AIRO Computed Tomography (CT) X-ray System

K160126 · Mobius Imaging · JAK · Apr 19, 2016 · Radiology

Device Facts

• Record ID: K160126
• Device Name: AIRO Computed Tomography (CT) X-ray System
• Applicant: Mobius Imaging
• Product Code: JAK · Radiology
• Decision Date: Apr 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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 procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.

Device Story

Mobile intraoperative CT system; 107cm bore; 51.2cm FOV. Inputs: X-ray irradiation of patient anatomy. Transformation: Rotating gantry with solid-state X-ray generator and CdWO4/photodiode detector array; data acquisition system; reconstruction computer using filtered-back projection algorithms. Outputs: CT images for clinical review. Used in OR, ICU, ED, clinic, or radiology by physicians/technicians. Features motorized base, battery power, and retractable casters for mobility. Includes sequential axial/helical scanning, tube current modulation, and metal artifact reduction. Output assists clinicians in diagnostic imaging and surgical planning/navigation. Benefits: Intraoperative imaging capability without moving patient to fixed radiology suite.

Clinical Evidence

Bench testing only. Evidence includes risk analysis, design verification, software unit/system integration testing, image quality metrics using phantoms, and offline reconstruction clinical image comparisons for the metal artifact reduction feature. No clinical trials were conducted.

Technological Characteristics

Mobile CT system; 107cm aperture; 51.2cm FOV. Detector: Solid-state CdWO4 scintillator array (32x16 pixels). X-ray source: Rotating anode, liquid-cooled (water/propylene glycol). Power: LiFePO4 battery system. Connectivity: PACS/DICOM 3.0. Software: Windows-based, filtered-back projection reconstruction. Safety: Emergency stop, X-ray indicators, interlocks, patient alignment lasers. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-44, 62366, 60825-1, 62133, UL 1642.

Indications for Use

Indicated for X-ray computed tomography imaging of anatomy within a 107cm aperture. Excludes pediatric patients and patients weighing >400 lbs (182 kg). Contraindicated for use as primary guidance during invasive procedures requiring real-time imaging (e.g., CT Fluoroscopy).

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 (K131431)

Submission Summary (Full Text)

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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.

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

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<br>used for X-ray computed<br>tomography applications for<br>anatomy that can be imaged in<br>the 107cm aperture excluding<br>pediatric patients and patients<br>weighing over 400 lbs (182 kg).<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>In addition, the physician must<br>verify navigation accuracy<br>using an adequate verification<br>method when used with<br>Navigation Systems during<br>surgical procedures. | The AIRO is intended to be used<br>for non-contrast X-ray computed<br>tomography applications for<br>anatomy that can be imaged in<br>the 107cm aperture excluding<br>pediatric patients and patients<br>weighing over 400 lbs (182 kg).<br>Airo is contraindicated as the<br>principal means of guidance<br>during surgical procedures. The<br>physician must verify navigation<br>accuracy using known<br>anatomical landmarks or an<br>equivalent verification method<br>when used in surgical<br>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<br>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%<br>Propylene Glycol) | Liquid (50% Water, 50%<br>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<br>(subject of this 510(k) | Airo® CT System<br>(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<br>integrated with base) | Yes (Trumpf table column<br>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<br>(subject of this 510(k) | Airo® CT System<br>(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<br>Testing | ETL Testing | ETL Testing…