(267 days)
The Video Endoscopy System & 3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.
The proposed Video Endoscopy Systems include the Video Endoscopy System and 3D Video Endoscopy System, Video Endoscopy System supports 2D imaqe output, 3D Video Endoscopy System supports 2D/3D image output.
Video Endoscopy System is composed of Video Endoscope (LPS21000/LPS21030) and Video Endoscopy processor (EVS100).
The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 2D Video Endoscope (LPS21000/LPS21030) are available, one image sensor is located at the distal of the endoscope (LPS21000/LPS21030), they are used in conjunction with Video Endoscopy Processor (EVS100) to output 2D images.
3D Video Endoscopy System is composed of Video Endoscope (LPS31000/LPS31030) and Video Endoscopy Processor (EVS200).
The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 3D Video Endoscope (LPS31000/LPS31030) are available, two image sensors are located at the distal of the endoscope (LPS31000/LPS31030), they are used in conjunction with Video Endoscopy Processor (EVS200) to output 2D/3D images.
Video Endoscopy processor is non-sterile device. The Video Endoscope is terminallysterilized device. The Video Endoscope must be sterilized by users before being used in surgery.
This submission describes the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Video Endoscopy System & 3D Video Endoscopy System (K210116).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for optical performance. Instead, it states that "The device met all acceptance criteria for optical performance testing and was shown to have equivalent image quality to the predicate." This implies a comparative standard rather than absolute numerical targets.
The reported device performance is qualitative for equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Resolution | Equivalent to Predicate (1920x1080 HD) | 1920x1080 HD (Same as predicate) |
| Brightness | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| White Balance | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| 3D-2D Mode | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Color Performance | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Field of View | Equivalent to Predicate (90°) | 90° (Same as predicate) |
| Geometric Distortion | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Signal-to-Noise Ratio (SNR) | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Dynamic Range | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Image Intensity Uniformity (IIU) | Met acceptance criteria (not specified quantitatively) | Met acceptance criteria (shown to have equivalent image quality to predicate) |
| Photobiological Safety | Compliance with IEC 62471:2006 | In compliance with IEC 62471:2006 |
| Biocompatibility | Not toxic, irritating, or sensitizing (ISO 10993 standards) | Not toxic, irritating or sensitizing |
| Software Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | In compliance with FDA Guidance |
| Sterilization Validation | Compliance with ISO 17665-1 | According to ISO 17665-1 |
| Package Verification | Compliance with ISTA 2A-11 & ASTM D 4169-16 | According to ISTA 2A-11 & ASTM D 4169-16 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on sample sizes for the "test set" in terms of images or data points for the individual optical performance tests. The testing described is non-clinical bench testing rather than a study involving clinical data from patients. Therefore, terms like "country of origin of the data," "retrospective or prospective," or "test set" in the context of patient data do not apply here. The testing was performed on the device prototypes or production units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance evaluation was based on bench testing against established standards and comparison to a predicate device's specifications, not on human expert review of clinical images to establish ground truth such as disease presence/absence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no adjudication method used, as the testing involved objective measurements and comparisons against technical specifications and standards, not subjective expert reviews requiring consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This submission is for a video endoscopy system as a medical device for visualization, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the primary evaluation was standalone performance simulation/bench testing of the device's optical and functional characteristics. The device itself (the video endoscopy system) is essentially the "algorithm only" in this context, as its performance is independently measured without human operators for the technical specifications listed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was based on:
- Established engineering and performance standards: e.g., IEC 60601 series, ISO 10993 series, IEC 62471.
- Predicate device specifications: The comparison table explicitly states characteristics like resolution, field angle, and depth of field that are identical or comparable to the predicate.
- Objective measurements: The various optical performance tests (Resolution, Brightness, White Balance, Color Performance, etc.) would have involved objective measurement techniques with specific targets or ranges derived from industry standards or performance requirements for such devices.
