The 'ECAT Scintron PET' integrated workstation is designed to acquire data, process and display images, by appropriated trained health care professionals, from ECAT EXACT and ECAT ACCEL PET scanners of CTI PET Systems via measuring the distribution of injected positron emitting radiopharmaceutical in humans for purpose of determining various metabolic and physiologic functions within the human body.

Device Description

The 'ECAT SCINTRON PET' is designed to replace the integrated workstation (advanced computational system) of the legally market devices ECAT EXACT PET System and ECAT ACCEL PET scanner. The 'ECAT SCINTRON PET' integrated workstation is proposed to perform simultaneous 2D or 3D acquisitions, image reconstruction, processing and analysis of data received from ECAT Positron Emission Tomographs of CTI PET Systems. In addition it controls the motion of the patient handling system, the transmission sources and septa for 2D scans with the scanner. The 'ECAT SCINTRON PET' is used to acquire data from whole body positron emission tomography system and providing 3D volume measurements of metabolic and physiologic processes. The software is designed to run only on 'ECAT SCINTRON PET' integrated workstations. The software is only available as package and in combination with the computer hardware. Some software modules not needed for the basic usage are optional. The development processes of the software and hardware are based on the legally market device, name SCINTRON, K101013. The 'ECAT SCINTRON PET' uses industry standard and well tried hardware components and software techniques which ensures long term support.

AI/ML Overview

The provided 510(k) summary for the ECAT Scintron PET device does not contain a study to demonstrate that the device meets specific acceptance criteria.

Instead, the submission relies on a substantial equivalence claim to predicate devices (ECAT EXACT PET System, K962797, and ECAT ACCEL PET Scanner, K002584). The core argument is that the ECAT Scintron PET is an updated workstation designed to replace the integrated workstation of these predicate devices, using updated electronics and software while maintaining the same fundamental functionality and compatibility with the existing PET scanners.

Here's an analysis based on the provided document, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission focuses on the design and development processes being conformant to standards and the functional equivalence to predicate devices rather than quantifiable performance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical or performance test set data is presented in this summary. The "test results" mentioned refer to the internal testing of the system to ensure its functionality and conformity with standards, rather than a clinical performance study.

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 ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication is described.

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

Not applicable. This device is a workstation for existing PET scanners and does not involve AI or a human-in-the-loop performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of an algorithm's diagnostic performance. The device itself is a standalone workstation, but its "performance" is tied to its ability to acquire, process, and display images from the existing PET scanners, consistent with the predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth for diagnostic performance is mentioned. The "ground truth" for this submission is implicitly the established functionality and performance of the predicate ECAT PET systems that the new workstation is designed to interface with and replace.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set in the conventional sense for diagnostic performance.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for diagnostic performance is described.

Summary of the K130269 Submission's Approach:

The K130269 submission for the ECAT Scintron PET is primarily a substantially equivalent claim. The manufacturer (MiE GmbH) argues that their new workstation simply replaces the integrated workstation of existing, legally marketed PET systems (ECAT EXACT and ECAT ACCEL).

Their reasoning for substantial equivalence relies on:

Identical Intended Use: To acquire, process, and display images from ECAT PET scanners for determining metabolic and physiologic functions.
Similar Function, Operating Principle, and Fundamental Technologies: The new workstation performs the same tasks (data acquisition, image reconstruction, processing, analysis) and interfaces with the PET scanner using the same core components (coincidence board, gantry communication board).
Technological Updates: The "major difference is the improvement of available electronics components as well as state-of-the-art software techniques for the acquisition, processing and viewing." This means newer industry-standard hardware (VMEbus PowerPC, Windows PC with multi-core processor) and software are used, but they aim to replicate the existing functionality.
No Mechanical Modifications to the Scanner: The PET scanner itself remains unchanged.
Conformity to Standards: The design and development processes comply with applicable medical device safety and performance standards.

In essence, the submission asserts that because the new workstation performs the same tasks as the original workstations in a commensurate manner with the existing PET scanners, and is built using validated processes and components, it is substantially equivalent and does not raise new questions of safety or effectiveness. They do not conduct a new clinical performance study because the device's function is to maintain the established performance of the overall PET system.

Summary

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K130269

Image /page/0/Picture/1 description: The image shows a logo with the letters "MiE" in a bold, sans-serif font. The letters are white and set against a black rectangular background. The letters are stylized, with the "M" having a unique, angular design. A horizontal line is present below the rectangle.

