K Number
K183675
Device Name
3D Visualization System
Date Cleared
2019-09-25

(271 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
Device Description
The 3D Visualization System can convert 2D endoscopic images synchronously. It is equipped HD-SDI and HDMI outputs ports which are compatible with 3D monitors of various interfaces. The 3DVS-S100 series 3D Visualization System includes 5 models, which are 3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D and 3DVS-S100E. The differences between the models are in the number and type of imaging modes supported (single-lens endoscope with enhanced or standard 3D effects, and dual-lens endoscope with enhanced or standard 3D effects). The system should be used with endoscopic image processors which have HDMI or SDI output interface, and monitors which have SDI, HDMI or DVI interface. The device is provided non-sterile and for repeat use, does not have patient-contact, and is intended for use by a qualified healthcare professional and is not for home use.
More Information

No
The description focuses on converting 2D endoscopic images to 3D signals using standard video processing techniques and hardware outputs. There is no mention of AI, ML, or any learning-based algorithms.

No
The device is a visualization system that converts 2D endoscopic images into 3D signals for display on a monitor; it does not directly treat or diagnose a disease or condition.

No
This device converts 2D endoscopic signals into 3D signals for display on a monitor. It does not perform any analysis or interpretation of medical data to diagnose a condition. Its function is purely for visualization.

No

The device description explicitly mentions hardware components such as output ports (HD-SDI, HDMI) and states it is a "System" with different models, implying hardware variations. It also requires connection to external hardware like endoscopic image processors and monitors.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to compose and convert imaging signals from a video system center into 3D signals for display on a monitor. This is related to image processing and visualization for medical procedures (specifically endoscopy), not for the examination of specimens derived from the human body to provide information for diagnostic purposes.
  • Device Description: The description focuses on the technical aspects of converting 2D endoscopic images to 3D and the compatibility with other medical imaging equipment. It does not mention any interaction with biological samples or diagnostic testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.

The device is clearly intended for use in a clinical setting to enhance the visualization of endoscopic procedures, which falls under the category of medical imaging and visualization systems, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.

Product codes (comma separated list FDA assigned to the subject device)

GCJ, HET

Device Description

The 3D Visualization System can convert 2D endoscopic images synchronously. It is equipped HD-SDI and HDMI outputs ports which are compatible with 3D monitors of various interfaces.

The 3DVS-S100 series 3D Visualization System includes 5 models, which are 3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D and 3DVS-S100E. The differences between the models are summarized below.

ModelFunctionMode Description
3DVS-S100AFour imaging modes (1, 2, 3, 4)Mode 1: single-lens endoscope, enhanced 3D effects
3DVS-S100BTwo imaging modes (1, 2)
3DVS-S100CTwo imaging modes (3, 4)Mode 2: single-lens endoscope, standard 3D effects
3DVS-S100DTwo imaging modes (1, 3)Mode 3: dual-lens endoscope, enhanced 3D effects
3DVS-S100ETwo imaging modes (2, 4)Mode 4: dual-lens endoscope, standard 3D effects

The 3D Visualization System should be used with the endoscopic image processors which have HDMI or SDI output interface, and the monitors which have SDI, HDMI or DVI interface.

The 3D Visualization System is provided non-sterile and for repeat use. The 3D Visualization System does not have patient-contact and is intended for use by a qualified healthcare professional and is not for home use.

The 3D Visualization System is intended for use in one of two combinations, as summarized in Table 2 and Table 3 below.

No.Device nameManufacturerModelK number
13D VISUALIZATION
SYSTEMSCIVITA3DVS-S100A/
2EVIS EXERA III
VIDEO SYSTEM
CENTER
(2D Image system)OLYMPUSCV-190K123365

| 3 | ENDOEYE FLEX 3D
DEFLECTABLE
VIDEOSCOPE
(double-lens endoscope) | OLYMPUS | LTF-190-10-3D | K123365 |
|----------|-------------------------------------------------------------------------|---------|---------------|---------|
| 4 | EVIS EXERAIII
XENON LIHT
SOURCE
(light source) | OLYMPUS | CLV-190 | K121959 |
| 5 | MONITOR | SONY | LMD-2451MT | K113203 |
| 6 | 3D GLASSES | SONY | TDG-500P | / |

