NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat

K241751 · Positrigo AG · KPS · Jul 15, 2024 · Radiology

Device Facts

• Record ID: K241751
• Device Name: NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
• Applicant: Positrigo AG
• Product Code: KPS · Radiology
• Decision Date: Jul 15, 2024
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.

Device Story

NeuroLF is a small-aperture PET scanner for head/neck imaging. System includes a scanning unit with an octagonal detector ring (384 LYSO crystals) and a patient positioning seat. Input: gamma rays from injected positron-emitting radiopharmaceuticals. Operation: detectors capture coincidence events; software performs iterative reconstruction to generate tomographic images. Used in hospitals; operated by clinical staff. Output: tomographic images displayed on a console. Clinicians use images for diagnosis, therapeutic planning, and outcome assessment. Benefits: dedicated brain imaging in a seated position, potentially reducing acquisition time or required radiopharmaceutical activity due to high sensitivity.

Clinical Evidence

No formal clinical trial; clinical effectiveness supported by four clinical case images provided to demonstrate image capability and fulfillment of predetermined specifications.

Technological Characteristics

PET scanner with octagonal detector ring; 384 LYSO crystals; silicon photomultipliers; 260mm aperture; 163mm axial FoV. Connectivity: Ethernet, DICOM/PACS support. Software: iterative reconstruction. Electrical safety: IEC 60601-1:2005/A1:2012/A2:2020. EMC: IEC 60601-1-2:2014. Non-sterile.

Indications for Use

Indicated for adults and adolescents requiring PET imaging of the head or neck to detect abnormal distribution of positron-emitting radiopharmaceuticals for diagnosis, therapeutic planning, and outcome assessment. Contraindicated for patients weighing 200kg (440lb) or more.

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)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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.

July 15, 2024

Positrigo AG % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K241751

Trade/Device Name: NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: June 20, 2024 Received: June 21, 2024

## 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FDA

Daniel M. Krainak, Ph.D. Assistant Director 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K241751

Device Name

NeuroLF (Basic);NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat

Indications for Use (Describe)

NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

### 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 information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "Positrigo". The logo consists of a blue icon on the left and the company name on the right. The icon is a geometric shape with circles at the vertices. Below the company name is the tagline "Imaging Everyone".

#### 1. Contact Details:

| Company Name: | Positrigo AG |
|---------------|-----------------------------------------------|
| Address: | Technoparkstrasse 1, 8005 Zürich, Switzerland |
| Contact Name: | Mr. Jannis Fischer |
| Phone: | 0041 44 515 53 30 |
| Email: | [e-mail] |

#### 2. Device Name:

Device trade name:

Common name: Classification name: Regulation number: Product code:

NeuroLF Basic NeuroLF Pro NeuroLF Advanced NeuroLF Seat

PET Scanner Emission computed tomography system 892.1200 KPS

#### 3. Legally Marketed Predicate Device:

Predicate device application number: Predicate trade name: Predicate product code:

K210450 BBX-PET Scanner KBS

#### 4. Device description summary:

The NeuroLF is a small aperture Positron Emission Tomography (PET) scanner that produces images of the distribution of positron-emitting isotopes from parts of a subject that are put into the aperture for medical diagnostic purposes. The NeuroLF System comprises the Scanning Unit and the Patient Positioning System (NeuroLF Seat). The circular opening in the scanner head has an effective inner diameter of 260mm and is designed such that the entire brain fits within the scanner's field of view (FoV). With a length of an axial FoV of 163mm, the NeuroLF is designed to capture a single image. The NeuroLF scanner head consists of an octagonal detector, which is composed of 8 detector module contains a total of 384 Lutetium Yttrium Orthosilicate (LYSO) Crystals. The software of the NeuroLF System integrates the equipment, allows acquisition, reconstruction and export of tomographic images.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Positirigo. The logo consists of a blue icon on the left and the word "POSITRIGO" in black on the right. Below the word "POSITRIGO" is the phrase "IMAGING EVERYONE" in a smaller font size. The icon on the left is a geometric shape with circles at the vertices.

It also allows the user to detect the current state of the running system. The device shall only be used with patients whose weight is lower than 200kg (440lb).

There are three different versions of the NeuroLF; 10 mm (NeuroLF Basic), 15 mm (NeuroLF Pro) and 20 mm (NeuroLF Advanced). The number corresponds to the length of the LYSO crystals in the detector modules. The absorption probability of gamma radiation is proportional to the volume of scintillating material in the scanner and therefore the highest absorption probability is to be expected from the 20 mm detectors. The longer the LYSO crystals the higher the sensitivity of the device, therefore in clinical use the acquisition time or the activity in the field of view could be reduced.

#### Intended Use/Specification for Use: 5.

NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.

