HJY VisualNext Endoscopic Vision System

K222735 · Hjy Smart Medical Device Co., Ltd. · GWG · Jul 28, 2023 · Neurology

Device Facts

• Record ID: K222735
• Device Name: HJY VisualNext Endoscopic Vision System
• Applicant: Hjy Smart Medical Device Co., Ltd.
• Product Code: GWG · Neurology
• Decision Date: Jul 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

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 Story

System captures internal surgical site images via rigid endoscope containing CMOS sensor and 2 LED lamps; transmits data via 5m BNC cable to Endoscope Control Unit (ECU) for processing; outputs video to external monitor. Used in OR by surgeons for visualization during general, neurological, and spinal surgeries. Images are recordable/markable for analysis. System is single-use; ECU is non-networked. Provides real-time visualization to assist surgical navigation and decision-making; benefits patient through minimally invasive access and improved site visibility.

Clinical Evidence

Bench testing only. Performance verified via goniometer, theodolite, and integrating sphere for FOV, DOV, magnification, distortion, intensity uniformity, SNR, sensitivity, DOF, and resolution. Image quality validated in live pig model (GLP/AAALACi) comparing subject device to cleared comparators across light/working distance variables. No significant difference (p=0.569) between aged/non-aged units.

Technological Characteristics

Rigid metal arthroscope with CMOS sensor and integrated LED illumination. Connectivity: 5m BNC cable to ECU; no intranet/internet. Standards: ISO 10993 (biocompatibility), IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 (electrical/EMC). Single-use endoscope. Adjustable light intensity.

Indications for Use

Indicated for patients undergoing general surgical procedures, neurological surgical procedures involving visualization of brain structures, and anterior or posterior spinal procedures (e.g., nucleotomy, discectomy, foraminotomy).

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• QEVO System with KINEVO 900 (K170667)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

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) | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

==============================================================================================================================================================================

{3}------------------------------------------------

#### 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: | [phone] |
| Fax: | [phone] |
| Contact: | John Jiannyuh Chen, MS., Ph.D |
| | ([e-mail]) |
| 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 |

{4}------------------------------------------------

#### 5.7 Indications for Use

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.

#### 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.

{5}------------------------------------------------

#### 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<br>(FOV) | Test apparatus: Goniometer<br><br>(Möller-Wedel/Goniometer-Spectrometer II<br>goniometer)<br><br>Conditions: Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br><br>Purpose: To verify the characteristic of field<br>of view of the subject device and compare to<br>that of predicate device | Results:<br>1. Non-Aged:120.15 ± 0.2 degrees<br><br>2. Aged:120.41 ± 0.2 degrees<br><br>3. These two conditions passed pre-defined<br>acceptance criteria.<br><br>Discussion on SE: The field of view of the subject<br>device is larger than that of the predicate device. The<br>difference in FOV does not raise different safety and<br>effectiveness questions. |

