The TipVision™ 0°/30° Videoscopes and EleVision™ HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

Device Description

The Tip Vision™ Videoscope System, consisting of the Tip Vision 0° / 30° Videoscope and the EleVision™ HD 2 Camera Control Unit (CCU), is used for 2D visualization of anatomical structures of the human body during endoscopic surgery including general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures. The TipVision™ Videoscope can only be used with the EleVision™ HD 2 CCU; this combination of videoscope and camera controller results in a camera based on complementary metal-oxide-semiconductor (CMOS) technology with LED illumination. When used with a compatible monitor, the camera delivers a native full HD image resolution using progressive scanning (1080p). All parameters that can be adjusted through the user interface of the CCU (magnification, illumination brightness, saturation, selective color enhancement, color shift, image storage, etc.) can also be controlled by the buttons on the TipVision™ Videoscope.

The Tip Vision™ Videoscope is connected to the Ele Vision™ HD 2 CCU by means of a cable attached to the scope handpiece. The user has the ability to adjust videoscope imaging parameters using the buttons on the videoscope handle, or via the CCU. The EleVision™ HD 2 CCU is available in two configurations: image recording only, or image and video recording.

AI/ML Overview

The provided text is a 510(k) summary for the TipVision Videoscope System. It describes the device, its indications for use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not contain information about acceptance criteria and a study that proves an AI/ML device meets those criteria.

The document details testing related to:

Reprocessing: Cleaning and sterilization validations per FDA guidance and AAMI/ISO standards.
Biocompatibility: Evaluation and testing according to ISO 10993 series and USP <151>.
Performance Testing (Optical and Mechanical): Optical characteristics (field of view, resolution, color, etc.), photobiological safety, thermal safety, usability, noise/dynamic range, and tip rotation per ISO and IEC standards.
Software Documentation: Adherence to FDA guidance for Moderate Level of Concern devices and IEC 62304.
Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601 series.

All these tests are for the physical and software aspects of a traditional medical device (a videoscope system), not for an AI/ML-driven device that would have "acceptance criteria" related to its algorithm's performance (e.g., accuracy, sensitivity, specificity, AUC) and requiring a "test set" with "ground truth" established by experts.

Therefore, I cannot fulfill the request for a table of acceptance criteria and the study proving an AI/ML device meets them, as the provided text does not describe an AI/ML device or its associated performance studies. The request specifically asks for details related to "AI vs without AI assistance," "standalone (algorithm only) performance," and "ground truth" establishment, which are concepts relevant to AI/ML device validation and are entirely absent from this 510(k) summary.

Summary

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March 12, 2021

Schoelly Fiberoptic GmbH % Pamela Papineau, RAC Regulatory Affairs Consultant (Alternate Application Contact) Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

Re: K201617

Trade/Device Name: TipVision Videoscope System (TipVision VideoScope 09/30°; EleVision HD 2 Camera Control Unit (CCU)) Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ, FET Dated: February 4, 2021 Received: February 5, 2021

Dear Pamela Papineau:

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,

For

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201617

Device Name

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

Indications for Use (Describe)

The TipVision 0%30° Videoscopes and EleVision HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

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

A. GENERAL INFORMATION

510(k) Sponsor:	Schoelly Fiberoptic GmbH
Address:	Robert-Bosch-Str. 1 – 379211 DenzlingenGermany
FDA Registration Number:	8043903
Telephone Number:	+49-7666-980-0
Fax Number:	+49-7666-908-380
Contact Person:	Dr. Sandra Baumann
Date Prepared:	11 March 2021

B. DEVICE IDENTIFICATION:

Trade/Device Name:	TipVision™ Videoscope System (TipVision Videoscope 0°/30°;EleVision HD 2 Camera Control Unit (CCU))
Regulation Name:	Gynecologic Laparoscope And Accessories
Regulation Number:	21 CFR 884.1720 (Gynecologic Laparoscope and Accessories)
Product Code:	HET (laparoscope, gynecologic (and accessories))GCJ (laparoscope, general & plastic surgery)FET (endoscopic video imaging system/component,gastroenterology-urology)
Regulatory Class:	Class II

C. PREDICATE DEVICES:

Predicate 1 - Videoscope

Trade Name:	EndoEYE HD II Videoscope;
510(k) Sponsor:	Olympus America, Inc.
510(k) Number:	K111788

Recall: The Endoeye HD II Video Telescope cleared in predicate K111788 was the subject of a class II design related recall due to a damaged temperature sensor in the distal end of the endoscope. The issue has been successfully resolved and design changes have been cleared via K190744. The installed heating element warms the distal tip to minimize or eliminate fogging of the lens during the procedure and aids in the prevention of endoscope removal to clean the lens due to fogging during a procedure. The TipVision Videoscope System does not include this feature.