#### 6. Indications for Use Comparison:

Both the subject and predicate device have the same intended use for obtaining positron emission tomography (PET) images of parts of the human body that fit in its patient aperture.

#### 7. Technological Comparison:

NeuroLF 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 NeuroLF 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 images using iterative reconstruction methods.
- Attenuation correction method is in both cases Calculated Attenuation Correction. ●
- Main differences between predicate device and NeuroLF are: ●
- Patient is in a seated/reclined position in NeuroLF, while the predicate device is lying on ● a bed.
- Cylinder diameter is 26 cm in NeuroLF, while in predicate device is 29cm.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for "Positrigo". The logo consists of a blue geometric shape on the left and the word "POSITRIGO" in black on the right. Below the word "POSITRIGO" is the phrase "IMAGING EVERYONE" in a smaller font size. The geometric shape is a stylized representation of interconnected nodes or molecules.

- · Crystals are Lutetium Yttrium OrthoSilicate (LYSO) in NeuroLF, while in predicate lutetium fine-silicate (LFS) crystals are used.
#### 7.1. Comparison Table:

| Attributes | Predicate device<br>BBX-PET Scanner | Subject device<br>NeuroLF | Justification of<br>equivalence |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Image: BBX-PET Scanner | Image: NeuroLF | n/a |
| Intended Use | Dedicated Positron<br>Emission Tomography | Dedicated Positron<br>Emission Tomography | Same as<br>predicate |
| Indication for<br>use | BBX-PET is scanner<br>intended to obtain Positron<br>Emission Tomography<br>(PET) images of parts of<br>the human body that fit in<br>the patient aperture (e.g.,<br>head) to detect abnormal<br>pattern of Distribution of<br>radioactivity after injection<br>of a positron emitting<br>radiopharmaceutical. This<br>information can assist in<br>research, Diagnosis,<br>therapeutic planning and<br>therapeutic outcome<br>assessment. | NeuroLF is a positron<br>emission tomography<br>system that is used to detect<br>and display the distribution<br>of positron-emitting<br>radionuclides within parts of<br>the human body to assist in<br>diagnosis, therapeutic<br>planning, and therapeutic<br>outcome assessment. | Same as<br>predicate |
| Principle of<br>detection | Positron Emission<br>Tomography (PET) system<br>to image the distribution of<br>injected positron emitting | NeuroLF is a small<br>aperture Positron Emission<br>Tomography (PET) scanner<br>to image the distribution of | Same as<br>predicate |
| | radiopharmaceuticals into<br>live humans or animals.<br>The BBX-PET Scanner<br>produces images that<br>represent the internal<br>distribution of radioactivity<br>in the head. | injected positron emitting<br>radiopharmaceuticals in the<br>head of live humans, as<br>defined in 21 CFR 892.1200.<br>NeuroLF generates<br>tomographic images that<br>represent the internal<br>distribution of radioactivity in<br>the patient's brain. | |
| Scintillator<br>configuration<br>/ Scanner | Double-layer staggered<br>Silicate Lutetium Fine<br>pixelated crystals (13 x 13<br>and 14 x 14 arrays,<br>1.76-mm pitch) coupled to<br>light detector solid state<br>silicon photomultiplier. One<br>hundred twenty-eight<br>blocks positioned in a<br>circular shape make up the<br>gantry, with bore diameter<br>of 288mm, and 250mm and<br>100mm transaxial and axial<br>FoVs. | Pixelated lutetium-based<br>scintillator coupled in<br>light-sharing architecture<br>with silicon photomultipliers.<br>A single crystal array is<br>composed of 4x4<br>scintillators. The pitch of the<br>crystals is 3.19 mm. Overall,<br>12288 pixels disposed in<br>octagonal shape forms the<br>detection ring. The transaxial<br>FoV is 268 mm, the axial<br>FoV is 164 mm. | Detectors<br>design and<br>fields of view<br>are similar.<br>NeuroLF axial<br>FoV is longer.<br>While the pitch<br>for NeuroLF is<br>larger, the use<br>of a single layer<br>of scintillators<br>facilitates the<br>correct<br>assignment of<br>the gamma<br>absorption<br>location. These<br>differences do<br>not affect the<br>indications, only<br>the<br>performance. |
| Target<br>Population | Adults, young adults | Adults and adolescent | Same as<br>predicate |
| Anatomical<br>site | Parts of the human body<br>that fit in the patient<br>aperture | Parts of the human body that<br>fit in the patient aperture | Same as<br>predicate |
| Where used | Hospital | Hospital | Same as<br>predicate |
| Energy used<br>and/or | Detects distribution of<br>radioactivity after injection | Detects distribution of<br>radioactivity after injection of | Same as<br>predicate |
| delivered | of a positron emitting<br>radiopharmaceutical. No<br>energy delivered. | a positron emitting<br>radiopharmaceutical. No<br>energy delivered. | |
| Human<br>factors | PET detection system in a<br>movable cart. Its gantry can<br>move up to allow brain<br>imaging while the patient is<br>seated. It can also move<br>down to image the breast<br>without compression, while<br>a patient is lying on a<br>biopsy table or rotate and<br>allow imaging the breast,<br>hand, or leg in a seated<br>position. | The PET detection system is<br>fixed and includes a chair.<br>Gantry can be manually<br>moved up, down,<br>horizontally and with tilt<br>adjusted to properly fit the<br>height of the patient for<br>imaging the brain while the<br>patient is seated. | Only brain<br>imaging in a<br>seated position<br>is possible. This<br>position is the<br>same as in<br>predicate. Main<br>difference is<br>that the chair is<br>part of the<br>system, as<br>explained in the<br>discussion<br>section.<br>Imaging in a<br>lying position is<br>not possible. |
