(322 days)
Not Found
No
The summary describes standard image processing within the Endoscope Control Unit, but there is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on traditional optical and image quality metrics, not AI/ML performance metrics.
No.
The device is described as an "Endoscopic Vision System" intended for "viewing internal surgical sites." It captures and processes images to be displayed on an external monitor, which is a diagnostic or visualization function, not a therapeutic one.
No
The device is an endoscopic vision system intended for viewing internal surgical sites during surgical procedures. Its primary function is visualization, not the diagnosis of a condition or disease from the images.
No
The device description explicitly lists hardware components (Endoscope Control Unit, Endoscope with LED lamps and CMOS camera) and describes their physical connection and function in capturing and transmitting images. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "viewing internal surgical sites" and "visualization of structures within the brain" during surgical procedures. This is a direct visualization tool used during a medical procedure on a patient.
- Device Description: The description details a system with an endoscope and a control unit that captures and displays images of internal anatomy. This aligns with a surgical visualization device, not a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely to provide visual access to internal structures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform that function.
N/A
Intended Use / 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 and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
Product codes
GWG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal surgical sites, brain, spinal (anterior and posterior)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed including:
- Sterilization test
- Shelf life test
- Biocompatibility test: In vitro cytotoxicity test, Intracutaneous irritation study, Skin sensitization study, Acute Systemic Toxicity Study, Pyrogen study. Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-23 and USP.
- Software validation
- Electromagnetic compatibility and electrical safety
- Usability test
- Performance test
Performance Test Results:
- Field of view (FOV):
- Test apparatus: Goniometer (Möller-Wedel/Goniometer-Spectrometer II goniometer)
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: 120.15 ± 0.2 degrees; Aged: 120.41 ± 0.2 degrees. Both passed pre-defined acceptance criteria. The FOV of the subject device is larger than the predicate device.
- Direction of view:
- Test apparatus: High accuracy theodolite (Leica/TM5100A)
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: 4.02 ± 0.2 degrees; Aged: 2.10 ± 0.2 degrees. Both passed pre-defined acceptance criteria. Accuracy met ISO 8600-1 requirements.
- Optical magnification:
- Test apparatus: two-dimensional ruler glass
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: 0.014@ 38 mm object distance; Aged: 0.013 @38 mm object distance. Both passed pre-defined acceptance criteria.
- Distortion:
- Test apparatus: two-dimensional ruler glass
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: Maximal distortion 22.7%; Aged: Maximal distortion 22.7%. Both passed pre-defined acceptance criteria.
- Image intensity uniformity:
- Test apparatus: Sphere-optics integration sphere.
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: R:0.52 for Red, G:0.60 for Green, B:0.60 for Blue; Aged: R:0.60 for Red, G:0.61 for Green, B:0.65 for Blue. Both passed pre-defined acceptance criteria.
- Signal-to-noise ratio:
- Test apparatus: Sphere-optics integration sphere.
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: 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 level; Aged: R:20.24 @117.82 average gray level, G:35.18 @109.38 average gray level, B:21.47 @111.34 average gray level. Both passed pre-defined acceptance criteria.
- Sensitivity:
- Test apparatus: optronic integrating sphere and Photo-Research/PR670 Spectro-radiometer
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: Signal to noise ratio@0.9 cd/m²: R:10.9058, G:9.99283, B:13.0905; Aged: Signal to noise ratio@0.81 cd/m²: R:13.14, G:8.88, B:14.85. Both passed pre-defined acceptance criteria.
- Depth of field:
- Test apparatus: diffusing reflective slant edge and external light source.
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions
- Results: Non-Aged: 5-100 mm; Aged: 5-100 mm. Both passed pre-defined acceptance criteria. The DOF is wider than the predicate.
- Image resolution:
- Test apparatus: diffusing reflective slant edge and external light source.
- Conditions: Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions. Measure MTF @ 20, 30 and 100 mm object distance. Determine image resolution in terms of TV lines at 15% MTF.
- Results: Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV; Aged: 54.1% on axis, 44.8% @ 0.6 FOV. Both passed pre-defined acceptance criteria. Image resolution at 15% MTF: 730 and 670 TV lines/mm for pre and post shelf-life testing. Similar to predicate (642 TV lines @ 15% MTF).
