(276 days)
Not Found
No
The document mentions image processing techniques like ADRO, but explicitly states they are "based on CPU" or "based on GPU," and there is no mention of AI, ML, or related terms.
No.
The Device Description and Intended Use sections state that the device is an X-ray system used for generating images to help physicians visualize anatomy and localize clinical regions, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device description states that the OEC One ASD is used during "diagnostic, interventional, and surgical procedures" and helps physicians "visualize the patient's anatomy and localize clinical regions of interest," indicating its role in diagnosis.
No
The device description clearly outlines a physical C-arm X-ray system with hardware components like a mobile stand, articulating arm, image display monitor, TechView tablet, C-shaped apparatus, flat panel detector, and X-ray Source assembly. While it includes software for image processing, it is not solely 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 OEC One ASD is an X-ray system that provides fluoroscopic and digital spot images of the patient's anatomy during procedures. It directly images the patient's body, not samples taken from the body.
- Intended Use: The intended use clearly states it's for providing images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. This involves imaging the living patient.
- Device Description: The description details a mobile C-arm X-ray system with a flat panel detector and X-ray source, designed to be positioned around the patient.
The device is a medical imaging system used for visualizing internal structures of the body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
Product codes
OXO, JAA, OWB
Device Description
The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.
The subject device is labelled as OEC One ASD.
The primary change for the subject device is to introduce an amorphous silicon (a-Si) flat panel detector as the image receptor. Roadmap functionality, which is optional in the predicate device (K182626), has been removed and a printer shelf has been integrated into the subject device to place the applicable printer on.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patient populations
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 Performance Testing: The verification and validation testing has been successfully completed as required by design control procedures under GE HealthCare's quality system and is compliant with FDA-recognized consensus standards and FDA guidance documents. All applicable 21CFR Subchapter J performance standards are met. Quality assurance measures included Risk Analysis, Required Reviews, Design Reviews, Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation).
Clinical Testing: Comparative clinical images were evaluated to demonstrate substantial equivalence for the OEC One ASD compared to the cleared predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the date December 27, 2024. The month is December, the day is the 27th, and the year is 2024. The date is written in a clear, sans-serif font. The text is black on a white background.
Image /page/0/Picture/1 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 and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name, "U.S. Food & Drug Administration," is in blue text.
GE Hualun Medical Systems Co. Ltd. % Michelle Huettner Director, Regulatory Affairs - IGT and Oncology No 1 Yong Chang North Road. Beijing Economic Technological Development Zone, Beijing CHINA 100176
Re: K240828
Trade/Device Name: OEC One ASD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, JAA, OWB Dated: November 28, 2024 Received: November 29, 2024
Dear Michelle Huettner:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/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,
Digitally signed Gabriela M. by Gabriela M. Rodal -S for Rodal -S
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
Enclosure
3
Indications for Use
510(k) Number (if known) K240828
Device Name OEC One ASD
Indications for Use (Describe)
The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
| 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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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. The logo is clean and professional, representing the brand identity of GE Healthcare.
510(k) Number: K240828
510(k) Summary of Safety and Effectiveness
OEC One ASD
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Image /page/5/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of the GE monogram in a purple circle on the left, followed by the text "GE HealthCare" in purple. The text is written in a sans-serif font.
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: | December 27, 2024 |
|---|---|
| Submitter: | GE HUALUN MEDICAL SYSTEMS CO., Ltd |
| No. 1 Yong Chang North Road, | |
| Beijing Economic Technological Development Zone, Beijing 100176 | |
| China | |
| Primary Contact: | Lifeng Wang |
| Regulatory Affairs Manager- IGT | |
| Tel: +8613381164329 | |
| e-mail: lifeng.wang@gehealthcare.com | |
| Secondary Contacts: | Michelle Huettner |
| Director, Regulatory Affairs - IGT and Oncology | |
| GE HealthCare | |
| Tel: 901-558-8035 | |
| e-mail: michelle.huettner@gehealthcare.com |
PRODUCT IDENTIFICATION
| Device Trade Name: | OEC One ASD |
|---|---|
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OXO |
| Subsequent Product Codes | JAA, OWB |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., Ltd |
| No. 1 Yong Chang North Road, | |
| Beijing Economic Technological Development Zone | |
| Beijing 100176 China |
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Image /page/6/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is a shade of purple.