| Design | The BBX-PET Scanner is<br>comprised of two parts; the<br>Gantry containing detectors<br>and electronics, and the<br>Universal Console that the<br>computer contains<br>workstation. These two<br>parts are connected to<br>each other using optical<br>fiber and an USB cable. | NeuroLF has three<br>separable parts. The<br>NeuroLF Seat is used to<br>place the subject's head<br>precisely in the Detector<br>Ring. The Scanning Unit<br>contains the Detector Ring<br>that performs the data<br>acquisition with custom<br>electronics, a Scanning<br>Computer System located in<br>the gantry and the<br>Reconstruction Computer<br>System performing<br>tomographic image<br>reconstruction. The NeuroLF<br>system comes with two User<br>Interfaces.The first is located<br>on the gantry of the<br>Scanning Unit and is used<br>for monitoring, starting, and<br>interrupting scans directly<br>next to the patient. The | Same as<br>predicate, that<br>the except<br>connection is<br>standard<br>ethernet cable<br>instead of a<br>fiber optics<br>cable and USB |
| | | second User interface is an<br>application on a separate<br>Console Computer System.<br>Scanning Unit and Console<br>Computer System are<br>connected by ethernet cable<br>with and through the hospital<br>network. The system has<br>DICOM Worklist support and<br>PACS connectivity. | |
| Performance<br>Data<br>Specifications | Spatial resolution in FWHM<br>at the center: 2.2mm | Spatial resolution in FWHM<br>at 1 cm:<br>2.7 mm (NeuroLF Basic)<br>3.1 mm (NeuroLF Advanced) | |
| | Spatial resolution in FWHM<br>at 10 cm: Not published | Spatial resolution in FWHM<br>at 10 cm:<br>3.5 mm (NeuroLF Basic)<br>3.7 mm (NeuroLF Advanced) | |
| | Energy resolution: Not<br>Published | Energy resolution: 17-25%<br>FHWM | |
| | System sensitivity: 1.1% | System sensitivity: 3.1%<br>(NeuroLF Basic)<br>(NEMA-NU4-2008) | |
| | Coincidence timing window:<br>Not published | Coincidence timing window:<br>3ns-5ns | |
| | Scatter fraction: Not<br>published | Scatter fraction: 38%<br>(NeuroLF Basic)<br>(NEMA-NU2-2018) | |
| | Scatter correction method:<br>Not published | Scatter correction method:<br>SSS - single scatter<br>simulation | |
| | Slice thickness: Depends<br>on reconstruction | Slice thickness: 1.66 mm | |
| | | | |
| | (2mm/4mm)<br>Count rate sensitivity: 10<br>cps/kBq<br>Isolation of the detector<br>from background: Not<br>applicable for PET<br>Intrinsic spatial resolution:<br>Not applicable for PET<br>Attenuation:<br>Calculated method<br>Computer: GPU | Count rate sensitivity: 4.8<br>cps/kBq (center), 6.8<br>cps/kBq (100mm)<br>(NeuroLF Basic)<br>(NEMA-NU2-2018)<br>Isolation of the detector from<br>background: Not applicable<br>for PET<br>Intrinsic spatial resolution:<br>Not applicable for PET<br>Attenuation:<br>Calculated method<br>Computer: CPU | |
| Materials and<br>bio-<br>compatibility | Standard electronics and<br>medical grade materials | Standard electronics and<br>medical grade materials | Same as<br>predicate |
| Compatibility<br>with the<br>environment<br>and other<br>devices | Complies with standard IEC<br>60601-1-2 ed 4.0 (2014-02)<br>Medical equipment<br>electrical Part 1-2: General<br>requirements for basic<br>safety and essential<br>performance - Collateral<br>Standard: Electromagnetic:<br>disturbances -<br>Requirements and tests for<br>EMC. | Complies with standard IEC<br>60601-1-2:2014 Medical<br>equipment electrical Part<br>1-2: General requirements<br>for basic safety and<br>essential performance -<br>Collateral Standard:<br>Electromagnetic<br>compatibility-requirements<br>and tests. | Same as<br>predicate |
| Sterility | The product is not sterile<br>and has not to be sterilized<br>by the user. Cleaning<br>procedure devices.<br>Cleaning of standard<br>medical devices | The product is not sterile<br>and has not to be sterilized<br>by the user. Cleaning<br>procedure devices. Cleaning<br>of standard medical devices | Same as<br>predicate |
| Mechanical<br>and electrical | Complies with standard IEC<br>(Third 60601-1:2005 Edition) | Complies with standard IEC<br>(Third 60601-1:2005 Edition) | Same as<br>predicate |
| safety | + COOR.1:2006 +<br>CORR.2:2007 + A1:2012<br>Medical equipment<br>electrical Part 1: General<br>requirements for basic<br>safety and essential<br>performance for electrical<br>safety | + COOR.1:2006 +<br>CORR.2:2007 + A1:2012 +<br>A2:2020 Medical equipment<br>electrical Part 1: General<br>requirements for basic safety<br>and essential performance<br>for electrical safety | |
| Clinical<br>effectiveness | 3 clinical images are<br>provided from Prescient<br>BBX-PET to demonstrate<br>the image capability and<br>the fulfillment with its<br>predetermined<br>specification. | 4 clinical images are<br>provided by Positrigo AG<br>from NeuroLF to<br>demonstrate the image<br>capability and the fulfillment<br>with its predetermined<br>specification. | Same or better<br>as predicate |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Positron Imaging. The logo consists of a blue atom-like symbol on the left, followed by the company name "POSITRIGO" in bold, black letters. Below the company name, in smaller, lighter font, is the tagline "IMAGING EVERYONE."