510(k) summary

APR 1 9 2013

(in accordance to 21 C.F.R. § 807.92)

Submitter Identification

Holder / Headquarters:

MiE GmbH Hauptstrasse 112 23845 Seth, Schleswig-Holstein Germany

+49 4194 9977 0 +49 4194 9977 55

Contact Person:

Fax Number:

Telephone Number:

Thomas Kuehl th.kuehl@miegermany.de

Date summary prepared:

8th January 2013

Product Identification

Name:	ECAT Scintron PET
Common Name:	Nuclear Medicine Workstation for Acquisition, Viewing and Processing
Classification Name:	Emission computed tomography system 21 C.F.R. § 892.1200
Classification:	Class II

Identification of Legally Market and Equivalent Devices

510(k) #	Device	Manufacturer
K962797	ECAT EXACT PET System	CTI PET Systems, Inc.
K002584	ECAT ACCEL PET Scanner	CTI PET Systems, Inc.

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Device Description

The 'ECAT SCINTRON PET' is designed to replace the integrated workstation (advanced computational system) of the legally market devices ECAT EXACT PET System and ECAT ACCEL PET scanner.

The 'ECAT SCINTRON PET' integrated workstation is proposed to perform simultaneous 2D or 3D acquisitions, image reconstruction, processing and analysis of data received from ECAT Positron Emission Tomographs of CTI PET Systems. In addition it controls the motion of the patient handling system, the transmission sources and septa for 2D scans with the scanner.

The 'ECAT SCINTRON PET' is used to acquire data from whole body positron emission tomography system and providing 3D volume measurements of metabolic and physiologic processes.

The software is designed to run only on 'ECAT SCINTRON PET' integrated workstations. The software is only available as package and in combination with the computer hardware. Some software modules not needed for the basic usage are optional.

The development processes of the software and hardware are based on the legally market device, name SCINTRON, K101013. The 'ECAT SCINTRON PET' uses industry standard and well tried hardware components and software techniques which ensures long term support.

Indications for Use

Performance

Generally the CTI PET scanner itself, including its specification reqarding performance is not modified. The usage of the same coincidence board and gantry communication board (including patient handling system) is necessary.

As in the OEM integrated workstation, the computers are divided into an acquisition and an evaluation part. The acquisition is done by a powerful industrial VMEbus PowerPC with a real-time operating system OS9. This makes the acquisition safe and stable. For processing and viewing a state-of-the-art Windows PC with a multi core processor, at least 3 GByte RAM modules as well as state-of-the-art graphical interfaces and network components is used. Both computers, the PowerPC and the PC communicate via a TCP/IP interface, same as in the original integrated workstation (ACS<(TCP/IP)>SUN).

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Image /page/2/Picture/0 description: The image shows a logo with the letters 'MiE' in a bold, sans-serif font. The letters are white and set against a black rectangular background. The 'M' and 'i' are connected, and the 'E' is slightly separated from the 'i'. The overall design is simple and modern.

Device Comparison

The integrated workstation 'ECAT SCINTRON PET' is similar to the integrated workstation of the PET Scanner, name ECAT EXACT PET System, K962797 and name ECAT ACCEL PET Scanner, K002584. This involves all computer applications as well hardware interfaces.

The maior difference is the improvement of available electronics components as well as state-of-the-art software techniques for the acquisition, processing and viewing.

No mechanical modifications are necessary or will be made to the ECAT PET scanner itself. Other than the integrated 'ECAT SCINTRON PET' workstation, the ECAT PET scanner will consist of the same components as those used in the original CTI PET System including gantry and the patient handling system.

The design and development processes of the 'ECAT SCINTRON PET' integrated workstation are conform to currently valid standards including applicable medical device safety and performance. All modifications do not significantly affect the safety and effectiveness of the device. All test results are, in opinion of MiE GmbH, that the 'ECAT SCINTRON PET' is substantially equivalent to the predicated devices integrated workstation.

Conclusion

ﺴﺪ

The current device 'ECAT SCINTRON PET' is based on well established technologies and components. It uses the reliable and long term available VME-bus, PowerPC based CPUs and specialized MiE Hard- and Software. Permanent quality control of the delivered components as well as extensive tests of all systems before installation ensures the quality and reliability of the MiE devices.

The 'ECAT SCINTRON PET' integrated workstation has similar intended use, function, operating principle and fundamental technologies as legally market devices with changes in the availability of hardware components and software technologies e.g. graphical user interface. The design and development processes of the 'ECAT SCINTRON PET' are in conformity to currently valid standards including applicable medical device safety and performance.

All test results are, in opinion of MiE GmbH, that the 'ECAT SCINTRON PET' is ' substantially equivalent to the predicated devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 19, 2013

MiE GmbH % Mr. Thomas Kuehl Hauptstrasse 112 23845 Seth, Schleswig-Holstein GERMANY

Re: K130269

Trade/Device Name: ECAT Scintron PET Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: February 6, 2013 Received: February 11, 2013

Dear Mr. Kuehl:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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

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Page 2 – Thomas Kuehl

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130269

Device Name:

ECAT Scintron PET

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) 130269

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Regulation Number and Section

N/A