This device is a self-help tool for individuals aged 18 or older with diagnosed depression. It is intended to be used in addition to usual care and not as a replacement for it.

Device Description

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AI/ML Overview

The provided FDA 510(k) Clearance Letter for the HJY VisualNext 3D Endoscopic Vision System focuses on the device's substantial equivalence to a predicate device, as opposed to a detailed standalone or comparative effectiveness study of an AI-powered diagnostic device. Therefore, many of the requested details, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, and effect size of human reader improvement with AI assistance), are not present in this document.

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

Device Type: The HJY VisualNext 3D Endoscopic Vision System is an endoscopic vision system, not an AI-powered diagnostic device. Its primary function is to provide 3D visualization during surgical procedures, differentiating it from an AI-based system that might perform automated image analysis or diagnosis.

Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria implicitly through the performance of various non-clinical tests. The criteria are met if the device "Pass[es]" the respective tests and demonstrates performance metrics comparable to predefined standards or the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Sterility (Device must be sterile as labeled)	Testing completed in accordance with FDA guidance. (Result: Met)
Biocompatibility (Safe for contact with neural tissue, bone, dentin, blood)	All acceptance criteria for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, neurotoxicity, and hemocompatibility met. (Result: Favorable biocompatibility profile)
Software Validation (Software functions as intended and safely)	Completed in accordance with FDA guidance document "Content of Premarket Submissions for Device Software Functions". (Result: Met requirements)
Electromagnetic Compatibility (EMC) & Thermal Safety (Meets safety standards for electrical and thermal properties)	Completed in accordance with IEC60601-1, IEC60601-1-2, IEC60601-2-18. (Result: Met standards)
Photobiological Safety (No hazardous light emission)	Completed in accordance with IEC 62471. (Result: Met standards)
Bench Testing - Image Quality & Performance (FOV, DOV, DOF, Optical Magnification, Distortion, Image Intensity Uniformity, Signal-to-Noise Ratio, Sensitivity, Resolution (MTF) of aged and non-aged devices comparable to predicate)	Both aged and non-aged subject devices met the predefined acceptance criteria, demonstrating consistent image quality metrics comparable to the predicate device. (Result: Pass)
Animal Study Testing - 3D Visualization Performance (Clear and stable 3D visualization of brain and spine tissues, with resolution, color representation, contrast, and noise comparable to predicate, and compatibility with 3D monitor)	The subject device provided clear and stable 3D visualization of brain and spine tissues across all tested conditions. Image quality parameters, including resolution, color representation, contrast, and noise, met the predefined acceptance criteria when compared to the predicate device. Testing also validated compatibility with the Sony LMD-2451MT 3D Monitor. (Result: Pass)

Study Details (for the Non-Clinical Performance Testing):

Since the device is a vision system and not an AI algorithm, the traditional "test set" and "training set" concepts as applied to AI models do not directly apply in the same way. The non-clinical testing evaluates the physical and functional performance of the device itself.

Sample size used for the Test Set and Data Provenance:
- Bench Testing: The sample size is not explicitly stated, but it involved "aged and non-aged subject devices" and direct comparison to the predicate device. The data provenance would be laboratory-generated data from device performance measurements.
- Animal Study Testing: "A porcine animal model" was used. The specific number of animals or trials within the animal study is not provided. The data provenance is described as being from a porcine animal model. This would be prospective data collection, specifically for this study.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This metric is not applicable in the context of this device's testing. The "ground truth" for a vision system's performance is typically established by objective physical measurements (e.g., MTF for resolution, calibrated light meters for illumination) and expert subjective evaluation of visual quality in a controlled setting, rather than a consensus on diagnostic findings. The document does not specify the number or qualifications of any human evaluators involved in the image quality assessment during bench or animal testing, only that the data "met the predefined acceptance criteria."
Adjudication Method for the Test Set:
- Not applicable as the testing involves objective performance measurements and comparison against predefined criteria, not diagnostic interpretations requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is a surgical visualization tool, not a diagnostic imaging device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm, so the concept of "standalone performance" of an algorithm is not applicable. The core function of the device is to provide images for human viewing. The non-clinical tests assess the device's ability to produce high-quality images and function as intended.
The Type of Ground Truth Used:
- For Bench Testing: Objective physical measurements (e.g., resolution targets, light sensors, distortion grids) served as the "ground truth" for parameters like FOV, DOF, resolution, etc., along with comparison to the known performance of the predicate device.
- For Animal Study Testing: The "ground truth" for image quality (resolution, illumination, color representation, contrast, noise) was likely based on objective evaluation against predefined standards and comparative assessment by skilled observers (e.g., surgeons, imaging specialists) who could judge the clarity and utility of the visualization in an anatomical context, compared to the predicate device's 2D view. Anatomical structures within the porcine model served as the "true" objects being visualized.
The Sample Size for the Training Set:
- Not applicable. This device is a hardware system, not an AI algorithm trained on data. There is no "training set" in the context of machine learning.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.

Summary

FDA 510(k) Clearance Letter for HJY VisualNext 3D Endoscopic Vision System

Page 1

U.S. Food & Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

May 21, 2025

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

Re: K243429
Trade/Device Name: HJY VisualNext 3D Endoscopic Vision System (HDSES01 / HDSES301)
Regulation Number: 21 CFR 882.1480
Regulation Name: Neurological Endoscope
Regulatory Class: Class II
Product Code: GWG
Dated: April 21, 2025
Received: April 21, 2025

Dear Dr. John 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 (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 Register.

