The 'ANCORIS' PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

Device Description

The proposed device 'ANCORIS' is a PET system providing volume measurements of metabolic and physiologic processes. It is the same as the legally market device, name 'ECAT ACCEL PET scanner', K002584, from CTI PET Systems (now Siemens Medical), combined with the legally market device, name 'ECAT Scintron PET', K130269 from MiE GmbH. It is designed to close the economical gap between the demand and availability of stand-alone PET scanner. 'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices. The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).

AI/ML Overview

The provided text describes the ANCORIS PET Scanner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on:

Regulatory clearance: Obtaining 510(k) clearance based on substantial equivalence.
Device description: How ANCORIS combines elements of existing, cleared PET scanners.
Key differences from predicates: Primarily a patient handling system (PHS) for higher patient weights and an integrated trigger unit and graphical user interface.
Performance verification and validation: Stating that performance was successfully checked and meets specifications, and that safety tests (IEC 60601-1) were conducted.
Transmission technology: Confirmation that the Ge68 rod source transmission technology is similar to that of a predicate device.

Therefore, I cannot provide the requested information for the following items based on the given text:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria for diagnostic accuracy/clinical performance are mentioned.
Sample size used for the test set and the data provenance: No clinical test set or data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
Adjudication method for the test set: Not applicable as no clinical test set is described.
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 MRMC study or AI assistance is mentioned. The device is a PET scanner, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a PET scanner, not a standalone algorithm.
The type of ground truth used: Not applicable as no diagnostic ground truth for a clinical study is described.
The sample size for the training set: Not applicable as no training set for an AI algorithm is described.
How the ground truth for the training set was established: Not applicable as no training set for an AI algorithm is described.

The document instead highlights engineering verification and validation which confirm the device functions as intended and meets safety standards, rather than clinical performance criteria. The "Conclusion" states that the manufacturing, design, and development processes conform to valid standards and that the system is substantially equivalent, implying that its performance is expected to be comparable to the predicate devices it is based upon.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

MiEGmbH % Mr. Thomas Kuehl CEO Hauptstrasse 112 Seth, Schleswig-Holstein 23845 GERMANY

August 27, 2020

Re: K201807

Trade/Device Name: ANCORIS Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: June 25, 2020 Received: July 1, 2020

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. 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 located 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.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or post-marketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201807

Device Name

ANCORIS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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 MiE, which is displayed in white text on a blue rectangle. The letters "MiE" are stylized with the "M" and "i" connected at the top, and the "E" is slightly offset to the right. The blue rectangle provides a solid background for the logo, making it stand out.

Submitter Identification

Holder / Headquarters:	MiE GmbHHauptstrasse 11223845 Seth, Schleswig-HolsteinGermany
Telephone Number:Fax Number:	+49 4194 9977 0+49 4194 9977 55
Contact Person:	Thomas Kuehlth.kuehl@miegermany.de
Date summary prepared:	24th August 2020
Registration Number:	3005128583
Product Identification
Name:	ANCORIS
Common Name:	Positron Emission Tomography (PET) Scanner
Classification Name:	Emission Computed Tomography System21 C.F.R. § 892.1200

Class II

Classification:

Identification of Legally Market and Equivalent Devices

510(k) #	Device	Manufacturer
K130269	ECAT Scintron PET	MiE GmbH
K002584	ECAT ACCEL PET Scanner	CTI PET Systems, Inc.
K013504	ECAT LSO PET/CT Scanner	CTI PET Systems, Inc.

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Image /page/4/Picture/0 description: The image shows the letters 'MiE' in white against a blue background. The letters are stylized with the 'M' and 'E' being larger and bolder than the 'i'. The overall design is simple and clean, with a focus on the acronym.

Device Description

It is designed to close the economical gap between the demand and availability of stand-alone PET scanner.

'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices.

The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).

Indications for Use

Comparison with Predicate Devices

The 'ANCORIS' PET Scanner is similar in measuring design and function to the legally market device 'ECAT ACCEL PET scanner', K002584, as well as the PET Scanner used in the legally market device, name 'ECAT LSO PET/CT Scanner', K013504. Same as in the 'ECAT ACCEL PET scanner' rotating source are used to perform the transmission scan. The main difference of the current device 'ANCORIS' is a PHS (patient handling system) for higher patient weight.

The 'ANCORIS' PET Scanner will use the same computer hard- and software technology as used in the legally market device, name 'ECAT Scintron PET', K130269.

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Image /page/5/Picture/0 description: The image shows a logo with the letters "MiE" in white against a blue background. The letters are stylized, with the "M" having a sharp, angular design and the "i" having a circular dot above it. The blue background is a solid, uniform color, providing a clean and simple backdrop for the text.

New changes in the current device

The patient handling system (PHS) is designed for higher patient weights up to -227kg (500lbs). The mechanical technologies are similar to the legally market device 'ECAT ACCEL PET Scanner', K002584. The PHS pallet is designed for higher patient weights and similar attenuation properties.
-The trigger unit for ECG and respiratory gating is integrated into the rear of the ANCORIS PHS and moves together with the pallet. The operation is done via the user touch interface at the gantry.
The graphical user touch interface displays more information of the acquisition and system status including operation of the trigger unit. The touch interface allows a modern usage of the system.

Performance verification and validation of the device

The performance of the ANCORIS is successful checked by verification and validation of the ANCORIS system. Furthermore, it is checked if the system meets the specifications and fulfills its intended purpose.

The higher patient load of the PHS and the general requirements for basic safety and essential performance is checked during the IEC 60601-1 tests.

The transmission technology by Ge68 rod sources is similar to transmission technology of the legally market device 'ECAT ACCEL PET Scanner', K002584. This is checked by a comparison of the rod source holder, septa, parking positions, attenuation of PHS pallet and the attenuation correction procedure.

Conclusion

The 'ANCORIS' PET System has similar intended use, operating principle and fundamental technologies as legally market devices. The manufacturing, design and development processes of the 'ANCORIS' PET System are conform to currently valid standards including applicable medical device safety and performance.

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

Regulation Number and Section

§ 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.