(28 days)
Not Found
No
The summary describes a standard PET scanner and its performance metrics, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a PET scanner intended to obtain images to detect abnormal patterns of radioactivity, which assists in research, diagnosis, therapeutic planning, and outcome assessment. Its primary function is diagnostic imaging, and it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to obtain Position Emission Tomography (PET) images of human brain to detect abnormal pattern of distribution of radioactivity" and that this information "can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment." The mention of "diagnosis" confirms its use as a diagnostic device.
No
The device description explicitly states that CareMiBrain is a PET scanner with integrated hardware components including detection systems, acquisition and control electronics, crystals, and photosensor arrays. While it includes software for image acquisition, reconstruction, and export, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- CareMiBrain Function: The description clearly states that CareMiBrain is a PET scanner that obtains images of the human brain after injection of a position emitting radiopharmaceutical. This is an in vivo imaging technique, meaning it is performed within the living body.
- No Specimen Analysis: The device description focuses on the hardware and software for acquiring and reconstructing images based on the distribution of the radiopharmaceutical within the brain. There is no mention of analyzing biological specimens.
Therefore, based on the provided information, CareMiBrain is a medical imaging device, specifically a PET scanner, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CareMiBrain is dedicated brain PET scanner, and intended to obtain Position Emission Tomography (PET) inages of human brain to detect abnormal pattern of distribution of radioactivity after injection of a position emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Product codes
KPS
Device Description
CareMiBrain is a small aperture Positron Emission Tomography (PET) scanner to image the distribution of injected positron emitting radiopharmaceuticals in the head of live humans in seating/reclined position. CareMiBrain is a PET (Positron Emission Tomography) dedicated to brain imaging. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. The scanner consists of 48 monolithic Lutetium OrthoSilicate (LYSO) crystals arranged in 3 rings of 16 modules each. Physical ring diameter is 260mm, with an effective 220 mm transaxial and 152 mm axial FOV. Crystal dimensions are 50x50x15mm (width x height x thickness). Crystals are coupled to a photosensor array of 12x12 silicon photo-multiplier (SiPM), 3x3 mm each. The detectors of the equipment are integrated in a circular housing with the appropriate dimensions so that the patient can insert the head. The software that integrates the equipment allows the acquisition, reconstruction and export of tomographic images of the brain, as well as to make a diagnosis of the state of the detectors.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
human brain
Indicated Patient Age Range
Adults and adolescent > 140cm height
Intended User / Care Setting
trained healthcare professionals / Hospital
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)
Bench Performance Testing:
The CareMiBrain performance was tested by an independent institute (Instrumentation of Molecular Imaging, i3m) according to NEMA NU 2-2012 (for whole-body PETs) and NEMA NU 4-2008 (for small animal PETs), with NEMA NU 4-2008 tests being more restrictive. The results were published in Scientific Reports Journal (DOI 10.1038/s41598-019-51898-z).
Measurements performed include:
- Spatial Resolution
- Scatter Fraction and count rate (NECR)
- Sensitivity
- Image Quality, accuracy of attenuation correction and scatter correction
- Accuracy: corrections for count losses and randoms
Test results indicated that CareMiBrain PET Scanner complies with its predetermined specification and the applicable standards.
Clinical Performance Testing:
Clinical effectiveness was tested by independent hospitals and the results published in Spanish Journal of Nuclear Medicine and Molecular imaging (DOI 10.1016/j.remn.2021.04.002).
Sample images from several clinical cases with different PET tracers using the CareMiBrain PET Scanner were provided.
