TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures.

IMAGE1 S is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Device Description

The TIPCAM®1S 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within nasal cavity and nasal pharynx. The TIPCAM®1S 3D System is a medical device system which consists of a 4mm Tipcam®1S and a previously 510k cleared camera control unit (CCU), K150525.

The TIPCAM®1S 3D System includes the following components: 4mm 3D TIPCAM®1S Videoendoscope, 0° or 30° Image1S CCU (Image1S Connect + D3-Link) The 4mm TIPCAM®1S 3D Videoendoscope is intended to be connected to a compatible light source via a light cable as the source of illumination to allow visualization of inside the patient's anatomy and the Image1S CCU for image processing. The live image will be captured by the videoendoscope, processed by the CCU and finally projected to any connected medical grade monitors.

AI/ML Overview

The provided document is a 510(k) Summary for the TIPCAM 1S 3D System. This document outlines the device's technical characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or diagnostic accuracy.

The "Non-Clinical Performance Data" section lists several types of tests, primarily related to:

Software Verification and Validation Testing: Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" and states the software is a "moderate level of concern." This is about software quality, not diagnostic performance.
Performance Testing: White Balance, Brightness, Image Enhancement, Video Output Format, Zoom, Image Quality, Image Capture, Latency, Interface Control, 3D-2D mode. These are functional performance aspects of an endoscopic camera system.
Reprocessing (Cleaning and Steam Sterilization): Adherence to AAMI and ISO standards for sterilization. This is about device safety and reusability.

The document explicitly states: "No clinical information is required for this submission." This means a study on diagnostic performance or clinical outcomes was not conducted or provided as part of this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them in the context of diagnostic accuracy or AI performance, as this information is not present in the provided text.

Based on the available text, here's what can be inferred:

A table of acceptance criteria and the reported device performance:
- No specific quantitative acceptance criteria or reported performance (e.g., sensitivity, specificity, AUC) for diagnostic accuracy or AI performance are provided.
- The document lists areas of "Performance Testing" which include qualitative aspects like White Balance, Brightness, Image Enhancement, Image Quality, Image Capture, Latency, Interface Control, 3D-2D mode, Video Output Format, and Zoom. The "acceptance criteria" for these would likely be that the system functions as intended and meets engineering specifications, but specific metrics are not detailed.
Sample size used for the test set and the data provenance: Not applicable, as no diagnostic or AI performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 study was done, and there is no mention of AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was studied, as there is no mention of an algorithm or AI.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as there is no mention of an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2017

Karl Storz Endoscopy America, Inc. Ms. Winkie Wong Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K162410

Trade/Device Name: TIPCAM 1S 3D System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: January 27, 2017 Received: January 31, 2017

Dear Ms. Wong:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162410

Device Name TIPCAM 1S 3D System

Indications for Use (Describe)

IMAGE1 S is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

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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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	KARL STORZ Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Winkie WongSenior Regulatory Affairs Specialist424-218-8379424-218-8519
Date of Preparation:	January 24, 2017
Device Identification:	Trade Name: TIPCAM®1S 3D SystemCommon Name: Endoscopic Camera SystemClassification Name: Endoscopic Camera System
Product Code:	EOB
Regulation:	21 CFR 874.4760
Predicate Device(s):	VSII Visionsense Stereoscopic Vision System (K082667)The above predicate has not been subject to any recall
Reference Device	SPIES 3D System (K150525)KARL STORZ Rigid Telescopes (K945788)The above reference device has not been subject to any recall
Device Description:	The TIPCAM®1S 3D System is intended for use during diagnosticand/or surgical procedures when endoscopic video assistance isrequired within nasal cavity and nasal pharynx. The TIPCAM®1S3D System is a medical device system which consists of a 4mmTipcam®1S and a previously 510k cleared camera control unit(CCU), K150525.
Indications For Use:	TIPCAM®1S 3D: The Rigid Videoendoscope is intended to beused together with the camera control unit for use to visualizethe nasal cavity and nasal pharynx during diagnostic andtherapeutic procedures.IMAGE1 S is a camera control unit (CCU) for use with cameraheads or videoendoscopes for the visualization anddocumentation of endoscopic and microscopic procedures.
TechnologicalCharacteristics:	The TIPCAM®1S 3D System includes the following components:4mm 3D TIPCAM®1S Videoendoscope, 0° or 30° Image1S CCU (Image1S Connect + D3-Link) The 4mm TIPCAM®1S 3D Videoendoscope is intended to beconnected to a compatible light source via a light cable as the sourceof illumination to allow visualization of inside the patient's anatomyand the Image1S CCU for image processing. The live image will becaptured by the videoendoscope, processed by the CCU and finallyprojected to any connected medical grade monitors.
Non-ClinicalPerformance Data:	There are no performance standards or special controlsdeveloped under Section 514 of the FD&C Act for endoscopes.However, SPIES 3D System follows the FDA recognizedconsensus standards and is tested according to the following
	Maximization sensitization Mucosal Irritation Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device The software is moderate level of concern Performance Testing White Balance Brightness Image Enhancement Video Output Format Zoom Image Quality Image Capture Latency Interface Control 3D-2D mode Reprocessing (Cleaning and Steam Sterilization) AAMI TIR30:2011 AAMI TIR12:2010 ANSI/AAMI/ISO 14937:2009 ANSI/AAMI ST79:2010/A4:2013 ISO TS 15883-5:2005 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Clinical Performance Data:	No clinical information is required for this submission
Substantial Equivalence:	The TIPCAM®1S 3D System has the same intended use and indication or use, similar principles of operation and technological characteristics as the cleared Visionsense's VSII Visionsense Stereoscopic Vision System (K082667).Below is a list of similarities between the TIPCAM®1S 3D System and its predicate devices: All systems use a 4mm diameter rigid endoscope with a length of 175mm and direction of view of 0° or 30°
All systems include a CCU for image processing. All systems include the same basic functional feature, such as zoom, image enhancement, image capture, video recording and switch between 2D and 3D images. The following technological differences exist between the subject and predicate devices: The subject device system includes a 4mm rigid videoendoscope while the predicate device system includes a 4mm and 5.5mm rigid endoscope to be attached to a camera head. Different resolution (HD vs. SD) LED light source compatibility
Conclusion:	The TIPCAM®1S 3D System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed devices.

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Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.