Predicate Device:
| Device Name: | OEC One |
|---|---|
| 510(k) number: | K182626 |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., Ltd |
| No. 1 Yong Chang North Road, | |
| Beijing Economic Technological Development Zone, | |
| Beijing 100176 China | |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB |
| Subsequent Product Code: | OXO, JAA |
Device Description:
The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.
The subject device is labelled as OEC One ASD.
The purpose of this premarket notification is to demonstrate that the subject device, OEC One ASD, is a modification of and is substantially equivalent to the predicate device OEC One (K182626).
Proposed Device Modification:
The modified OEC One ASD employs the same fundamental scientific technology as that of the unmodified predicate device (K182626). The primary change for the subject device is to introduce an amorphous silicon (a-Si) flat panel detector as the image receptor. Roadmap functionality, which is optional in the predicate device (K182626), has been removed and a printer shelf has been integrated into the subject device to place the applicable printer on.
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Image /page/7/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a purple circle on the left, followed by the text "GE HealthCare" in purple. The text is in a sans-serif font and is aligned to the right of the monogram.
Indications for Use:
The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
The intended use and indications for use are unchanged from the predicate device.
Technology:
The indications for use are identical and the technology is similar to the predicate device.
The primary change on the subject device is to introduce an Amorphous Silicon (a-Si) solid state flat panel X-ray detector. A printer shelf is integrated into the subject device for the user to place the applicable printer on. The electrical boards have been re-laid out or redesigned to be more compact to make space for the printer shelf. The image shape changed from a circle to a squircle by introducing the flat panel detector and squircle secondary collimator. The X-Ray source monoblock remains unchanged from that of the predicate device OEC One (K182626). The hardware changes also include using an up-to-date computer, tablet and monitor that offers more image storage, processing speed, and higher resolution display, driven by IT technology advancement.
Its software is based on the architecture, design and code base of the predicate device OEC One (K182626). The software architecture framework was updated to a platform-based architecture with no significant changes in order to support different OEC C-Arm products. The modifications were also being made to support the flat panel detector, the necessary imaging and post-processing applications related to the flat panel detector, and device specific features/functionality. The design followed the same design control process and software development lifecycle process that is compliant to IEC 62304 used in the predicate OEC One.
The table below compares the main performance data of the proposed device with the predicate device.
| | Predicate Device
OEC One (K182626) | Subject Device
OEC One ASD | Discussion of differences |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Receptor | Image Intensifier
Detective Quantum
Efficiency (DQE): 65%
Modulation Transfer
Function (MTF): 45% | 21cm Amorphous Silicon
(a-Si) Flat Panel Detector
DQE: 70% (0 lp/mm)
MTF: 46% (1.0 lp/mm) | Substantially Equivalent.
The change of the image receptor is
to enhance the device performance. |
| | Predicate Device
OEC One (K182626) | Subject Device
OEC One ASD | Discussion of differences |
| | Field of View:
• 9 inch
• 6 inch
• 4.5 inch | Field of View:
• 21 cm
• 15 cm
• 11 cm | No new hazards or hazard situations were raised due to this change.
The performance testing indicated that the subject device is still effective.
This change did not raise any new safety and effectiveness concerns. |
| Image Matrix Size | $1000\times1000$ | $1520\times1520$ | Substantially Equivalent.
This change is driven by the detector pixel matrix to get higher resolution.
This change did not raise any new safety and effectiveness concerns. |
| Image Shape | Circle | Squircle | Substantially Equivalent.
The squircle shape provides an enhanced viewing area without exposing the areas at the corners, which are not typically clinically needed.
The squircle design can maintain the identical size and shape even when the image is rotated.
This change did not raise any new safety and effectiveness concerns. |
| Anti-scatter Grid | Line Rate: 60 L/cm
Ratio: 10:1
Focal Distance: 100 cm | Line Rate: 74 L/cm
Ratio: 14:1
Focal Distance: 100 cm | Substantially Equivalent.
The grid's specification is defined based on the image receptor's pixel size, which has been updated because of the introduction of flat panel detector.
