(101 days)
No
The document describes a mobile x-ray system with software updates focused on imaging protocols, display features, and user access. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is an imaging system (mobile x-ray) used to provide 2D and 3D information of anatomical structures and objects during surgery, rather than providing or delivering any therapy.
Yes
Explanation: The device is an O-arm O2 Imaging System, a mobile x-ray system that provides 2D and 3D imaging for medical diagnosis. It is intended to be used where a physician benefits from 2D and 3D information of anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. This indicates its use in aiding physicians in diagnosing conditions by providing visual information, which is a key function of a diagnostic device.
No
The device description explicitly states it is a "mobile x-ray system" and details hardware components like the Image Acquisition System (IAS) and Mobile View Station (MVS), including power requirements and battery packs. While the submission is for a software release, the device itself is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the O-arm O2 Imaging System is a "mobile x-ray system" used to provide "2D and 3D information of anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects." This describes an imaging device used to visualize structures within the body.
- Device Description: The description reinforces that it is a "mobile x-ray system that provides 3D and 2D imaging."
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The O-arm O2 Imaging System does not perform tests on biological samples. It uses X-rays to create images of internal structures.
- Classification: The device is classified under product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650. This classification falls under Radiology devices, not In Vitro Diagnostic devices.
Therefore, the O-arm O2 Imaging System is a medical imaging device, 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 adults and pediatric patients weighing 601bs 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 anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm O2 Imaging System in 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 and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.
This submission for the O-arm™ O2 Imaging System 4.2.0 software release introduces following features:
- . "2D Long Film" Imaging Protocol (Intraoperative Radiographic Scan)
- . Gantry Rotor Angle and Tilt Angle Display
- User Access Enhancements ●
The O-arm™ O2 Imaging System consists of two main assemblies that are used together:
- The Image Acquisition System (IAS) ●
- The Mobile View Station (MVS) .
The two units are interconnected by a single cable that provides power and signal data. The 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™ O2 Imaging System operates off standard line voltage within the following voltages:
- VAC 100, 120 or 240 ●
- Frequency 60Hz or 50Hz ●
- Power Requirements 1440 VA
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
anatomical structures, bony anatomy
Indicated Patient Age Range
adult and pediatric patients
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)
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 with the predicate device and verify that device will perform as intended in meeting all the design inputs:
- AAMI/ANSI ES 60601-1 2005+A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-3:2008 + A1:2013 Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
- 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
- IEC 60601-2-43:2010 + A1:2017 Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential
- IEC60601-1-6:2010 + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 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 Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm™ O2 Imaging System with 4.2.0 software.
- Usability Testing was conducted according to the FDA guidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- The Image Quality Assessment of the O-arm™ O2 Imaging System provides a quantitative image quality assessment of the O-arm O2 Imaging System with 4.2.0 in comparison to the predicate O-arm™ O2 Imaging System with 4.1.0.
- The O-arm™ Cadayer Image Pair Study evaluated the clinical utility of the images obtained using the O-arm™ O2 Imaging System with 4.2.0 compared to the images obtained using the predicate O-arm™ O2 Imaging System with 4.1.0.
Conclusion:
The O-arm™ O2 Imaging System with 4.2.0 software is similar in technological characteristics, imaging performance and indications for use as the predicate device listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that Oarm™ O2 Imaging System with 4.2.0 software does not raise new risks of safety and effectiveness when compared to the predicate.
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.
Not Found
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
April 24, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic, Inc. % Mr. Dean Honkonen Sr. Regulatory Affairs Manager 300 Foster Street LITTLETON MA 01460
Re: K200074
Trade/Device Name: Medtronic O-arm™ O2 Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: March 27, 2020 Received: March 30, 2020
Dear Mr. Honkonen:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200074
Device Name Medtronic O-arm™ O2 Imaging System
Indications for Use (Describe)
The O-arm O2 Imaging System is a mobile x-ray system designed for adults and pediatric patients weighing 601bs 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 anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm O2 Imaging System in compatible with certain image guided surgery systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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: | Dean Honkonen (Primary)
Sr. Regulatory Affairs Manager
Phone: (978) 698-6065
Fax: (978) 698-6090
e-mail: dean.honkonen@medtronic.com
Tijana Prodanovic (Alternate)
Sr. Regulatory Affairs Specialist
Phone: (978) 339-4134
Fax: (978) 698-6090
e-mail: tijana.prodanovic@medtronic.com |
| Date Summary Prepared: | January 13, 2020 |
| 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: | K173664 – O-arm™ O2 Imaging System 4.1.0 software |
Device Description:
The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.