{6}------------------------------------------------

| Test | Test Method Summary | Results |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Direction<br>of<br>view | <b>Test apparatus:</b> High accuracy theodolite<br>(Leica/TM5100A)<br><br><b>Conditions:</b> Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br><br><b>Purpose:</b> To verify the characteristic of<br>direction of view of the subject device and<br>compare to that of predicate device | <b>Results:</b><br>1. Non-Aged: 4.02 ± 0.2 degrees<br>2. Aged: 2.10 ± 0.2 degrees<br>3. These two conditions passed pre-defined<br>acceptance criteria.<br><br><b>Discussion on SE:</b> The accuracy of direction of view<br>met the requirements by ISO 8600-1. Although the<br>direction of view of the subject device is different<br>from that of predicate device, the difference in DOV<br>does not raise different safety and effectiveness<br>questions. |
| Optical<br>magnification | <b>Test apparatus:</b> two-dimensional ruler glass<br><br><b>Conditions:</b> Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br><br><b>Purpose:</b> To verify the characteristic of<br>optical Magnification of the subject device<br>and determine if both non-aged and aged test<br>results will pass the pre-defined performance<br>criteria. | <b>Results:</b><br>1. Non-Aged: 0.014@ 38 mm object distance<br>2. Aged: 0.013 @38 mm object distance<br>3. These two conditions passed pre-defined<br>acceptance criteria.<br><br><b>Discussion on SE:</b><br>1. The predicate does not claim the optical<br>magnification. |
| Distortion | <b>Test apparatus:</b> two-dimensional ruler glass<br><br><b>Conditions:</b> Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br><br><b>Purpose:</b> To verify the characteristic of<br>distortion of the subject device and determine<br>if both non-aged and aged test results will pass<br>the pre-defined performance criteria. | <b>Results:</b><br>1. Non-Aged: Maximal distortion 22.7%<br>2. Aged: Maximal distortion 22.7%<br>3. These two conditions passed pre-defined<br>acceptance criteria.<br><br><b>Discussion on SE:</b><br>1. The predicate does not claim the distortion. |
| Test | Test Method Summary | Results |
| Image<br>intensity<br>uniformity | Test apparatus: Sphere-optics integration<br>sphere.<br>Conditions: Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br>Purpose: To verify the characteristic of the<br>subjected device on image intensity<br>uniformity and determine if both non-aged and<br>aged test results will pass the pre-defined<br>performance criteria. | Results:<br>1. Non-Aged: R:0.52 for Red, G:0.60 for Green,<br>B:0.60 for Blue<br>2. Aged: R:0.60 for Red, G:0.61 for Green, B:0.65<br>for Blue<br>3. These two conditions passed pre-defined<br>acceptance criteria.<br>Discussion on SE:<br>1. The predicate does not claim the image intensity<br>uniformity. |
| Signal-to-<br>noise ratio | Test apparatus: Sphere-optics integration<br>sphere.<br>Conditions: Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions<br>Purpose: To verify the characteristic of<br>signal-to-noise ratio of images of the subject<br>device and determine if both non-aged and<br>aged test results will pass the pre-defined<br>performance criteria. | Results:<br>1. Non-Aged: R:20.47 @101.88 average gray level,<br>G:40.90 @102.88 average gray level, B:22.24 @<br>99.54 average gray level<br>2. Aged: R:20.24 @117.82 average gray level,<br>G:35.18 @109.38 average gray level, B:21.47<br>@111.34 average gray level<br>3. These two conditions passed pre-defined<br>acceptance criteria.<br>Discussion on SE:<br>1. The predicate does not claim the signal-to-noise<br>ratio of images.<br>The results indicate that the device will be as safe and<br>as effective in terms of signal-to noise over the course<br>of proposed shelf life. |
| Sensitivity | Test apparatus: optronic integrating sphere<br>and Photo-Research/PR670<br>Spectro-radiometer<br>Conditions: Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions | Results:<br>1. Non-Aged: Signal to noise ratio@0.9 cd/m²:<br>R:10.9058, G:9.99283, B:13.0905<br>2. Aged: Signal to noise ratio@0.81 cd/m²: R:13.14,<br>G:8.88, B:14.85<br>3. These two conditions passed pre-defined |
| Test | Test Method Summary | Results |
| | <b>Purpose:</b> To verify the characteristic of<br>sensitivity of the subject device and determine<br>if both non-aged and aged test results will pass<br>the pre-defined performance criteria. | acceptance criteria. |
| | | <b>Discussion on SE:</b> |
| | | 1. The predicate does not claim the sensitivity of<br>images. |
| | | |
| | | |
| Depth of field | <b>Test apparatus:</b> diffusing reflective slant edge<br>and external light source. | <b>Results:</b> |
| | <b>Conditions:</b> Disposable endoscope and<br>Endoscope Control Unit (ECU) in both<br>non-aged and aged conditions | 1. Non-Aged: 5-100 mm |
| | | 2. Aged: 5-100 mm |
| | <b>Purpose:</b> To verify the characteristic of depth<br>of field of the subject device and compare to<br>that of predicate device. | 3. These two conditions passed pre-defined<br>acceptance criteria.<br><b>Discussion on SE:</b> The DOF is wider than the<br>predicate, and the difference in DOF does not raise<br>different safety and effectiveness questions. |
| Image<br>resolution | <b>Test apparatus:</b> diffusing reflective slant edge<br>and external light source. | <b>Results:</b> |
| | <b>Conditions:</b> | 1. Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV |
| | 1. Disposable endoscope and Endoscope<br>Control Unit (ECU) in both non-aged and<br>aged conditions | 2. Aged: 54.1% on axis, 44.8% @ 0.6 FOV |
| | 2. Measure MTF @ 20, 30 and 100 mm<br>object distance | 3. These two conditions passed pre-defined<br>acceptance criteria. |
| | 3. Determine image resolution in terms of<br>TV lines at 15% MTF<br><b>Purpose:</b> To verify the characteristic of spatial<br>frequency response of the subject device and<br>compare to that of predicate device. | 4. For image resolution at 15% MTF, the results are<br>730 and 670 TV lines/mm, respectively for pre and<br>post shelf- life testing.<br><b>Discussion on SE:</b> The image resolution in terms of<br>spatial frequency response of the subject device over<br>the course of the proposed shelf life is similar to that<br>of predicate (642 TV lines @ 15% MTF). The<br>difference in resolution does not raise different safety<br>and effectiveness questions. |
| Test | Test Method Summary | Results |
| Working<br>length | Test apparatus: Digital Caliper<br>Conditions: only measure the working length<br>of the Disposable endoscope<br>Purpose: To verify the working length of the<br>endoscope and compare to that of predicate<br>device. | Results:<br>1. Working length: 180.76 mm<br>2. It passed pre-defined acceptance criteria.<br>Discussion on SE: Although the working length of<br>the subject device is longer than that of predicate, the<br>difference in working length does not raise different<br>safety and effectiveness questions. |
| Outer<br>Diameter | Test apparatus: Outside Micrometer<br>Conditions: Only measure the outer diameter<br>of the disposable endoscope<br>Purpose: To verify the outer diameter of the<br>endoscope and compare to that of predicate<br>device. | Results:<br>1. Outer diameter: 5.28 - 5.32 mm<br>2. It passed pre-defined acceptance criteria.<br>Discussion on SE: Although the outer diameter is<br>wider than the predicate, the difference does not raise<br>different safety and effectiveness questions. |
| Image quality<br>test utilizing a<br>clinically<br>relevant<br>biological<br>tissue model | Test set up: Use a live pig model and conduct<br>the animal testing following the GLP standard<br>in an animal operating room of a facility<br>accredited under AAALACi standards.<br>Conditions:<br>1. The non-aged and aged ECU units were<br>used for brain and spinal surgery tests.<br>2. Six pieces of endoscopes each from<br>non-aged and aged conditions were used<br>for brain and spinal surgery, respectively,<br>as indicated in the intended use of the<br>subject device.<br>3. Test under three different levels of<br>reducing light intensity conditions and<br>working lengths, respectively.<br>4. Two cleared devices each for spine and<br>brain were applied for comparing with<br>non-aged and aged subject devices | Results:<br>1. The image quality of the non-aged and aged<br>subject device passed the pre-defined acceptance<br>criteria for the intended use on brain and spine<br>endoscopic surgery.<br>2. Based on multiple ANOVA model, there is no<br>significant difference (P=0.569) in image quality<br>between the non-aged and aged subject device<br>over the proposed shelf life of endoscope and<br>service life of ECU.<br>3. Based on the agreement test, the image quality of<br>both the non-aged and aged subject devices was<br>found to be comparable to that of the<br>FDA-cleared comparator devices for both brain<br>and spine endoscopy.<br>4. Considering the significant impact of light<br>intensity on image quality during spine and brain<br>endoscopy, along with the influence of working |
| Test | Test Method Summary | Results |
| | <b>Purpose:</b><br>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. |
| | <b>Discussion on SE:</b> | |
| | | 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. |

