The uEXPLORER is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

The proposed device uEXPLORER combines a 194 cm axial field of view (AFOV) PET and multi-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET gantry, CT gantry, patient table, power supply cabinet, console and reconstruction system, chiller, vital signal module.

The uEXPLORER has been previously cleared by FDA via K182938. The mainly modifications performed on the uEXPLORER (K182938) in this submission are due to the addition of HYPER Iterative, HYPER DLR, Digital gating, remote assistance and CT system modification.

Details about the modifications are listed as below:

HYPER Iterative (has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
HYPER DLR (has been cleared in K193210), uses a deep learning technique to produce better SNR (signal-to-noise-ratio).
Digital Gating (has been cleared in K193241), uses motion correction method to ● provide better alternatives to reduce motion effects without sacrificing image statistics.
Remote assistance.
PET recon matrix: 1024×1024.
TG-66 compliant flat tabletop.
Update the performance according to the NEMA NU 2-2018 standard.
Update the operation system.
CT system modification: add Low Dose CT Lung Cancer Screening, Auto ALARA kVp, Organ-Based Auto ALARA mA, EasyRange, Injector Linkage, Shuttle Perfusion, Online MPR and Dual Energy analysis function. All functions have been cleared via K230162.

AI/ML Overview

This document appears to be a 510(k) Premarket Notification from Shanghai United Imaging Healthcare Co., Ltd. for their uEXPLORER device.

Here's an analysis of the provided text to extract information about the acceptance criteria and study that proves the device meets them:

Crucial Observation: The document explicitly states: "No Clinical Study is included in this submission." This means that the information typically found in an FDA submission regarding "acceptance criteria" through a clinical performance study (like an MRMC study or standalone performance) is not present here. Instead, the substantial equivalence relies on non-clinical testing and comparison to predicate devices, particularly regarding modifications to previously cleared components.

Therefore, many of the requested points below cannot be fully answered as they pertain to clinical or human-in-the-loop performance studies that were not conducted or provided in this submission for the specific device being reviewed.

However, I can extract information related to the "non-clinical testing" and the rationale for substantial equivalence.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Substantial Equivalence Rationale):

Given the statement "No Clinical Study is included in this submission," the acceptance criteria are primarily related to non-clinical performance, safety, and functionality demonstrating equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is essentially that it met these non-clinical criteria and maintained safety/effectiveness equivalent to the predicate.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (Implied from document)	Reported Device Performance (Implied from document)
Functional Equivalence	Maintains same basic operating principles/fundamental technologies as predicate.	"The uEXPLORER employs the same basic operating principles and fundamental technologies... The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness."
Indications for Use Equivalence	Has similar indications for use as predicate.	"The uEXPLORER has ... the similar indications for use as the predicate device." (Indications for Use are listed in detail in section 6 of the document, matching the predicate's intent)
Physical/Technical Specifications	Key specifications (e.g., gantry bore, scintillator, axial FOV, maximum table load) remain equivalent to predicate device.	Confirmed: Gantry bore (760mm), Scintillator material (LYSO), Number of detector rings (672), Axial FOV (194 cm), Gantry bore (76 cm for PET), Maximum table load (250 kg) are identical to the predicate (K182938).
Addition of New Features (Non-Clinical Validation)	New features (HYPER Iterative, HYPER DLR, Digital Gating, CT system modifications) are either identical to previously cleared devices or validated through non-clinical testing.	HYPER Iterative: "has been cleared in K193241." "uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function." (Implies non-clinical validation of this algorithm in prior submission).HYPER DLR: "has been cleared in K193210." "uses a deep learning technique to produce better SNR." (Implies non-clinical validation of this algorithm in prior submission).Digital Gating: "has been cleared in K193241." "uses motion correction method..." (Implies non-clinical validation in prior submission).CT system modification: "All functions have been cleared via K230162." (Implies non-clinical validation of these functions in prior submission). Non-clinical tests were conducted for "Algorithm and Image performance."
Safety - Electrical Safety & EMC	Conformance to relevant electrical safety and electromagnetic compatibility (EMC) standards.	Claims conformance to: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-44, IEC 60601-1-3, IEC 60825-1. (Implies positive test results against these standards).
Safety - Software	Conformance to software development and cybersecurity standards.	Claims conformance to: IEC 60601-1-6 (Usability), IEC 62304 (Software life cycle processes), NEMA PS 3.1-3.20 (DICOM), FDA Guidance for Software Contained in Medical Devices, FDA Guidance for Cybersecurity. (Implies software development and testing followed these standards).
Safety - Biocompatibility	Conformance to biocompatibility standards for patient contact materials (if applicable, which for a large imaging system is less direct but still relevant for patient tables/touch points).	Claims conformance to: ISO 10993-1, ISO 10993-5, ISO 10993-10. (Implies positive results for relevant components).
Performance - PET	Conformance to PET performance measurement standards.	Claims conformance to: NEMA NU 2-2018 (Performance Measurements of Positron Emission Tomographs). "Update the performance according to the NEMA NU 2-2018 standard." (Implies the device meets or exceeds the specifications in this standard).
Risk Management	Application of risk management processes.	Claims conformance to: ISO 14971: 2019 (Application of risk management to medical devices). (Implies risks were identified, assessed, and mitigated).
Quality System	Compliance with Quality System Regulation.	Claims conformance to: 21 CFR Part 820 Quality System Regulation. (This is a general requirement for all medical device manufacturers).
Radiological Health	Compliance with radiological health regulations.	Claims conformance to: Code of Federal Regulations, Title 21, Subchapter J - Radiological Health. (This is a general requirement for X-ray emitting devices).