4
Modified Device:
This submission for the O-arm™ O2 Imaging System 4.2.0 software release introduces following features:
- . "2D Long Film" Imaging Protocol (Intraoperative Radiographic Scan)
- . Gantry Rotor Angle and Tilt Angle Display
- User Access Enhancements ●
These features are described in more detail in the Substantial Equivalence section.
The O-arm™ O2 Imaging System consists of two main assemblies that are used together:
- The Image Acquisition System (IAS) ●
- The Mobile View Station (MVS) .
The two units are interconnected by a single cable that provides power and signal data. The 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™ O2 Imaging System operates off standard line voltage within the following voltages:
- VAC 100, 120 or 240 ●
- Frequency 60Hz or 50Hz ●
- Power Requirements 1440 VA
Indications for Use:
The O-arm™ O2 Imaging System is a mobile x-ray system designed for 2D and 3D imaging for adult and pediatric patients weighing 601bs 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.
Substantial Equivalence:
O-arm™ O2 Imaging System with 4.2.0 software is substantially equivalent to the following device:
K173664 - O-arm™ O2 Imaging System 4.1.0 software The unmodified device (predicate - K173664) and the modified device are compared in table below:
5
Device Comparison Table
| Predicate Device | Modified Device | ||
|---|---|---|---|
| O-arm O2 Imaging System | |||
| K173664 | With revision 4.2.0 software | Discussion | |
| Classification | Class II | Class II | Identical |
| Product Code | OWB; 892.1650 | OWB; 892.1650 | Identical |
| 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 O-arm O2 Imaging System is a | ||
| mobile x-ray system designed for 2D 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. | Changed to remove the word | ||
| "fluoroscopic". | |||
| O-arm O2 Imaging System 4.2.0 | |||
| software uses more than one 2D | |||
| mode. Modes of operation are | |||
| described in the Instructions for Use. | |||
| 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 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. | Identical | ||
| Predicate Device | Modified Device | ||
| O-arm O2 Imaging System K173664 | With revision 4.2.0 software | Discussion | |
| Detector Technology | 40 x 30 cm (RoHS compliant, Flat-Panel Detector using a CsI scintillation) | 40 x 30 cm (RoHS compliant, Flat-Panel Detector using a CsI scintillation) | Identical |
| Generator Technology | 32 kW, RoHS compliant generator | 32 kW, RoHS compliant generator | Identical |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 2D Imaging | Manually stitched fluoroscopy | Added Feature: | |
| Automatically stitched 2D Radiographic | |||
| (Long Film) | Added Feature: | ||
| The O-arm O2 2D Long Film feature | |||
| leverages the motion capability of | |||
| the O-arm to provide an imaging | |||
| mode, whereby 2D narrowly | |||
| collimated projection images would | |||
| be automatically acquired while the | |||
| gantry is moving from two | |||
| preprogramed gantry locations. | |||
| These projections would then be | |||
| automatically stitched together using | |||
| knowledge of the motion profile to | |||
| form a single 2D Long Film. | |||
| 3D Imaging | |||
| (20 cm FOV) | Full Fan (20cm FOV) scan acquisition | Full Fan (20cm FOV) scan acquisition | Identical |
6
7
| Predicate Device | Modified Device | Discussion | ||||
|---|---|---|---|---|---|---|
| O-arm O2 Imaging System | ||||||
| K173664 | With revision 4.2.0 software | |||||
| 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 | ||||||
| Low Dose 3D | Identical | |||||
| 3D Imaging | ||||||
| (40 cm FOV) | Half-fan single scan acquisition | Half-fan single scan acquisition | Identical | |||
| 3D Imaging Protocols | ||||||
| (40 cm FOV) | Available presets: | |||||
| HD3D (high definition) equivalent to | ||||||
| 750 projections | ||||||
| Stereotaxy protocols | Available presets: | |||||
| HD3D (high definition) equivalent to | ||||||
| 750 projections | ||||||
| Stereotaxy protocols | Identical | |||||
| Annotation | Allows for adding arrows lines and text to | |||||
| 2D images | ||||||
| Additional annotation capability to | ||||||
| perform angular measurements onto a 2D | ||||||
| images. These measurements include | ||||||
| closed, open and Cobb angles. It also | ||||||
| provides the ability to place a right angle | ||||||
| on the image. | Allows for adding arrows lines and text to | |||||
| 2D images | ||||||
| Additional annotation capability to | ||||||
| perform angular measurements onto a 2D | ||||||
| images. These measurements include | ||||||
| closed, open and Cobb angles. It also | ||||||
| provides the ability to place a right angle | ||||||
| on the image. | Changed to accommodate the larger | |||||
| image size of 2D Radiographic | ||||||
| (Long Film). |
8
| Predicate Device | Modified Device | ||
|---|---|---|---|
| O-arm O2 Imaging System | |||
| K173664 | With revision 4.2.0 software | Discussion | |
| Image Transfer | Automatically transfers auto-registered | ||
| navigation scans. |
Easy Image Transfer:
Depending upon the clinical application
and workflow within the procedure, this
will automatically transfer non-auto-
registered (non-navigated) images to the
navigation system | Automatically transfers auto-registered
navigation scans.