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

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.

{11}------------------------------------------------

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 | Substantial<br>equivalence<br>determination |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | HJY VisualNext™ Endoscopic<br>Vision System | QEVO System<br>with KINEVO 900 | |
| 510(k) No. | K222735 | K170667 | |
| Intended use | HJY VisualNext™ Endoscopic<br>Vision System is intended for<br>viewing internal surgical sites<br>during general surgical procedures<br>and for use in visualization of<br>structures within the brain during<br>neurological surgical procedures as<br>well as for viewing internal surgical<br>sites during anterior and posterior<br>spinal procedures, such as<br>nucleotomy, discectomy, and<br>foraminotomy. | The QEVO System with KINEVO<br>900 is intended for viewing internal<br>surgical sites during general surgical<br>procedures and for use in<br>visualization of ventricles and<br>structures within the brain during<br>neurological surgical procedures as<br>well as for viewing internal surgical<br>sites during anterior and posterior<br>spinal procedures, such as<br>nucleotomy, discectomy, and<br>foraminotomy. | Equivalence.<br>Although the wording or<br>intended use between the<br>subject device and the<br>predicate is slightly<br>different, it doesn't raise<br>any new issues of<br>substantial equivalence. |
| Type of use | Prescription Use | Prescription Use | Equivalence |
| System<br>components | Rigid endoscope, ECU | Rigid endoscope, ECU | Equivalence |
| Light transmission | Light emitted from integrated LED<br>at proximal end of endoscope<br>insertion tube | Light source in endoscope main<br>body, light transmission through<br>insertion tube via fiber optics | Similar.<br>The difference doesn't<br>raise any new issues of<br>substantial equivalence. |
| Light source | Integrated LED<br>(Intensity adjustable) | Integrated LED<br>(Intensity adjustable) | Equivalence |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Proprietary name | HJY VisualNext™ Endoscopic<br>Vision System | QEVO System<br>with KINEVO 900 | |
| 510(k) No. | K222735 | K170667 |…