No.Device nameManufacturerModelK number
13D VISUALIZATION
SYSTEMSCIVITA3DVS-S100A/
2Endoscopic Video
Imaging
System/Component
(2D Image system)STORZImage 1 SPIESK131953
3Rhino-Laryngoscope
(single-lens endoscope)STORZ11101VPK072387
4KARL STORZ XENON
LIGHT SOURCE
MODEL 201320-20STORZ201320-20K934559
5MONITORSONYLMD-2451MTK113203
63D GLASSESSONYTDG-500P/

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified healthcare professional; Not for home use.

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 tests were conducted to verify that the proposed device met all design specifications as is substantially equivalent to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

  • A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests

  • A IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

The software of the proposed device was validated in accordance with the following guidance documents:

  • A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff
  • Off-The-Shelf Software Use in Medical Devices - Guidance for Industry, FDA Reviewers, and Compliance

  • A Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software -Guidance for Industry
  • A General Principles of Software Validation - Final Guidance for Industry and FDA Staff

For both 2D and 3D images, image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices in terms of field of view and direction of view, depth of field, geometric distortion, noise and dynamic range, intensity uniformity, artifacts, and image frame frequency and system delay. For both 2D and 3D images, the four modes of the proposed device in both combinations were all tested in comparison to the predicate device. The image quality of the proposed device was equivalent to that of the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123365

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K123365, K121959, K113203, K131953, K072387, K934559, K113203

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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.

September 25, 2019

Scivita Medical Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 CHINA

Re: K183675

Trade/Device Name: 3D Visualization System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: GCJ, HET Dated: August 16, 2019 Received: August 22, 2019

Dear Diana Hong:

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.

1

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 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 medical devices and radiation-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.

Sharon Andrews Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K183675

Device Name 3D Visualization System

Indications for Use (Describe)

This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.

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)

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 PRAStaff(@fda.hhs.gov

"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: K183675

Submitter Information 1.

Scivita Medical Technology Co., Ltd.

Submitter Name: Ruqin Wu Submitter Address: No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China. Position: Quality Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com

Mid-Link Consulting Co., Ltd Contact Person: Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person) Contact Address: P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net

Date of Preparation: 9/24/2019

2. Device Information

Trade Name: 3D Visualization System Models: 3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D and 3DVS-S100E Classification Name: Gynecologic laparoscope and accessories. Classification: II Product Code: HET (laparoscope, gynecologic (and accessories)) and GCJ (laparoscope, general & plastic surgery) Regulation Number: 21 CFR 884.1720 Review Panel: Obstetrics and Gynecology

3. Identification of Predicate Device

Predicate Device

510(k) Number: K123365

Product Name: OLYMPUS LTF-190-10-3D ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE, MAJ-YO154 3D PROCESSOR, OLYMPUS CV-190, EVIS EXERA III VIDEO SYSTEM CENTER

4

The predicate has not been subject to a design-related recall.

Device Description 4.

The 3D Visualization System can convert 2D endoscopic images synchronously. It is equipped HD-SDI and HDMI outputs ports which are compatible with 3D monitors of various interfaces.

The 3DVS-S100 series 3D Visualization System includes 5 models, which are 3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D and 3DVS-S100E. The differences between the models are summarized below.

ModelFunctionMode Description
3DVS-S100AFour imaging modes (1, 2, 3, 4)Mode 1: single-lens endoscope, enhanced 3D effects
3DVS-S100BTwo imaging modes (1, 2)
3DVS-S100CTwo imaging modes (3, 4)Mode 2: single-lens endoscope, standard 3D effects
3DVS-S100DTwo imaging modes (1, 3)Mode 3: dual-lens endoscope, enhanced 3D effects
3DVS-S100ETwo imaging modes (2, 4)Mode 4: dual-lens endoscope, standard 3D effects

Table 1. Differences between Each Model

The 3D Visualization System should be used with the endoscopic image processors which have HDMI or SDI output interface, and the monitors which have SDI, HDMI or DVI interface.

