HJY VisualNext™ Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.

Device Description

The HJY VisualNext™ Endoscopic Vision System is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:

. Endoscope Control Unit (ECU) (Model number: HDSES01)
. Endoscope (Model number: HDSE201)
The endoscope is physically connected via a 5m BNC cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera, embedded in the proximal end of a rigid metal arthroscope, which captures the image and transmits to and is processed by the Endoscope Control Unit (ECU), subsequently output to and presented on an external monitor. Images are recordable and markable for further analysis. The Endoscope Control Unit (ECU) is not connectable to intranet or Internet.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the HJY VisualNext Endoscopic Vision System, a neurological endoscope.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests performed, each with a "Purpose" (which implicitly contains the acceptance criteria) and "Results" (reported device performance). Since the original document doesn't provide a consolidated table of acceptance criteria with numerical targets before the results, the "Purpose" section of each test effectively serves as the acceptance criteria statement. For clarity, I will present the key performance parameters.

Test Parameter	Acceptance Criteria (from "Purpose" / implies meeting pre-defined criteria)	Reported Device Performance ("Results")
Field of View (FOV)	To verify the characteristic of field of view of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria)	Non-Aged: 120.15 ± 0.2 degrees; Aged: 120.41 ± 0.2 degrees. Both passed pre-defined acceptance criteria. Subject device FOV is larger than predicate.
Direction of View	To verify the characteristic of direction of view of the subject device and compare to that of predicate device. (Met requirements by ISO 8600-1; passed pre-defined acceptance criteria)	Non-Aged: 4.02 ± 0.2 degrees; Aged: 2.10 ± 0.2 degrees. Both passed pre-defined acceptance criteria and met ISO 8600-1 requirements.
Optical Magnification	To verify the characteristic of optical Magnification... and determine if both non-aged and aged test results will pass the pre-defined performance criteria.	Non-Aged: 0.014 @ 38 mm object distance; Aged: 0.013 @ 38 mm object distance. Both passed pre-defined acceptance criteria.
Distortion	To verify the characteristic of distortion... and determine if both non-aged and aged test results will pass the pre-defined performance criteria.	Non-Aged: Maximal distortion 22.7%; Aged: Maximal distortion 22.7%. Both passed pre-defined acceptance criteria.
Image IntensityUniformity	To verify the characteristic of the subjected device on image intensity uniformity and determine if both non-aged and aged test results will pass the pre-defined performance criteria.	Non-Aged: R:0.52, G:0.60, B:0.60; Aged: R:0.60, G:0.61, B:0.65. Both passed pre-defined acceptance criteria.
Signal-to-Noise Ratio	To verify the characteristic of signal-to-noise ratio of images... and determine if both non-aged and aged test results will pass the pre-defined performance criteria.	Non-Aged: R:20.47, G:40.90, B:22.24; Aged: R:20.24, G:35.18, B:21.47. Both passed pre-defined acceptance criteria.
Sensitivity	To verify the characteristic of sensitivity... and determine if both non-aged and aged test results will pass the pre-defined performance criteria.	Non-Aged: SNR@0.9 cd/m²: R:10.9058, G:9.99283, B:13.0905; Aged: SNR@0.81 cd/m²: R:13.14, G:8.88, B:14.85. Both passed pre-defined acceptance criteria.
Depth of Field	To verify the characteristic of depth of field of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria)	Non-Aged: 5-100 mm; Aged: 5-100 mm. Both passed pre-defined acceptance criteria. Subject device DOF is wider than predicate.
Image Resolution	To verify the characteristic of spatial frequency response of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria)	Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV (TV lines: 730); Aged: 54.1% on axis, 44.8% @ 0.6 FOV (TV lines: 670). Both passed pre-defined acceptance criteria. Similar to predicate (642 TV lines @ 15% MTF).
Working Length	To verify the working length of the endoscope and compare to that of predicate device. (Passed pre-defined acceptance criteria)	Working length: 180.76 mm. Passed pre-defined acceptance criteria. Longer than predicate.
Outer Diameter	To verify the outer diameter of the endoscope and compare to that of predicate device. (Passed pre-defined acceptance criteria)	Outer diameter: 5.28 - 5.32 mm. Passed pre-defined acceptance criteria. Wider than predicate.
Image Quality Test (Biological Tissue Model)	To verify subject device performance in terms of image quality under different light levels and working distances in a clinically relevant biological tissue model to support the device intended use and substantial equivalence to the predicate. (Passed pre-defined acceptance criteria)	Image quality of non-aged and aged subject device passed criteria for brain and spine surgery. No significant difference (P=0.569) between non-aged and aged devices. Image quality comparable to FDA-cleared comparators for brain and spine endoscopy.