- Working length:
- Test apparatus: Digital Caliper
- Conditions: only measure the working length of the Disposable endoscope
- Results: Working length: 180.76 mm. Passed pre-defined acceptance criteria. The working length is longer than that of predicate.
- Outer Diameter:
- Test apparatus: Outside Micrometer
- Conditions: Only measure the outer diameter of the disposable endoscope
- Results: Outer diameter: 5.28 - 5.32 mm. Passed pre-defined acceptance criteria. The outer diameter is wider than the predicate.
- Image quality test utilizing a clinically relevant biological tissue model:
- Test set up: Live pig model, GLP standard, AAALACi accredited facility.
- Conditions: Non-aged and aged ECU units used for brain and spinal surgery tests. Six pieces of endoscopes each from non-aged and aged conditions used for brain and spinal surgery. Test under three different levels of reducing light intensity conditions and working lengths. Two cleared devices for spine and brain applied for comparison with non-aged and aged subject devices.
- Results: Image quality of non-aged and aged subject device passed acceptance criteria for intended use on brain and spine endoscopic surgery. No significant difference (P=0.569) in image quality between non-aged and aged subject device over proposed shelf life of endoscope and service life of ECU. Image quality of both non-aged and aged subject devices comparable to FDA-cleared comparator devices for both brain and spine endoscopy. Caution is advised for extreme light intensity or working lengths; surgeons should avoid higher light intensity settings and long working lengths during spine endoscopy.
- Conclusion: 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. The subject device is as safe and as effective to the predicate on image quality.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The document includes a section titled "Sensitivity" under Non-clinical testing results.
- Sensitivity:
- Non-Aged: Signal to noise ratio@0.9 cd/m²: R:10.9058, G:9.99283, B:13.0905
- Aged: Signal to noise ratio@0.81 cd/m²: R:13.14, G:8.88, B:14.85
- Both conditions passed pre-defined acceptance criteria.
Predicate Device(s)
Reference Device(s)
Not Found
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).
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 (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
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) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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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: | +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 |
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.
- . 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 II
goniometer)
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: To verify the characteristic of field
of view of the subject device and compare to
that of predicate device | Results:
-
Non-Aged:120.15 ± 0.2 degrees
-
Aged:120.41 ± 0.2 degrees
-
These two conditions passed pre-defined
acceptance criteria.
Discussion on SE: The field of view of the subject
device is larger than that of the predicate device. The
difference in FOV does not raise different safety and
effectiveness questions. |
6
| Test | Test Method Summary | Results |
|---|---|---|
| Direction | ||
| of | ||
| view | Test apparatus: High accuracy theodolite | |
| (Leica/TM5100A) |
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: To verify the characteristic of
direction of view of the subject device and
compare to that of predicate device | Results:
- Non-Aged: 4.02 ± 0.2 degrees
- Aged: 2.10 ± 0.2 degrees
- These two conditions passed pre-defined
acceptance criteria.
Discussion on SE: The accuracy of direction of view
met the requirements by ISO 8600-1. Although the
direction of view of the subject device is different
from that of predicate device, the difference in DOV
does not raise different safety and effectiveness
questions. |
| Optical
magnification | Test apparatus: two-dimensional ruler glass
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: To verify the characteristic of
optical Magnification of the subject device
and determine if both non-aged and aged test
results will pass the pre-defined performance
criteria. | Results:
- Non-Aged: 0.014@ 38 mm object distance
- Aged: 0.013 @38 mm object distance
- These two conditions passed pre-defined
acceptance criteria.
Discussion on SE:
- The predicate does not claim the optical
magnification. |
| Distortion | Test apparatus: two-dimensional ruler glass
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: To verify the characteristic of
distortion of the subject device and determine
if both non-aged and aged test results will pass
the pre-defined performance criteria. | Results:
- Non-Aged: Maximal distortion 22.7%
- Aged: Maximal distortion 22.7%
- These two conditions passed pre-defined
acceptance criteria.
Discussion on SE:
- The predicate does not claim the distortion. |
| Test | Test Method Summary | Results |
| Image
intensity
uniformity | Test apparatus: Sphere-optics integration
sphere.
