Image1 SPIES System

K160044 · Karl Storz Endoscopy America, Inc. · FET · Feb 1, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160044
• Device Name: Image1 SPIES System
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Feb 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization. image recording and documentation during general endoscopic and microscopic procedures.

Device Story

The Image1 SPIES is a camera control unit (CCU) used in endoscopic and microscopic procedures. It processes video signals from connected camera heads or video endoscopes to provide real-time visualization, recording, and documentation. The system includes an X-link module for camera head connectivity and utilizes software for image enhancement. Operated by clinicians in clinical settings, the device assists in surgical and diagnostic visualization. The output is displayed for the physician to guide clinical decision-making and procedural performance. The system benefits patients by providing high-quality imaging for minimally invasive procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verification and validation included resolution, brightness, white balance, color performance, latency, temporal noise, residual spatial noise, automated exposure system step response, and software verification tests.

Technological Characteristics

Camera control unit (CCU) for endoscopic/microscopic visualization. Key components: CMOS sensor (replacing CCD), X-link module for camera head connectivity. Features software updates for feature improvement and bug fixes. Connectivity via camera head/endoscope interfaces. Bench testing verified performance specifications.

Indications for Use

Indicated for visualization, image recording, and documentation during general endoscopic and microscopic procedures in patients requiring such interventions.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Image1 SPIES (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

February 1, 2016

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

Re: K160044 Trade/Device Name: Image1 SPIES System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET Dated: January 6, 2016 Received: January 8, 2016

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.

for

Sincerely yours,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. 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)

K160044

Device Name Image1 SPIES System

#### Indications for Use (Describe)

The IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization. image recording and documentation during general endoscopic and microscopic procedures.

Type of Use (Select one or both, as applicable)

| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 phrase "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 1, 2016 |
| Device Identification: | Trade Name: Image1 SPIES System<br>Common Name: Endoscopic Camera System<br>Classification Name: Endoscope and accessories |
| Product Code: | FET |
| Regulation: | CFR 876.1500 |
| Predicate Device: | Image1 SPIES (K131953) |
| Device Description: | The modified Image1 SPIES (Storz Professional Image<br>Enhancement System) camera control unit includes an<br>additional camera head that can be connected to the X-link<br>module and software updates for improvement of existing<br>features and bug fixes. The SPIES Camera System is<br>intended and designed for use during endoscopic and<br>microscopic procedures. |
| Indications For Use: | The IMAGE1 SPIES is a camera control unit (CCU) for use<br>with camera heads or video endoscopes for the<br>visualization, image recording and documentation during<br>general endoscopic and microscopic procedures. |
| Technological<br>Characteristics: | The predicate and subject devices are both camera systems that<br>are used for the visualization and documentation of endoscopic<br>and microscopic procedures. There are some minor differences<br>in the technological characteristics. These differences are:<br>The subject device uses a CMOS sensor instead of a CCD sensor. The subject device has a smaller telescope size attachment than the predicate device. |
| | The bench test data for the Image1 SPIES System demonstrates<br>that the design characteristics used as the basis for the<br>comparison have been met. The results show that the subject<br>device has met all its specifications. The performance<br>validation test report can be provided upon request. |
| | The minor difference in specifications when compared to the<br>predicate device, Image1 SPIES System, does not raise new<br>issues of safety and effectiveness and the devices are<br>substantially equivalent for the visualization and<br>documentation of endoscopic and microscopic procedures. |
| Non-Clinical<br>Performance Data: | Image1 SPIES System undergone bench testing for<br>performance verification and validation purposes:<br>Resolution Brightness White Balance Color Performance Latency Temporal Noise Residual Spatial Noise Step Response of Automated Exposure System Software Verification Tests |
| | The bench testing performed verified and validated that the<br>Image1 SPIES System has met all its design specification<br>and is substantially equivalent to the predicate device,<br>Image1 SPIES, for use in all endoscopic procedures within |
| | the peritoneal and thoracic cavity, including gynecological<br>and urological anatomy. |
| Clinical | No clinical information is required for this submission |
| Performance Data: | |
| Conclusion: | The Image1 SPIES 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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