(113 days)
Artis Zeego
No
The summary describes a standard mobile x-ray imaging system with image processing capabilities, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is an imaging system (mobile x-ray system) used to provide 2D fluoroscopic and 3D imaging for diagnostic purposes, specifically for visualizing anatomic structures and objects with high x-ray attenuation like bones and metallic objects. It does not provide any direct therapy or treatment.
Yes
The device is an imaging system designed to provide 2D fluoroscopic and 3D information of anatomic structures, which is used by a physician to gain information about a patient's internal anatomy. This process of obtaining information about a patient's medical condition is characteristic of a diagnostic device.
No
The device is explicitly described as a mobile x-ray system consisting of hardware components like an x-ray generator, detector, and user interfaces, in addition to image processing capabilities. It also mentions hardware verification and validation testing.
Based on the provided information, the O-arm® O2 Imaging System is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening.
- O-arm® O2 Function: The O-arm® O2 Imaging System is an in vivo imaging system. It uses X-rays to create images of internal anatomical structures within the living body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a mobile x-ray system for imaging patients directly, not for analyzing specimens.
- Device Description: The description details the hardware components of an X-ray imaging system (generator, detector, processors, etc.), not equipment for laboratory analysis of biological samples.
- Classification: The device is classified under product code OWB (secondary OXO, JAA), ref 21 CFR 892.1650. This classification falls under the category of Radiology devices, specifically Diagnostic X-ray Systems, not In Vitro Diagnostic devices.
Therefore, the O-arm® O2 Imaging System is a medical imaging device used for diagnostic and surgical guidance purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
The O-arm® O2 Imaging System is a mobile x-ray system that provides 3D imaging as well as 2D fluoroscopic imaging. It was originally cleared for market in 2005 via K050996. Additional submissions were made in 2006 (K060344) and 2009 (K092564). The device is classified under primary product code OWB (secondary OXO, JAA) , ref 21 CFR 892.1650.
O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds an extended field of view imaging mode that offers twice the lateral field of view as the prior design to provide clinicians further visualization options in larger anatomic regions and anatomical structures. It accomplishes this task with essentially the same hardware design as described within.
The system consists of two parts: the O-arm® Image Acquisition System (IAS), comprising of a x-ray generator, amorphous silicon flat panel x-ray detector and the x-ray control user interface and the Mobile View Station (MVS), comprising of the image processors, a user interface for image and patient handling and viewing monitor.
The O-arm® O2 Imaging System consists of two main assemblies that are used together during fluoroscopic imaging:
• The Mobile View Station (MVS)
• The Image Acquisition System (IAS)
The two units are interconnected by a single cable that provides power and signal data. The O-arm® IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected.
The O-arm® operates off standard line voltage within the following voltages:
• VAC 100, 120 or 240
• Frequency 60Hz; 50Hz
• Power Requirements 1440 VA
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (2D fluoroscopic and 3D imaging)
Anatomical Site
Anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Indicated Patient Age Range
Adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm.
Intended User / Care Setting
Physician / 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)
Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the O-arm O2 Imaging System device to establish substantial equivalence of the O-arm O2 Imaging System and verify that device will perform as intended meeting all of the design inputs.
- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment -● Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: . General requirements for safety; Electromagnetic Compatibility -Requirements and Tests (2/2014)
- IEC 60601-1-3:2008 - Medical Electrical Equipment - Part 1-3:General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (1/2014)
- IEC 60601-2-28:2010 Medical electrical equipment part 2: . Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (8/2013)
- . IEC 60601-2-43:2010 – Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (3/2010)
- Software Verification and Validation testing verifying the software requirements perform as intended
- . Hardware verification ensuring the hardware requirements identified for the system perform as intended.
- The Dose Setting Guidance for Extra-small Patient Size determines ● recommended dose settings (kVp/mA pairs) for an extra-small patient population to help the end user when imaging such patients.
- . The Image Quality Assessment of the O-arm® O2 System provides a quantitative image quality assessment of the O-arm® O2 system in comparison to the predicate O-arm® 1000 device.
- . The Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm O2 System.