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Predicate 2 – Camera Control Unit
Trade Name:	Visera Elite Video System Center (OTV-S190)
Sponsor:	Olympus Medical Systems Corp.
510(k) Number:	K111425

There were no design-related recalls associated with this device.

D. DEVICE DESCRIPTION:

INDICATIONS FOR USE: E.

The TipVision™ 09/30° Videoscopes and EleVision™ HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

COMPARISON OF SUBJECT DEVICE TECHNILOGICAL F. CHARACTERISTICS WITH THE PREDICATE DEVICES

A comparison of the technicological characteristics was conducted between the subject device and two predicate devices, one for the videoscope (Olympus EndoEYE HD II videoscope cleared under K111788) and one for the CCU (Olympus Visera Elite Video System Center cleared under K111425). A detailed comparison of the subject and predicate devices is provided in the table below.

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Technological Characteristics Comparison Table - Videoscope

Attribute	ProposedTipVision 0° / 30°Videoscope(current submission)	Predicate DeviceOlympus EndoEYE HD II(K111788)	Similarities and Differences
Indications for Use	The TipVision™ 0°/30°Videoscopes andEleVision™ HD 2 CCUare indicated forvisualization during generallaparoscopy, gynecologicallaparoscopy, urologicallaparoscopy, and video-assisted minimally invasivethoracic surgicalprocedures.	This instrument has beendesigned to be used with avideo system center, lightsource, documentationequipment, monitor, handinstruments, electrosurgicalinstrument, and otherancillary equipment forendoscope and endoscopicsurgery within the thoracicand abdominal cavitiesincluding the femalereproduction organs	Different indications for use;Same intended use:visualization during generallaparoscopic / endoscopic,gynecological, urological,and thoracic surgicalprocedures
Use Environment	Hospital, clinic, medicaloffice	Hospital, clinic, medicaloffice	Same
System Components	TipVision™ Videoscope(rigid video endoscope)	Olympus Endoeye HD 2Videoscope (rigid videoendoscope)	Same
Principle ofOperation	Rigid videoscope withimaging chip in distal tip;wired connection betweenvideoscope and CCU	Rigid videoscope withimaging chip in distal tip;wired connection betweenvideoscope and CCU	Same
Light Source	Integrated LEDs inendoscope tip, powered byCCU	External light sourceconnected to the endoscope,light transmission throughendoscope via fiber optics	Different technology; sameperformance
ImageTransmission	CMOS chip in scope tip	CCD chip in scope tip	Different technology:same performance
Direction of View	0°, 30°	0°, 30°	Same
Field of View	76°	72°, 80°, 90°	Similar; within predicate range
Tip Rotation	170°	N/A	Different
Depth of Field	20 mm – 200 mm	20 mm – 200 mm	Same
Image Resolution	Full HD (1080)	Full HD (1080)	Same
Insertion TubeWorking Length	341 mm	300 mm – 330 mm	Similar
Insertion TubeOuter Diameter	10 mm	5.4 mm, 10 mm	Same; within predicate range
Scope InternalChannels	None	None	Same
Scope Power Source	Wired connectionbetween videoscope andCCU	Wired connectionbetween videoscope andCCU	Same
Control Buttons onScope Handpiece	Yes, user-configurable	Yes, user-configurable	Same
Biocompatibility	Yes	Yes	Same
Single Use /Reusable	Reusable	Reusable	Same
Scope Reprocessing	Cleaning (manual orautomated) and steamsterilization	Cleaning (manual orautomated), steamsterilization	Same
Scope MoistureResistance	IPX 7	IPX 7	Same
Electrical Safety &Thermal Safety	Yes	Yes	Same
ElectromagneticCompatibility	Yes	Yes	Same
Scope SafetyPerformance	Yes	Yes	Same

