(90 days)
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.
The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.
The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.
Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.
The provided document describes a 510(k) premarket notification for the Hamamatsu PET Scanner Model SHR-22000. This is a medical imaging device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/CADe device.
Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for a hardware device like a PET scanner.
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a specific diagnostic task like an AI/CADe device. The primary "acceptance criteria" for a 510(k) submission for a traditional medical device are demonstrating substantial equivalence to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and performance (e.g., image quality, resolution, safety) to the predicate.
- Reported Device Performance: The document states:
- "Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution." (This is a design characteristic, implying improved resolution).
- "The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation."
- "Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device." However, specific numerical performance metrics (e.g., spatial resolution in mm, sensitivity in cps/kBq) are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not explicitly detailed. This document is for a hardware PET scanner. The "testing" mentioned refers to compliance with electrical safety and general imaging performance characteristic equivalence, not a clinical study on a patient test set for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No such clinical test set or ground truth establishment is described in this 510(k) summary for a PET scanner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a hardware device (PET scanner), not an AI/CADe algorithm. MRMC studies are typically performed for AI or CADe devices to assess improved reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This describes a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth is mentioned for performance evaluation in this 510(k) summary. The "testing" focused on device characteristics and safety.
8. The sample size for the training set:
- Not applicable. This is a hardware device; there isn't a "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary for the Hamamatsu PET Scanner Model SHR-22000:
This 510(k) summary demonstrates that the Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797). The equivalence is based on similar indications for use, technological characteristics (coincidence detection, scintillator segments, image reconstruction), and the results of imaging performance tests to ensure similar image characteristics. The details provided are typical for a hardware device submission, focusing on safety and equivalence to established technology rather than rigorous clinical performance metrics for a diagnostic algorithm.
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SEP 17 1998
510(k) Summary
Hamamatsu PET Scanner Model SHR-22000
Common/Classification Name: PET Scanner, 21 CFR 892.1200
Hamamatsu Photonics, K.K. 325-6, Sunayama-cho Hamamatsu City 430 JAPAN
Contact: Keith Kobayashi, Prepared: May 18, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797).
DEVICE DESCRIPTION B.
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.
The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.
Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.
C. INTENDED USE
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are
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particularly useful in the assessment of brain function.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Hamamatsu PET Scanner Model SHR-22000 is a medical device, and it has similar indications for use as the legally marketed predicate device. The two devices have the same intended use.
The Hamamatsu PET Scanner Model SHR-22000 has the same technological characteristics as the predicate devices.
- This premarket notification describes most of the characteristics of the Hamamatsu PET Scanner Model SHR-22000 in sufficient detail to assure substantial equivalence. For a few characteristics, performance data is provided to assure equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The Hamamatsu PET Scanner Model SHR-22000 has the "same technological characteristics" as the predicate devices. Both employ coincidence detection from thousands of scintillator segments to reconstruct cross-sectional medical images using standard image reconstruction algorithms. The image processing algorithms in the workstation manipulate and display medical images on the workstation monitor.
F. TESTING
4
The Hamamatsu PET Scanner Model SHR-22000 was tested for compliance with the Japanese Industry Standard on electrical safety. Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device.
G. CONCLUSIONS
The 510(k) decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 1998
Hamamatsu Photonics, K.K. T. Whit Athey, Ph.D. c/o C.L. McIntosh & Associates 12300 Twinbrook Parkway Suite 625 Rockville. Maryland 20852
Re:
K982171 Hamamatsu PET Imaging System Model SHR-22000 Dated: June 18, 1998 Received: June 19, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your ........ responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Hamamatsu PET Scanner Model SHR-22000 Device Name:
Indications For Use:
ﺎﺕ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . . . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE) ----------
David W. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
000034
§ 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.