HYPER Focus can be used to correct respiratory motion in PET images. Relative to non - corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.

Device Description

HYPER Focus is a software-only device. It is intended to be implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER Focus serves as an additional function for uMI 550 and uMI 780 to carry the respiratory correction. It uses the similar respiratory motion correction technique, non-rigid image registration, as the predicate device.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device called "HYPER Focus" (K210418), a software-only device designed to correct respiratory motion in PET images.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics like a typical clinical study report would. Instead, the acceptance criteria are implicitly tied to the device's ability to achieve "substantial equivalence" to a predicate device (GE Q.Freeze software, K113408) in terms of its ability to reduce respiratory motion effects and improve the accuracy of SUV and lesion volume.

The reported device performance is described qualitatively as:

Acceptance Criterion (Implicit)	Reported Device Performance/Conclusion
Reduce respiratory motion effects in PET images.	"HYPER Focus can reduce respiratory motion effects..."
Improve the measurement accuracy of SUV. (Standardized Uptake Value)	"...and thus improve the measurement accuracy of SUV..."
Improve the measurement accuracy of lesion volume.	"...and lesion volume."
Technological characteristics equivalent to predicate device's respiratory motion correction function.	"HYPER Focus has the equivalent technological characteristic to the function of respiratory motion correction of predicate device." "Both devices are based on non-rigid image registration technique." "HYPER Focus also utilizes 100% of the acquired data counts, similar to the predicate device."
No new restrictions on use compared to predicate.	"...and does not introduce any new restrictions on use."
As safe and effective as the predicate.	"HYPER Focus is as safe and effective as the predicate." "HYPER Focus is substantially equivalent as safe as the legally marketed predicate device." "Design verification, along with bench testing demonstrates that HYPER Focus is substantially equivalent as effective as the legally marketed predicate device."
Software documentation and cybersecurity conformance.	"Software documentation for a Moderate Level of Concern software per FDA Guidance Document... is included as a part of this submission." "Cybersecurity information in accordance with guidance document... is included in this submission."
Risk analysis completed and risk control implemented.	"The risk analysis was completed and risk control was implemented to mitigate identified hazards."
All software specifications met acceptance criteria.	"The testing results show that all the software specifications have met the acceptance criteria."
Verification and validation testing acceptable to support substantial equivalence.	"Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence."

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

Sample Size: The document does not specify a numerical sample size for the test set. It mentions "identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241)." This suggests that existing datasets were used, but the quantity of these datasets or individual patient cases is not provided.
Data Provenance: The data was obtained from UIH's uMI 780 and uMI 550 devices. Given that the company, Shanghai United Imaging Healthcare Co., Ltd., is based in China, it is highly probable that the data originated from China. The document does not explicitly state whether the data was retrospective or prospective, but given they are "identical raw datasets obtained" and "existing data" for bench testing, it strongly implies retrospective use of previously acquired patient data.

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)

This information is not provided in the document. The document describes "engineering bench testing" and "performance verification" using "identical raw datasets," which suggests a technical analysis rather than an expert-read clinical study to establish ground truth for the test set.

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

This information is not provided in the document. The study described appears to be a technical bench test comparing reconstructed images with and without motion correction, rather than a reader study requiring adjudication.

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, an MRMC comparative effectiveness study involving human readers is not described in this document. The study focuses on the device's quantitative performance (SUV and lesion volume accuracy) and its ability to reduce motion effects in comparison to non-corrected images, and on demonstrating substantial equivalence to a predicate device.

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

Yes, a standalone performance evaluation was done. The "Performance Verification" section states: "Engineering bench testing was performed to support substantial equivalence and product performance claims. The evaluation and analysis used the identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241), and then respectively performed image reconstruction with/without HYPER Focus." This indicates that the algorithm's performance was assessed independently of human interpretation.

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

The document primarily refers to "bench testing" and "analysis" of quantitative metrics like SUV (Standardized Uptake Value) and sphere/lesion volume accuracy. The "ground truth" for this type of test is typically based on:

Known physical properties of phantoms: For sphere volume and potentially SUV accuracy, phantom studies with known dimensions and activity concentrations are commonly used. While not explicitly stated, "bench test" often implies phantom studies.
Comparison to "ideal" or "reference" motion-corrected images: The document states a comparison "in comparison with no motion correction." This implies an assessment against a baseline reference, where the ground truth is the improved accuracy obtained by the algorithm. For motion correction, perfect motion-free images are the ideal ground truth, which is often approximated or modeled.
The document implies that the "ground truth" for proving efficacy is the demonstrated improvement in SUV and lesion volume accuracy and reduction of motion effects when HYPER Focus is applied, compared to images without motion correction.

The document does not suggest the use of expert consensus, pathology, or outcomes data as a ground truth for this particular submission, which is focused on validating the technical performance of motion correction software for PET images in the context of substantial equivalence.

8. The sample size for the training set

The document does not provide any information about the sample size used for the training set of the HYPER Focus algorithm.

