Who is the manufacturer of CAREMIBRAIN?

General Equipment For Medical Imaging, S.A. filed the 510(k) submission for CAREMIBRAIN (K232569).

What is the FDA product code for CAREMIBRAIN?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CAREMIBRAIN?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CAREMIBRAIN?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CAREMIBRAIN

K232569 · General Equipment For Medical Imaging, S.A. · KPS · Sep 21, 2023 · Radiology

Device Facts

Record ID	K232569
Device Name	CAREMIBRAIN
Applicant	General Equipment For Medical Imaging, S.A.
Product Code	KPS · Radiology
Decision Date	Sep 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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.

Device Story

CareMiBrain is a dedicated brain PET scanner for use in hospitals by trained healthcare professionals. It captures gamma rays emitted by injected radiopharmaceuticals using 48 monolithic LYSO crystals arranged in 3 rings, coupled to SiPM photosensors. The device features an integrated patient chair for seated/reclined imaging. Data acquisition and control electronics process coincidence events; software performs iterative image reconstruction. The system outputs tomographic brain images for clinical review. By using monolithic crystals, the device enables depth-of-interaction (DOI) measurement, minimizing parallax error and improving spatial resolution compared to standard pixelated systems. The output assists clinicians in diagnosis, therapeutic planning, and outcome assessment, potentially benefiting patients through higher-resolution brain imaging.

Clinical Evidence

Clinical effectiveness demonstrated via published literature (Rev Esp Med Nucl Imagen Mol., 2021) and submission of >40 clinical images using various PET tracers. No prospective clinical trial data provided; evidence relies on bench performance testing and clinical case examples.

Technological Characteristics

Dedicated brain PET scanner. Materials: Monolithic LYSO scintillator crystals, SiPM photosensors. Geometry: 3 rings of 16 modules, 260mm bore diameter. Connectivity: Networked (DICOM/PACS). Software: Iterative reconstruction. Safety: Complies with ANSI/AAMI ES 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for adults and adolescents >140cm height requiring brain PET imaging to detect abnormal radioactivity distribution following injection of positron-emitting radiopharmaceuticals. Used by trained healthcare professionals for research, diagnosis, therapeutic planning, and outcome assessment.

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

BBX™-PET Scanner (K210450)

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Submission Summary (Full Text)

{0}------------------------------------------------ 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) k232569 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *PRAStaff@fda.hhs.gov* "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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: < 20% Transverse resolution: 1.55mm Axial resolution; 1.45mm Spatial linearity: ±0,12mm Flood field uniformity: 10% System sensitivity: >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: < 4mm | | | Computer: | GPU | Computer: GPU | | | Materials and biocompatibility | Standard electronic and medical grade materials | Standard electronic and medical grade materials | Same as predicate | | Compatibility with the environment and other devices | Complies with standard IEC 60601-1-2 ed 4.0 (2014-02) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic | Complies with standard ANSI/AAMI IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic | Same as predicate | | | disturbances – Requirements and tests for EMC. | compatibility – Requirements and tests. | | | Sterility | The product is not sterile and has not to be sterilized by the user. Cleaning standard procedure of medical devices. | The product is not sterile and has not to be sterilized by the user. Cleaning standard procedure of medical devices. | Same as predicate | | Mechanical and electrical safety | Complies with standard IEC 60601-1: 2005 (Third Edition) + COOR.1:2006 + CORR.2:2007 + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance for electrical safety | Complies with standard ANSI/AAMI ES 60601- 1:2005 (Third Edition)/ (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. | Same as predicate | | Clinical efectiveness2 | 3 clinical images are provided from Prescient BBX-PET to demonstrate the image capability and the fulfillment with its predetermined specification. | More than 40 clinical images are provided from CareMiBrain to demonstrate the image capability and the fulfillment with its predetermined specification. | Same or better as predicate | # INNOVATIVE MEDICAL IMAGING ONCOVISION | General Equipment for Medical Inaging S.A | Clerinino de Monsoni, 92 Bajo Iz., 46022, Valencia, Spain | +34 963 722 | info@oncovision.com | www.oncovision.com {7}------------------------------------------------ Image /page/7/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 above the word "VISION" in green on the right. The sphere has a pattern of lines on it. # INNOVATIVE MEDICAL IMAGING ONCOVISION | General Equipment for Medical Inaging S.A | Clerinino de Monsoriu, 92 Bajo Izq., 46022, Valencia, Spain | +34 963 722 | Info@onovision.com | www.oncovision.com {8}------------------------------------------------ Image /page/8/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 above the word "VISION" in green on the right. The sphere has a white design on it. # INNOVATIVE MEDICAL IMAGING ONCOVISION | General Equipment for Medical Inaging S.A | Jerónimo de Monsoriu, 92 Bajo Iza, 46022, Valencia, Spain | +34 963 722 | info@onovision.com | www.oncovision.com {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left, with the word "ONCO" in blue on the right. Below "ONCO" is the word "VISION" in green. The sphere has a pattern of intersecting lines, giving it a three-dimensional appearance. 1 Performance data for CareMiBrain published in Scientific Reports, (2019) 9:15484 | https://doi.org/10.1038/s41598-019-51898-z ONCOVISION | General Equipment for Medical Inaging S.A | Clerimo de Monsoni, 92 Bajo Iza, 46022, Valencia, Spain | +3 963 722 472 | info@oncovision.com | www.oncovision.com {10}------------------------------------------------ Image /page/10/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 and "VISION" in green on the right. The sphere has a white X across it. # INNOVATIVE MEDICAL IMAGING ONCOVISION | General Equipment for Medical Inaging S.A | C.erchimo de Monsoni, 92 Bajo Lz., 46022, Valencia, Spain | +34 963 722 | info@onovision.com | www.oncovision.com {11}------------------------------------------------ Image /page/11/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 above the word "VISION" in green on the right. The sphere has a gradient of blue colors, with the darker shades on the left and lighter shades on the right. ### IX. PERFORMANCE DATA CareMiBrain performance has been independently tested, and the following data is provided in support of substantial equivalence determination. See in section 18 the Summary testing for each non-clinical test performed following the guidance "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". 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 {12}------------------------------------------------ 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) ● {13}------------------------------------------------ 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…