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Positron Imaging. The logo consists of a stylized atom symbol on the left and the word "POSITRON" in bold, sans-serif font on the right. Below "POSITRON" is the phrase "IMAGING EVERYWHERE" in a smaller, lighter font. The atom symbol is light blue and appears to be made up of interconnected circles and lines.

# 510(k) Summary K241751

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for "Positron Imaging". The logo consists of a stylized atom symbol on the left and the company name on the right. The atom symbol is light blue and the company name is in black. Below the company name is the phrase "Imaging Everyone" in a smaller font.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Positron Imaging. The logo consists of a stylized atom-like icon in light blue, followed by the company name "POSITRIG" in bold, black letters. Below the company name is the tagline "IMAGING EVERYONE" in a smaller, lighter font.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains the logo for "Positrigo". The logo consists of a stylized, interconnected network of circles and lines, resembling a molecule or a network node, on the left side. To the right of the icon is the company name, "POSITRIGO", in bold, sans-serif font. Below the company name, in a smaller font size, is the tagline "IMAGING EVERYONE".

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for "Positrigo Imaging Everyone". The logo consists of a blue icon on the left and the company name on the right. The icon is a stylized representation of interconnected nodes, while the company name is written in a clean, sans-serif font, with "Positrigo" in a larger font size than "Imaging Everyone".

#### 8. Performance Data:

- 8.1. Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the NeuroLF System and certified by the independent certification company TÜV SÜD Product Service GmbH. The system complies with:

- IEC 60601-1:2005 / A1:2012 / A2:2020. Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
- 8.2. Software Verification and Validation testing:

Software verification and validation is conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of premarket submission for Device Software Functions (CDRH, 2023).

According to the referred FDA guidance, the software documentation level is classified as basic. A failure or latent flaw of the device software function(s) would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures.

- 8.3. 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 Nuclear Tomography Systems" Section IX.C.2. (CDRH, 1998).

The performance of the NeuroLF System has been tested by Positrigo AG according to NEMA NU-2:2018 - Performance Measurements of Positron Emission Tomography. The testing performed include:

- Spatial resolution ●
- Scatter Fraction and count rate (NECR) .
- Sensitivity
- Accuracy: Corrections for count losses and randoms ●
- Image quality, accuracy of corrections ●

Test results indicate that the NeuroLF System complies with its predetermined specifications and the applicable standards.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image contains the logo for "Positrigo". To the left of the company name is a blue icon that looks like a molecule. Below the company name is the text "Imaging Everyone".

#### Performance Testing - Clinical Effectiveness 8.4.

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 notification for Emission computed Tomography Devices and accessories (SPECT and PET) and nuclear Tomography Systems" Section IX.F: (CDRH, 1998).

Sample images from four clinical cases using the NeuroLF System were provided.

#### 9. Conclusion:

The data support the safety of the device and the hardware and software verification and validation demonstrate that the NeuroLF System should perform as intended in the specified use conditions. The publication including the sample images from four clinical cases supported the clinical effectiveness of the NeuroLF system. Based upon performance data the NeuroLF System is substantially equivalent to the predicate device.