8. The sample size for the training set
Not applicable. This device is a video endoscopy system, not an AI or machine learning algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
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October 13, 2021
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang MA QARA Director No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict Cixi. Zhejiang 315300 China
Re: K210116
Trade/Device Name: Video Endoscopy System & 3D Video Endoscopy System Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ, FGB Dated: August 31, 2021 Received: September 7, 2021
Dear Guofang MA:
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Jason R. Roberts, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210116
Device Name
Video Endoscopy System &3D Video Endoscopy System
Indications for Use (Describe)
The Video Endoscopy System &3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section III 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
3.1 Submitter Information
510(k) Submitter/Holder: ●
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, China
● Contact
Guofang Ma QARA Director Telephone: +86-10-64116115 Fax: +86-10-64113261 Email: QARA@surgnova.com
● Date Prepared: October 12, 2021
3.2 Device Information
Trade/Proprietary Name: Video Endoscopy System & 3D Video Endoscopy System Common Name: Video Endoscopy System Models: EVS100, LPS21000, LPS21030, EVS200, LPS31000, LPS31030 Classification Name: Gynecologic laparoscope and accessories Classification Regulation: 21 CFR 884.1720 Product Code: HET, GCJ, FGB Device Class: Class II
3.3 Predicate Device
510(k) Number: K150525 Trade/Device Name: SPIES 3D System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: Class II Product Code: HET, GCJ, FGB Manufacturer: Karl Storz Endoscopy-America, Inc.
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Premarket Notification 510(k) Submission-Section III 510(k) Summary
| Proposed device | Predicate device(K150525) | |
|---|---|---|
| Video EndoscopySystem / 3D VideoEndoscopy System | Video Endoscopy Processor,EVS100, EVS200 | IMAGE1 SPIES |
| Video Endoscope,LPS21000, LPS21030LPS31000, LPS31030 | 3D TIPCAM®1 |
The predicate device has not been subject to a design related recall.
3.4 Device Description
The proposed Video Endoscopy Systems include the Video Endoscopy System and 3D Video Endoscopy System, Video Endoscopy System supports 2D imaqe output, 3D Video Endoscopy System supports 2D/3D image output.
Video Endoscopy System is composed of Video Endoscope (LPS21000/LPS21030) and Video Endoscopy processor (EVS100).
| Name | Model | |
|---|---|---|
| Video EndoscopySystem | Video EndoscopyProcessor | EVS100 |
| 0° Video Endoscope | LPS21000 | |
| 30° Video Endoscope | LPS21030 |
The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 2D Video Endoscope (LPS21000/LPS21030) are available, one image sensor is located at the distal of the endoscope (LPS21000/LPS21030), they are used in conjunction with Video Endoscopy Processor (EVS100) to output 2D images.
3D Video Endoscopy System is composed of Video Endoscope (LPS31000/LPS31030) and Video Endoscopy Processor (EVS200).
| Name | Model | |
|---|---|---|
| 3D VideoEndoscopy System | Video EndoscopyProcessor | EVS200 |
| 0° Video Endoscope | LPS31000 | |
| 30° Video Endoscope | LPS31030 |
The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 3D Video Endoscope (LPS31000/LPS31030) are available, two image sensors are located at the distal of the endoscope (LPS31000/LPS31030), they are used in conjunction with Video Endoscopy Processor (EVS200) to output 2D/3D images.
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
Video Endoscopy processor is non-sterile device. The Video Endoscope is terminallysterilized device. The Video Endoscope must be sterilized by users before being used in surgery.
This device is intended to be used in the hospital environment, such as surgical operation room.
3.5 Indications for use
The Video Endoscopy System & 3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic and therapeutic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.