2. Sample size used for the test set and data provenance:

Sample Size for Physical/Optical Tests: For most physical and optical performance tests (FOV, Direction of View, Optical Magnification, Distortion, Image Intensity Uniformity, Signal-to-Noise Ratio, Sensitivity, Depth of Field, Image Resolution), the tests were conducted using a "Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions." The specific number of individual units tested for each parameter is not explicitly stated beyond "disposable endoscope."
Sample Size for Image Quality Test (Biological Tissue Model):
- ECU: Non-aged and aged ECU units were used. (Quantity not specified, but implied as at least one of each).
- Endoscopes: "Six pieces of endoscopes each from non-aged and aged conditions were used for brain and spinal surgery, respectively." This means 6 non-aged endoscopes for brain surgery, 6 non-aged for spinal surgery, 6 aged for brain surgery, and 6 aged for spinal surgery.
- Comparators: "Two cleared devices each for spine and brain were applied for comparing with non-aged and aged subject devices."
Data Provenance: The tests were non-clinical laboratory studies. The "Image Quality Test utilizing a clinically relevant biological tissue model" was performed using a "live pig model" in "an animal operating room of a facility accredited under AAALACi standards," following "GLP standard." The country of origin for the data is not specified directly, but the company is based in Taiwan. The document states "No clinical test data was used to support the decision of substantial equivalence," indicating these were not human subject trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For the physical/optical tests, the "ground truth" is established by the measurement apparatus and methods themselves. For the Image Quality Test on a biological tissue model, the results state "The image quality of the non-aged and aged subject device passed the pre-defined acceptance criteria," and was "comparable to that of the FDA-cleared comparator devices." It's highly probable that expert assessment was involved in determining "image quality" or "comparability," but the number and qualifications of these experts are not explicitly mentioned in the provided text.

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

This information is not provided in the document. For most non-clinical performance tests, adjudication (as in clinical image review) is not typically applicable. For the image quality assessment in the biological tissue model, while agreement was tested, details of an adjudication method among multiple evaluators (if any) are not specified.

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:

This information is not applicable/not provided. The device is an endoscopic vision system, not an AI-assisted diagnostic tool for image interpretation by human readers. The studies described are non-clinical performance evaluations of the device's optical and imaging capabilities, and comparison of its image quality to a predicate device. No MRMC study regarding human reader performance with or without AI assistance was conducted or is relevant to this submission.

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

This information is not applicable/not provided as the device is not an AI algorithm. It is an endoscopic vision system that provides direct visual output for human use. The performance tests are of the hardware's image capture and display capabilities in a standalone manner (i.e., the system itself creating the image).

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

For the various physical and optical parameters, the "ground truth" is based on instrumented measurements against defined engineering specifications and comparison to the predicate device's characteristics. For the "Image Quality Test utilizing a clinically relevant biological tissue model," the ground truth for acceptability was based on pre-defined acceptance criteria and comparability to FDA-cleared comparator devices. While expert evaluation likely played a role in assessing "image quality" and "comparability," the final "ground truth" for the test was determined by whether these qualitative and quantitative assessments met the pre-defined criteria. The results state: "The image quality... passed the pre-defined acceptance criteria" and was "comparable to that of the FDA-cleared comparator devices." There is no mention of pathology or outcomes data being used as ground truth.

8. The sample size for the training set:

This information is not applicable/not provided. The HJY VisualNext Endoscopic Vision System is a hardware device (endoscope and control unit) that captures and displays images; it is not an AI/ML device that requires a training set.