The 3D Visualization System is provided non-sterile and for repeat use. The 3D Visualization System does not have patient-contact and is intended for use by a qualified healthcare professional and is not for home use.

The 3D Visualization System is intended for use in one of two combinations, as summarized in Table 2 and Table 3 below.

No.Device nameManufacturerModelK number
13D VISUALIZATION
SYSTEMSCIVITA3DVS-S100A/
2EVIS EXERA III
VIDEO SYSTEM
CENTER
(2D Image system)OLYMPUSCV-190K123365

Table 2. Combination 1 for proposed device

5

| 3 | ENDOEYE FLEX 3D
DEFLECTABLE
VIDEOSCOPE
(double-lens endoscope) | OLYMPUS | LTF-190-10-3D | K123365 |
|----------|-------------------------------------------------------------------------|---------|---------------|---------|
| 4 | EVIS EXERAIII
XENON LIHT
SOURCE
(light source) | OLYMPUS | CLV-190 | K121959 |
| 5 | MONITOR | SONY | LMD-2451MT | K113203 |
| 6 | 3D GLASSES | SONY | TDG-500P | / |

Table 3. Combination 2 for proposed device

No.Device nameManufacturerModelK number
13D VISUALIZATION
SYSTEMSCIVITA3DVS-S100A/
2Endoscopic Video
Imaging
System/Component
(2D Image system)STORZImage 1 SPIESK131953
3Rhino-Laryngoscope
(single-lens endoscope)STORZ11101VPK072387
4KARL STORZ XENON
LIGHT SOURCE
MODEL 201320-20STORZ201320-20K934559
5MONITORSONYLMD-2451MTK113203
63D GLASSESSONYTDG-500P/

Indications for Use ട.

This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.

The indications for use statement of the subject device is similar to that of the video processor component of the predicate device; accordingly, the subject and predicate device have the same intended use.

6

6. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device
K123365 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HET, GCJ | HET, GCJ |
| Regulation Number | 21 CFR 884.1720 | 21 CFR 884.1720 |
| Class | II | II |
| Indications for Use | This 3D Visualization System is intended
to compose the imaging signals from
video system center and convert them into
3D signals displayed on the monitor. | This 3D processor is intended to be used
with 3D videoscope and video system
center for 3D observation. |
| Sterile | No | No |
| Single Use | No | No |
| Principle | Obtain the video signal from two image
processor, mix them and convert into 3D
image signal, and output it to monitor. | Obtain the video signal from two image
processor, mix them and convert into 3D
image signal, and output it to monitor. |
| Signal Output | SDI and HDMI | SDI |
| Signal Synchronization | Yes | Yes |
| 2D/3D Image Switching | Yes | Yes |
| Image modes | Mode 1: single-lens endoscope, enhanced
3D effects
Mode 2: single-lens endoscope, standard
3D effects
Mode 3: dual-lens endoscope, enhanced
3D effects
Mode 4: dual-lens endoscope, standard 3D
effects | 3D effect |
| Power Supply | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz |

Table 4. Substantially Equivalence Comparison

The proposed device can receive the HDMI signal and output the 3D HDMI signal to the monitor via HDMI cables, which is an additional function compared to predicate device. The HDMI function is optional for the proposed device. In addition, the proposed device has four image modes and the predicate device has one image mode.

The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

7

7. Summary of Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as is substantially equivalent to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

  • A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests

  • A IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

The software of the proposed device was validated in accordance with the following guidance documents:

  • A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff
  • Off-The-Shelf Software Use in Medical Devices - Guidance for Industry, FDA Reviewers, and Compliance

  • A Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software -Guidance for Industry
  • A General Principles of Software Validation - Final Guidance for Industry and FDA Staff

For both 2D and 3D images, image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices in terms of field of view and direction of view, depth of field, geometric distortion, noise and dynamic range, intensity uniformity, artifacts, and image frame frequency and system delay. For both 2D and 3D images, the four modes of the proposed device in both combinations were all tested in comparison to the predicate device. The image quality of the proposed device was equivalent to that of the predicate device.

Conclusion 8.

The performance testing summarized above support a substantial equivalence determination. The performance testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device.