(271 days)
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 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.
The provided document describes the Scivita Medical Technology Co., Ltd. 3D Visualization System (K183675). The document clarifies that this device is intended to process imaging signals from a video system center and convert them into 3D signals for display on a monitor. The FDA's 510(k) clearance process focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical performance targets for the proposed device itself. However, the document does describe non-clinical testing conducted to demonstrate this equivalence and ensure the device meets design specifications.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (Electrical) | The proposed device complies with: - IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance) - IEC 60601-1-2:2014 (Electromagnetic compatibility) - IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment) |
| Software Validation | The software was validated in accordance with FDA guidance documents: - "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" - "Off-The-Shelf Software Use in Medical Devices" - "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software" - "General Principles of Software Validation" |
| Image Quality Equivalence (2D and 3D) | Image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices for both 2D and 3D images. Parameters evaluated: - Field of view - Direction of view - Depth of field - Geometric distortion - Noise and dynamic range - Intensity uniformity - Artifacts - Image frame frequency and system delay Result: The image quality of the proposed device was equivalent to that of the predicate device (OLYMPUS LTF-190-10-3D ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE, MAJ-YO154 3D PROCESSOR, OLYMPUS CV-190, EVIS EXERA III VIDEO SYSTEM CENTER - K123365). This equivalence was tested across all four modes of the proposed device in both described combinations. |
| Substantial Equivalence to Predicate Device (K123365) | The non-clinical performance testing summarized supported a substantial equivalence determination, demonstrating the subject device is as safe and as effective as the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size (e.g., number of images, cases, or videos) used for the image quality performance tests. It vaguely states "image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices."
The data provenance (country of origin, retrospective/prospective) is also not mentioned. Given the manufacturer is based in China, it's plausible the testing was conducted there, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts or any process for establishing ground truth as typically understood in a clinical study (e.g., for diagnostic accuracy). The testing described is purely technical and comparative against a predicate device's performance characteristics.
4. Adjudication Method for the Test Set
As no expert review or human assessment of diagnostic accuracy is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described is a non-clinical, technical performance comparison between the proposed device and a predicate device, focusing on image quality characteristics, not on human reader performance with or without AI assistance. The device's function is to convert existing video signals into 3D signals, not to provide AI-assisted diagnostic capabilities.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a form of standalone performance was assessed. The "image quality performance tests" were conducted on the device itself, comparing its output directly to the predicate device's output based on various technical image parameters. This is an evaluation of the algorithm's output (3D visualization) in isolation from human interpretation for diagnostic purposes.
7. Type of Ground Truth Used
For the non-clinical image quality tests, the "ground truth" was implicitly derived from technical performance metrics of the predicate device and established engineering standards for image quality. It was a comparative measurement against the performance characteristics of the legally marketed predicate device, not against clinical outcomes, pathology, or expert consensus on a diagnostic task.
8. Sample Size for the Training Set
The document does not mention a training set. This device is a "3D Visualization System" that converts video signals. It does not appear to be an AI/ML-driven diagnostic or image analysis tool that would typically involve a "training set" in the machine learning sense. Its function is signal processing and conversion.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this section is not applicable.
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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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
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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.
| Model | Function | Mode Description |
|---|---|---|
| 3DVS-S100A | Four imaging modes (1, 2, 3, 4) | Mode 1: single-lens endoscope, enhanced 3D effects |
| 3DVS-S100B | Two imaging modes (1, 2) | |
| 3DVS-S100C | Two imaging modes (3, 4) | Mode 2: single-lens endoscope, standard 3D effects |
| 3DVS-S100D | Two imaging modes (1, 3) | Mode 3: dual-lens endoscope, enhanced 3D effects |
| 3DVS-S100E | Two 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 name | Manufacturer | Model | K number |
|---|---|---|---|---|
| 1 | 3D VISUALIZATIONSYSTEM | SCIVITA | 3DVS-S100A | / |
| 2 | EVIS EXERA IIIVIDEO SYSTEMCENTER(2D Image system) | OLYMPUS | CV-190 | K123365 |
Table 2. Combination 1 for proposed device
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| 3 | ENDOEYE FLEX 3DDEFLECTABLEVIDEOSCOPE(double-lens endoscope) | OLYMPUS | LTF-190-10-3D | K123365 |
|---|---|---|---|---|
| 4 | EVIS EXERAIIIXENON LIHTSOURCE(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 name | Manufacturer | Model | K number |
|---|---|---|---|---|
| 1 | 3D VISUALIZATIONSYSTEM | SCIVITA | 3DVS-S100A | / |
| 2 | Endoscopic VideoImagingSystem/Component(2D Image system) | STORZ | Image 1 SPIES | K131953 |
| 3 | Rhino-Laryngoscope(single-lens endoscope) | STORZ | 11101VP | K072387 |
| 4 | KARL STORZ XENONLIGHT SOURCEMODEL 201320-20 | STORZ | 201320-20 | K934559 |
| 5 | MONITOR | SONY | LMD-2451MT | K113203 |
| 6 | 3D GLASSES | SONY | TDG-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.
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6. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate DeviceK123365 |
|---|---|---|
| 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 intendedto compose the imaging signals fromvideo system center and convert them into3D signals displayed on the monitor. | This 3D processor is intended to be usedwith 3D videoscope and video systemcenter for 3D observation. |
| Sterile | No | No |
| Single Use | No | No |
| Principle | Obtain the video signal from two imageprocessor, mix them and convert into 3Dimage signal, and output it to monitor. | Obtain the video signal from two imageprocessor, mix them and convert into 3Dimage 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, enhanced3D effectsMode 2: single-lens endoscope, standard3D effectsMode 3: dual-lens endoscope, enhanced3D effectsMode 4: dual-lens endoscope, standard 3Deffects | 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.
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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.
§ 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.