(86 days)
No
The summary describes a standard PET/CT imaging system for specimens and does not mention any AI/ML capabilities, image processing beyond standard reconstruction, or performance metrics typically associated with AI/ML algorithms.
No.
Explanation: The device is described as a "diagnostic imaging device" intended to "provide rapid verification that the correct tissue has been excised during the surgical procedure" and to "help the surgeon with further patient management." It does not provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The AURA 10 PET/CT system is a cabinet diagnostic imaging device..." and describes its function in providing images to help surgeons with patient management.
No
The device is described as a "cabinet diagnostic imaging device" and a "mobile, vertical-bore PET/CT system," clearly indicating it is a hardware system that includes both PET and CT components, not solely software.
Based on the provided text, the AURA 10 PET/CT system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the living body.
- AURA 10's function: The AURA 10 images harvested specimens (tissue removed during surgery). While this is done in vitro (outside the body), the device itself is an imaging system that uses PET and CT technology to visualize the specimen. It is not performing a biochemical, immunological, or molecular test on the specimen's components.
- Intended Use: The intended use is to provide rapid verification that the correct tissue has been excised and to help the surgeon with further patient management based on the imaging information. This is a diagnostic imaging function, not an in vitro diagnostic test.
- Device Description: The description reinforces that it's an imaging system for pathology specimens.
In summary, the AURA 10 is a medical imaging device used to visualize excised tissue specimens, not a device that performs in vitro diagnostic tests on those specimens.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
QXL, MWP
Device Description
The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View (FOV) suitable for small pathology specimens. It is intended to be used in both the operating room (OR) as well as the pathology department to image pathology specimens from various anatomical regions in order to provide rapid pathology imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so that it is easily portable by one person and can be moved to different surgical suites or between departments as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
Anatomical Site
harvested specimens from various anatomical regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, operating room (OR), pathology department
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)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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
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 |
| Ottergemsesteenweg Zuid 808 bus 358 | |
| 9000 Gent | |
| BELGIUM | |
| Primary Contact | |
| Person: | Bjorn Delbeecke |
| Head of QARA and Legal | |
| +32 (0)9 277 77 93 | |
| Bjorn.delbeecke@xeos.care | |
| Device: | Trade Name: AURA 10 PET/CT |
| Common Name: Cabinet, Emission Tomography System | |
| Cabinet, CT system | |
| Classification Name (Regulation): Cabinet, Emission Tomography System | |
| Cabinet, CT system | |
| Classification Panel: Radiology | |
| Device Class Class II | |
| Product Code QXL | |
| Secondary product code MWP | |
| Predicate Device: | Trade Name: Vereos Pet/Ct |
| Company: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K210880 | |
| Classification Name (Regulation): Emission computed tomography system (21 CFR 892.1200) | |
| Computed tomography x-ray system (21 CFR 892.1750) | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: KPS | |
| Secondary Product Code: JAK | |
| Reference Device: | Trade Name: Faxitron Visionct |
| Company: Faxitron Bioptics Llc | |
| 510(k) Clearance: K173309 | |
| Classification Name (Regulation): Stationary x-ray system (21 CFR 892.1680) | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: MWP | |
| Device description: | The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View |
| (FOV) suitable for small pathology specimens. It is intended to be used in both the | |
| operating room (OR) as well as the pathology department to image pathology | |
| specimens from various anatomical regions in order to provide rapid pathology | |
| imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide | |
| range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so | |
| that it is easily portable by one person and can be moved to different surgical suites or | |
| between departments as needed. | |
| Intended Use / | |
| 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) |
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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
AURA 10 PET/CT | Predicate device
Vereos PET/CT
(K210880) | Reference device
Faxitron Vision CT
(K173309) |
|--------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| GENERAL | | | |
| Size(s) | 162 x 52 x 65 cm³ | 485 x 220 x 207 cm³ (L x
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
110-250 VAC
50/60 Hz
1.2 kW | 3-phase
200/208/240/380/400/415/4
80/500 VAC
50/60 Hz
150,000 VA | Single-phase
100 - 250 VAC
50/60 Hz
200 VA |
| Mobility | Mobile | Stationary | Mobile |
| PET SUBSYSTEM | | | |
| Scintillator Crystal Material | LYSO | LSO/LYSO | N/A |
| Photomultiplier technology | Silicon
Photomultipliers | Silicon
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 | 4.2 mm | N/A |
| Peak NEC Rate | 38,395 kpcs at 26.6
kBq/mL | 687 kcps @ 50
kBq/mL
222 kcps @ 5.3
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
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
1.0 mm² |