend Sliding CT system can be fully tested on the engineering bench thus no additional clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
February 22, 2024
GE Hangwei Medical Systems Co., Ltd. % Wenging Tian Lead Specialist, Regulatory Affairs West Area of Building No 3, No.1 Yongchang North Road Beijing Economic & Technological Development Area, Beijing 100176 CHINA
Re: K233749
Trade/Device Name: Revolution Ascend Sliding Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: January 23, 2024 Received: January 23, 2024
Dear Wenqing Tian:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233749
Device Name Revolution Ascend Sliding
Indications for Use (Describe)
The system 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 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 trans-axial and reformatted planes. Further the image can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
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3
Image /page/3/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of the GE monogram enclosed in a circle on the left, followed by the text "GE HealthCare" on the right. The color of the logo and text is a light purple.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 22, 2023 |
|---|---|
| Submitter: | GE Hangwei Medical System Co., Ltd. |
| West Area of Building No.3, No.1 Yongchang North Road, | |
| Beijing Economic and Technological Development Area, 100176 Beijing, | |
| P.R. China. | |
| Primary Contact: | Wenqing Tian |
| Lead Specialist, Regulatory Affairs | |
| Phone: +86-155-9370-8328 | |
| Email: Wenqing.TIAN@ge.com | |
| Secondary Contacts: | Helen Peng |
| Sr Regulatory Affairs Director | |
| Phone: 262-4248222 | |
| Email: hong.peng@med.ge.com | |
| Haibo He | |
| Regulatory Affairs Leader | |
| Phone: +86-010-5708-3413 | |
| Email: haibo.he1@ge.com | |
| Proposed Device/ | |
| Device Trade Name: | Revolution Ascend Sliding |
| Device Classification: | Class II |
| Regulation Number/ | |
| Product Code: | 21 CFR 892.1750 Computed Tomography X-ray System / JAK |
| Predicate Device Information | |
| Device Name: | Revolution Ascend |
| Manufacturer: | GE Healthcare Japan Corporation |
510(k) Number: K213938, Cleared on February 4, 2022
Device Classification: Class II
4
Image /page/4/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple.
Regulation Number/ 21 CFR 892.1750 Computed Tomography X-ray System / JAK Product Code:
Reference Device Information
| Device Name: | GE LightSpeed ACT FP16 |
|---|---|
| Manufacturer: | GE Medical System, LLC |
| 510(k) Number: | K091673 |
| Device Classification: | Class II |
| Regulation Number/ | |
| Product Code: | 21 CFR 892.1750 Computed Tomography X-ray System / JAK |
Device Description
The proposed device Revolution Ascend Sliding is a head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections.
Revolution Ascend Sliding generates cross-sectional images of the body by computer reconstruction of xray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.
CT is routinely used in interventional radiology (IR) and radiation oncology because it can provide outstanding spatial resolution and valuable geometric structure information for determining the treatment plan before a treatment procedure takes place. In some clinical scenarios in radiation oncology and/or IR, it is not optimal to transport a patient to a separate room and/or a separate table to get a diagnostic CT image. To simplify the clinical workflow, some hospitals desire to have the treatment procedure to be done in the CT suite where the clinicians can do CT imaging and the treatment procedure in the same room without moving the patient between rooms. To support such improved clinical workflow, we have modified predicate device Revolution Ascend (K213938) by mounting the gantry to a transporter which allows the gantry linear movement on rails in longitude direction to scan the desired region of interest instead of having the patient on a traditional CT tabletop (a.k.a. Cradle) that moves in and out of the gantry bore in the predicate device.
Revolution Ascend Sliding includes all the available features on predicate device (K213938) and maintains the identical/equivalent performance and image quality specifications. Its Intended Use and indications for use remain identical to those of the unmodified predicate device. Revolution Ascend Sliding remains compliant with IEC 60601-1 Ed. 3.2 and associated collateral and particular standards, NEMA XR25, XR26, XR28, and 21CFR Subchapter J performance standards.
Intended Use
The system is intended to be used for head, whole body Computed Tomography applications.
5
GE HealthCare 510(k) Premarket Notification Submission
Revolution Ascend Sliding
Image /page/5/Picture/2 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram in purple on the left, followed by the text "GE HealthCare" in purple. The monogram is a stylized version of the letters G and E intertwined.