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

This information is not applicable/not provided as there is no training set for this type of device.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 28, 2023

HJY Smart Medical Device Co., Ltd. John Jiannyuh Chen, Ph.D. Chairman & CEO 12F., No. 415, Sec. 4, Xinyi Dist. Taipei City, 11051 Taiwan

Re: K222735

Trade/Device Name: HJY VisualNext Endoscopic Vision System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: June 28, 2023 Received: June 30, 2023

Dear Dr. John Jiannyuh Chen:

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

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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 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 (OS) 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,

Digitally signed by Adam D Adam D. Pierce -S Date: 2023.07.28 Pierce -15:11:18 -04'00'

Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222735

Device Name

HJY VisualNext™ Endoscopic Vision System

Indications for Use (Describe)

HJY VisualNext™ Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.

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

5.1 Type of submission:	Traditional
5.2 Date of summary:	July 28, 2023
5. 3 Submitter:	HJY Smart Medical Device Co., Ltd.
Address:	12F., No. 415, Sec. 4, Xinyi Rd., Xinyi Dist.,
	Taipei City 11051, Taiwan
Phone:	+886-933-869246
Fax:	+886-2-2298-3287
Contact:	John Jiannyuh Chen, MS., Ph.D
	(john.chen@hjy-med.com)
Job title:	Chairman & CEO

5.4 Identification of the device:

Proprietary/Trade name:	HJY VisualNext™ Endoscopic Vision System
Product code:	GWG
Regulation number:	882.1480
Regulation description:	Endoscope, Neurological
Review panel:	Neurology
Device class:	II

5.5 Identification of the predicate device:

Predicate device name:	QEVO System with KINEVO 900
Manufacturer:	Carl Zeiss Meditec AG.
Product code:	GWG
Regulation number:	882.1480
Device class:	II
510(k) number:	K170667

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5.7 Indications for Use

5.8 Device description

The HJY VisualNext™ Endoscopic Vision System is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:

. Endoscope Control Unit (ECU) (Model number: HDSES01)
. Endoscope (Model number: HDSE201)

The endoscope is physically connected via a 5m BNC cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera, embedded in the proximal end of a rigid metal arthroscope, which captures the image and transmits to and is processed by the Endoscope Control Unit (ECU), subsequently output to and presented on an external monitor. Images are recordable and markable for further analysis. The Endoscope Control Unit (ECU) is not connectable to intranet or Internet.

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5.9 Non-clinical testing

A series of tests were performed to assess the safety and effectiveness of HJY VisualNext™ Endoscopic Vision System. All the test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use.

. Sterilization test
. Shelf life test
Biocompatibility test ●
In vitro cytotoxicity test -
-Intracutaneous irritation study
Skin sensitization study -
-Acute Systemic Toxicity Study
Pyrogen study -

Test results performed in biocompatibility test reports demonstrated that subject device complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-23 and USP<151>.

. Software validation
. Electromagnetic compatibility and electrical safety
Usability test .
Performance test .

Test	Test Method Summary	Results
Field of view(FOV)	Test apparatus: Goniometer(Möller-Wedel/Goniometer-Spectrometer IIgoniometer)Conditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic of fieldof view of the subject device and compare tothat of predicate device	Results:1. Non-Aged:120.15 ± 0.2 degrees2. Aged:120.41 ± 0.2 degrees3. These two conditions passed pre-definedacceptance criteria.Discussion on SE: The field of view of the subjectdevice is larger than that of the predicate device. Thedifference in FOV does not raise different safety andeffectiveness questions.