Key Results:
- Spatial Resolution (NEMA NU 4-2008):
- Transverse Resolution FWHM @5mm: 1.55 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @10mm: 1.45 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @15mm: 1.52 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @25mm: 1.59 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @5mm: 1.45 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @10mm: 1.40 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @15mm: 1.58 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @25mm: 1.41 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @5mm: 1.51 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @10mm: 1.58 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @15mm: 1.64 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @25mm: 1.52 mm (Acceptance criteria: 2 mm)
- Extra Spatial resolution values (NEMA NU 4-2008):
- Transverse Resolution FWHM @0 mm: 1.53 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @50 mm: 1.51 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @75 mm: 1.76 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @100mm: 1.66 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @0 mm: 1.36 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @50 mm: 1.44 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @75 mm: 1.44 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @100mm: 1.44 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @0 mm: 1.57 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @50 mm: 1.67 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @75 mm: 1.64 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @100mm: 1.64 mm (Acceptance criteria: 2 mm)
- Spatial resolution (NEMA NU 2-2012):
- Transverse Resolution FWHM @10mm: 1.68 mm (Acceptance criteria: 2 mm)
- Transverse Resolution FWHM @100mm: 1.86 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @10 mm: 1.39 mm (Acceptance criteria: 2 mm)
- Axial Resolution FWHM @100 mm: 1.40 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @10 mm: 1.87 mm (Acceptance criteria: 2 mm)
- Radial Resolution FWHM @100 mm: 1.86 mm (Acceptance criteria: 2 mm)
- Count rate evaluation and sensitivity (NEMA NU 2-2012):
- Sensitivity along transverse center: 17.83 cps/kBq (Acceptance criteria: 15 cps/kBq)
- Sensitivity off center: 13.82 cps/kBq (Acceptance criteria: 12cps/kBq)
- Count rate peak NECR: 49 kcps (Acceptance criteria: 30 kcps)
- Count rate peak trues: 193 kcps (Acceptance criteria: 160 kcps)
- Scatter fraction at peak NECR: 7.4 MBq (Acceptance criteria: 9.25 MBq)
- Scatter fraction Mean: 48 % (Acceptance criteria: 60 %)
- Image Quality - % contrast/ background variability (NEMA NU 4-2008):
- 4.5 mm: 0.73 (Acceptance criteria: 0.65)
- 6mm: 0.78 (Acceptance criteria: 0.65)
- 9mm: 1.14 (Acceptance criteria: 0.65)
- 12mm: 1.01 (Acceptance criteria: 0.65)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for sensitivity values, spatial resolution in FWHM, count rates, and image quality metrics.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 21, 2023
General Equipment for Medical Imaging, S.A. % Dave Yungvirt Chief Executive Officer Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K232569
Trade/Device Name: CareMiBrain Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: August 21, 2023 Received: August 24, 2023
Dear Dave Yungvirt:
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. Rayfield
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 Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name CAREMIBR AIN
Indications for Use (Describe)
CareMiBrain is dedicated brain PET scanner, and intended to obtain Position Emission Tomography (PET) inages of human brain to detect abnormal pattern of distribution of radioactivity after injection of a position emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the text "ONCO VISION" on the right. The word "ONCO" is in blue, and the word "VISION" is in green.
510(K) SUMMARY K232569
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
SUBMITTER´S INFORMATION l.
| Submitter | General Equipment for Medical Imaging, S. A. |
|---|---|
| (Oncovision Gem-Imaging S.A.) | |
| Calle de Jeroni de Montsoriu, 92 – BJ IZ | |
| 46022 Valencia | |
| +34 96 372 24 72 | |
| info@oncovision.com | |
| 510(K) Contact person | María Climent Vicedo |
| Quality and Regulatory Affairs Manager | |
| General Equipment for Medical Imaging, S.A. | |
| Phone: (+34) 653 76 32 68 | |
| Email: calidad@oncovision.com | |
| Date | 13 Sep 2023 |
II. DEVICE
| Trade / Device Name | CareMiBrain |
|---|---|
| Common Name | Dedicated brain Positron Emission Tomography system |
| Classification Name | Emission Computed Tomography System |
| 21 CFR Reference | 892.1200 |
| Classification | Class II |
| Panel | Radiology |
| Product Code | KPS |
INNOVATIVE MEDICAL IMAGING
ONCOVISION | General Equipment for Medical Inaging S.A | Clerimo de Monsoni, 92 Bajo Lzq, 46022, Valencia, Spain | +3 963 722 472 | info@onovision.com | www.oncovision.com
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Image /page/4/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue on the right, stacked on top of the word "VISION" in green. The sphere has a swirling pattern of blue and white lines, giving it a three-dimensional appearance.