Indications for Use
The system is intended to produce cross-sectional images of the body by computer reconstruction of Xray 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 supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial 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
Revolution Ascend Sliding employs the same basic operating principles and fundamental technologies as the predicate device and reference device.
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Subsystem | Revolution Ascend
(Predicate Device, K213938) | Revolution Ascend Sliding
(Proposed Device) |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gantry | Revolution Ascend Gantry
- Bore size: 75cm
- Physical Tilt | Revolution Ascend Sliding Gantry
- Bore size: 75cm
- Physical Tilt: Disabled |
| | Performix 40 Plus X-Ray Tube - Supports 40 mm beamwidth
- Liquid Metal rotor bearing
JEDI60DC High Voltage Generator - Peak Power: 72 kW
-55 kW option (software limit
on mA) | Performix 40 Plus X-Ray Tube - Supports 40 mm beam width
- Liquid Metal rotor bearing
JEDI60DC High Voltage Generator - Peak Power: 72 kW |
| | NGX Collimator (75cm bore) - 40 mm max z-coverage
Merc40H Detector - Backlit Diode technology
- Chiclet Module design
- GE low noise ASIC technology
used for signal conversion | NGX Collimator (75cm bore) - 40 mm max z-coverage
Merc40H Detector - Backlit Diode technology
- Chiclet Module design
- GE low noise ASIC technology used
for signal conversion |
6
Image /page/6/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple. The overall design is clean and corporate, representing the brand identity of GE Healthcare.
| Patient Support | - VT1700v Table
- Lite Table
- Table accessories | Patient Support equipment is stationary in
the horizontal axis, Gantry moves
horizontally with rails system. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Horizontal
movement | The patient table moves horizontally
to the gantry bore during a CT exam
while the gantry is stationary | The gantry mounted on a transporter
moves horizontally on rails towards the
patient who is positioned on a patient
support device that is stationary. The
transporter uses substantial design and
manufacturing process as the reference
device cleared in K091673. |
| Reconstruction | FBP
ASIR-V (K133640)
DLIR cleared with Revolution Ascend
(K212067, K230807). | Same |
| Standards | IEC 60601-1 Ed. 3.1
IEC 60601-1-2 Ed 4.0
IEC 60601-1-3 Ed 2.1
IEC 60601-2-28 Ed 3.0
IEC 60601-2-44 Ed. 3.2
IEC 61223-3-5 Ed. 2.0
NEMA XR-25
NEMA XR-26
NEMA XR-28 | IEC 60601-1 Ed. 3.2
IEC 60601-1-2 Ed 4.0
IEC 60601-1-3 Ed 2.2
IEC 60601-2-28 Ed 3.0
IEC 60601-2-44 Ed. 3.2
IEC 61223-3-5 Ed. 2.0
NEMA XR-25
NEMA XR-26
NEMA XR-28 |
The changes described above do not change the fundamental control mechanism, operating principle, energy type, and do not change the intended use from the predicate device Revolution Ascend.
Determination of Substantial Equivalence
The Revolution Ascend Sliding has completed testing and is in compliance with AAMI/ANSI ES 60601-1 and IEC60601-1 Ed. 3.2 and its associated collateral and particular standards, 21 CFR Subchapter J, and NEMA standards XR 25, XR 26, and XR 28. The device has successfully completed engineering design V &V and bench testing in support of substantial equivalence to the predicate device. The following quality assurance measures were applied to the development of the system:
- -Risk Analysis and Control
- -Required Reviews
- -Design Reviews
- -Testing on unit level (Module verification)
- -Integration testing (System verification)
- -Performance testing (Verification)
- -Safety testing (Verification)
GEHC believes the Revolution Ascend Sliding CT system is of comparable type and substantially equivalent to our currently marketed system Revolution Ascend (K213938).
7
GE HealthCare 510(k) Premarket Notification Submission Revolution Ascend Sliding
Image /page/7/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple.
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, software verification and validation testing as well as dose specifications and image quality testing in accordance with IEC 61223-3-5 ed.2 to demonstrate the overall system performance in a standardized and referenceable manner.
Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device.
Clinical Testing:
The Revolution Ascend Sliding CT system can be fully tested on the engineering bench thus no additional clinical testing was required.
Substantial Equivalence Conclusion
Based on the conformance to standards, development under our quality system, and the engineering testing provided, GE HealthCare believes that the Revolution Ascend Sliding is as safe and effective, and performs in a substantially equivalent manner to the unmodified predicate device Revolution Ascend (K213938).