Easy Image Transfer:
Depending upon the clinical application
and workflow within the procedure, this
will automatically transfer non-auto-
registered (non-navigated) images to the
navigation system | Identical |
| 3D Visualization
(Enhanced Dynamic
Range) | 3D visualization of CBCT image on the
MVS. It allows the user to window level
the images as well as render oblique
views
Improved visualization of images that
contain objects of high-x-ray attenuation
such as metal implants on the Mobile
View Station. | 3D visualization of CBCT image on the
MVS. It allows the user to window level
the images as well as render oblique
views
Improved visualization of images that
contain objects of high-x-ray attenuation
such as metal implants on the Mobile
View Station. | Identical |
9
| Cybersecurity | Added Feature: | Added Feature | |
|---|---|---|---|
| Industry standard protocols with error | |||
| detection for data transmission and | |||
| storage. |
Authentication that includes user
names and passcodes
Software integrity check | Enhanced user access | • The ability to have a user log in to
the O-arm system through the
Lightweight Directory Access
Protocol (LDAP) by using hospital
domain credentials set up by hospital
IT.
• The ability for the hospital IT team
to configure group policies on their
hospital IT systems and assign the
proper user group to individuals with
O-arm user and/or O-arm hospital
administrator privileges.
• The ability to maintain legacy O-
arm O2 4.1.0 local authentication
methods if customers prefer this
method over LDAP.
• The ability for Medtronic Service
or Manufacturing to configure the
authentication feature based on
customer requests.
• The ability for Authorized
personnel to audit changes made
within the system related to
Protected Health Information (PHI),
User Management and System
Configuration.
• Encryption of PHI information
stored on MVS computer for easier
integration of the improved User
Access Enhancements into various
Hospital IT systems. |
10
| Predicate Device | Modified Device | ||
|---|---|---|---|
| O-arm O2 Imaging System | |||
| K173664 | With revision 4.2.0 software | Discussion | |
| Hardware – Collimator | |||
| Assembly | No slot filter present in Collimator | ||
| Assembly | Changed hardware | ||
| Collimator Assembly includes a slot filter | |||
| for 2D Long Film Imaging | Changed hardware | ||
| Collimator Assembly includes a slot | |||
| filter for 2D Long Film Imaging | |||
| capability. New filter ladder | |||
| assembly designed for 2D Long Film | |||
| allows for higher repeatability of | |||
| filter positioning than the current | |||
| design. | |||
| Software - Gantry Tilt | |||
| & Rotor Angle Display | Not present | Added Feature | |
| Display of the Gantry Rotor Angle and | |||
| Gantry Tilt Angle on the Pendant | Added feature: | ||
| Gantry Tilt & Rotor Angle Display | |||
| will provide following capability: | |||
| • Will enable users to view the tilt | |||
| angles of the gantry from the O- | |||
| arm pendant. | |||
| • Will enable users to view the | |||
| relative angle/location of X-ray | |||
| source & detector. |
11
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 with the predicate device and verify that device will perform as intended in meeting all the design inputs:
- AAMI/ANSI ES 60601-1 2005+A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- · IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-3:2008 + A1:2013 Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
- 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
- IEC 60601-2-43:2010 + A1:2017 Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential
- IEC60601-1-6:2010 + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · 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 Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm™ O2 Imaging System with 4.2.0 software.
- · Usability Testing was conducted according to the FDA guidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- · The Image Quality Assessment of the O-arm™ O2 Imaging System provides a quantitative image quality assessment of the O-arm O2 Imaging System with 4.2.0 in comparison to the predicate O-arm™ O2 Imaging System with 4.1.0.
- · The O-arm™ Cadayer Image Pair Study evaluated the clinical utility of the images obtained using the O-arm™ O2 Imaging System with 4.2.0 compared to the images obtained using the predicate O-arm™ O2 Imaging System with 4.1.0.
Conclusion:
The O-arm™ O2 Imaging System with 4.2.0 software is similar in technological characteristics, imaging performance and indications for use as the predicate device listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that Oarm™ O2 Imaging System with 4.2.0 software does not raise new risks of safety and effectiveness when compared to the predicate.