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Test	Test Method Summary	Results
Directionofview	Test apparatus: High accuracy theodolite(Leica/TM5100A)Conditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic ofdirection of view of the subject device andcompare to that of predicate device	Results:1. Non-Aged: 4.02 ± 0.2 degrees2. Aged: 2.10 ± 0.2 degrees3. These two conditions passed pre-definedacceptance criteria.Discussion on SE: The accuracy of direction of viewmet the requirements by ISO 8600-1. Although thedirection of view of the subject device is differentfrom that of predicate device, the difference in DOVdoes not raise different safety and effectivenessquestions.
Opticalmagnification	Test apparatus: two-dimensional ruler glassConditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic ofoptical Magnification of the subject deviceand determine if both non-aged and aged testresults will pass the pre-defined performancecriteria.	Results:1. Non-Aged: 0.014@ 38 mm object distance2. Aged: 0.013 @38 mm object distance3. These two conditions passed pre-definedacceptance criteria.Discussion on SE:1. The predicate does not claim the opticalmagnification.
Distortion	Test apparatus: two-dimensional ruler glassConditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic ofdistortion of the subject device and determineif both non-aged and aged test results will passthe pre-defined performance criteria.	Results:1. Non-Aged: Maximal distortion 22.7%2. Aged: Maximal distortion 22.7%3. These two conditions passed pre-definedacceptance criteria.Discussion on SE:1. The predicate does not claim the distortion.
Test	Test Method Summary	Results
Imageintensityuniformity	Test apparatus: Sphere-optics integrationsphere.Conditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic of thesubjected device on image intensityuniformity and determine if both non-aged andaged test results will pass the pre-definedperformance criteria.	Results:1. Non-Aged: R:0.52 for Red, G:0.60 for Green,B:0.60 for Blue2. Aged: R:0.60 for Red, G:0.61 for Green, B:0.65for Blue3. These two conditions passed pre-definedacceptance criteria.Discussion on SE:1. The predicate does not claim the image intensityuniformity.
Signal-to-noise ratio	Test apparatus: Sphere-optics integrationsphere.Conditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditionsPurpose: To verify the characteristic ofsignal-to-noise ratio of images of the subjectdevice and determine if both non-aged andaged test results will pass the pre-definedperformance criteria.	Results:1. Non-Aged: R:20.47 @101.88 average gray level,G:40.90 @102.88 average gray level, B:22.24 @99.54 average gray level2. Aged: R:20.24 @117.82 average gray level,G:35.18 @109.38 average gray level, B:21.47@111.34 average gray level3. These two conditions passed pre-definedacceptance criteria.Discussion on SE:1. The predicate does not claim the signal-to-noiseratio of images.The results indicate that the device will be as safe andas effective in terms of signal-to noise over the courseof proposed shelf life.
Sensitivity	Test apparatus: optronic integrating sphereand Photo-Research/PR670Spectro-radiometerConditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditions	Results:1. Non-Aged: Signal to noise ratio@0.9 cd/m²:R:10.9058, G:9.99283, B:13.09052. Aged: Signal to noise ratio@0.81 cd/m²: R:13.14,G:8.88, B:14.853. These two conditions passed pre-defined
Test	Test Method Summary	Results
	Purpose: To verify the characteristic ofsensitivity of the subject device and determineif both non-aged and aged test results will passthe pre-defined performance criteria.	acceptance criteria.
		Discussion on SE:
		1. The predicate does not claim the sensitivity ofimages.