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"

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(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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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Sincerely,

Adam D. 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

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243429

Device Name: HJY VisualNext 3D Endoscopic Vision System

Indications for Use (Describe)

HJY VisualNext 3D 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

1 Date of summary:

May 21, 2025

2 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, M.S., Ph.D.
(john.chen@hjy-med.com)

3 Identification of the device:

Proprietary/Trade name: HJY VisualNext 3D Endoscopic Vision System

Product code: GWG

Regulation number: 882.1480

Regulation description: Endoscope, Neurological

Device class: II

4 Identification of the predicate device:

Predicate device name: HJY VisualNext Endoscopic Vision System

Manufacturer: HJY Smart Medical Device Co., Ltd.

Product code: GWG

Regulation number: 882.1480

Device class: II

510(k) number: K222735

5 Indications for Use

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6 Device Description

The HJY VisualNext 3D Endoscopic Vision System is a system used for viewing internal surgical sites during neurosurgical procedures. The system consists of the following components:
• Endoscope Control Unit (ECU) (Model number: HDSES01)
• Endoscope (Model number: HDSE301)

The endoscope is physically connected via a 5m BNC coaxial cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera with 2 sensors, 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.

7 Comparison of Technological Characteristics

Item	Subject device	Predicate device	Comment
Proprietary name	HJY VisualNext 3D Endoscopic Vision System	HJY VisualNext Endoscopic Vision System
510(k) No.	K243429	K222735
Indications for Use	HJY VisualNext 3D 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.	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.	Same
Type of use	Prescription Use	Prescription Use	Same
System components	Rigid endoscope, ECU	Rigid endoscope, ECU	Same
Light transmission	Light emitted from integrated LED at proximal end of endoscope insertion tube	Light emitted from integrated LED at proximal end of endoscope insertion tube	Same
Light source	Integrated LED	Integrated LED	Same
Image	Rigid rod lenses + CMOS imaging sensor in endoscope main body	Rigid rod lenses + CMOS imaging sensor in endoscope main body	Same

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8 Non-Clinical Testing

A series of performance tests were performed to assess the safety and effectiveness of HJY VisualNext 3D Endoscopic Vision System. All test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use.

Sterility testing was completed in accordance with the FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Biocompatibility testing – The endoscope (Model number: HDSE301) is categorized as an externally communicating device with limited contact duration (<24 hours) with neural tissue/bone/dentin and blood (indirect contact through reabsorption of CSF into the venous system) in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The following biocompatibility endpoints were assessed in accordance with the methods specified in the FDA

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biocompatibility guidance: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, neurotoxicity, and hemocompatibility (indirect hemolysis). Test results demonstrated that all acceptance criteria were met, supporting a favorable biocompatibility profile for the subject device.

Software validation (Enhanced Documentation Level) was completed in accordance with requirements specified in the FDA guidance document "Content of Premarket Submissions for Device Software Functions"
Electromagnetic compatibility and thermal safety testing were completed in accordance with IEC60601-1, IEC60601-1-2 and IEC60601-2-18
Photobiological safety testing of the lamp was completed in accordance with IEC 62471.
Non-clinical performance testing was conducted to evaluate image quality and establish substantial equivalence to the predicate device throughout the subject device's entire shelf life. This comprehensive assessment included the following tests:

Test	Test Method Summary	Results
Bench Testing	The study assessed image quality and overall performance of both aged and non-aged subject devices with direct comparison to the predicate device to ensure long-term stability and comparability to the predicate device. Key parameters evaluated included: • Field of View (FOV) • Direction of View (DOV) • Depth of Field (DOF) • Optical Magnification • Distortion • Image Intensity Uniformity • Signal-to-Noise Ratio • Sensitivity • Resolution (MTF - Modulation Transfer Function).	Pass Both aged and non-aged subject devices met the predefined acceptance criteria, demonstrating consistent image quality metrics comparable to the predicate device.

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| Animal Study Testing | The study was conducted in a porcine animal model to evaluate the 3D visualization performance of the subject device compared to the 2D visualization of the predicate device in brain and spine procedures. Testing was performed with aged and non-aged subject devices and the predicate device to assess image quality to the following parameters: • Resolution • Illumination • Color Representation • Contrast • Noise The subject device was connected to the Sony LMD-2451MT 3D Monitor (K113203) to assess 3D visualization performance in comparison to the predicate device (2D visualization). | Pass The subject device provided clear and stable 3D visualization of brain and spine tissues across all tested conditions. Image quality parameters, including resolution, color representation, contrast, and noise, met the predefined acceptance criteria when compared to the predicate device. Testing also validated compatibility with the Sony LMD-2451MT 3D Monitor. |

9 Conclusion

The results of non-clinical testing, demonstrate that the technological differences, between the subject and predicate device, do not raise different questions of safety or effectiveness. Based on the demonstrated identical intended use, similar technological characteristics and the evidence from all the performance testing, the subject VisualNext 3D Endoscopic Vision System is substantially equivalent to the predicate device HJY VisualNext Endoscopic Vision System (K222735).

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).