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: 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. | Results: - Non-Aged: R:0.52 for Red, G:0.60 for Green,
B:0.60 for Blue - Aged: R:0.60 for Red, G:0.61 for Green, B:0.65
for Blue - These two conditions passed pre-defined
acceptance criteria.
Discussion on SE: - The predicate does not claim the image intensity
uniformity. |
| Signal-to-
noise ratio | Test apparatus: Sphere-optics integration
sphere.
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions
Purpose: To verify the characteristic of
signal-to-noise ratio of images of the subject
device and determine if both non-aged and
aged test results will pass the pre-defined
performance criteria. | Results: - 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 level - Aged: R:20.24 @117.82 average gray level,
G:35.18 @109.38 average gray level, B:21.47
@111.34 average gray level - These two conditions passed pre-defined
acceptance criteria.
Discussion on SE: - The predicate does not claim the signal-to-noise
ratio of images.
The results indicate that the device will be as safe and
as effective in terms of signal-to noise over the course
of proposed shelf life. |
| Sensitivity | Test apparatus: optronic integrating sphere
and Photo-Research/PR670
Spectro-radiometer
Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions | Results: - Non-Aged: Signal to noise ratio@0.9 cd/m²:
R:10.9058, G:9.99283, B:13.0905 - Aged: Signal to noise ratio@0.81 cd/m²: R:13.14,
G:8.88, B:14.85 - These two conditions passed pre-defined |
| Test | Test Method Summary | Results |
| | Purpose: To verify the characteristic of
sensitivity of the subject device and determine
if both non-aged and aged test results will pass
the pre-defined performance criteria. | acceptance criteria. |
| | | Discussion on SE: |
| | | 1. The predicate does not claim the sensitivity of
images. |
| | | |
| | | |
| Depth of field | Test apparatus: diffusing reflective slant edge
and external light source. | Results: |
| | Conditions: Disposable endoscope and
Endoscope Control Unit (ECU) in both
non-aged and aged conditions | 1. Non-Aged: 5-100 mm |
| | | 2. Aged: 5-100 mm |
| | Purpose: To verify the characteristic of depth
of field of the subject device and compare to
that of predicate device. | 3. These two conditions passed pre-defined
acceptance criteria.
Discussion on SE: The DOF is wider than the
predicate, and the difference in DOF does not raise
different safety and effectiveness questions. |
| Image
resolution | Test apparatus: diffusing reflective slant edge
and external light source. | Results: |
| | Conditions: | 1. Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV |
| | 1. Disposable endoscope and Endoscope
Control Unit (ECU) in both non-aged and
aged conditions | 2. Aged: 54.1% on axis, 44.8% @ 0.6 FOV |
| | 2. Measure MTF @ 20, 30 and 100 mm
object distance | 3. These two conditions passed pre-defined
acceptance criteria. |
| | 3. Determine image resolution in terms of
TV lines at 15% MTF
Purpose: To verify the characteristic of spatial
frequency response of the subject device and
compare to that of predicate device. | 4. For image resolution at 15% MTF, the results are
730 and 670 TV lines/mm, respectively for pre and
post shelf- life testing.
Discussion on SE: The image resolution in terms of
spatial frequency response of the subject device over
the course of the proposed shelf life is similar to that
of predicate (642 TV lines @ 15% MTF). The
difference in resolution does not raise different safety
and effectiveness questions. |
| Test | Test Method Summary | Results |
| Working
length | Test apparatus: Digital Caliper
Conditions: only measure the working length
of the Disposable endoscope
Purpose: To verify the working length of the
endoscope and compare to that of predicate
device. | Results: - Working length: 180.76 mm
- It passed pre-defined acceptance criteria.
Discussion on SE: Although the working length of
the subject device is longer than that of predicate, the
difference in working length does not raise different
safety and effectiveness questions. |
| Outer
Diameter | Test apparatus: Outside Micrometer
Conditions: Only measure the outer diameter
of the disposable endoscope
Purpose: To verify the outer diameter of the
endoscope and compare to that of predicate
device. | Results: - Outer diameter: 5.28 - 5.32 mm
- It passed pre-defined acceptance criteria.