Depth of field	Test apparatus: diffusing reflective slant edgeand external light source.	Results:
	Conditions: Disposable endoscope andEndoscope Control Unit (ECU) in bothnon-aged and aged conditions	1. Non-Aged: 5-100 mm
		2. Aged: 5-100 mm
	Purpose: To verify the characteristic of depthof field of the subject device and compare tothat of predicate device.	3. These two conditions passed pre-definedacceptance criteria.Discussion on SE: The DOF is wider than thepredicate, and the difference in DOF does not raisedifferent safety and effectiveness questions.
Imageresolution	Test apparatus: diffusing reflective slant edgeand external light source.	Results:
	Conditions:	1. Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV
	1. Disposable endoscope and EndoscopeControl Unit (ECU) in both non-aged andaged conditions	2. Aged: 54.1% on axis, 44.8% @ 0.6 FOV
	2. Measure MTF @ 20, 30 and 100 mmobject distance	3. These two conditions passed pre-definedacceptance criteria.
	3. Determine image resolution in terms ofTV lines at 15% MTFPurpose: To verify the characteristic of spatialfrequency response of the subject device andcompare to that of predicate device.	4. For image resolution at 15% MTF, the results are730 and 670 TV lines/mm, respectively for pre andpost shelf- life testing.Discussion on SE: The image resolution in terms ofspatial frequency response of the subject device overthe course of the proposed shelf life is similar to thatof predicate (642 TV lines @ 15% MTF). Thedifference in resolution does not raise different safetyand effectiveness questions.
Test	Test Method Summary	Results
Workinglength	Test apparatus: Digital CaliperConditions: only measure the working lengthof the Disposable endoscopePurpose: To verify the working length of theendoscope and compare to that of predicatedevice.	Results:1. Working length: 180.76 mm2. It passed pre-defined acceptance criteria.Discussion on SE: Although the working length ofthe subject device is longer than that of predicate, thedifference in working length does not raise differentsafety and effectiveness questions.
OuterDiameter	Test apparatus: Outside MicrometerConditions: Only measure the outer diameterof the disposable endoscopePurpose: To verify the outer diameter of theendoscope and compare to that of predicatedevice.	Results:1. Outer diameter: 5.28 - 5.32 mm2. It passed pre-defined acceptance criteria.Discussion on SE: Although the outer diameter iswider than the predicate, the difference does not raisedifferent safety and effectiveness questions.
Image qualitytest utilizing aclinicallyrelevantbiologicaltissue model	Test set up: Use a live pig model and conductthe animal testing following the GLP standardin an animal operating room of a facilityaccredited under AAALACi standards.Conditions:1. The non-aged and aged ECU units wereused for brain and spinal surgery tests.2. Six pieces of endoscopes each fromnon-aged and aged conditions were usedfor brain and spinal surgery, respectively,as indicated in the intended use of thesubject device.3. Test under three different levels ofreducing light intensity conditions andworking lengths, respectively.4. Two cleared devices each for spine andbrain were applied for comparing withnon-aged and aged subject devices	Results:1. The image quality of the non-aged and agedsubject device passed the pre-defined acceptancecriteria for the intended use on brain and spineendoscopic surgery.2. Based on multiple ANOVA model, there is nosignificant difference (P=0.569) in image qualitybetween the non-aged and aged subject deviceover the proposed shelf life of endoscope andservice life of ECU.3. Based on the agreement test, the image quality ofboth the non-aged and aged subject devices wasfound to be comparable to that of theFDA-cleared comparator devices for both brainand spine endoscopy.4. Considering the significant impact of lightintensity on image quality during spine and brainendoscopy, along with the influence of working
Test	Test Method Summary	Results
	Purpose:To verify subject device performance in terms of image quality under different light levels and working distances in a clinically relevant biological tissue model to support the device intended use and substantial equivalence to the predicate.	length on image quality during spine endoscopy, it is crucial to exercise caution when utilizing the subject device under worse-case clinical use conditions, such as extreme light intensity or working lengths. Based on the statistical analysis, surgeons should be mindful of avoiding higher light intensity settings during brain and spine endoscopy and refrain from employing long working lengths during spine endoscopy procedures. Light intensity level is adjustable with the subject device as well as the predicate.
	Discussion on SE:
		1. Compared to cleared device, the quality image of subject device is similar to FDA cleared devices for the intended use of endoscopic application on brain and spine.
		2. Based on the results, the subject device is as safe and as effective to the predicate on image quality.

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All the test results demonstrate HJY VisualNext™ Endoscopic Vision System meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

5.10 Clinical testing

No clinical test data was used to support the decision of substantial equivalence.

