SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

K150525 · KARL STORZ Endoscopy-America, Inc. · HET · Nov 20, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150525
• Device Name: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Nov 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy. IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Device Story

SPIES 3D System is an endoscopic camera system for visualization and documentation during diagnostic/surgical procedures. System components include 3D Tipcam®1 (rigid videoendoscope) and camera control unit (CCU) comprising Image1 Connect module and D3-Link module. Device captures endoscopic video via CMOS sensor; processes signals for 3D/2D display; outputs visualization to external monitors. Used in OR by surgeons/physicians for peritoneal/thoracic cavity procedures. Provides real-time visualization to assist clinical decision-making and surgical navigation. Benefits include enhanced depth perception and visualization during minimally invasive surgery.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via resolution, brightness, white balance, 3D-2D mode, color performance, latency, electrosurgical unit susceptibility, minimum illumination, auto exposure step response, and zero degree parallax testing. Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

System includes 3D Tipcam®1 and CCU (Image1 Connect/D3-Link). Uses CMOS sensor technology. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18. Biocompatible materials per ISO 10993 standards. Field of view: 82°. Connectivity: CCU-based video output.

Indications for Use

Indicated for patients undergoing diagnostic or surgical endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological anatomy, where endoscopic video assistance is required.

Regulatory Classification

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.

Predicate Devices

• ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM (K123365)

Reference Devices

• Image1 Connect module (TC200) (K131953)

Submission Summary (Full Text)

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

November 20, 2015

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

Re: 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 Dated: October 16, 2015 Received: October 19, 2015

Dear Winkie 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

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the quality systems (OS) 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 [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.

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150525

Device Name SPIES 3D System

#### Indications for Use (Describe)

3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.

IMAGE1 SPIES 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) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px;">☐</span> 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 logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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<br>2151 E. Grand Avenue<br>El Segundo, CA 90245 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong<br>Regulatory Affairs Specialist<br>424-218-8379<br>424-218-8519 |
| Date of Preparation: | February 25, 2015 |
| Device Identification: | Trade Name: SPIES 3D System<br>Common Name: Endoscopic Camera System<br>Classification Name: Gynecologic Laparoscope And<br>Accessories |
| Product Code: | HET, GCJ, FGB |
| Regulation: | 21 CFR 884.1720 |
| Predicate Device(s): | ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE<br>SYSTEM (K123365) |
| Device Description: | The SPIES 3D System is intended for use during diagnostic<br>and/or surgical procedures when endoscopic video<br>assistance is required within the peritoneal and thoracic<br>cavity, including gynecological and urological anatomy.<br><br>The SPIES 3D System is a medical device system which<br>consists of the camera control unit (CCU) – a combination of<br>the previously 510k cleared device (K131953) – Image1<br>Connect module (TC200) and the D3-Link module, and 3D<br>Tipcam®1. |

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| Indications For Use: | 3D TIPCAM®1: The Rigid Videoendoscope is intended to be<br>used together with the camera control unit is for use during<br>diagnostic and/or surgical procedures when endoscopic<br>video assistance is required. For use in all endoscopy and<br>endoscopic surgery within the peritoneal and thoracic<br>cavity, including gynecological and urological anatomy.<br>IMAGE1 SPIES is a camera control unit (CCU) for use with<br>camera heads or videoendoscopes for the visualization and<br>documentation of endoscopic and microscopic procedures. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The predicate and subject devices are both camera systems<br>that are used for observation purposes in general<br>endoscopic surgery within the thoracic and peritoneal<br>cavity, including gynecological and urological anatomy.<br>There are some minor differences in the technological<br>characteristics. These differences are: |
| | • The subject device uses a CMOS sensor instead of a<br>CCD sensor.<br>• The subject device has a more limited specification<br>on field of view (82° vs. 90°) due to the deflectable tip<br>in the predicate device.<br>• The subject device includes different patient<br>contacting materials |
| | The bench test data for the SPIES 3D System demonstrates<br>that the design characteristics used as the basis for the<br>comparison have been met. The results show that the<br>subject device has met all its specifications. The<br>performance validation test report is provided in section<br>021_Performance Testing of this submission. |
| | The minor difference in specifications when compared to the<br>predicate device, ENDOEYE FLEX 3D DEFLECTABLE<br>Videoscope System, is that the SPIES 3D System does not<br>raise new issues of safety and effectiveness and the devices<br>are substantially equivalent for general endoscopic<br>application within the thoracic and peritoneal cavity. |
| Non-Clinical | Software validation was completed for a moderate level of concern per the FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. |
| Performance Data: | Reprocessing validation as completed per the FDA guidance document: "Reprocessing Medical Devices in Heath Care Settings: Validation Methods and Labeling" dated March 2, 2015. |
| | SPIES 3D System is tested according to the following standard: |
| | • IEC 60601-1 |
| | • IEC 60601-1-2 |
| | • IEC 60601-2-18 |
| | • ISO 10993-5, 2009 (Cytotoxicity) |
| | • ISO 10993-11, 2010 (Systemic Toxicity) |
| | • 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 |
| | • Latency |
| | • Electrosurgical Unit Susceptibility |
| | • Minimum Illumination |
| | • Auto Exposure Setp Response |
| | |
| | • Zero Degree Parallax |
| | The bench testing performed verified and validated that the SPIES 3D System has met all its design specification and is substantially equivalent to the predicate device, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM, for use in all endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological |
| | anatomy. |
| Clinical | No clinical information is required for this submission |
| Performance Data: | |
| Conclusion: | The SPIES 3D System is substantially equivalent to its<br>predicate devices. The non-clinical testing demonstrates<br>that the device is as safe and effective as the legally<br>marketed devices. |

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