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

The document does not provide any information about how the ground truth for the training set was established. It focuses solely on the performance verification (testing) of the final algorithm.

Summary

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Shanghai United Imaging Healthcare Co.,Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

Re: K210418

Trade/Device Name: HYPER Focus Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: February 7, 2021 Received: February 11, 2021

Dear Xin Gao:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

April 9, 2021

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devices or postmarketing 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-devices/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.

Michael D. O'Hara
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) K210418

Device Name HYPER Focus

Indications for Use (Describe)

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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510 (k) SUMMARY

K210418

1. Date of Preparation

February 7, 2021

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

3. Identification of Proposed Device

Trade Name: HYPER Focus Common Name: Emission Computed Tomography System Model(s): HYPER Focus

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K113408 Device Name: Emission Computed Tomography System Model(s): GE Q.Freeze software

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology

5. Device Description:

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the respiratory correction. It uses the similar respiratory motion correction technique, non-rigid image registration, as the predicate device.

Indications for Use 6.

HYPER Focus can be used to correct respiratory motion in PET images. Relative to non-corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.

7. Comparison of Technological Characteristics with the Predicate Devices

A comparison between the technological characteristics of proposed and predicate devices is provided as below.

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ITEM	Predicate Device	Proposed Device	Comment
	Q.freeze Software (K113408)	HYPER Focus
Product Code	KPS	KPS	same
Regulation Number	21 CFR 892.1200	21 CFR 892.1200	same
Regulatory Class	II	II	same
Indications for Use	MotionVUE2 (Q.freeze) is a PET/CT, no-invasiveimage analysis software application designed tosupport the viewing and manipulation of medicalimages from PET and CT imaging modalities.MotionVUE2 (Q.freeze) offers processing tools tooptimize workflow of respiratory gated exams forPET. CT and fused images of respiratory gateddatasets for simultaneous viewing in multi-planarvolumes and cine loops.MotionVUE2 (Q.freeze) allows the users togenerate from their 4D-PET or 4D-PET/CT series aregistered 4D-PET series used for quantification oflesions and analysis of functional activity. WithMotionVUE2 (Q.freeze), users will have thepossibility to compare static PET/CT, 4D-PET/CT,and registered 4DPET series including visualcomparison, quantification of lesions and analysisof functional activity.MotionVUE2 (Q.freeze) provides registrationperformance of up to 2mm of center of mass motionwhen motion is no larger than the diameter of theobject.MotionVUE2 (Q.freeze) providescomparable/equivalent improvement ofquantification results (SUV and size) as 4D PETtechniques.MotionVUE2 (Q.freeze) can be used for featureswith locally concentrated activity within the entire	HYPER Focus can be used tocorrect respiratory motion in PETimages. Relative to non-correctedimages, HYPER Focus can reducerespiratory motion effects andthus improve the measurementaccuracy of SUV and lesionvolume.	HYPER Focus is equivalentto the function of respiratorymotion correction ofQ.freeze. Both devicesimprove the SUV and lesionvolume.
	Thorax area. This area includes the organs wherePET/CT imaging has the most challenges due torespiratory motion: Lung, Liver, Pancreas.
Algorithm	GE Healthcare Q.freeze software is designed tominimize the effect of respiratory motion using anon-rigid optical flow registration technique tocreate a single static image containing 100% ofacquired counts.	HYPER Focus is a respiratorymotion correction technique basedon the non-rigid imageregistration, which is capable ofcorrecting motion effects,eliminating the activity-attenuation mismatch artifacts, aswell as improving the accuracy ofSUV and lesion volume. It alsoutilizes 100% of the acquired datacounts.	HYPER Focus has theequivalent technologicalcharacteristic to the functionof respiratory motioncorrection of Q.freeze. Bothdevices are based on non-rigid image registrationtechnique.

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HYPER Focus has the equivalent technological characteristic to the function of respiratory motion correction of predicate device and does not introduce any new restrictions on use. HYPER Focus is as safe and effective as the predicate.

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8. Performance Data

Non-Clinical Testing

Image performance tests were conducted for HYPER Focus during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Software

NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine > (DICOM)
IEC 62304: Medical Device Software - software life cycle process
A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Other Standards and Guidance

ISO 14971: Medical Devices Application of risk management to medical > devices
A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation

Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission. The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence. UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

Performance Verification

Engineering bench testing was performed to support substantial equivalence and product performance claims. The evaluation and analysis used the identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241), and then respectively performed image reconstruction with/without HYPER Focus.

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Bench test shows that HYPER Focus can reduce respiratory motion effects and improve the accuracy of SUV and sphere volume in comparison with no motion correction.

9. Conclusions

HYPER Focus is developed under UIH's quality management system. Design verification, along with bench testing demonstrates that HYPER Focus is substantially equivalent as effective as the legally marketed predicate device.

Based on the comparison and analysis above, the proposed device has similar performance, equivalent safety and effectiveness as the predicate device. The differences between the proposed device and predicate devices do not affect the indications for use, safety and effectiveness. And no issues are raised regarding safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate 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.