(27 days)
Not Found
No
The description focuses on the hardware components, image acquisition, and standard iterative reconstruction methods. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is a positron emission tomography (PET) system used for imaging to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" states that NeuroLF is used "to assist in diagnosis" and "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."
No
The device description explicitly states that the NeuroLF System comprises a Scanning Unit and a Patient Positioning System (NeuroLF Seat), both of which are hardware components. While software is mentioned for image acquisition, reconstruction, and system state detection, it is an integral part of a larger hardware system.
Based on the provided information, the NeuroLF device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- NeuroLF Function: The NeuroLF is a Positron Emission Tomography (PET) system. It works by detecting and displaying the distribution of radioactive tracers within the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's used to "detect and display the distribution of positron-emitting radionuclides within parts of the human body" and to "assist in diagnosis, therapeutic planning, and therapeutic outcome assessment." This is consistent with in vivo imaging, not in vitro testing.
Therefore, the NeuroLF is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
KPS
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
parts of the human body, head, neck, brain
Indicated Patient Age Range
Adults and adolescent
Intended User / Care Setting
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)
Electrical safety and electromagnetic compatibility (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 and IEC 60601-1-2:2014.
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).
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, and Image quality, accuracy of corrections. Test results indicate that the NeuroLF System complies with its predetermined specifications and the applicable standards.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Spatial resolution in FWHM at 1 cm: 2.7 mm (NeuroLF Basic), 3.1 mm (NeuroLF Advanced)
Spatial resolution in FWHM at 10 cm: 3.5 mm (NeuroLF Basic), 3.7 mm (NeuroLF Advanced)
Energy resolution: 17-25% FHWM
System sensitivity: 3.1% (NeuroLF Basic) (NEMA-NU4-2008)
Coincidence timing window: 3ns-5ns
Scatter fraction: 38% (NeuroLF Basic) (NEMA-NU2-2018)
Slice thickness: 1.66 mm
Count rate sensitivity: 4.8 cps/kBq (center), 6.8 cps/kBq (100mm) (NeuroLF Basic) (NEMA-NU2-2018)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X 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 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: | jannis.fischer@positrigo.com |
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.
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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.
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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
BBX-PET Scanner | Subject device
NeuroLF | Justification of
equivalence |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Image: BBX-PET Scanner | Image: NeuroLF | n/a |
| Intended Use | Dedicated Positron
Emission Tomography | Dedicated Positron
Emission Tomography | Same as
predicate |
| Indication for
use | BBX-PET is scanner
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. | 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. | Same as
predicate |
| Principle of
detection | Positron Emission
Tomography (PET) system
to image the distribution of
injected positron emitting | NeuroLF is a small
aperture Positron Emission
Tomography (PET) scanner
to image the distribution of | Same as
predicate |
| | radiopharmaceuticals into
live humans or animals.
The BBX-PET Scanner
produces images that
represent the internal
distribution of radioactivity
in the head. | injected positron emitting
radiopharmaceuticals in the
head of live humans, as
defined in 21 CFR 892.1200.
NeuroLF generates
tomographic images that
represent the internal
distribution of radioactivity in
the patient's brain. | |
| Scintillator
configuration
/ Scanner | Double-layer staggered
Silicate Lutetium Fine
pixelated crystals (13 x 13
and 14 x 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. | Pixelated lutetium-based
scintillator coupled in
light-sharing architecture
with silicon photomultipliers.
A single crystal array is
composed of 4x4
scintillators. The pitch of the
crystals is 3.19 mm. Overall,
12288 pixels disposed in
octagonal shape forms the
detection ring. The transaxial
FoV is 268 mm, the axial
FoV is 164 mm. | Detectors
design and
fields of view
are similar.
NeuroLF axial
FoV is longer.
While the pitch
for NeuroLF is
larger, the use
of a single layer
of scintillators
facilitates the
correct
assignment of
the gamma
absorption
location. These
differences do
not affect the
indications, only
the
performance. |
| Target
Population | Adults, young adults | Adults and adolescent | 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 | Detects distribution of
radioactivity after injection | Detects distribution of
radioactivity after injection of | Same as
predicate |
| delivered | of a positron emitting
radiopharmaceutical. No
energy delivered. | a positron emitting
radiopharmaceutical. No
energy delivered. | |
| 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. | The PET detection system is
fixed and includes a chair.
Gantry can be manually
moved up, down,
horizontally and with tilt
adjusted to properly fit the
height of the patient for
imaging the brain while the
patient is seated. | Only brain
imaging in a
seated position
is possible. This
position is the
same as in
predicate. Main
difference is
that the chair is
part of the
system, as
explained in the
discussion
section.
