(30 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The software changes listed are standard image processing and system features.
No
The device is an imaging system designed to provide 2D fluoroscopic and 3D imaging for diagnostic purposes, not for treating or curing a medical condition.
Yes
The device is an imaging system (mobile x-ray system) that provides 2D fluoroscopic and 3D imaging to generate information about anatomic structures, which physicians can use to inform their medical decisions. This falls under the definition of a diagnostic device, as it aids in the identification or diagnosis of medical conditions through imaging.
No
The device is described as a mobile x-ray system consisting of hardware components (Image Acquisition System and Mobile View Station) in addition to the software features being added in this submission.
Based on the provided information, the O-arm O2 Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a mobile x-ray system for imaging anatomic structures and objects within the body (bony anatomy, metallic objects). IVD devices are used to examine specimens from the body, such as blood, urine, or tissue, in vitro (outside the body).
- Device Description: The description details an x-ray system with an image acquisition system and a mobile view station. This aligns with imaging equipment used on patients, not laboratory equipment for analyzing samples.
- Input Imaging Modality: The input is 2D fluoroscopic and 3D imaging (Cone Beam CT), which are modalities used for imaging the inside of a living body.
- Anatomical Site: The anatomical site is described as structures within the body.
- Performance Studies: The performance studies listed are related to the safety and performance of an x-ray imaging system, not the analytical performance of a diagnostic test on biological samples.
- Classification: The device is classified under product codes related to diagnostic x-ray equipment (OWB, OXO, JAA) under 21 CFR 892.1650, which is for diagnostic x-ray systems. IVD devices are classified under different sections of the CFR.
In summary, the O-arm O2 Imaging System is a medical imaging device used for diagnostic and potentially interventional purposes in vivo (within the body), not an IVD device used for testing samples in vitro.
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 under 510(k) K151000. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.
This is a special submission for the addition of the following software features:
- Angular Annotation
- Easy Image Transfer
- Enhance Dynamic Range
- Cybersecurity Enhancements
These changes are only changes in software. There are no changes related to radiation performance. There are no changes to the device hardware required for these software changes. This software also includes defect corrections.
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 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
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
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.
Performed a Risk / Hazard Analysis in accordance to company procedures which was used to assess the impact of the modifications listed above.
Based on the Risk / Hazard Analysis an identification of the verification and / or, validation activities required was made and appropriate methods or tests and the applicable pass / fail criteria applied were performed.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in bold blue letters, and the word 'ADMINISTRATION' in smaller blue letters below.
Medtronic Inc. % Mr. Dean Honkonen Regulatory Affairs Manager 300 Foster Street LITTLETON MA 01460
December 29, 2017
Re: K173664
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: II Product Code: OWB, OXO, JAA, Dated: November 28, 2017 Received: November 29, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Page 2 - Mr. Dean Honkonen
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
| Submitter: | Medtronic Navigation, Inc. (Littleton)
300 Foster Street
Littleton, MA 01460 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dean Honkonen
Regulatory Affairs Manager
Phone: (978)698-6065
(978)698-6090
Fax:
E-mail: dean.honkonen@medtronic.com |
| Date Summary Prepared: | October 11, 2017 |
| 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 |
| Predicate Device: | K151000 – Medtronic O-arm O2 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 under 510(k) K151000. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.
Modified Device:
This is a special submission for the addition of the following software features:
- Angular Annotation
- Easy Image Transfer ●
- Enhance Dynamic Range ●
- Cybersecurity Enhancements ●
These changes are only changes in software. There are no changes related to radiation performance. There are no changes to the device hardware required for these software changes. These features are described in more detail below and in the Device Description. This software also includes defect corrections.
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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 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 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.
Substantial Equivalence:
O-arm O2 with revision 4.1.0 software is viewed as substantially equivalent to the unmodified device as there are no changes that impact indications for use or fundamental technology. We have compared the unmodified device (predicate) and the modified device in Table 5-1 below:
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| Table 5-1: Device Comparison Table |
|---|
| ------------------------------------ |
| Predicate | Modified Device | Discussion | |
|---|---|---|---|
| O-arm O2 Imaging System | O-arm O2 Imaging System | ||
| With revision 4.1 Software | |||
| Classification | Class 2 | Class 2 | 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 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. | Identical | ||
| Predicate | Modified Device | Discussion | |
| O-arm O2 Imaging System | O-arm O2 Imaging System | ||
| With revision 4.1 Software | |||
| 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 |
| 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 with improved electrical interface. | 32 kW, RoHS compliant generator with improved electrical interface. | Identical |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 3D Imaging | |||
| (20 cm FOV) | Full Fan (20cm FOV) scan acquisition | Full Fan (20cm FOV) scan acquisition | Identical |
| 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 |
| | Predicate | Modified Device | Discussion |
| | O-arm O2 Imaging System | O-arm O2 Imaging System | |
| | | With revision 4.1 Software | |
| 3D Imaging
Protocols (40
cm FOV) | Available presets:
HD3D (high definition)
equivalent to 750 projections | Available presets:
HD3D (high definition)
equivalent to 750 projections | Identical |
| Annotation | Stereotaxy protocols
Allows for adding arrows, lines and
text to 2D images | Stereotaxy protocols
Allows for adding arrows lines and
text to 2D images
Added:
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. | Additional functionality |
| Image
Transfer | Allows for transfer of data to
external devices. | Automatically transfers auto-
registered navigation scans.
Added:
Depending upon the clinical
application and workflow within the
procedure, this will automatically
transfer non-auto-registered (non-
navigated) images to the navigation
system | Improves workflow
The capability to transfer
non-auto-registered (non-
navigated) images to the
navigation system existed in
510(k) K15000 but required
several manual steps |
| | Predicate | Modified Device | Discussion |
| | O-arm O2 Imaging System | O-arm O2 Imaging System | |
| | | With revision 4.1 Software | |
| 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 | 3D visualization of CBCT image on
the MVS. It allows the user to
window level the images as well as
render oblique views
Added:
Improved visualization of images
that contain objects of high-x-ray
attenuation such as metal implants
on the Mobile View Station. | Improved visualization
capability |
| Cybersecurity | Hardcoded passcodes for system
access
Industry standard protocols with
error detection for data transmission
and storage. | Industry standard protocols with
error detection for data
transmission and storage.
Removed hardcoded passwords
Added:
Authentication that includes user
names and passcodes
Software integrity check | Increased cybersecurity
protection. |
6
7
8
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Performance Testing:
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted in accordance to the following FDA recognized standards:
- 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)
As required in Special 510(k) submissions Medtronic Navigation Inc. (Littleton) performed a Risk / Hazard Analysis in accordance to company procedures which was used to assess the impact of the modifications listed above.
Based on the Risk / Hazard Analysis an identification of the verification and / or, validation activities required was made and appropriate methods or tests and the applicable pass / fail criteria applied were performed.
The following guidance documents used in the development of 0-arm O2 Imaging System:
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices .
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . Off-The-Shelf Software Use in Medical Devices
Conclusion:
The O-arm O2 Imaging 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 0-arm 02 Imaging System with 4.1 software does not raise new risks of safety and effectiveness when compared to the predicates.