This change did not raise any new safety and effectiveness concerns. |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| Monoblock | Type: Stationary Anode | Type: Stationary Anode | Identical. |
| | Focal Spot: 0.6 x 1.4 & 1.4
(IEC60336) | Focal Spot: 0.6 x 1.4 & 1.4
(IEC60336) | |
| | Anode Heat Capacity:
76,000 H.U. | Anode Heat Capacity:
76,000 H.U. | |
| | Anode Cooling Rate:
37,000 H.U/min | Anode Cooling Rate:
37,000 H.U/min | |
| | Housing Heat Capacity:
900,000 H.U | Housing Heat Capacity:
900,000 H.U | |
| | Housing Cooling Rate:
12,500 H.U./min | Housing Cooling Rate:
12,500 H.U./min | |
| X-ray
Generator | 40 kHz High Frequency | 40 kHz High Frequency | Substantially Equivalent.
mA range changing in Fluoroscopy
mode is caused by different image
processing parameters of Auto
Brightness Stable (ABS) to get
optimized image quality.
mA range changing in Digital Spot
mode is to get optimized image
quality by increasing tube current
(mA) especially on thin anatomy
such as hands.
This change did not raise any new
safety and effectiveness concerns. |
| | Max Power 2.5 kW | Max Power 2.5 kW | |
| | Peak Tube Potential: 40-110 kVp | Peak Tube Potential: 40-110 kVp | |
| | Fluoroscopy: 0.1-4.0 mA | Fluoroscopy: 0.1-8.0 mA | |
| | High Level Fluoro: 0.2-25.0 mA | High Level Fluoro: 0.2-25.0 mA | |
| | Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | |
| | Digital Spot: 0.2-10.0 mA
(for 100-120V system) | Digital Spot: 2-10.0 mA
(for 100-120V system) | |
| Collimator | Iris, Tungsten Dual Leaf
Shutter | Iris, Tungsten Dual Leaf
Shutter | Substantially Equivalent.
Secondary collimator has been
modified to achieve the squircle
field of view.
This change did not raise any new
safety and effectiveness concerns. |
| | Collimator Iris Preview | Collimator Iris Preview | |
| | Collimator Shutter
Preview | Collimator Shutter
Preview | |
| | Circle shape secondary
collimator | Squircle shape secondary
collimator | |
| X-ray Control
Modes | Auto Mode
Manual Mode
(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Auto Mode
Manual Mode
(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Identical. |
| | Predicate Device
OEC One (K182626) | Subject Device
OEC One ASD | Discussion of differences |
| Imaging
Modes | Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose | Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose | Substantially Equivalent. |
| | Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose | Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose | Digital Spot Low Dose mode will not be provided as Digital Spot mode creates a short-duration, high mA exposure to produce a single high quality image. Therefore, the low dose mode is not necessary for Digital Spot mode. The user can still get similar functionality by using Fluoroscopy. |
| | Digital Spot Normal Dose Low Dose | Digital Spot Normal Dose | Roadmap mode will not be provided based on marketing positioning, however, user can still get the similar functionality by applying the peak opacify function on contrast-agent-flowed cine. |
| | Roadmap Normal Dose Low Dose | Subtraction Normal Dose Low Dose | |
| | Subtraction Normal Dose Low Dose | | This change did not raise any new safety and effectiveness concerns. |
| Imaging
Features | Auto X-Ray technique control | Auto X-Ray technique control | Substantially Equivalent. |
| | Noise and motion reduction (TNR) | Noise and motion reduction (TNR) | Digital Pen (previously cleared in OEC Elite K171565) has been added so that user can draw lines on image display for planning or educational purposes. |
| | Auto/Manual Brightness and Contrast Control | Auto/Manual Brightness and Contrast Control | Zoom feature has improved with Live Zoom so it could be performed during a fluoro shot or Cine run. |
| | Negate | Negate | |
| | Swap and auto-swap | Swap and auto-swap | |
| | Save and auto-save | Save and auto-save | These changes did not raise any new safety and effectiveness concerns. |
| | Last image hold | Last image hold | |
| | Edge enhancement | Edge enhancement | |
| | Zoom & Roam | Zoom (Live Zoom) & Roam | |
| | Image rotation | Image rotation | |
| | Image flip/invert | Image flip/ invert | |
| | Manual/Auto Smart Metal | Manual/Auto Smart Metal | |
| | AutoTrak | AutoTrak | |
| | Patient Annotation | | |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| | Markers | Patient Annotation | |
| | Measurement Functions | Markers | |
| | Peak Opacification | Measurement Functions | |
| | Cine Recording/Playback | Peak Opacification | |
| | • Cine Automatic Image
Playback | Cine Recording/Playback | |
| | • Cine Frame-by-Frame
Review
• Fluorostore(up to 240
frames recording) | • Cine Automatic Image
Playback
• Cine Frame-by-Frame
Review
• Fluorostore(up to 240
frames recording) | |
| | Re-Registration | Re-Registration | |
| | Variable Landmarking | Variable Landmarking | |
| | Mask save/Recall | Mask save/Recall | |
| | Reference Image Hold | Reference Image Hold | |
| | | Digital Pen | |
| Monitor
Display | Colored 27" monitor | Colored 27" monitor | Substantially Equivalent. |
| | Resolution: 1920x1080 | Resolution: 3840 x 2160 | The monitor was updated to a |
| | Brightness: 600 cd/m2 | Brightness: 600 cd/m2 | higher resolution one. This change |
| | Touch screen | Touch screen | was driven by IT technology |
| | 8bit image display on
monitor | 10bit image display on
monitor | advancement by using a more state
of the art display technology which
achieves the same or better
functionality.
