PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER

K130826 · Stryker Endoscopy · GCJ · Aug 1, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130826
• Device Name: PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
• Applicant: Stryker Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations.

Device Story

Passport® Trocars and accessories are single-use laparoscopic access devices. The system includes trocars, a Robotic Reducer Cap, and a Stopcock with Rotating Male Luer. The Reducer Cap attaches to 8.5 mm and 12 mm robotic trocars to accommodate smaller instruments; the Stopcock attaches to 3 mm and 5 mm trocars to control CO2 flow. Used in clinical settings by surgeons during laparoscopic procedures to facilitate instrument entry and maintain pneumoperitoneum. Devices are sterilized via ethylene oxide. The system provides a stable access port, enabling surgeons to perform minimally invasive procedures, potentially reducing patient trauma and recovery time.

Clinical Evidence

Bench testing only. No clinical data provided. Accessories were verified for performance per design specifications and biocompatibility per ISO 10993-1:2009. Sterilization validated per ISO 11135-1:2007.

Technological Characteristics

Single-use laparoscopic access ports. Materials verified for biocompatibility per ISO 10993-1:2009. Sterilization via ethylene oxide per ISO 11135-1:2007. Accessories include a mechanical reducer cap and a manual stopcock for CO2 flow control. No software or electronic components.

Indications for Use

Indicated for adult and adolescent (12-21 years) patients undergoing laparoscopic procedures, including general, gynecologic, thoracic, and urological surgeries, to create and maintain instrument access.

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

• Passport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula Anchor (K080161)

Submission Summary (Full Text)

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## Section 5. 510(k) Summary

#### PER 21 CFR 807.92

| 510(k) Owner/Sponsor:<br>Address: | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 | AUG<br>1 2013 |
|-----------------------------------|--------------------------------------------------------------------------------------------|---------------|
| Establishment Number: | 2936485 | |
| Telephone Number: | [phone] | |
| Contact Person: | Rebecca Goldberg; Regulatory Affairs Analyst | |
| Email Address: | [e-mail] | |
| Proposed Device: | Passport® Trocars and Accessories | |
| Common/Usual Name: | Disposable Surgical Trocar/Cannula Accessory | |
| Product Code: | GCJ | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Predicate Device: | Passport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded<br>Trocar, Cannula Anchor | |
| Common/Usual Name: | Disposable Surgical Trocar/Cannula and Accessories | |
| Product Code: | GCJ | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Premarket Notification: | K080161 | |

#### Device Description

The Passport® Trocars with pediatric indication and Accessories (herein referred to as 'proposed devices') are a family of single-use devices that serve as an access port for laparoscopic instruments during laparoscopic surgery. The two accessory devices included in the submission are the Robotic Reducer Cap and Stopcock with Rotating Male Luer. These devices are to be used with the Passport® Trocars previously cleared in K080161 (herein referred to as 'predicate devices'). The Robotic Reducer Cap can be attached to the 8.5 mm and 12 mm robotic Passport® Trocars to reduce the seal size to accommodate smaller instruments. The Stopcock with Rotating Male Luer can be attached to 3 and 5 mm Passport® Trocars that do not have built-in stopcocks in order to control flow of CO2. The proposed devices are sterilized by ethylene oxide.

#### Intended Use/Indications for Use

Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations.

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#### Technological Comparison

マ

Passport® Trocars with pediatric indications employ the same technological characteristics as the predicate devices (K080161). The Robotic Reducer Cap and Stopcock with Rotating Male Luer employ many of the same technological characteristics as the predicate The differences in the technological characteristics do not impact safety or devices. effectiveness (See Section 12 - Substantial Equivalence).

#### Performance Testing

The pediatric indication expansion is the only change to the Passport® Trocars portion of the submission. Therefore this submission does not contain any performance data for the previously cleared Passport® Trocars (K08161). The accessories were tested for performance in accordance with design specifications and applicable performance standards. Biocompatibility was verified per ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials. Sterilization was verified per ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Bench performance testing performed on the accessories verifies the safety and effectiveness of the devices per design specifications and acceptance criteria. Test results obtained indicate that the accessories comply with applicable performance standards.

#### Conclusion

The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the intended use for predicate devices, Passport® Trocars and Accessories raise no new questions of safety and effectiveness and can be considered to be substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 1, 2013

Stryker Endoscopy % Ms. Rebecca Goldberg Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138

Re: K130826

Trade/Device Name: Passport® Trocars and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 27, 2013 Received: July 1, 2013

Dear Ms. Goldberg:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rebecca Goldberg

forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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.

### Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

Device Name: Passport® Trocars and Accessories

510(k) Number if known: K130826

Indications for Use:

Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures, in adult and adolescent (12 to 21 years of age) populations.

Over-The-Counter Use Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

-

# Joshua C. Nipper -S

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130826

Stryker Passport® Trocars and Accessories 510(k) Submission K130826-S005