AIRO Computed Tomography (CT) X-ray System

K180393 · Mobius Imaging, LLC · JAK · Mar 15, 2018 · Radiology

Device Facts

• Record ID: K180393
• Device Name: AIRO Computed Tomography (CT) X-ray System
• Applicant: Mobius Imaging, LLC
• Product Code: JAK · Radiology
• Decision Date: Mar 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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).

Device Story

Mobile intraoperative CT system; 107cm bore; 51.2cm FOV. Inputs: X-ray irradiation of patient anatomy. Transformation: Solid-state X-ray generator/detector array (GOS scintillator/photodiode) captures signals; reconstruction computer processes data via filtered-back projection. Outputs: CT images for clinical review. Used in surgical, ICU, ED, or radiology settings; operated by trained clinicians. System features motorized gantry translation, battery power, and DICOM/PACS connectivity. Provides intraoperative imaging to assist surgical navigation and clinical decision-making. Benefits: Enables real-time or near-real-time diagnostic imaging in sterile or acute care environments without patient transport.

Clinical Evidence

Bench testing only. No clinical data. Validation included phantom image quality metrics for pediatric protocols, radiation/dose testing, electrical/mechanical safety, and EMI/EMC testing. Software verification and validation performed per IEC 62304.

Technological Characteristics

Mobile CT with 107cm aperture; 51.2cm FOV. Rotating anode X-ray tube; liquid cooling (water/propylene glycol). Detector: Gadolinium Oxysulfide (GOS) scintillator with photodiode array. Power: LiFePO4 batteries. Connectivity: DICOM 3.0/PACS. Software: Windows-based, filtered-back projection reconstruction. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-44, 62304, 62366; NEMA XR 25, XR 29.

Indications for Use

Indicated for X-ray computed tomography imaging of anatomy fitting within a 107cm aperture; excludes patients >400 lbs (182 kg). Contraindicated as principal guidance for invasive procedures requiring real-time imaging (e.g., CT fluoroscopy). Navigation accuracy must be verified when used with surgical navigation systems.

Regulatory Classification

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.

Predicate Devices

• Airo Mobile CT System (K160126)

Submission Summary (Full Text)

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March 15, 2018

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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 ([e-mail]) or phone [phone] 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: [phone] Email: [e-mail]

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 | Comparison |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>used for X-ray computed<br>tomography applications for<br>anatomy that can be imaged<br>in the 107cm aperture<br>excluding patients weighing<br>over 400 lbs (182 kg).<br><br>Airo is contraindicated as the<br>principal means of guidance<br>during invasive procedures<br>when real-time imaging is<br>needed (e.g., CT Fluoroscopy<br>procedures). In addition, the<br>physician must verify<br>navigation accuracy using an<br>adequate verification method<br>when used with Navigation<br>Systems during surgical<br>procedures. | The AIRO is intended to be<br>used for X-ray computed<br>tomography applications for<br>anatomy that can be imaged<br>in the 107cm aperture<br>excluding pediatric patients<br>and patients weighing over<br>400 lbs (182 kg).<br><br>Airo is contraindicated as the<br>principal means of guidance<br>during invasive procedures<br>when real-time imaging is<br>needed (e.g., CT Fluoroscopy<br>procedures). In addition, the<br>physician must verify<br>navigation accuracy using an<br>adequate verification method<br>when used with Navigation<br>Systems during surgical<br>procedures. | Equivalent -Removal of pediatric<br>restriction only. Battery of bench<br>testing with phantom images<br>presented in Section 18. |
| Product Classification Code | JAK | JAK | Identical |
| Aperture (cm) | 107 | 107 | Identical |
| Image Field of View (cm) | 51.2 | 51.2 | Identical |
| Detector Material | Gadolinium Oxysulfide<br>(GOS) | Gadolinium Oxysulfide<br>(GOS) | Identical |
| Detector Configuration | 32 x 2.0mm | 32 x 2.0 mm | Identical |
| Spatial Resolution for<br>Sharpest Clinical Algorithm<br>(Ip/cm at 2%) | 6.9 | 6.9 | Identical |
| X-ray Tube Type | Rotating Anode | Rotating Anode | Identical |
| Heat Storage (MHU) | 1.7 | 1.7 | Identical |
| X-ray Tube Cooling | Liquid (50% Water, 50%<br>Propylene Glycol) | Liquid (50% Water, 50%<br>Propylene Glycol) | Identical |
| X-ray Fan Angle (deg) | 45 | 45 | Identical |
| Company | Mobius Imaging, LLC | Mobius Imaging, LLC | |
| 510(k) Number | This 510(k) | K160126 | |
| Model Name | Airo CT System | Airo CT System | |
| Technological Characteristics | | | Comparison |
| Scanning capabilities (kV) | 80, 100, 120 kV | 120 kV (80 and 100 kV<br>was not used) | Equivalent - SW change for<br>Pediatrics- Battery of bench<br>testing has been completed |
| Max X-ray Power (kW) | 32 | 32 | Identical |
| Rotating Speed (seconds) | 2 | 2 | Identical |
| Gantry Weight (kg) | 1068 | 1068 | Identical |
| Transfer of electric current | Data Dock system | Data Dock system | Identical |
| Mechanism to translate<br>Gantry | Rails on Mobile Base<br>System | Rails on Mobile Base<br>System | Identical |
| Wireless | No | No | Identical |
| Mobile | Yes (motorized) | Yes (motorized) | Identical |
| Battery System | Yes (LiFePO4) | Yes (LiFePO4) | Identical |
| Wheels (casters) | Wheels (3 inch) | Wheels (3 inch) | Identical |
| Input Voltage | 1 phase 100-240 volt | 1 phase 100-240 volt | Identical |
| Input Power Max | 1.5 kW | 1.5 kW | Identical |
| PACS/DICOM 3.0 | Yes | Yes | Identical |
| 2D Scout | Yes | Yes | Identical |
| Bolus tracking | No | No | Identical |
| Dynamic Scan | No | No | Identical |
| Axial/Helical Modes | Axial and Helical | Axial and Helical | Identical |
| Tube Modulation Feature | Yes (Helical mode only) | Yes (Helical mode only) | Identical |
| MPR | Yes | Yes | Identical |
| 3D Viewing | No | No | Identical |
| Patient Table | Yes (optional Trumpf table<br>column integrated with<br>base) | Yes (optional Trumpf table<br>column integrated with<br>base) | Identical |
| 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 | | | Comparison |
| Scan Motion | Scanner Moves | Scanner Moves | Identical |
| Laser Alignment | Patient Alignment | Patient Alignment | Identical |
| Radiation Safeguards Hardware | | | |
| X-ray warning lights | Yes | Yes | Identical |
| 110% X-ray Timer | Yes | Yes | Identical |
| Emergency Stop | Yes…