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K222735/S001 Appendix 11 - 510(k) Summary

5.11 Substantial equivalence determination

HJY VisualNext™ Endoscopic Vision System submitted in this 510(k) file is substantially equivalent to the predicate device. Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

Item	Subject device	Predicate device	Substantialequivalencedetermination
Proprietary name	HJY VisualNext™ EndoscopicVision System	QEVO Systemwith KINEVO 900
510(k) No.	K222735	K170667
Intended use	HJY VisualNext™ EndoscopicVision System is intended forviewing internal surgical sitesduring general surgical proceduresand for use in visualization ofstructures within the brain duringneurological surgical procedures aswell as for viewing internal surgicalsites during anterior and posteriorspinal procedures, such asnucleotomy, discectomy, andforaminotomy.	The QEVO System with KINEVO900 is intended for viewing internalsurgical sites during general surgicalprocedures and for use invisualization of ventricles andstructures within the brain duringneurological surgical procedures aswell as for viewing internal surgicalsites during anterior and posteriorspinal procedures, such asnucleotomy, discectomy, andforaminotomy.	Equivalence.Although the wording orintended use between thesubject device and thepredicate is slightlydifferent, it doesn't raiseany new issues ofsubstantial equivalence.
Type of use	Prescription Use	Prescription Use	Equivalence
Systemcomponents	Rigid endoscope, ECU	Rigid endoscope, ECU	Equivalence
Light transmission	Light emitted from integrated LEDat proximal end of endoscopeinsertion tube	Light source in endoscope mainbody, light transmission throughinsertion tube via fiber optics	Similar.The difference doesn'traise any new issues ofsubstantial equivalence.
Light source	Integrated LED(Intensity adjustable)	Integrated LED(Intensity adjustable)	Equivalence
Item	Subject device	Predicate device	Substantialequivalencedetermination
Proprietary name	HJY VisualNext™ EndoscopicVision System	QEVO Systemwith KINEVO 900
510(k) No.	K222735	K170667
Imagetransmission	Rigid rod lenses + CMOS imagingsensor in endoscope main body	Rigid rod lenses + CMOS imagingsensor in endoscope main body	Equivalence
Direction of view	0°	45°	Different.The difference doesn'traise any new issues ofsubstantial equivalence.
Field of view	120°	100°	Different.The difference doesn'traise any new issues ofsubstantial equivalence.
Depth of field	5-100 mm	5-30 mm	Similar.The difference doesn'traise any new issues ofsubstantial equivalence.
Image resolution	Optical resolution:800x800 pixels (HD imager)TV Lines:667 LW/PH @ 15% MTF	Optical resolution:2 Mega Pixel (Full HD imager)TV lines:642 TV lines at 15% MTF	Similar.The difference doesn'traise any new issues ofsubstantial equivalence.
Image display	External monitor	External monitor	Equivalence
2D / 3D Imaging	2D only	2D only	Equivalence
Recordingattribute	Via USB-port	Via USB-port	Equivalence
Insertion tubeworking length	180 mm	120 mm	Different. The subjectdevice is longer than thepredicate device. It doesn'traise any new issues ofsubstantial equivalence.
Insertion tubeouter diameter	5.0 mm	3.6 mm	Different. The subjectdevice is wider than thepredicate device. It doesn'traise any new issues ofsubstantial equivalence.
Single use orReusable	Single use	Reusable	Different.The difference doesn'traise any new issues ofsubstantial equivalence.
Item	Subject device	Predicate device	Substantialequivalencedetermination
Proprietary name	HJY VisualNext™ EndoscopicVision System	QEVO Systemwith KINEVO 900	Substantialequivalencedetermination
510(k) No.	K222735	K170667
			substantial equivalence.
Electrical safety	IEC60601-1, IEC60601-1-2 andIEC60601-2-18 compliant	IEC60601-1, IEC60601-1-2 andIEC60601-2-18 compliant	Equivalence

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5.12 Similarity and difference

The HJY VisualNext™ Endoscopic Vision System has been compared with the QEVO System with KINEVO 900 (K170667). The subject device has the similar intended use, type of use, system components, light transmission, image transmission and image display as the predicate devices.

Although the direction of view, field of view, depth of field, image resolution, insertion tube working length and insertion tube outer diameter are different between the subject device and predicate devices, a series of tests were conducted and results demonstrated that the differences do not raise any new issue of substantial equivalence.

The subject device has undergone a series of testing, and the results passed the acceptance criteria defined by the testing standard used; Therefore, the differences between the subject device and the predicate device do not raise any new issues on safety and effectiveness. The subject device is substantially equivalent to the predicate devices as it claims.

5.13 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that HJY VisualNext™ Endoscopic Vision System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).