(90 days)
No
The document describes standard CT technology and reconstruction algorithms (filtered-back projection). There is no mention of AI, ML, or related terms in the device description, intended use, or performance studies.
No
The device is an X-ray computed tomography system primarily used for imaging and diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is an X-ray computed tomography system intended for imaging anatomy. Imaging, especially for "anatomy that can be imaged," is a core function of diagnostic devices, as it allows medical professionals to visualize internal structures and identify abnormalities for diagnosis.
No
The device description clearly outlines numerous hardware components including an x-ray generator, detector array, gantry, power system, and mechanical drive systems. While it includes software for reconstruction, it is an integral part of a physical CT system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "X-ray computed tomography applications for anatomy". This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details a "Mobile Intraoperative Computed Tomography (CT) System". It describes the physical components and operation of a CT scanner, which is an imaging modality.
- Input Imaging Modality: The input is "X-ray computed tomography".
- Anatomical Site: The device images "anatomy that can be imaged in the 107cm aperture".
- Performance Studies: The performance studies focus on image quality metrics, phantom data, and comparisons to historical and offline reconstructed clinical image data. These are typical evaluations for imaging devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens. It directly images the patient's anatomy using X-rays.
N/A
Intended Use / Indications for Use
The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs (182 kg).
Contraindications:
Airo is contraindicated as the principal means of guidance during invasive procedures when real-time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.
Product codes
JAK
Device Description
The Mobius Airo is a Mobile Intraoperative Computed Tomography (CT) System. The Airo has a large-diameter bore designed for intraoperative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning (both helical and axial in patient mode). In its scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).
The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array (that includes detector modules that consist of a layered Cadmium Tungstate (CdWO4) and Photodiode Array). Each detector module includes a 32 x 16 pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).
The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.
In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical and axial reconstruction algorithms are both based on an exact filtered-back projection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray computed tomography
Anatomical Site
Anatomy that can be imaged in the 107cm aperture. That which can be imaged in 51.2cm FOV and 107cm Aperture.
Indicated Patient Age Range
Excluding 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)
Non-clinical tests were performed. These include Risk Analysis, Design Reviews, Design Verification Testing, SW Unit Integration Testing, System Software Verification & Validation Testing, Image Quality Metrics, Image Phantom Data, Historical Clinical Image Data Reconstruction Comparison, Offline Reconstruction Clinical Image Comparison (for NMAR feature), Independent Review Analysis for Diagnostic Image Quality, Radiation/Dose Testing, Electrical Safety, Mechanical & Stability Testing, and EMI/EMC Testing. The results of all testing performed indicate that the modified Airo CT System meets the acceptance criteria and is substantially equivalent to the currently cleared baseline device.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2016
Mobius Imaging, LLC % Ms. Norma LeMay Regulatory Affairs Contractor 2 Shaker Road SHIRLEY MA 01464
Re: K160126
Trade/Device Name: AIRO® Computed Tomography (CT) X-ray System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2016 Received: March 8, 2016
Dear Ms. LeMay:
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.
Mechon D.'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
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Indications for Use
510(k) Number (if known) K160126
Device Name
AIRO® Computed Tomography (CT) X-ray System
Indications for Use (Describe)
The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs (182 kg).
Contraindications:
Airo is contraindicated as the principal means of guidance during invasive procedures when real-time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Mobius Imaging logo at the top, with the words "IMAGING Now You See" below it. The logo consists of an orange circle and the word "Mobius" in black letters. Below the logo is the text "510(k) Summary" in a large, bold font. The text is centered on the page.
This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.
1. Submitter:
Mobius Imaging, LLC 2 Shaker Road, Suite F100 Shirley, MA 01464 USA
Contact: Norma LeMay Regulatory Affairs Consultant Telephone: 978-391-9644 Email: nlemay@mobiusimaging.com
Date of Preparation: March 7, 2016
2. Device Name & Regulatory Classification:
Proprietary or Trade Name: AIRO® Computed Tomography (CT) X-ray System Classification Name: Computed Tomography X-ray System Product Code: 90 JAK Device Classification: Class II Regulation Number: 21 CFR 892.1750
3. Predicate Device(s):
The legally marketed device to which substantial equivalence is being claimed is as follows:
- . Airo Mobile CT System – Premarket Notification K131431 (cleared on September 26, 2013, product code 90 JAK)
4. Device Description:
The Mobius Airo is a Mobile Intraoperative Computed Tomography (CT) System. The Airo has a large-diameter bore designed for intraoperative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning (both helical and axial in patient mode). In its scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).
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The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array (that includes detector modules that consist of a layered Cadmium Tungstate (CdWO4) and Photodiode Array). Each detector module includes a 32 x 16 pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).