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 for Test Set: Not applicable in the context of clinical data. For non-clinical performance and algorithm testing, the "sample size" would refer to the types and number of phantoms/datasets used. The document states "Algorithm and Image performance tests were conducted," but does not specify the number or nature of these test sets.
Data Provenance: Not specified for any test data. The company is based in China.

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, as no clinical study with expert ground truth establishment was conducted or presented in this submission.

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

Not applicable, as no clinical study requiring adjudication was conducted or presented.

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 was explicitly NOT done. The submission states: "No Clinical Study is included in this submission." The new features (HYPER Iterative, HYPER DLR, Digital Gating, and CT modifications) had "been cleared" in other predicate devices via non-clinical performance evaluations, not human reader studies.

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

Yes, in essence, standalone performance validation of the algorithms was done, but as part of prior submissions for the predicate components. The document states "Algorithm and Image performance tests were conducted for the uEXPLORER during the product development." The key new features, HYPER Iterative, HYPER DLR, and Digital Gating, as well as the CT system modifications, are explicitly stated as having been "cleared" in previous 510(k) submissions (K193241, K193210, K230162). This implies their standalone performance was evaluated and accepted in those prior submissions through non-clinical means (e.g., phantom studies, image quality metrics like SNR, spatial resolution, noise reduction). The details of those prior standalone studies are not provided here, but the current submission leverages their previous clearance.

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

For the non-clinical "Algorithm and Image performance tests," the ground truth would typically be established based on well-defined physical phantoms with known properties or simulated data, rather than expert consensus, pathology, or outcomes data, which are associated with clinical studies. The specific details are not provided.

8. The sample size for the training set

Not applicable directly to this submission. The algorithms (HYPER DLR being deep learning) would have had training data, but those details pertain to their original development and previous clearances (K193210, K193241), not this particular 510(k) submission.

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

Not applicable directly to this submission. This information would be found in the documentation for the previous 510(k) clearances for the HYPER DLR and Digital Gating algorithms if they involved supervised learning that required established ground truth. Typically, for medical imaging algorithms, this could involve large datasets with expertly annotated images, but no specifics are in this document.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2024

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

Re: K231762

Trade/Device Name: uEXPLORER Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: December 18, 2023 Received: December 18, 2023

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 (the 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 available 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 Reg

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

D. Ray K

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K231762

Device Name uEXPLORER

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/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font and is stacked on top of each other. To the right of the text is a stylized "U" shape that is dark gray with a white horizontal line through the middle.

