(8 days)
Toshiba Medical Systems PCA-8000A, Mark II, PET / CT System
Not Found
No
The document describes a standard PET imaging system and its components, focusing on data acquisition, reconstruction, and image viewing. There is no mention of AI, ML, or any related concepts in the provided text. The performance studies compare it to a predicate PET system based on standard imaging metrics, not AI/ML performance.
No
The device is used for diagnosis and research, and to assist in therapeutic planning and outcome assessment, but it is not directly involved in providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the information provided by the device "can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment." The "Device Description" section also mentions that the NeuroPET produces images for "medical diagnostic and research purposes."
No
The device description clearly states that the system consists of three subsystems: the NeuroPET Ring Gantry/Acquisition System, Patient Table, and the Console/PC. These are physical hardware components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This device, a PET system, directly images the distribution of radionuclides within the human body.
- The intended use describes imaging the human body directly. The description focuses on detecting and displaying the distribution of radionuclides in parts of the human body.
- The device description details a scanner that interacts with the patient. The NeuroPET Ring Gantry/Acquisition System and Patient Table are designed for direct patient interaction and imaging.
While the information gathered by this device can assist in diagnosis, the device itself is an in vivo imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The PhotoDetection Systems' NeuroPET is a small aperture positron emission tomography PET scanner that produces images based on the distribution of positron emitting isotopes in parts of the human body that will fit in the patient aperture for medical diagnostic and research purposes.
The NeuroPET system consists of three subsystems (shown below); the NeuroPET Ring Gantry/Acquisition System, Patient Table and the Console/PC. The NeuroPET Ring detects coincident gamma pairs emitted from positron annihilation and contains all the data acquisition electronics and reconstruction computers. The Patient Table is used to comfortably position the patient relative to the scanner. The Console/PC provides the operator interface for the system including such functions as system and scan control, reconstruction, data archiving, image viewing, analysis, and network connectivity.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
parts of the human body that will fit in the patient aperture
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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)
Based on submitted non-clinical and image data consistent with FDA's guidance for PET systems and for devices that include software, the NeuroPET is substantially equivalent in technology, intended use, safety, and effectiveness to the PET imaging component of the Toshiba PCA-8000A/Mark II.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Toshiba Medical Systems PCA-8000A, Mark II, PET / CT System
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.
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Traditional 510(k) Section 5 - 510(k) Summary PhotoDetection Systems- NeuroPET KO 91269
510(k) Summary
Date prepared
March 23, 2009
Company PhotoDetection Systems, Inc. 85 Swanson Rd Boxborough, MA 01719-1300
Official Contact
Paul Domigan, President Phone: (978) 266-0420 Fax: (978) 266-0426
Trade name
NeuroPET
Common name PET (positron emission tomography) system
Classification name System, tomography, computed, emission
Regulation: 21 CFR 892.1200
Product code: KPS
Predicate device: Toshiba Medical Systems PCA-8000A, Mark II, PET / CT System
PhotoDetection Systems, Inc. 85 Swanson Rd Boxborough, MA 01719-1300 MAY ัง 8 2009
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Device description:
The PhotoDetection Systems' NeuroPET is a small aperture positron emission tomography PET scanner that produces images based on the distribution of positron emitting isotopes in parts of the human body that will fit in the patient aperture for medical diagnostic and research purposes.
The NeuroPET system consists of three subsystems (shown below); the NeuroPET Ring Gantry/Acquisition System, Patient Table and the Console/PC. The NeuroPET Ring detects coincident gamma pairs emitted from positron annihilation and contains all the data acquisition electronics and reconstruction computers. The Patient Table is used to
Image /page/1/Picture/5 description: The image shows a medical examination room with a table, a computer, and a medical imaging machine. The table is in the center of the room and has wheels on the bottom. The computer is on a rolling stand to the left of the table. The medical imaging machine is on the right side of the room and has a large opening in the front.
comfortably position the patient relative to the scanner. The Console/PC provides the operator interface for the system including such functions as system and scan control, reconstruction, data archiving, image viewing, analysis, and network connectivity.
-For a more detailed description see Section 11 of this submission.
PhotoDetection Systems, Inc. 85 Swanson Rd Boxborough, MA 01719-1300 Page 2 of 3
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Indications for Use:
This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Differences Between Other Legally Marketed Predicate Devices
The NeuroPET is viewed as substantially equivalent to the PET portion of the Toshiba PCA-8000A/Mark II.
The primary differences between the two PET systems are the:
- Standalone PET vs. PET integrated into PET/CT
- 후 Method of attenuation correction: CAC vs. CTAC
- t Bore size: 31 cm vs. 90 cm
- . Operator Workstation: NeuroPET GUI vs. Toshiba PET/CT GUI
A detailed comparison of the two systems is found in section 12.
The two PET systems are substantially equivalent in function, safety, and effectiveness to the PET component of the Toshiba Mark II CT.
Conclusion:
Based on submitted non-clinical and image data consistent with FDA's guidance for PET systems and for devices that include software, the NeuroPET is substantially equivalent in technology, intended use, safety, and effectiveness to the PET imaging component of the Toshiba PCA-8000A/Mark II.
PhotoDetection Systems, Inc. 85 Swanson Rd Boxborough, MA 01719-1300 Page 3 of 3
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PhotoDetection Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K091269
Trade/Device Name: NeuroPET Positron Emission Tomography (PET) System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: April 29, 2009 Received: April 30, 2009
Dear Mr. Job:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Section 4 - Indications for Use
Indications for Use
510(k) Number (if known): K071267
Device Name: NeuroPET Positron Emission Tomography (PET) System Indications for Use:
This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin Mc Pollard
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
PhotoDetection Systems, Inc. 85 Swanson Rd Boxborough, MA 01719-1300 Page 1 of 1