lll. IDENTIFICATION OF PREDICATE DEVICE
| Predicate Trade/Device Name | BBX™-PET Scanner |
|---|---|
| 510(k) Number | K210450 |
| Common Name | PET Scanner |
| 21 CFR Reference | 892.1200 |
| Regulation Name | Emission Computed Tomography System |
| Classification | Class II |
| Panel | Radiology |
| Product Code | KPS |
| Applicant | Prescient Imaging LLC. |
IV. APPLICABLE FDA GUIDANCES
This document has been prepared according to the required content described in the FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k). Guidance for Industry and FDA", and "Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff".
V. DEVICE DESCRIPTION
CareMiBrain is a small aperture Positron Emission Tomography (PET) scanner to image the distribution of injected positron emitting radiopharmaceuticals in the head of live humans in seating/reclined position. CareMiBrain is a PET (Positron Emission Tomography) dedicated to brain imaging. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. The scanner consists of 48 monolithic Lutetium OrthoSilicate (LYSO) crystals arranged in 3 rings of 16 modules each. Physical ring diameter is 260mm, with an effective 220 mm transaxial and 152 mm axial FOV. Crystal dimensions are 50x50x15mm (width x height x thickness). Crystals are coupled to a photosensor array of 12x12 silicon photo-multiplier (SiPM), 3x3 mm each. The detectors of the equipment are integrated in a circular housing with the appropriate dimensions so that the patient can insert the head. The software that integrates the equipment allows the acquisition, reconstruction and export of tomographic images of the brain, as well as to make a diagnosis of the state of the detectors.
The use of the device is limited only to patients whose height is higher than 140cm (55.2 inches).
INNOVATIVE MEDICAL IMAGING
ONCOVISON | General Equipment for Medical Inaging S.A | C/ Jerónimo de Monsoriu, 92 Bajo Lzq, 4002, Valencia, Spain | +34 963 722 472 | info@onovisio.com www.oncovision.com
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Image /page/5/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the text "ONCOVISION" on the right. The word "ONCO" is in blue, and the word "VISION" is in green.
VI. INDICATIONS FOR USE
CareMiBrain is dedicated brain PET scanner, and intended to obtain Positron Emission Tomography (PET) images of human brain to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
CareMiBrain and the predicate device are both Positron Emission Tomography systems used to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings. Main technological elements of CareMiBrain and predicate device are the same:
- PET detectors are arranged in a cylindrical shape.
- Detectors are composed of scintillator crystals and Silicon photomultipliers, that detect gamma rays emitted by radioactivity located inside the cylinder.
- Single and coincidence events are captured on detector electronics and acquired and processed by software, that generates image using iterative reconstruction methods.
- . Attenuation correction method is in both cases Calculated Attenuation Correction.
Main differences between predicate device and CareMiBrain are:
- . Patient is in seated/reclined position in CareMiBrain, while in predicate device is lying on a bed.
- Cylinder diameter is 26 cm in CareMiBrain, while in predicate device is 29cm.
- Crystals are monolithic Lutetium Yttrium OrthoSilicate (LYSO) in CareMiBrain, while in predicate pixelated lutetium fine-silicate (LFS) crystals are used.
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Image /page/6/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left side and the word "ONCO" in blue and "VISION" in green on the right side. The sphere has a white design on it.