510(k) SUMMARY

K231762

1. Date of Preparation:

June 16, 2023

2. Sponsor Identification

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

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

Identification of Proposed Device 3.

Trade Name: uEXPLORER Common Name: Positron Emission Tomography and Computed Tomography Systems Model(s): uEXPLORER

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

Identification of Primary/ Reference Device(s) 4.

Predicate Device

510(k) Number: K182938 Device Name: uEXPLORER Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

Reference Device#1

510(k) Number: K193241

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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is divided into three sections by two vertical lines. The logo is simple and modern, and the use of bold fonts and geometric shapes gives it a strong and recognizable presence.

Device Name: uMI 550 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

Reference Device#2

510(k) Number: K193210 Device Name: HYPER DLR Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology

Reference Device#3

510(k) Number: K230162 Device Name: uCT 780 with uWS-CT-Dual Energy Analysis Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

5. Device Description

Details about the modifications are listed as below:

HYPER Iterative (has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
HYPER DLR (has been cleared in K193210), uses a deep learning technique to produce better SNR (signal-to-noise-ratio).

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is likely a graphical element of the logo. The overall design is clean and modern.

Digital Gating (has been cleared in K193241), uses motion correction method to ● provide better alternatives to reduce motion effects without sacrificing image statistics.
Remote assistance.
PET recon matrix: 1024×1024.
TG-66 compliant flat tabletop.
Update the performance according to the NEMA NU 2-2018 standard.
Update the operation system.
CT system modification: add Low Dose CT Lung Cancer Screening, Auto ALARA kVp, Organ-Based Auto ALARA mA, EasyRange, Injector Linkage, Shuttle Perfusion, Online MPR and Dual Energy analysis function. All functions have been cleared via K230162.

6. Indications for Use

The uEXPLORER is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

7. Comparison of Technological Characteristics with the Predicate Devices

The uEXPLORER employs the same basic operating principles and fundamental technologies, and has the similar indications for use as the predicate device. A comparison between the technological characteristics of proposed and predicate devices is provided as below.

ITEM	Proposed Device	Predicate Device (K182938)
------	-----------------	----------------------------

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.

Gantry	760 mm bore	760 mm bore
PET system	Scintillator material: LYSO	Scintillator material: LYSO
	Number of detector rings: 672	Number of detector rings: 672
	Axial FOV: 194 cm	Axial FOV: 194 cm
	Gantry bore: 76 cm	Gantry bore: 76 cm
CT System	Cleared via K230162	Cleared via K172135
Maximum table load	250 kg	250 kg
Post-processing software
HYPER Iterative	Yes	No
HYPER DLR	Yes	No
Digital gating	Yes	No

uEXPLORER's technological characteristics do not raise new safety and effectiveness concerns.

Performance Data 8.

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

Non-clinical testing including Algorithm and Image performance tests were conducted for the uEXPLORER during the product development.

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

Electrical Safety and Electromagnetic Compatibility (EMC)

A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)
A IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
A IEC 60825-1 Edition 3.0 2014 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol. The symbol is a dark teal color and has a white vertical line running through the center of the "U".

A IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
A IEC 62304 Edition 1.1 2015-06 Consolidated version, Medical device software -Software life cycle processes
A NEMA NU 2-2018. Performance Measurements of Positron Emission Tomographs

Software

A NEMA PS 3.1-3.20(2022d): Digital Imaging and Communications in Medicine (ICOM)
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

Biocompatibility

ISO 10993-1: 2018, Edition 5.0, Biological evaluation of medical devices Part 1: A Evaluation and testing within a risk management process.
A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Other Standards and Guidance

ISO 14971: 2019, Edition 3.0, Medical Devices Application of risk management A to medical devices
Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health

Clinical Testing

No Clinical Study is included in this submission.

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uEXPLORER was found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

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

Regulation Number and Section

N/A