Discussion on SE: Although the outer diameter is
wider than the predicate, the difference does not raise
different safety and effectiveness questions. |
| Image quality
test utilizing a
clinically
relevant
biological
tissue model | Test set up: Use a live pig model and conduct
the animal testing following the GLP standard
in an animal operating room of a facility
accredited under AAALACi standards.
Conditions: - The non-aged and aged ECU units were
used for brain and spinal surgery tests. - Six pieces of endoscopes each from
non-aged and aged conditions were used
for brain and spinal surgery, respectively,
as indicated in the intended use of the
subject device. - Test under three different levels of
reducing light intensity conditions and
working lengths, respectively. - Two cleared devices each for spine and
brain were applied for comparing with
non-aged and aged subject devices | Results: - The image quality of the non-aged and aged
subject device passed the pre-defined acceptance
criteria for the intended use on brain and spine
endoscopic surgery. - Based on multiple ANOVA model, there is no
significant difference (P=0.569) in image quality
between the non-aged and aged subject device
over the proposed shelf life of endoscope and
service life of ECU. - Based on the agreement test, the image quality of
both the non-aged and aged subject devices was
found to be comparable to that of the
FDA-cleared comparator devices for both brain
and spine endoscopy. - Considering the significant impact of light
intensity on image quality during spine and brain
endoscopy, 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. |
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
equivalence
determination |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | HJY VisualNext™ Endoscopic
Vision System | QEVO System
with KINEVO 900 | |
| 510(k) No. | K222735 | K170667 | |
| 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. | The QEVO System with KINEVO
900 is intended for viewing internal
surgical sites during general surgical
procedures and for use in
visualization of ventricles and
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. | Equivalence.
Although the wording or
intended use between the
subject device and the
predicate is slightly
different, it doesn't raise
any new issues of
substantial equivalence. |
| Type of use | Prescription Use | Prescription Use | Equivalence |
| System
components | Rigid endoscope, ECU | Rigid endoscope, ECU | Equivalence |
| Light transmission | Light emitted from integrated LED
at proximal end of endoscope
insertion tube | Light source in endoscope main
body, light transmission through
insertion tube via fiber optics | Similar.
The difference doesn't
raise any new issues of
substantial equivalence. |
| Light source | Integrated LED
(Intensity adjustable) | Integrated LED
(Intensity adjustable) | Equivalence |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Proprietary name | HJY VisualNext™ Endoscopic
Vision System | QEVO System
with KINEVO 900 | |
| 510(k) No. | K222735 | K170667 | |
| Image
transmission | Rigid rod lenses + CMOS imaging
sensor in endoscope main body | Rigid rod lenses + CMOS imaging
sensor in endoscope main body | Equivalence |
| Direction of view | 0° | 45° | Different.
The difference doesn't
raise any new issues of
substantial equivalence. |
| Field of view | 120° | 100° | Different.
The difference doesn't
raise any new issues of
substantial equivalence. |
| Depth of field | 5-100 mm | 5-30 mm | Similar.
The difference doesn't
raise any new issues of
substantial 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't
raise any new issues of
substantial equivalence. |
| Image display | External monitor | External monitor | Equivalence |
| 2D / 3D Imaging | 2D only | 2D only | Equivalence |
| Recording
attribute | Via USB-port | Via USB-port | Equivalence |
| Insertion tube
working length | 180 mm | 120 mm | Different. The subject
device is longer than the
predicate device. It doesn't
raise any new issues of
substantial equivalence. |
| Insertion tube
outer diameter | 5.0 mm | 3.6 mm | Different. The subject
device is wider than the
predicate device. It doesn't
raise any new issues of
substantial equivalence. |
| Single use or
Reusable | Single use | Reusable | Different.
The difference doesn't
raise any new issues of
substantial equivalence. |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Proprietary name | HJY VisualNext™ Endoscopic
Vision System | QEVO System
with KINEVO 900 | Substantial
equivalence
determination |
| 510(k) No. | K222735 | K170667 | |
| | | | substantial equivalence. |
| Electrical safety | IEC60601-1, IEC60601-1-2 and
IEC60601-2-18 compliant | IEC60601-1, IEC60601-1-2 and
IEC60601-2-18 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.