The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.
In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical and axial reconstruction algorithms are both based on an exact filtered-back projection.
5. Indications for Use:
The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients weighing over 400 lbs (182 kg).
Contraindications:
AIRO is contraindicated as the principal means of guidance during invasive procedures when realtime imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.
6. Comparison of Technological Characteristics with the Predicate Device:
As detailed in Section 12 of this 510(k) Premarket Notification, the modified Airo CT System, for its intended use, is of comparable type in design, material, functionality, technology and is considered substantially equivalent to its baseline device Airo CT System (K131431, cleared on September 26, 2013) based on the following comparison.
Most importantly, the differences noted below and/or in the comparison table raise no new issues of safety or effectiveness based on all testing performed and presented in this 510(k) submission:
- Sequential Axial Scanning Mode
- Tube Current Modulation Feature (Helical only)
- . Metal Artifact Reduction Algorithm
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| Model Name | Airo® CT System | Airo® CT System |
|---|---|---|
| (subject of this 510(k) | (K131431) | |
| Technological Characteristics | ||
| Indications for Use | The AIRO is intended to be | |
| used for X-ray computed | ||
| tomography applications for | ||
| anatomy that can be imaged in | ||
| the 107cm aperture excluding | ||
| pediatric patients and patients | ||
| weighing over 400 lbs (182 kg). | ||
| Airo is contraindicated as the | ||
| principal means of guidance | ||
| during invasive procedures | ||
| when real-time imaging is | ||
| needed (e.g., CT Fluoroscopy). | ||
| In addition, the physician must | ||
| verify navigation accuracy | ||
| using an adequate verification | ||
| method when used with | ||
| Navigation Systems during | ||
| surgical procedures. | The AIRO is intended to be used | |
| for non-contrast X-ray computed | ||
| tomography applications for | ||
| anatomy that can be imaged in | ||
| the 107cm aperture excluding | ||
| pediatric patients and patients | ||
| weighing over 400 lbs (182 kg). | ||
| Airo is contraindicated as the | ||
| principal means of guidance | ||
| during surgical procedures. The | ||
| physician must verify navigation | ||
| accuracy using known | ||
| anatomical landmarks or an | ||
| equivalent verification method | ||
| when used in surgical | ||
| procedures. | ||
| Aperture (cm) | 107 | 107 |
| Image Field of View (cm) | 51.2 | 51.2 |
| Detector Material | Solid State CdWO4 | Solid State CdWO4 |
| Detector Configuration | 32 x 2.0mm | 32 x 2.0 mm |
| Spatial Resolution for Sharpest | ||
| Clinical Algorithm (Ip/cm at 2%) | 6.9 | 6.9 |
| X-ray Tube Type | Rotating Anode | Rotating Anode |
| Heat Storage (MHU) | 1.7 | 1.7 |
| X-ray Tube Cooling | Liquid (50% Water, 50% | |
| Propylene Glycol) | Liquid (50% Water, 50% | |
| Propylene Glycol) | ||
| X-ray Fan Angle (deg) | 45 | 45 |
| Max X-ray Power (kW) | 32 | 32 |
| Rotating Speed (seconds) | 2 | 2 |
| Gantry Weight (kg) | 1068 | 1068 |
| Transfer of electric current | Data Dock system | Data Dock system |
| Model Name | Airo® CT System | |
| (subject of this 510(k) | Airo® CT System | |
| (K131431) | ||
| Technological Characteristics | ||
| Mechanism to translate Gantry | Rails on Mobile Base System | Rails on Mobile Base System |
| Wireless | No | No |
| Mobile | Yes (motorized) | Yes (motorized) |
| Battery System | Yes (LiFePO4) | Yes (LiFePO4) |
| Wheels (casters) | Wheels (3 inch) | Wheels (3 inch) |
| Input Voltage | 1 phase 100-240 volt | 1 phase 100-240 volt |
| Input Power Max | 1.5 kW | 1.5 kW |
| PACS/DICOM 3.0 | Yes | Yes |
| 2D Scout | Yes | Yes |
| Bolus tracking | No | No |
| Dynamic Scan | No | No |
| Axial/Helical | Axial and Helical | Helical |
| Tube Modulation Feature | Yes (Helical only) | No |
| MPR | Yes | Yes |
| 3D Viewing | No | No |
| Patient Table Option | Yes (Trumpf table column | |
| integrated with base) | Yes (Trumpf table column | |
| integrated with base) | ||
| Scan Motion | Scanner Moves | Scanner Moves |
| Laser Alignment | Patient Alignment | Patient Alignment |
| X-ray warning lights | Yes | Yes |
| 110% X-ray Timer | Yes | Yes |
| Emergency Stop | Yes | Yes |
| Internal Lead Shield | Yes | Yes |
| External Lead Curtains | No | No |
| Operator X-ray On Switch | Yes | Yes |
| Quality Test Phantom | Yes | Yes |
