Aura 10 PET/CT

K231420 · Xeos Medical · QXL · Aug 10, 2023 · Radiology

Device Facts

• Record ID: K231420
• Device Name: Aura 10 PET/CT
• Applicant: Xeos Medical
• Product Code: QXL · Radiology
• Decision Date: Aug 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Indications for Use

The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, PET only, or a combination of both by surgeon's discretion. The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management. The AURA 10 PET/CT system is not validated for margin detection.

Device Story

AURA 10 PET/CT is a mobile, vertical-bore cabinet imaging system for harvested surgical specimens. It integrates PET (LYSO crystals, SiPM) and CT (tungsten anode, 50 kV) to provide co-registered images of radiopharmaceutical uptake and anatomical structure. Operated by surgeons or pathology staff in ORs or pathology departments, the device provides rapid verification of excised tissue. Input consists of physical specimens; output is a combined PET/CT image displayed to the clinician to assist in surgical management. The mobile cart design allows portability between suites. It benefits patients by confirming correct tissue excision during surgery.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including analytical performance testing per NEMA NU 4-2008, electrical safety (IEC 61010-1, 61010-2-091, 61010-2-101), EMC (IEC 61326-2-6), and usability engineering (IEC 62366-1).

Technological Characteristics

Mobile cabinet PET/CT system. PET: LYSO scintillator, SiPM, 100mm transaxial FOV. CT: Tungsten anode, 50 kV, 1.0 mA max, 0.050 mm focal spot. Connectivity: Networked. Software: Moderate level of concern. Standards: IEC 61010-1, IEC 61010-2-091, IEC 61010-2-101, IEC 61326-2-6, IEC 62304, NEMA NU 4-2008, IEC 62366-1.

Indications for Use

Indicated for imaging harvested surgical specimens from various anatomical regions to verify tissue excision; intended for use in operating rooms and pathology departments; not validated for margin detection.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Vereos Pet/Ct (K210880)

Reference Devices

• Faxitron Visionct (K173309)

Submission Summary (Full Text)

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August 10, 2023

XEOS Medical % Bjorn Delbeecke Head of OARA and Legal Ottergemsesteenweg-Zuid 808 Bus 358 Gent, Oost-Vlaanderen 9000 BELGIUM

Re: K231420

Trade/Device Name: AURA 10 PET-CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: QXL, MWP Dated: May 5, 2023 Received: May 16, 2023

Dear Bjorn Delbeecke:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K231420

Device Name AURA 10 PET/CT

## Indications for Use (Describe)

The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verfication that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, or a combination of both by surgeon's discretion.

The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.

The AURA 10 PET/CT system is not validated for margin detection.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

K231420

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.

#### 5.1. General information

| Date Prepared: | 5 May 2023 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | XEOS Medical NV<br>Ottergemsesteenweg Zuid 808 bus 358<br>9000 Gent<br>BELGIUM |
| Primary Contact<br>Person: | Bjorn Delbeecke<br>Head of QARA and Legal<br>[phone]<br>[e-mail] |
| Device: | Trade Name: AURA 10 PET/CT<br>Common Name: Cabinet, Emission Tomography System<br>Cabinet, CT system<br>Classification Name (Regulation): Cabinet, Emission Tomography System<br>Cabinet, CT system<br>Classification Panel: Radiology<br>Device Class Class II<br>Product Code QXL<br>Secondary product code MWP |
| Predicate Device: | Trade Name: Vereos Pet/Ct<br>Company: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K210880<br>Classification Name (Regulation): Emission computed tomography system (21 CFR 892.1200)<br>Computed tomography x-ray system (21 CFR 892.1750)<br>Classification Panel: Radiology<br>Device Class: Class II<br>Product Code: KPS<br>Secondary Product Code: JAK |
| Reference Device: | Trade Name: Faxitron Visionct<br>Company: Faxitron Bioptics Llc<br>510(k) Clearance: K173309<br>Classification Name (Regulation): Stationary x-ray system (21 CFR 892.1680)<br>Classification Panel: Radiology<br>Device Class: Class II<br>Product Code: MWP |
| Device description: | The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View<br>(FOV) suitable for small pathology specimens. It is intended to be used in both the<br>operating room (OR) as well as the pathology department to image pathology<br>specimens from various anatomical regions in order to provide rapid pathology<br>imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide<br>range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so<br>that it is easily portable by one person and can be moved to different surgical suites or<br>between departments as needed. |
| Intended Use /<br>Indications for Use | The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines<br>Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) |

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systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, PET only, or a combination of both by surgeon's discretion.

The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.

The AURA 10 PET/CT system is not validated for margin detection.

#### Technological characteristics

The following table provides a detailed overview of the technological similarities and differences between the subject AURA 10 PET/CT, the predicate Vereos PET/CT and the reference device Faxitron Vision CT.

