TIPCAM 1S 3D System

K162880 · Karl Storz Endoscopy America, Inc. · GWG · Mar 16, 2017 · Neurology

Device Facts

• Record ID: K162880
• Device Name: TIPCAM 1S 3D System
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: GWG · Neurology
• Decision Date: Mar 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures. IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Device Story

System comprises 4mm 3D TIPCAM 1S videoendoscope and IMAGE 1S camera control unit (CCU). Endoscope connects to external light source via light cable; captures anatomical images within brain ventricles; transmits signals to CCU for processing. CCU performs image enhancement, zoom, and 3D-to-2D switching; outputs video to medical-grade monitors for surgeon visualization. Used in neurological surgical procedures; operated by surgeons. Provides real-time endoscopic visualization to assist in surgical navigation and documentation. Benefits include high-definition 3D visualization of intracranial structures.

Clinical Evidence

No clinical data provided. Bench testing only, including electrical safety (IEC 60601-1, 60601-1-2, 60601-2-18), ISO endoscope standards (ISO 8600 series), biocompatibility (ISO 10993-1), and software verification/validation.

Technological Characteristics

System includes 4mm 3D videoendoscope (0° or 30°) and IMAGE 1S CCU. Compatible with Xenon/LED light sources. Connectivity via light cable to source and video output to medical-grade monitors. Software is moderate level of concern. Reprocessing via steam sterilization per AAMI/ISO standards.

Indications for Use

Indicated for visualization of ventricles and brain structures during neurological surgical procedures. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• VS3 Stereoscopic High Definition Vision System (K131434)

Reference Devices

• SPIES 3D System (K150525)

Submission Summary (Full Text)

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Public Health Service

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

March 16, 2017

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

Re: K162880

Trade/Device Name: TIPCAM 1S 3D System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 10, 2017 Received: February 14, 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.

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Michaelリ. Hoffmann -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162880

Device Name TIPCAM 1S 3D System

Indications for Use (Describe)

TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures.

IMAGE 1S is a camera control unit (CCU) for use with camera heads of 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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

## 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, Inc |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2151 E. Grand Avenue |
| | EI Segundo, CA 90245 |
| Contact: | Winkie Wong |
| | Senior Regulatory Affairs Specialist |
| | 424-218-8379 |
| | 424-218-8519 |
| Date of Preparation: | October 12th, 2016 |
| Device Identification: | Trade Name: TIPCAM®1S 3D System |
| | Common Name: Endoscopic Camera System |
| | Classification Name: Endoscopic Camera System |
| Product Code: | GWG |
| Regulation: | 21 CFR 882.1480 |
| Predicate Device(s): | VS3 Stereoscopic High Definition Vision System (K131434) |
| Reference Device | SPIES 3D System (K150525) |
| Device Description: | The TIPCAM®1S 3D System is intended for use during diagnostic<br>and/or surgical procedures when endoscopic video assistance is<br>required for visualization within ventricles and structures within<br>the brain during neurological surgical procedures. The<br>TIPCAM®1S 3D System is a medical device system which consists<br>of a 4mm Tipcam®1S and a previously 510k cleared camera<br>control unit (CCU), K150525. |
| Indications For Use: | TIPCAM®1S 3D: The Rigid Videoendoscope is intended to be<br>used together with the camera control unit for use in the |
| | visualization of ventricles and structures within the brain during<br>neurological surgical procedures. |
| | IMAGE1 S is a camera control unit (CCU) for use with camera<br>heads or videoendoscopes for the visualization and<br>documentation of endoscopic and microscopic procedures. |
| Technological<br>Characteristics: | The TIPCAM®1S 3D System includes the following components:<br>4mm 3D TIPCAM®1S Videoendoscope, 0° or 30° Image1S CCU (Image1S Connect + D3-Link) The 4mm TIPCAM®1S 3D Videoendoscope is intended to be<br>connected to a compatible light source via a light cable as the source<br>of illumination to allow visualization of inside the patient's anatomy captured by the videoendoscope, processed by the CCU and finally<br>projected to any connected medical grade monitors. |
| Non-Clinical<br>Performance Data: | There are no performance standards or special controls<br>developed under Section 514 of the FD&C Act for endoscopes.<br>However, SPIES 3D System follows the FDA recognized<br>consensus standards and is tested according to the following<br>standard and FDA Guidance: Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO Endoscopes Standards ISO 8600-1 ISO 8600-3 ISO 8600-4 ISO 8600-5 ISO 8600-6 Biocompatibility testing (ISO 10993-1) Cytotoxicity Systemic toxicity Intracutaneous irritation |
| | 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 also has the same intended use, similar indications, principles of operation and technological characteristics as the cleared Visionsense's VS3 Stereoscopic High Definition Vision System (K131434).<br><br>Standard Performance Parameters Performance: |

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| | | TIPCAM®1S 3D System | VS3 Stereoscopic High Definition Vision System |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------|
| | | | K131434 |
| | | Subject Device | Primary Predicate |
| | Depth of Field | 7 – 44 mm | 7 – 30mm and 15 – 60 mm |
| | Direction of View | 0° & 30° | 0 - 70° |
| | Field of View | 80° | 70 - 95° |
| | Working Length | 175 mm | 175 – 300 mm |
| | Diameters | 4mm | 4mm & 5.5mm |
| | Light Source Compatibility | Xenon & LED | Xenon |
| | Zoom | Yes | Yes |
| | Image Enhancement | Yes | Yes |
| | Image Capture | Yes | Yes |
| | Video Recording | Yes | Yes |
| | Switch Between 2D and 3D Image | Yes | Yes |
| | Scope Diameters | 4 mm | 4mm & 5.5mm |
| | Resolution | HD | SD |
| Conclusion: | The TIPCAM®1S 3D System is substantially equivalent to its<br>predicate devices. The non-clinical testing demonstrates that the<br>device is as safe and effective as the legally marketed devices. | | |