| Model Name | Airo® CT System | |
| (subject of this 510(k) | Airo® CT System | |
| (K131431) | ||
| Technological Characteristics | ||
| Login ID/password | Yes | Yes |
| Administrator Privileges | Yes | Yes |
| Dose Display | Yes | Yes |
| Dose Report/Audit | Yes | Yes |
| Protocol Override Protection | Yes | Yes |
| Protocols by weight/body region | Yes | Yes |
| QA Test Report | Yes | Yes |
| Quality Test Phantom | Yes - Included | Yes - Included |
| Operating System | Microsoft Windows | Microsoft Windows |
| Biocompatibility | N/A | N/A |
| EM Emissions | ETL Testing | ETL Testing |
| Sterility | N/A | N/A |
| Chemical Safety | N/A | N/A |
| Thermal Safety | ETL Testing | ETL Testing |
| IEC EN 60601 Electrical Safety | ||
| Testing | ETL Testing | ETL Testing |
| IEC EN 60601 Mechanical Safety | ||
| Testing | ETL Testing | ETL Testing |
| Where Used | Mobile or Fixed Radiology, ICU, | |
| ED, Surgical, Clinic, Office | Mobile or Fixed Radiology, ICU, | |
| ED, Surgical, Clinic, Office | ||
| Anatomical Site | That which can be imaged in | |
| 51.2cm FOV and 107cm | ||
| Aperture | That which can be imaged in | |
| 51.2cm FOV and 107cm | ||
| Aperture |
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7. General Safety and Effectiveness Concerns:
ldentical to its baseline device, all components of the Airo CT System are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR Part 1020.30 and
8
1020.33 are certified to meet those requirements. Initial and Annual Reports are filed with the Center for Devices and Radiological Health (CDRH) according to 21 CFR 1002.10, respectively.
To minimize electrical, mechanical and radiation hazards, Mobius adheres to recognized and established industry practices. Additionally, the Airo CT System was designed and tested to the following FDA recognized International harmonized and National standards:
- IEC 60601-1 Issued: 2005/01/01 Ed:3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2 Issued: 2007/03/01 Ed:3 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-3 Issued: 2008/01/22 Ed:2 Medical Elec. Equipment - P. 1: General Req. for Safety 3. Collateral Standard: General Req. for Radiation Protection in Diagnostic X-Ray Equipment
- IEC 62366 Issued: 2007/10 Ed:1, Medical devices – Application of usability engineering to medical devices
- IEC 60601-2-44 Issued: 2009/02/25 Ed:3 Medical Electrical Equipment - Part 2-44: Particular Requirements for the basic safety and essential performance of X-ray Equipment for computed Tomography
- . IEC 61223:2004 – Evaluation and routine testing in medical imaging departments - Part 3-5 Acceptance Tests – Imaging Performance of Computed Tomography X-ray equipment
- IEC 60825-1:2007 – Safety of laser products
- IEC 62133:2002: Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- UL 1642:1995: Standard for Lithium Batteries
Relating to concerns regarding unintentional radiation exposure, the Airo CT System has software safeguards such as: ID password/login, dose display/reporting, safety warning to prevent excessive dose, protocol protection and required quality assurance testing.
8. Determination of Substantial Equivalence:
Summary of Non-clinical tests:
The Airo CT System complies with the voluntary harmonized standards as detailed above and in Section 9 and 17 of this 510(k) Premarket Notification. In addition, the following quality assurance measures were applied to the development of the System and performance testing was performed to support substantial equivalence:
9
- Risk Analysis ●
- Design Reviews
- Design Verification Testing
- SW Unit Integration Testing
- System Software Verification & Validation Testing
- Image Quality Metrics
- Image Phantom Data
- Historical Clinical Image Data Reconstruction Comparison
- . Offline Reconstruction Clinical Image Comparison (for NMAR feature)
- Independent Review Analysis for Diagnostic Image Quality
- Radiation/Dose Testing
- Electrical Safety, Mechanical & Stability Testing
- . EMI/EMC Testing
The results of all testing performed indicate that the modified Airo CT System meets the acceptance criteria and is substantially equivalent to the currently cleared baseline device (Airo Mobile CT System - K131431).
9. Conclusion:
Based upon the above considerations, including all testing presented in this 510(k) submission, Mobius considers the modified Airo CT System to be as safe, as effective, and performance is substantially equivalent to its baseline device. We also believe that the proposed modifications to the Airo CT System raise no new issues of safety and/or efficacy and the device performs as intended.