| Features | Subject device<br>AURA 10 PET/CT | Predicate device<br>Vereos PET/CT<br>(K210880) | Reference device<br>Faxitron Vision CT<br>(K173309) |
|--------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| GENERAL | | | |
| Size(s) | 162 x 52 x 65 cm³ | 485 x 220 x 207 cm³ (L x<br>W x H) | 180 x 70 x 65 cm³ |
| Mass | 150 kg | 4220 kg | 140 kg |
| Battery or Mains powered | Mains | Mains | Mains |
| Power requirements | Single-phase<br>110-250 VAC<br>50/60 Hz<br>1.2 kW | 3-phase<br>200/208/240/380/400/415/4<br>80/500 VAC<br>50/60 Hz<br>150,000 VA | Single-phase<br>100 - 250 VAC<br>50/60 Hz<br>200 VA |
| Mobility | Mobile | Stationary | Mobile |
| PET SUBSYSTEM | | | |
| Scintillator Crystal Material | LYSO | LSO/LYSO | N/A |
| Photomultiplier technology | Silicon<br>Photomultipliers | Silicon<br>Photomultipliers | N/A |
| FOV, Transaxial | 100 mm | 576 mm | N/A |
| FOV, Axial | 60 mm | 164 mm | N/A |
| Energy Window | 358 keV - 664 keV | 450 - 613 keV | N/A |
| Spatial Resolution | < 1.0 mm | > 4.2 mm | N/A |
| Peak NEC Rate | 38,395 kpcs at 26.6<br>kBq/mL | 687 kcps @ 50<br>kBq/mL<br>222 kcps @ 5.3<br>kBq/mL | N/A |
| ToF Resolution | N/A | 310 ps | N/A |
| Scatter fraction | 16% | 34% | N/A |
| Max Count rate Error | N/A | 6.8% | N/A |
| Energy resolution | 18% | 11% | N/A |
| Sensitivity | 60 cps/kBq | 5.2 cps/kBq | N/A |
| CT SUBSYSTEM | | | |
| X-ray tube anode material | Tungsten | Tungsten | Tungsten |
| X-ray tube kV settings | 50 kV | 80, 100, 120, 140 kV | 15 - 50 kV |
| X-ray tube current | 1.0 mA max (0.6 mA<br>actual) | 20 – 665 mA | 1.0 mA max |
| X-ray tube power | 50 W max | 80,000 W max | 11.5 W max |
| Focal spot size | 0.050 mm typical | 0.5 x 1.0 mm² or 1.0 x<br>1.0 mm² | < 0.015 mm |
| Anode angle | 20 degrees | 7 degrees | 45 degrees |
| Focus-isocenter distance | 260 mm | 570 mm | 230 mm |
| Focus-detector distance | 350 mm | 1040 mm | 370 mm |
| Magnification | 1.35X | 1.82X | 1.61X |
| Transaxial Modulation Transfer<br>Function (MTF) | 5 lp/mm (at cutoff)<br>4 lp/mm (at 20%<br>MTF) | 1.3 - 2.4 lp/mm (at<br>cutoff) | Unpublished |
| Axial MTF | 5 lp/mm (at cutoff)<br>4 lp/mm (at 20%<br>MTF) | 1.3 - 2.4 lp/mm (at<br>cutoff) with<br>appropriately thin<br>slice sensitivity profile<br>selection | Unpublished |
| Image matrix | 1024 x 1024 | Up to 1024 x 1024 | 1024 x 1024 |
| Slice thickness | 0.1 mm | 0.5 - 12.5 mm (axial<br>mode) | 0.1 mm |
| Number of slices | 620 | 64, 128 | Up to 1024 |
| Metal artifact reduction | Yes | Available as option | Yes |
| HOST AND NETWORKING | | | |
| Network connection | Yes | Yes | Yes |
| PRESCRIPTION / OVER THE COUNTER | | | |
| Prescription / Over the counter | Prescription | Prescription | Prescription |

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## Summary of non-clinical performance data

### Electrical Safety and Electromagnetic Compatibility (EMC)

The AURA 10 PET/CT was tested in accordance with IEC 61010-1 (2010 + A1 2016) Standard for Safety for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1: General requirements, including US deviations. The device passed all tests.

The AURA 10 PET/CT was tested in accordance with IEC 61010-2-091:2012 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-091: Particular requirements for cabinet X-ray systems. The device passed all tests. The device was also designed and developed in accordance to 21 CFR 1020.40 (Cabinet x-ray systems) and as recommended by FDA's Guidance for Industry and FDA Staff, "Compliance guide for cabinet X-ray systems."

The AURA 10 PET/CT was tested in accordance with IEC 61010-2-101:2018 2012 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.

The AURA 10 PET/CT was tested in accordance with IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment. The device passed all tests. The testing was conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for electromagnetic compatibility (EMC) of medical devices."

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern.

The AURA 10 PET/CT was tested in accordance with IEC 62304:2006 + A1:2015: Medical device software -Software life-cycle processes (FDA Recognition Number: 13-79).

### Bench Testing

The following bench testing was performed to demonstrate substantial equivalence:

- Analytical performance testing. The AURA 10 PET/CT was tested in accordance with NEMA NU 4-2008 -Performance measurements of small animal positron emission tomographs (PETs).
- -Usability testing. The AURA 10 PET/CT was tested in accordance with IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices (FDA Recognition Number: 5-114). Usability testing was conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance on Applying Human Factors and Usability Engineering to Medical Devices".

Information pursuant to the following FDA Guidance Documents was also included:

- -Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- -Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

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- -Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
- -Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
- -Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- Guidance for Radio Frequency Wireless Technology in Medical Devices -
- Guidance for Off-The-Shelf Software Use in Medical Devices -
- Guidance on General Principles of Software Validation -
- -Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems.

## Summary of clinical performance data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

## Final Conclusion

This summary includes information on the technological characteristics, performance data as well as verification and validation activities demonstrating that the AURA 10 PET/CT is as safe and effective as the predicate and does not raise different questions of safety and effectiveness, and therefore is substantially equivalent to the predicate device.