This change did not raise any new
safety and effectiveness concerns. |
| Display
Articulation | 180 degree swivel | 180 degree swivel | Identical |
| | 5 degrees tilt up | 5 degrees tilt up | |
| | 25 degrees tilt down | 25 degrees tilt down | |
| | Monitor viewable from all
4 sides | Monitor viewable from all
4 sides | |
| | Horizontal and Vertical
viewing angle 178 degrees | Horizontal and Vertical
viewing angle 178 degrees | |
| | 20cm up vertical travel | 20cm up vertical travel | |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| | 20cm down vertical travel | 20cm down vertical travel | |
| | Extension arm rotation 210 degrees | Extension arm rotation 210 degrees | |
| | Spring arm rotation 180 degrees | Spring arm rotation 180 degrees | |
| | Position monitor above C-arm by folding articulation arm within system footprint | Position monitor above C-arm by folding articulation arm within system footprint | |
| Tech View
Tablet | Size: 10.1 inch
Resolution: 1280 × 800
OS: Android 5.1 | Size: 10.1 inch
Resolution: 1280 × 800
OS: Android 11.0 | Substantially Equivalent
Android OS has been upgraded to Android 11.0. This change was driven by IT technology advancement by using a more state of the art display technology which achieves the same functionality.
This change did not raise any new safety and effectiveness concerns. |
| C-Arm
Physical
Dimensions | Depth of Arc: 26.0" (66 cm) | Depth of Arc: 26.0" (66 cm) | Substantially Equivalent.
The orbital rotation was changed to a larger range to make the user easily use the system. |
| | Source Image Distance:
39.4" (100 cm) | Source Image Distance:
39.4" (100 cm) | |
| | Lateral Rotation: 410°
(+205° / -205°) | Lateral Rotation: 410°
(+205° / -205°) | This change did not raise any new safety and effectiveness concerns. |
| | Wig/Wag: 25° (+12.5°/-
12.5°) | Wig/Wag: 25° (+12.5°/-
12.5°) | |
| | Orbital Rotation: 120° (90° underscan /30° overscan) | Orbital Rotation: 150° (95° underscan /55° overscan) | |
| | Horizontal Movement:
7.9" (20cm) | Horizontal Movement:
7.9" (20cm) | |
| | Vertical Travel: 17.5" (44 cm) | Vertical Travel: 17.5" (44 cm) | |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| Image Storage | 100,000 Images | 150,000 Images | Substantially Equivalent.
This change was driven by IT
technology advancement by using a
more state of the art computing
technology which achieves the
same or better functionality.
This change did not raise any new
safety and effectiveness concerns. |
| Wireless
Printing
Module and
Printers | N/A | Wireless Printing Module
Printers | Substantially Equivalent
The printer is used to create
reference image that is not for
diagnostic purpose.
The wireless printing module is not
used to control the device
operations nor X-ray activation.
The changes from wired printer to
wireless printer does not
significantly affect the use of the
device. No new risks raised or
existing risks was changed due to
this change.
This change did not raise any new
safety and effectiveness concerns. |
| Video
Distributor | DVI, BNC | DP, BNC | Substantially Equivalent.
This change was driven by IT
technology advancement by using a
more state of the art computing
technology which achieves the
same or better functionality.
This change did not raise any new
safety and effectiveness concerns. |
| Laser Aimer | Red Laser | Green Laser | Substantially Equivalent.