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Technological Characteristics Comparison

	ProposedTipVision™ VideoscopeSystem(current submission)	Predicate DeviceOlympus Visera EliteVideo System Center andLight Source (K111425)	Similarities and Differences
Indications for Use	The TipVision™ 0°/30°Videoscopes andEleVision™ HD 2 CCUare indicated forvisualization during generallaparoscopy, gynecologicallaparoscopy, urologicallaparoscopy, and video-assisted minimally invasivethoracic surgicalprocedures.	Visera elite video systemcenter: this video systemcenter has been designed tobe used with olympuscamera heads, endoscopes,light sources, monitors,endo-therapy accessoriesand other ancillaryequipment for endoscopicdiagnosis, treatment andvideo observation.	Different indications for use;Same intended use:visualization during generallaparoscopic / endoscopic,gynecological, urological, andthoracic surgical procedures
		Visera elite xenon lightsource: this light source hasbeen designed to be usedwith olympus endoscopes,video system center, andother ancillary equipmentfor endoscopic diagnosis.

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		treatment and video observation.
Use Environment	Hospital, clinic, medical office	Hospital, clinic, medical office	Same
Principle of Operation	CCU provides power to videoscope and performs video image processing; image can be viewed on a compatible video monitor	CCU provides power to videoscope and performs video image processing; image can be viewed on a compatible video monitor	Same
Single Use / Reusable	Reusable	Reusable	Same
Software	Yes	Yes	Same
Electrical Safety & Thermal Safety	Yes	Yes	Same
EMC	Yes	Yes	Same

Differences in technological characteristics do not raise different questions of safety and effectiveness.

A. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING:

Reprocessing:

Reprocessing validations weredesigned and conducted in accordance with FDA's 2015 guidance (including Appendix E revised June 2017) Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

Cleaning studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, AAMI TIR30:2011(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices.

Sterilization studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, and ANSVAAMI/ISO 17665-1:2006 (R)2013 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning and sterilization processes are defined in the device labeling per ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the user manual.

Biocompatibility:

The patient contacting component of the subject device system is the videoscope insertible. The contact category for this component is Tissue/Bone/Dentin Communicating, ≤24 hours.

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The videoscope insertion tube was evaluated and tested for biocompatibility in accordance with the following standards and the FDA guidance document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process":

ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in ● vitro cytotoxicity
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
. ISO 10993-11:2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
. 42-NF37:2019 USP <151> Pyrogen Test (USP Rabbit Test)

Performance Testing:

Optical performance (direction of view, field of view, distortion/resolution, luminous flux, color performance, photobiological safety), optical safety, and thermal safety testing were conducted in accordance with the standards listed below:

. ISO 8600-1:2015 Medical endoscopes and endotherapy devices – Part 1: General requirements
ISO 8600-3:2019 Medical endoscopes and endotherapy devices Part 3: . Determination of Field of View and Direction of View of Endoscopes with Optics
. ISO 8600-5:2005 Optics and photonics – Medical endoscopes and endotherapy devices - Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics
IEC 62471:2006 (First Edition) Photobiological safety of lamps and lamp systems
IEC 60601-2-18:2009 Medical electrical equipment, Part 2-18: Particular ● requirements for the basic safety and essential performance of endoscopic equipment

The following additional testing was performed by the sponsor in support of device performance:

Usability testing per IEC 60601-1-6:2016 .
Noise and Dynamic Range testing ●
Mechanical testing for the tip rotation ●

Software Documentation:

Software documentation for a Moderate Level of Concern device is provided in support of the subject device per FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device. The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes.

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Electrical Safety Testing:

The TipVision™ Videoscope System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (ed. 3.1, including the US deviations) Medical electrical equipment, Part 1: General requirements for basic safety and essential performance.

The TipVision™ Videoscope System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-2-18:2009 (3rd edition): Particular requirements for the basic safety and essential performance of endoscopic equipment.

Electromagnetic Compatibility Testing:

The TipVision™ Videoscope System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1-2 (4th Edition) Medical electrical equipment, Part 1-2: General requirements for safety – Collateral standard: Electromagnetic Compatibility - Requirements and tests.

B. CONCLUSION

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 devices.

Regulation Number and Section

§ 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.