- . The Usability Testing was conducted according to the FDA quidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- The O-arm® Cadaver Image Pair Study evaluates the clinical utility ● of the images obtained using the O-arm® O2 Imaging System compared to the images obtained using the predicate O-arm® 1000 and the reference Artis Zeego device.
All performance testing was conducted to ensure the product meets all prescribed design inputs.
Conclusion: The O-arm® O2 system is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that O-arm® O2 does not raise new risks of safety and effectiveness when compared to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Artis Zeego
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Medtronic, Inc. Medtronic Navigation, Inc. (Littleton) % Mr. Rishi Sinha Prinicipal Regulatory Affairs Specialist 300 Foster Street LITTLETON MA 01460
Re: K151000
Trade/Device Name: O-arm® O2 Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO and JAA Dated: June 30, 2015 Received: July 2, 2015
Dear Mr. Sinha:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) NA K151000
Device Name O-arm® O2 Imaging System
Indications for Use (Describe)
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
| 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
510(k) Summary
| Submitter: | Medtronic Navigation, Inc. (Littleton)
300 Foster Street
Littleton, MA 01460 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rishi Sinha (Primary)
Principal Regulatory Affairs Specialist
Phone: (269) 903-4373
Fax: (269) 353-5924
E-mail: rishi.k.sinha@medtronic.com
Paul Smolenski (Alternate)
Senior Regulatory Affairs Manager
Phone: (978)698-6065
Fax: (978)698-6090
E-mail: paul.d.smolenski@medtronic.com |
| Date Summary Prepared: | June 30th, 2015 |
| Device Trade Name: | Medtronic O-arm® O2 Imaging System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Device Classification: | Class II |
| Product Code: | Primary: OWB
Secondary: OXO, JAA |
| Classification Name: | 892.1650 - Image Intensified Fluoroscopic X-ray System, Mobile |
| Predicate Device: | K092564 - Medtronic O-arm® Imaging System |
| Device Description: | The O-arm® O2 Imaging System is a mobile x-ray system that provides
3D imaging as well as 2D fluoroscopic imaging. It was originally cleared
for market in 2005 via K050996. Additional submissions were made in
2006 (K060344) and 2009 (K092564). The device is classified under
primary product code OWB (secondary OXO, JAA) , ref 21 CFR
892.1650.
O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds an
extended field of view imaging mode that offers twice the lateral field of
view as the prior design to provide clinicians further visualization options
in larger anatomic regions and anatomical structures. It accomplishes
this task with essentially the same hardware design as described within.
The system consists of two parts: the O-arm® Image Acquisition System
(IAS), comprising of a x-ray generator, amorphous silicon flat panel x-ray
detector and the x-ray control user interface and the Mobile View Station
(MVS), comprising of the image processors, a user interface for image
and patient handling and viewing monitor.
The O-arm® O2 Imaging System consists of two main assemblies that
are used together during fluoroscopic imaging: |
| | • The Mobile View Station (MVS) |
| | The two units are interconnected by a single cable that provides power
and signal data. The O-arm® IAS has an internal battery pack that
provides power for motorized transportation and gantry positioning. In
addition the battery pack is used to power the X-ray tank. The MVS has
an internal UPS to support its function when mains power is
disconnected. |
| | The O-arm® operates off standard line voltage within the following
voltages:
• VAC 100, 120 or 240
• Frequency 60Hz; 50Hz
• Power Requirements 1440 VA |
| Indications for Use: | The O-arm® O2 Imaging System is a mobile x-ray system designed for
2D fluoroscopic and 3D imaging for adult and pediatric patients weighing
60lbs or greater and having an abdominal thickness greater than 16cm,
and is intended to be used where a physician benefits from 2D and 3D
information of anatomic structures and objects with high x-ray
attenuation such as bony anatomy and metallic objects. |
| | The O-arm® O2 Imaging System is compatible with certain image guided
surgery systems. |
- The Image Acquisition System (IAS) •
4
| Substantial Equivalence: | O-arm® O2 is substantially equivalent to the following device: | |