VIII. COMPARISON TABLE
| Attributes | Predicate device | Subject device | Justification of equivalence |
|---|---|---|---|
| BBX™-PET Scanner | CareMiBrain | ||
| Device | Image: BBX™-PET Scanner | Image: CareMiBrain | |
| Intended use | Dedicated Positron Emission Tomography | Dedicated Positron Emission Tomography | Same as predicate |
| Indications for use | BBX™-PET scanner is intended to obtain Positron Emission Tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment. | CareMiBrain is dedicated brain PET scanner, and intended to obtain Positron Emission Tomography (PET) images of human brain to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment. | Same as predicate |
| Principle of detection | Positron Emission Tomography (PET) system to image the distribution of injected positron emitting radiopharmaceuticals into live humans or animals. The BBX-PET Scanner produces images that represent the | CareMiBrain is a small aperture Positron Emission Tomography (PET) scanner to image the distribution of injected positron emitting radiopharmaceuticals in the head of live humans, as defined in 21 CFR 892.1200. | Same as predicate |
| internal distribution of | |||
| radioactivity in the head. | CareMiBrain generates | ||
| tomographic images that | |||
| represent the internal | |||
| distribution of radioactivity | |||
| in the patient's head and | |||
| brain. | |||
| Scintillator | |||
| configuration / | |||
| Scanner | Double-layer staggered | ||
| Lutetium Fine Silicate | |||
| pixelated crystals (13 × 13 | |||
| and 14 × 14 arrays, 1.76-mm | |||
| pitch) coupled to light | |||
| detector solid state silicon | |||
| photomultiplier. | |||
| One hundred twenty-eight | |||
| blocks positioned in a | |||
| circular shape make up the | |||
| gantry, with bore diameter | |||
| of 288mm, and 250mm and | |||
| 100mm transaxial and axial | |||
| FOVs. | Monolithic Lutetium-based | ||
| scintillator (LYSO) coupled | |||
| to solid state silicon | |||
| photomultiplier. Crystals | |||
| are 50x50x15mm. 3 rings of | |||
| 16 detectors positioned in | |||
| circular shao. | |||
| Bore diameter (opening | |||
| detector) is 260mm and | |||
| useful FOV is 220mm | |||
| transaxial and 150mm axial. | Both use scintillator | ||
| crystals coupled to solid | |||
| state silicon | |||
| photomultipliers in | |||
| circular shape. Bore | |||
| diameter is similar. Axial | |||
| FOV is bigger for | |||
| CareMiBrain. | |||
| The most important | |||
| innovation in the designof CareMiBrain PET | |||
| scanner is the use of | |||
| continuous crystals in | |||
| contrast to standard | |||
| pixelated crystals. | |||
| CareMiBrain uses | |||
| continuous crystals | |||
| which make it possible | |||
| to measure multiple | |||
| layers of depth of | |||
| interaction (DOI) of the | |||
| gamma rays in the | |||
| crystals. This allows the | |||
| system to minimize the | |||
| parallax error which | |||
| degrades the final | |||
| spatial resolution. | |||
| These differences do not | |||
| affect the indications, | |||
| only the performance | |||
| Target | |||
| population | Adults, young adults | Adults and adolescent > | |
| 140cm height | Same as predicate | ||
| Anatomical site | Parts of the human body | ||
| that fit in the patient | |||
| aperture | Parts of the human body | ||
| that fit in the patient | |||
| aperture | Same as predicate | ||
| Where used | Hospital | Hospital | Same as predicate |
| Energy used | |||
| and/or | |||
| delivered | Detects distribution of | ||
| radioactivity after injection | |||
| of a positron emitting | |||
| radiopharmaceutical. No | |||
| energy delivered | Detects distribution of | ||
| radioactivity after injection | |||
| of a positron emitting | |||
| radiopharmaceutical. No | |||
| energy delivered | Same as predicate | ||
| Human factors | PET detection system in a | ||
| movable cart. its gantry can | |||
| move up to allow brain | |||
| imaging while the patient is | |||
| seated. It can also move | |||
| down to image the breast | |||
| without compression, while | |||
| a patient is lying on a biopsy | |||
| table or rotate and allow | |||
| imaging the breast, hand, or | |||
| leg in a seated position. | PET detection system is | ||
| fixed and includes a chair. | |||
| Gantry can move up, down, | |||
| horizontally and with tilt | |||
| adjust to properly fit the | |||
| height of the patients for | |||
