Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on hardware components, scanning modes, and standard reconstruction algorithms (filtered-back projection). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies summary.

Therapeutic

No.
The device is an X-ray computed tomography system used for imaging, not for treating or preventing disease.

Diagnostic

Yes
The device is an X-ray computed tomography (CT) system, which is inherently a diagnostic imaging modality used to visualize internal body structures for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components including an X-ray generator, detector array, gantry, power system, and mechanical drive systems, indicating it is a physical medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture". 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". CT systems are imaging devices that use X-rays to create cross-sectional images of the body.
Lack of IVD Characteristics: The description does not mention any components or processes related to testing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose diseases or conditions. IVDs typically involve reagents, assays, or other methods for analyzing biological specimens.

The device is clearly an imaging system used in vivo (within the body) for diagnostic purposes through visualization, not through the analysis of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 patients weighing over 400 lbs (182 kg).

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 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 Gadolinium Oxysulfide (GOS) 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

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

X-ray computed tomography

Anatomical Site

anatomy that can be imaged in the 107cm aperture

Indicated Patient Age Range

Not Found. The device's original indication excluded pediatric patients, but this submission modifies the Indications for Use Statement to remove the pediatric restriction.

Intended User / Care Setting

Mobile or Fixed Radiology, ICU, ED, Surgical, Clinic, office

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:

Risk Analysis
Design Reviews
Design Verification Testing
SW Unit Integration Testing
System Software Verification & Validation Testing
Image Quality Metrics and phantom images for Pediatrics
Pediatrics Protocol Design & Validation (using Image Gently, ACR and AAPM guidelines)
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 — K160126).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160126

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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March 15, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Mobius Imaging, LLC % Ms. Norma J. LeMay Regulatory Affairs Consultant 2 Shaker Road SHIRLEY MA 01464

Re: K180393

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: February 12, 2018 Received: February 13, 2018

Dear Ms. Lemay:

We have reviewed vour 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 (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.

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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

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Indications for Use

510(k) Number (if known)

K180393

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 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 contains the Mobius Imaging logo at the top, with the words "Mobius" and "IMAGING Now You See" displayed. Below the logo, the text "510(k) Summary" is written in a large, bold font. The text is black and appears to be the title or heading of a document or presentation.

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: February 12, 2018

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 K160126 (cleared on April 19, 2016, 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 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 Gadolinium Oxysulfide (GOS) 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 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 (K160126, cleared on April 19, 2016) based on the following comparison. Most importantly, the differences noted below and in the comparison table raise no new issues of safety or effectiveness based on all testing performed and presented in this 510(k):

Added pediatric scanning feature/protocols
. Updated software to include scanning capabilities at 80 and 100kV to support pediatrics
Updated software to include age and height parameters to the system protocols
Modified the Indications for Use Statement to remove pediatric restriction

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Predicate Device Technological Comparison

Company	Mobius Imaging, LLC	Mobius Imaging, LLC
510(k) Number	This 510(k)	K160126
Model Name	Airo CT System	Airo CT System
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 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
procedures). 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 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).

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Predicate Device Technological Comparison

7

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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 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 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + A1:2012 Medical electrical equipment . Part 1: General requirements for basic safety and essential performance

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IEC 60601-1-2:2007 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
. IEC 60601-1-3:2008 + 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 60601-1-6:2010 +A1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-44:2009 + A1:2012 + A2:2016 - Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60825-1:2007 - Safety of laser products
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 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
IEC 62304:2006 +A1:2015 - Medical device software – Software life cycle processes
IEC 62366:2007 + A1:2014 - Medical devices – Application of usability engineering to medical devices
NEMA XR 25-2010 - Computed Tomography Dose Check
NEMA XR 29-2013 - Standard Attributes on CT Equipment Related to Dose

In addition to the standards above, the following FDA Guidance Documents for pediatric use with medical devices and for Cybersecurity were referenced when preparing this 510(k):

FDA Guidance for "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014
FDA Guidance for "Postmarket Management of Cybersecurity in Medical Devices" dated December 28, 2016
FDA Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications" dated November 28, 2017
. FDA Guidance for "Premarket Assessment of Pediatric Medical Devices" dated March 24, 2014

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.

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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 software modifications and performance testing was performed to support substantial equivalence:

Risk Analysis
Design Reviews
Design Verification Testing
. SW Unit Integration Testing
System Software Verification & Validation Testing ●
Image Quality Metrics and phantom images for Pediatrics
Pediatrics Protocol Design & Validation (using Image Gently, ACR and AAPM guidelines)
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 — K160126).

9. Conclusion:

Based upon the above considerations, including all testing presented in this 510(k), 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.