Laser has been updated for
introducing green laser as well as |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| | Image intensifier side laser
Aimer: | Flat panel detector side
laser aimer and Tube side
laser aimer: | introducing tube side laser aimer
for users' convenience. |
| | CLASS IIIa/3R laser
product | CLASS 2 laser product | Both lasers meet the IEC 60825-1:
2014 and 21CFR 1040.10 laser
products requirement. |
| | Wavelength: 650 nm | Wavelength: 510nm-
530nm | This change did not raise any new
safety and effectiveness concerns. |
| | Optical output power: $≤$ 5.0
mW | Optical output power:
1mW | |
| Image
Processing | Noise and motion artifact
reduction, Autotrak, ABS,
Smart window, smart
metal, ADRO (Adaptive
Dynamic Range
Optimization)
(based on CPU)
Note: ADRO is to
optimize the post
processing algorithm to
achieve optimized
dynamic range and
improved contrast for
visualization of more
anatomical details. | Noise and motion artifact
reduction, Autotrak, ABS
(based on CPU)
Smart window, smart
metal, ADRO (Adaptive
Dynamic Range
Optimization)
(based on GPU) | Substantially Equivalent
The noise and motion artifact
reduction, AutoTrak and ABS, are
same with OEC One (K182626)
while Smart window, smart metal
post processing modules are based
on GPU calculation which is
because GPU has a better
calculation speed which can more
suitable to detectors.
ADRO is an available feature on
OEC One (K182626) that is
changed to base on GPU for better
calculation speed.
This change did not raise any new
safety and effectiveness concerns. |
Comparison between the Subject Device and Predicate Device
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The system continues to meet all applicable IEC 60601-1 series of standards, NEMA XR-27, and applicable parts of 21CFR Subchapter J.
The changes described above do not change the control mechanism, operating principle, energy type, or the scientific technology of the predicate devices.
Determination of Substantial Equivalence:
GE HealthCare believes the OEC One ASD is of comparable type and substantially equivalent to the cleared predicate OEC One.
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Non-Clinical Performance Testing
The verification and validation testing has been successfully completed as required by design control procedures under GE HealthCare's quality system has been tested and is compliant with the following FDA-recognized consensus standards and FDA guidance documents:
FDA-recognized consensus standards
- · ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - FDA recognition number 19-46.
- · IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. FDA recognition number 19-36.
- · IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. FDA recognition number 12-336.
- IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability. FDA recognition number 5-132.
- · IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. FDA recognition number 12-309.
- · IEC 60601-2-54 Edition 1.2 2018-06 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. FDA recognition number 12-317.
- · IEC 60601-2-43 Edition 2.2 2019-10 Medical electrical equipment Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. FDA recognition number 12-329.
- · IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes. FDA recognition number 13-79.
- · IEC 62366-1 Edition 1.1 2020-06 Medical devices Part 1: Application of usability engineering to medical devices. FDA recognition number 5-129.
FDA guidance
- · Pediatric information for X-ray imaging device premarket notifications, Nov 28, 2017
- · Content of Premarket Submissions for Device Software Functions, June 14, 2023
- · Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 27, 2023
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- · Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff, Aug 14, 2013
- · Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff, Sep 01, 2016
All applicable 21CFR Subchapter J performance standards are met. 1020.30 Diagnostic X -Ray Systems and their major components, 1020.32 Fluoroscopic equipment, 1040.10 Laser products.
The OEC One ASD system was developed under the GE HealthCare Quality Management System, including design controls, risk management and software development life cycle processes. The following quality assurance measures were applied to the development of the system:
- · Risk Analysis
- · Required Reviews
- · Design Reviews
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
The substantial equivalence was also based on a basic software documentation level.
Clinical Testing
OEC One ASD is substantially equivalent to the cleared predicate OEC One. The indication for use is identical and has equivalent/identical technological characteristics. This type of premarket notification supports using scientific, established, engineering-based performance testing. The system has been fully tested/evaluated by using engineering bench testing. In addition, comparative clinical images were evaluated to demonstrate substantial equivalence for the OEC One ASD compared to the cleared predicate.
Substantial Equivalence Conclusion
OEC One ASD follows the same design control process and software development lifecycle processes as the predicate OEC One (K182626).
The differences discussed in this section do not introduce any adverse effects nor raise new questions of safety and effectiveness. Based on the successful verification and validation testing, additional performance bench testing, conformance to standards, and development under the GE HealthCare Quality Management System, we believe that OEC One ASD is substantially equivalent to the cleared predicate device OEC One (K182626) and therefore, is safe and effective for its intended use.