| imaging the brain while the | |||
| patient is seated. | Only brain imaging in | ||
| seating position is | |||
| possible. This position is | |||
| the same in predicate. | |||
| Main difference is that | |||
| the chair is integrated in | |||
| the system, as explained | |||
| in the discussion section. | |||
| Imaging in lying position | |||
| is not possible. | |||
| Design | The BBX-PET Scanner is | ||
| comprised of two parts; the | |||
| Gantry containing detectors | |||
| and electronics, and the | |||
| Universal Console that | |||
| contains the computer | |||
| workstation. These two | |||
| parts are connected to each | |||
| other using optical fiber and | |||
| an USB cable. | CareMiBrain is comprised of | ||
| two parts; the PET scanner, | |||
| that includes the patient's | |||
| chair for acquisition in | |||
| seated position and | |||
| contains the electronics and | |||
| detectors; and the control | |||
| station, including the PC and | |||
| the software for controlling | |||
| the data acquisition and | |||
| performing the | |||
| reconstruction. | |||
| Scanner and control station | |||
| are connected through a | |||
| dedicated network. Control | |||
| station is connected to | |||
| hospital's network with | |||
| DICOM Worklist support | |||
| and PACS connectivity. | Same as predicate, | ||
| except that the | |||
| connection is standard | |||
| ethernet cable instead | |||
| of a fiber optics cable | |||
| and USB | |||
| Performance | |||
| Data¹ | |||
| (Specifications | Spatial Resolution: 2.2 mm | ||
| FWHM |
Spatial resolution in FWHM
at the center: 2.2mm
Spatial resolution in FWHM
at 10 cm: Not published
Energy resolution: Not
published
Transverse resolution:
2.2mm
Axial resolution: 2.2mm
Spatial linearity: Not
published
Flood field uniformity: Not
published
System sensitivity: 1.1%
Coincidence timing window:
Not published
Coincidence dead time: Not
published | Spatial Resolution: 1.9 mm
FWHM
Spatial resolution in FWHM
at the center: 1.55mm
Spatial resolution in FWHM
at 10cm: 1.66mm
Energy resolution: 7% with
358-664 Kev window, >9%
with 255-767 KeV window.
Coincidence timing window:
5ns
Coincidence dead time:
700ns | Performance is same or
better than published
predicate data. Based on
the available, published
performance of the
predicate, the non-
published predicate
performance values
cannot be better than
CareMiBrain measured
values, as they are highly
related. A change in
performance does not
affect indications, as it is
in all cases improving
the images. |
| Scatter fraction: | Not published | Scatter fraction: 48% | |
| Scatter correction method: | Not published | Scatter correction method: dual energy window | |
| Slice thickness: | Depends on reconstruction (2mm/4mm) | Slice thickness: Depends on reconstruction (0.5/1/2mm) | |
| Count rate sensitivity: | 10 cps/kBq | 13.82 cps/kBq with 255-767 KeV window, 11.05 cps/kBq with 358-664 Kev window. | |
| Isolation of the detector from background: | Not applicable for PET | Isolation of the detector from background: Not applicable for PET | |
| Intrinsic spatial resolution: | Not applicable for PET | Intrinsic spatial resolution: Not applicable for PET | |
| Attenuation: | Calculated method | Attenuation: Calculated method | |
| Depth of Interaction: | Double-layer | Depth of interaction: 2 CareMiBrain clinical evaluation published in Rev Esp Med Nucl Imagen Mol., 2021. https://doi.org/10.1016/j.remn.2021.04.002
ONCOVISON | General Equipment for Medical Inaging S.A | Jerónimo de Monsoriu, 92 Bajo Lzq, 46022, Valencia, Spain | +34 963 722 472 | info@oncovison.com www.oncovision.com
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Image /page/12/Picture/0 description: The image shows the OncoVision logo. The logo consists of a blue sphere on the left and the word "ONCO" in blue on the right, above the word "VISION" in green. The sphere has a white design on it.
i. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CareMiBrain device and certified by independent certification company DEKRA and SGS. The system complies with the following standards:
- . ANSI / AAMI ES 60601-1:2005 / ( R ) 2012 and A1:2012, C1:2009/ (R ) 2012 and A2:2010/( R) 2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- ANSI / AAMI IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
ii. 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 (CDRH, 2005)."
