KSEA OPSERVER LAP

K031895 · KARL STORZ Endoscopy-America, Inc. · FET · Sep 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031895
• Device Name: KSEA OPSERVER LAP
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH. The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures. The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope. The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity. The UNIDRIVE® II is the control unit that operates the motorized handles during endoscopic surgical procedures. The AUTOCON® II 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries. The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures. The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.

Device Story

OPserver LAP is an integrated surgical console combining multiple legally marketed Karl Storz laparoscopic devices: XENON 300 light source, video camera system, THERMOFLATOR gas insufflator, UNIDRIVE II motorized handle controller, AUTOCON II 400 electrosurgical generator, LAPAROMAT suction/irrigation unit, and QUADRO SWITCH control. The system centralizes control of these components via the Karl Storz Communication Bus (SCB), allowing operation through a touch screen or voice activation. Used in operating rooms by surgeons to perform laparoscopic procedures; the integrated console streamlines the management of light, visualization, insufflation, tissue cutting/coagulation, and irrigation/suction. By consolidating control, the device facilitates efficient surgical workflow and equipment management during minimally invasive procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Integrated console system utilizing the Karl Storz Communication Bus (SCB) for centralized control. Components include a 300W Xenon light source, video camera system, CO2 gas insufflator, motorized handle controller, electrosurgical generator (HF current), and suction/irrigation pump. Connectivity is provided via the SCB architecture. User interface includes touch screen and voice activation modules.

Indications for Use

Indicated for use in laparoscopic and pelviscopic surgical and diagnostic procedures by qualified surgeons.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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

Karl Storz Endoscopy-America, Inc. Ms. Suzie Chen Director of Regulatory Affairs 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600

JUL 2 7 2013

Re: K031895 Trade/Device Name: The KSEA OPserver LAP Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCT Dated (Date on orig SE ltr): July 5, 2003 Received (Date on orig SE Itr): July 22, 2003

Dear Ms. Chen,

This letter corrects our substantially equivalent letter of September 23, 2003.

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

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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 device-related 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -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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Image /page/2/Picture/0 description: The image shows a dark banner with the "STORZ Karl Storz Endoscopy" logo on the right side. The logo is white and features the word "STORZ" in a stylized font with concentric circles inside the letter "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The rest of the banner is a dark, mottled texture.

510(k) Number (if known): Not yet assigned.

Device Name: Opserver LAP

Indications for Use: The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH.

The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures.

The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope.

The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity.

(continued on next page)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use:<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:top;"> <img height="5" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+wYmRiYGBgYGBgYGBgYGBgYAAKkAQk0R9WAAAAAElFTkSuQmCC" style="margin-bottom: 10px;" width="5"/> </div> OR Over-The-Counter Use: |

(Optional Format 1-2-96)

*Miriam C. Provost*

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K031895 |
|---------------|---------|
|---------------|---------|

003

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K031895

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The UNIDRIVE® II is the control unit that operates the motorized handles during endoscopic surgical procedures.

The AUTOCON® II 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries.

The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures.

The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

--------------------------

OR Over-The-Counter Use:

(Optional Format 1-2-96)

Miriam L. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

004

510(k) Number K031895

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## Koslogg

## SEP 2 3 2003 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.

Karl Storz Endoscopy - America, Inc. Applicant: 600 Corporate Pointe Drive Culver City, CA 90230 [phone]

Susie Chen Contact:

Common Name: Device Identification: Multi-component surgical equipment console

> Trade Name: (optional) The KSEA OPserver LAP

Indication: The OPserver LAP is an integral combination unit comprised of the legally marketed Karl Storz equipment intended for use in laparoscopic surgeries.

Device Description: The OPserver LAP is comprised of XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH. It is controlled via the Karl Storz SCB either by touch screen or by voice activation.

Substantial Equivalence: The KSEA OPserver LAP is substantially equivalent to the predicate devices since the performance specifications, safety features, and intended uses are identical. The minor differences between the KSEA OPserver LAP and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

Susie Chen Director of Regulatory Affairs