Imaging in a
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 the
computer contains
workstation. These two
parts are connected to
each other using optical
fiber and an USB cable. | NeuroLF has three
separable parts. The
NeuroLF Seat is used to
place the subject's head
precisely in the Detector
Ring. The Scanning Unit
contains the Detector Ring
that performs the data
acquisition with custom
electronics, a Scanning
Computer System located in
the gantry and the
Reconstruction Computer
System performing
tomographic image
reconstruction. The NeuroLF
system comes with two User
Interfaces.The first is located
on the gantry of the
Scanning Unit and is used
for monitoring, starting, and
interrupting scans directly
next to the patient. The | Same as
predicate, that
the except
connection is
standard
ethernet cable
instead of a
fiber optics
cable and USB |
| | | second User interface is an
application on a separate
Console Computer System.
Scanning Unit and Console
Computer System are
connected by ethernet cable
with and through the hospital
network. The system has
DICOM Worklist support and
PACS connectivity. | |
| Performance
Data
Specifications | Spatial resolution in FWHM
at the center: 2.2mm | Spatial resolution in FWHM
at 1 cm:
2.7 mm (NeuroLF Basic)
3.1 mm (NeuroLF Advanced) | |
| | Spatial resolution in FWHM
at 10 cm: Not published | Spatial resolution in FWHM
at 10 cm:
3.5 mm (NeuroLF Basic)
3.7 mm (NeuroLF Advanced) | |
| | Energy resolution: Not
Published | Energy resolution: 17-25%
FHWM | |
| | System sensitivity: 1.1% | System sensitivity: 3.1%
(NeuroLF Basic)
(NEMA-NU4-2008) | |
| | Coincidence timing window:
Not published | Coincidence timing window:
3ns-5ns | |
| | Scatter fraction: Not
published | Scatter fraction: 38%
(NeuroLF Basic)
(NEMA-NU2-2018) | |
| | Scatter correction method:
Not published | Scatter correction method:
SSS - single scatter
simulation | |
| | Slice thickness: Depends
on reconstruction | Slice thickness: 1.66 mm | |
| | | | |
| | (2mm/4mm)
Count rate sensitivity: 10
cps/kBq
Isolation of the detector
from background: Not
applicable for PET
Intrinsic spatial resolution:
Not applicable for PET
Attenuation:
Calculated method
Computer: GPU | Count rate sensitivity: 4.8
cps/kBq (center), 6.8
cps/kBq (100mm)
(NeuroLF Basic)
(NEMA-NU2-2018)
Isolation of the detector from
background: Not applicable
for PET
Intrinsic spatial resolution:
Not applicable for PET
Attenuation:
Calculated method
Computer: CPU | |
| Materials and
bio-
compatibility | Standard electronics and
medical grade materials | Standard electronics 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 equipment
electrical Part 1-2: General
requirements for basic
safety and essential
performance - Collateral
Standard: Electromagnetic:
disturbances -
Requirements and tests for
EMC. | Complies with standard IEC
60601-1-2:2014 Medical
equipment electrical Part
1-2: General requirements
for basic safety and
essential performance -
Collateral Standard:
Electromagnetic
compatibility-requirements
and tests. | Same as
predicate |
| Sterility | The product is not sterile
and has not to be sterilized
by the user. Cleaning
procedure devices.
Cleaning of standard
medical devices | The product is not sterile
and has not to be sterilized
by the user. Cleaning
procedure devices. Cleaning
of standard medical devices | Same as
predicate |
| Mechanical
and electrical | Complies with standard IEC
(Third 60601-1:2005 Edition) | Complies with standard IEC
(Third 60601-1:2005 Edition) | Same as
predicate |
| safety | + COOR.1:2006 +
CORR.2:2007 + A1:2012
Medical equipment
electrical Part 1: General
requirements for basic
safety and essential
performance for electrical
safety | + COOR.1:2006 +
CORR.2:2007 + A1:2012 +
A2:2020 Medical equipment
electrical Part 1: General
requirements for basic safety
and essential performance
for electrical safety | |
| Clinical
effectiveness | 3 clinical images are
provided from Prescient
BBX-PET to demonstrate
the image capability and
the fulfillment with its
predetermined
specification. | 4 clinical images are
provided by Positrigo AG
from NeuroLF to
demonstrate the image
capability and the fulfillment
with its predetermined
specification. | Same or better
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."
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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
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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".
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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.
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. 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.
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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.