(197 days)
Unfortunately, I can't directly access arbitrary files or content from your file system, including the content of the {{overview}} placeholder.
To tell you if this device contains an AI model, you need to provide me with the actual text from the "overview".
Once you provide the text, I can analyze it for keywords and phrases that commonly indicate the presence of AI, such as:
- "Artificial Intelligence"
- "Machine Learning"
- "AI-powered"
- "Neural Network"
- "Deep Learning"
- "Natural Language Processing (NLP)"
- "Computer Vision"
- "Predictive Modeling"
- "Smart features" (sometimes implies AI)
- Specific AI model names (e.g., "GPT", "BERT", "TensorFlow", "PyTorch")
Please copy and paste the content from the overview into our chat, and I will do my best to determine if it mentions AI.
No
The device is described as an "Endoscopic Vision System" intended for "viewing internal surgical sites" and "visualization of structures." Its function is to capture and display images, not to provide therapy.
No
Explanation: The device is described as an endoscopic vision system intended for "viewing internal surgical sites." Its components (endoscope, camera, ECU) are focused on capturing and processing images for visualization. While images can be "recordable and markable for further analysis," the primary function described is observation and visualization during surgery, not the interpretation of images to provide a diagnosis or identify a condition. Diagnostic devices typically analyze data to infer the presence or characteristics of diseases or conditions.
No
The 510(k) summary clearly indicates the device includes multiple hardware components (patient worn unit, bedside unit, clinician display) in addition to software. Therefore, it is not a software-only medical device.
Based on the overview provided ({{overview}}), here's an analysis to determine if the device is likely an IVD:
To be an IVD, a device generally needs to meet the core definition, which often involves:
- Being used on specimens derived from the human body: This data (blood, tissue, urine, etc.) is being tested outside of the body.
- Providing information for the purpose of diagnosis, screening, monitoring, prognosis, or prediction of a physiological or pathological state.
Let's consider the possibilities based on the overview:
-
If {{overview}} clearly describes testing of human-derived samples to aid in making medical decisions: Yes, it is highly likely to be an IVD. For example, if the overview mentions analyzing blood for markers of a disease, testing urine for infection, or analyzing tissue for cancerous cells, it fits the core definition of an IVD.
-
If {{overview}} describes a device used in a laboratory setting but NOT on human-derived samples: No, it is likely NOT an IVD. This could include devices used for general laboratory tasks like preparing reagents, sterilizing equipment, or performing quality control checks on non-human materials.
-
If {{overview}} describes a device used on humans, but the testing is done within the body (in vivo): No, it is NOT an IVD. Examples include imaging devices (MRI, X-ray), therapeutic devices (pacemakers), or surgical instruments. These are medical devices, but not IVDs.
-
If {{overview}} describes a device used on human-derived samples, but the purpose is not for medical diagnosis or related purposes: Likely No, it is NOT an IVD. This could include devices used for research purposes where the results are not intended to directly inform patient care, or forensic testing where the purpose is legal, not medical.
To give a definitive answer, I need to understand what {{overview}} describes.
Please provide the content of {{overview}}. Once you do, I can give you a much clearer determination.
In summary, based on the general criteria for IVDs, I need the specific details from your {{overview}} to confirm if the device meets the definition.
N/A
Intended Use / 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.
Product codes
GWG
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS camera
Anatomical Site
internal surgical sites, brain, anterior and posterior spinal procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
1. Non-Clinical Performance Testing (Bench Testing)
- Study type: Bench Testing
- Sample size: Not specified
- AUC: Not applicable
- MRMC: Not applicable
- Standalone performance: 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).
- Key results: Both aged and non-aged subject devices met the predefined acceptance criteria, demonstrating consistent image quality metrics comparable to the predicate device.
2. Non-Clinical Performance Testing (Animal Study Testing)
- Study type: Animal Study Testing
- Sample size: Not specified
- AUC: Not applicable
- MRMC: Not applicable
- Standalone performance: 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).
- Key results: 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.
Other tests performed:
- Sterility testing
- Biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, neurotoxicity, and hemocompatibility (indirect hemolysis))
- Software validation (Enhanced Documentation Level)
- Electromagnetic compatibility and thermal safety testing (IEC60601-1, IEC60601-1-2 and IEC60601-2-18)
- Photobiological safety testing of the lamp (IEC 62471)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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"
Page 2
(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).
Page 3
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
Page 4
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)
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Page 5
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
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.
Page 6
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 |
Page 7
| transmission | | | |
| Direction of view | 0° | 0° | Same |
| Field of view | 120° | 120° | Same |
| Depth of field | 5-100 mm | 5-100 mm | Same |
| Image resolution | Optical resolution: 800x800 pixels (HD imager) TV Lines: 667 LW/PH @ 15% MTF | Optical resolution: 800x800 pixels (HD imager) TV Lines: 667 LW/PH @ 15% MTF | Same |
| Image display | External monitor | External monitor | Same |
| 2D / 3D Imaging | 2D & 3D | 2D only | Different The subject device has 2 sensors while the predicate device has only 1 sensor. |
| Recording attribute | Via USB-port | Via USB-port | Same |
| Insertion tube working length | 180 mm | 180 mm | Same |
| Insertion tube outer diameter | 7.0 mm | 5.0 mm | Different The subject device is wider than the predicate device. |
| Single use or Reusable | Single use | Single use | Same |
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 (