3.6 Comparison of the technological characteristics
| ComparisonItems | Predicate Device | Proposed Device | Remark |
|---|---|---|---|
| product Name | SPIES 3D System | Video Endoscopy System &3D Video Endoscopy System | / |
| Regulation No. | 21 CFR 884.1720 | 21 CFR 884.1720 | Same |
| Classification | II | II | Same |
| Product Code | HET, GCJ, FGB | HET, GCJ, FGB | Same |
| Indications forUse | 3D TIPCAM®1: The RigidVideo endoscope is intended tobe used together with thecamera control unit is for useduring diagnostic and/orsurgical procedures whenendoscopic video assistance isrequired. For use in allendoscopy and endoscopicsurgery within the peritonealand thoracic cavity, includinggynecological and urologicalanatomy.IMAGE1 SPIES is a cameracontrol unit (CCU) for use withcamera heads or videoendoscopes for the | The Video Endoscopy System& 3D Video Endoscopy Systemare intended to be used toprovide illumination andvisualization of surgical field ina wide variety of diagnostic andtherapeutic abdominal andthoracic minimally invasiveprocedures, including femalereproductive organs(gynecology) and urologicalanatomy. | Same |
| Design | visualizationanddocumentation of endoscopicand microscopic procedures.The 3D TIPCAM®1 is connectwith IMAGE1 SPIES (CCU)and external light source foruniform illumination of thesurgical field, a high-resolutionoptical system captures thesignals from the surgical fieldand converged it into CMOS.The CMOS converts opticalsignals into electrical signals,electrical signals aretransmitted through electronicdevices and converted intovideo signals, after imageprocessing, video signal isdisplayed on the monitor, andendoscopic surgery isperformed under the guidanceof images displayed on a videomonitor.Need external light source. | The distal end of theendoscope is equipped withwhite LEDs for uniformillumination of the surgical field,a high-resolution optical systemcaptures the signals from thesurgical field and converged itinto CMOS. The endoscopicfront-end CMOS convertsoptical signals into electricalsignals, electrical signals aretransmitted through electronicdevices and converted intovideo signals, after imageprocessing, video signal isdisplayed on the monitor, andendoscopic surgery isperformed under the guidanceof images displayed on a videomonitor.Built-in LED light source andheat dissipation | Different |
| Resolution | 1920X1080 HD | 1920X1080 HD | Same |
| Directionofview | 0°, 30° | 0°, 30° | Same |
| Field angle | 90° | 90° | Same |
| Depth of field | 20 to 200mm | 20 to 120mm | Same |
| Outer diameterof distal end | 10mm | LPS21000/LPS21030:10mmLPS31000/LPS31030:10.2mm | / |
| Working length | 317mm, 320mm | LPS21000/ LPS21030:345.5mm, 348.2mmLPS31000/ LPS31030:338mm, 344mm | Different |
Table 1 Comparison of subject and predicate device technological characteristics
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
Compared with predicate, the proposed devices use built-in LEDs light source instead of external light source and have different working length. The non-clinical testing demonstrates that the differences in technological characteristics between the subject and predicate do not raise different questions of safety and effectiveness.
3.7 Testing
Non-Clinical Testing
The Video Endoscopy System and the predicate device are substantially equivalent in design concepts, technologies and materials. The Video Endoscopy System has been designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
Video Endoscopy System is tested according to the following standards:
- IEC 60601-1:2005, MOD ●
- IEC 60601-1-2:2014 .
- . IEC 60601-2-18:2009
- ISO 10993-5, 2009 (Cytotoxicity) ●
- . ISO 10993-11, 2010 (Acute Systemic Toxicity & Pyrogen)
- ISO 10993-10, 2010 (Sensitization and Irritation) ●
Additional bench testing for performance verification and validation purposes:
- Resolution ●
- Brightness
- . White Balance
- 3D-2D Mode
- . Color Performance
- . Field of View
- . Geometric Distortion
- . Signal-to-Noise Ratio (SNR) and Dynamic Range
- Image Intensity Uniformity (IIU)
- . Photobiological Safety per IEC 62471:2006
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Biocompatibility testing supports the device is not toxic, irritating or sensitizing. The device met all acceptance criteria for optical performance testing and was shown to have equivalent image quality to the predicate.
The list of non-clinical test performed on the proposed device.
Test Name No.
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Premarket Notification 510(k) Submission-Section III 510(k) Summary
| 1 | System Performance Verification Test |
|---|---|
| 2 | Package Verification Test according to ISTA 2A-11&ASTM D 4169-16 |
| 3 | Sterilization validation according to ISO 17665-1 |
Clinical Testing
Clinical studies were not required to demonstrate the substantial equivalence of the Video Endoscopy System and the predicated device.
3.8 Determination of substantial equivalence
The subject and predicate devices are both indicated for endoscopic observation during diagnostic and/or therapeutic procedures within the abdominal and thoracic cavities, including gynecological and urological anatomy; there is no difference in the intended use. The differences in technological characteristics between the subject and predicate do not raise different questions of safety and effectiveness. The non-clinical testing demonstrates that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.