According to the FDA regulations, the CareMiBrain Level of Concern is "Moderate". A software malfunction cannot directly cause any harm to the patient but might lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that might lead to minor injury. But as the scope of the CareMiBrain Suite is to provide additional information to other techniques which are usually performed (pathologic analysis, etc.), the physician criteria would always prevail over it.
On the other hand, the software validation process has been designed following the ISO/IEC 62304 guidelines. According to ISO/IEC 62304, it must comply with level B in the security level, which equals to "Moderate Level of Concern" in FDA regulation.
iii. Performance Testing - Bench
Performance testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff," Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and NuclearTomography Systems" Section IX.C.2. (CDRH, 1998).
Performance CareMiBrain PET Scanner has been tested by an independent institute for Instrumentation of Molecular Imaging, i3m) according to NEMA NU 2-2012 (for whole-body PETs) and the results published in Scientific Reports Journal (DOI 10.1038/s41598-019-51898-z). The measurements performed include:
- Spatial Resolution
- Scatter Fraction and count rate (NECR) ●
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Image /page/13/Picture/0 description: The image shows the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue on the right, stacked on top of the word "VISION" in green. The sphere has a white line running through it.
- Sensitivity ●
- Image Quality, accuracy of attenuation correction and scatter correction
- Accuracy: corrections for count losses and randoms
Test results indicate that CareMiBrain PET Scanner complies with its predetermined specification and the applicable standards.
For a better understanding of the performed tests, these have been following the NEMA NU 4-2008, the standard on performance measurement of small animal Positron Emission Tomographs, and NEMA NU 2-2018, used for performance measurements of human Positron Emission Tomographs.
This is because in some test the length of the ring prevented the NEMA NU 2-2018 from being followed. However, the NEMA NU 4-2008 tests are more restrictive.
Therefore, to establish an acceptance tolerance we have relied on other PETs, because when these tests were performed there was no dedicated brain PET available, as we can see in Moliner, L., Rodríguez-Alvarez, M.J., Catret, J.V. et al. NEMA Performance Evaluation of CareMiBrain dedicated brain PET and Comparison with the whole-body and dedicated brain PET systems. Sci Rep 9, 15484 (2019). https://doi.org/10.1038/s41598-019-51898-z
| Performance Criteria | Results | CareMiBrain - PET scanner
Acceptance criteria |
|---------------------------------------------------|---------|--------------------------------------------------|
| Spatial Resolution (NEMA NU 4-2008) | | |
| Transverse Resolution FWHM @5mm | 1,55 mm | 2 mm |
| Transverse Resolution FWHM @10mm | 1,45 mm | 2 mm |
| Transverse Resolution FWHM @15mm | 1,52 mm | 2 mm |
| Transverse Resolution FWHM @25mm | 1,59 mm | 2 mm |
| Axial Resolution FWHM @5mm | 1,45 mm | 2 mm |
| Axial Resolution FWHM @10mm | 1,40 mm | 2 mm |
| Axial Resolution FWHM @15mm | 1,58 mm | 2 mm |
| Axial Resolution FWHM @25mm | 1,41 mm | 2 mm |
| Radial Resolution FWHM @5mm | 1,51 mm | 2 mm |
| Radial Resolution FWHM @10mm | 1,58 mm | 2 mm |
| Radial Resolution FWHM @15mm | 1,64 mm | 2 mm |
| Radial Resolution FWHM @25mm | 1,52 mm | 2 mm |
| Extra spatial resolution values (NEMA NU 4-2008). | | |
| Transverse Resolution FWHM @0 mm | 1,53 mm | 2 mm |
| Transverse Resolution FWHM @50 mm | 1,51 mm | 2 mm |
| Transverse Resolution FWHM @75 mm | 1,76 mm | 2 mm |
| Transverse Resolution FWHM @100mm | 1,66 mm | 2 mm |
| Axial Resolution FWHM @0 mm | 1,36 mm | 2 mm |
| Axial Resolution FWHM @50 mm | 1,44 mm | 2 mm |
| Axial Resolution FWHM @75 mm | 1,44 mm | 2 mm |
We provide a table with a summary of the bench test have been performed.