|---|---|---|
| · K092564 – O-arm® Imaging System |
| Subject Device | Predicate | |
|---|---|---|
| O-arm® O2 Imaging System | O-Arm® 1000 Imaging System | |
| (K092564) | ||
| Classification | Class 2 | Class 2 |
| Product Code | OXO; 892.1650 | OXO; 892.1650 |
| Indications for Use | The O-arm® O2 Imaging System is | |
| a mobile x-ray system designed for | ||
| 2D fluoroscopic and 3D imaging and | ||
| is intended to be used where a | ||
| physician benefits from 2D and 3D | ||
| information of anatomic structures | ||
| and objects with high x-ray | ||
| attenuation such as bony anatomy | ||
| and metallic objects. | ||
| The O-arm® Imaging System is | ||
| compatible with certain Image | ||
| Guided Surgery Systems. | The O-arm® Imaging System is a | |
| mobile x-ray system designed for | ||
| 2D fluoroscopic and 3D imaging | ||
| and is intended to be used where | ||
| a physician benefits from 2D and | ||
| 3D information of anatomic | ||
| structures and objects with high | ||
| x-ray attenuation such as bony | ||
| anatomy and metallic objects. | ||
| The O-arm® Imaging System is | ||
| compatible with certain Image | ||
| Guided Surgery systems. |
Table 1: O-arm® O2 Predicate Device Comparison Table
5
| Subject Device | Predicate | |
|---|---|---|
| O-arm® O2 Imaging System | O-Arm® 1000 Imaging System (K092564) | |
| Cone Beam CT | The O-arm® O2 Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. | The O-arm® Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. |
| Detector Technology | 40 x 30 cm (RoHS compliant, Flat-Panel Detector using a Csl scintillation) | 40 x 30 cm (Flat-Panel Detector using a CsI scintillation) |
| Generator Technology | 32 kW, RoHS compliant generator with improved electrical interface. | 32kW Generator |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic |
| 3D Imaging (20 cm FOV) | Full Fan (20cm FOV) scan acquisition | Full Fan (20cm FOV) scan acquisition |
| 3D Imaging Protocols (20 cm FOV) | Available presets: |
- Standard 3D
- HD3D (High Definition)
- Enhanced Cranial
- Low Dose 3D | Available presets:
- Standard 3D
- HD3D (High Definition)
- Enhanced Cranial |
| 3D Imaging (40 cm FOV) | Half-fan single scan acquisition | No 3D Imaging at 40cm FOV |
| 3D Imaging Protocols (40 cm FOV) | Available presets: - HD3D (high definition) equivalent to 750 projections | No 3D Imaging at 40cm FOV |
Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the O-arm O2 Imaging System device to establish substantial equivalence of the O-arm O2 Imaging System and verify that device will perform as intended meeting all of the design inputs.
- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment -● Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: . General requirements for safety; Electromagnetic Compatibility -Requirements and Tests (2/2014)
- IEC 60601-1-3:2008 - Medical Electrical Equipment - Part 1-3:General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (1/2014)
- IEC 60601-2-28:2010 Medical electrical equipment part 2: . Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (8/2013)
6
- . IEC 60601-2-43:2010 – Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (3/2010)
- Software Verification and Validation testing verifying the software requirements perform as intended
- . Hardware verification ensuring the hardware requirements identified for the system perform as intended.
- The Dose Setting Guidance for Extra-small Patient Size determines ● recommended dose settings (kVp/mA pairs) for an extra-small patient population to help the end user when imaging such patients.
- . The Image Quality Assessment of the O-arm® O2 System provides a quantitative image quality assessment of the O-arm® O2 system in comparison to the predicate O-arm® 1000 device.
- . The Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm O2 System.
- . The Usability Testing was conducted according to the FDA quidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- The O-arm® Cadaver Image Pair Study evaluates the clinical utility ● of the images obtained using the O-arm® O2 Imaging System compared to the images obtained using the predicate O-arm® 1000 and the reference Artis Zeego device.
All performance testing was conducted to ensure the product meets all prescribed design inputs.
Conclusion: The O-arm® O2 system is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that O-arm® O2 does not raise new risks of safety and effectiveness when compared to the predicates.