INNOVATIVE MEDICAL IMAGING
ONCOVISON | General Equipment for Medical Inaging S.A | C/ Jerónimo de Monsoni, 92 Bajo Iza, 40022, Valencia, Spain | +34 963 722 472 | info@oncovisor.om www.oncovision.com
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Image /page/14/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left side, with the text "ONCO" in blue and "VISION" in green on the right side. The sphere has a design of intersecting lines, creating a sense of depth and dimension.
| Axial Resolution FWHM @100mm | 1,44 mm | 2 mm |
|---|---|---|
| Radial Resolution FWHM @0 mm | 1,57 mm | 2 mm |
| Radial Resolution FWHM @50 mm | 1,67 mm | 2 mm |
| Radial Resolution FWHM @75 mm | 1,64 mm | 2 mm |
| Radial Resolution FWHM @100mm | 1,64 mm | 2 mm |
| Spatial resolution (NEMA NU 2-2012). | ||
| Transverse Resolution FWHM @10mm | 1,68 mm | 2 mm |
| Transverse Resolution FWHM @100mm | 1,86 mm | 2 mm |
| Axial Resolution FWHM @10 mm | 1,39 mm | 2 mm |
| Axial Resolution FWHM @100 mm | 1,40 mm | 2 mm |
| Radial Resolution FWHM @10 mm | 1,87 mm | 2 mm |
| Radial Resolution FWHM @100 mm | 1,86 mm | 2 mm |
| Count rate evaluation and sensitivity (NEMA NU 2-2012). | ||
| Sensitivity along transverse center | 17,83 cps/kBq | 15 cps/kBq |
| Sensitivity off center | 13,82 cps/kBq | 12cps/kBq |
| Count rate peak NECR | 49 kcps | 30 kcps |
| Count rate peak trues | 193 kcps | 160 kcps |
| Scatter fraction at peak NECR | 7,4 MBq | 9,25 MBq |
| Scatter fraction Mean | 48 % | 60 % |
| Image Quality - % contrast/ background variability (NEMA NU 4-2008). | ||
| 4,5 mm | 0,73 | 0,65 |
| 6mm | 0,78 | 0,65 |
| 9mm | 1,14 | 0,65 |
| 12mm | 1,01 | 0,65 |
iv. Performance Testing - Animal
Not applicable
Performance Testing - Clinical V.
Clinical effectiveness was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff," Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems" Section IX.F. (CDRH, 1998).
Clinical effectiveness has been tested by independent hospitals and the results published in Spanish Journal of Nuclear Medicine and Molecular imaging (DOI 10.1016/j.remn.2021.04.002)
Sample images from several clinical cases with different PET tracers using the CareMiBrain PET Scanner were provided.
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Image /page/15/Picture/0 description: The image contains the logo for OncoVision. On the left side of the logo is a blue sphere with white lines running across it. To the right of the sphere is the word "ONCO" in blue, stacked on top of the word "VISION" in green. The logo is simple and modern, and the colors are calming and professional.
CONCLUSION X.
The data support the safety of the device and the hardware and software verification and validation demonstrate that the CareMiBrain PET Scanner should perform as intended in the specified use conditions. The publications and sample images from the provided clinical cases supported the clinical effectiveness of the CareMiBrain PET Scanner. Based upon performance data, CareMiBrain PET Scanner is substantially equivalent to the predicate device.
INNOVATIVE MEDICAL IMAGING
ONCOVISION | Geneal Equipment for Medical Inaging S.A | C. Jerónim de Monsoriu, 92 Bajo Lzi, 46022, Valencia, Spain | +34 963 722 472 | info@onovisio.com www.oncovision.com