8MM TROCAR KIT

K133845 · Intuitive Surgical · GCJ · Feb 19, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133845
• Device Name: 8MM TROCAR KIT
• Applicant: Intuitive Surgical
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To provide a port of entry for endoscopic instruments.

Device Story

8 mm Trocar consists of cannula, obturator, and universal cannula seal; provides port of entry for endoscopic instruments through abdominal or chest wall. Features include valve and stopcock for insufflation; fin for attachment to da Vinci Surgical System; markings for remote center placement. Available in standard and long versions. Used in endoscopic surgery by surgeons and OR staff. Device facilitates instrument access; enables insufflation maintenance; integrates with robotic surgical systems.

Clinical Evidence

No clinical trials; evidence based on bench testing, animal models, and cadaver studies. Performance testing included dimensional measurements, functional verification, and simulated use. Summative usability validation study conducted with surgeons and OR staff in simulated OR environment, covering workflow and safety-critical troubleshooting scenarios.

Technological Characteristics

Disposable surgical trocar/cannula. Components: cannula, obturator, universal seal. Features: valve, stopcock for insufflation, attachment fin for da Vinci Surgical System, depth markings. Materials and design equivalent to predicate. Sterilization method not specified.

Indications for Use

Indicated for use in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

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

• Unimax Trocar System (K112358)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

DEPA

February 19, 2014

Intuitive Surgical. Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K133845

Trade/Device Name: 8mm trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Disposable Surgical Trocar/Cannula Regulatory Class: Class II Product Code: GCJ Dated: January 24, 2014 Received: January 27, 2014

Dear Mr. Hansen:

We have reviewed vour 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 [OIR/IVD OPTION] and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR

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Page 2 - Mr. Brandon Hansen

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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 [OIR/IVD OFTION] and Part 809), 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/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

**Felipe Aguel**

for

Binita S. Ashar. M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### ......................... Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133845

Device Name S mm Tricar

#### Indications for Use (Describe)

The 8 mm Trocar has application in a variety of endoscopic provide a port of entry for endoscopic instruments.

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

区 Prescription Use (Part 21 CFR 801 Subpan D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | |
|------------------------------------------------------------------------------|------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Long H. Chen-A | for BSA |
| (Division Sign-off) | |
| Division of Surgical Devices | 510(k) Number: K133845 |
| FORM FDA 3881 (1/14) | Page 1 of 2 |

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# K133845

#### Page 1 of 2

#### 510(k) Summary

# FEB 1 9 2014

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen<br>Project Manager, Regulatory Affairs<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | January 24, 2014 |
| Trade Name: | 8 mm Trocar |
| Common Name: | Disposable Surgical Trocar/Cannula |
| Classification: | Class II<br>21 CFR 876.1500, Laparoscope, General & Plastic Surgery |
| Product Code: | GCJ |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Predicate Device: | Unimax Trocar System (K112358) |

## Device Description:

The 8 mm Trocar consists of a cannula, an obturator, and a universal cannula seal. It provides a port of entry for endoscopic instruments typically through the abdominal or chest wall of the patient during endoscopic surgery. It is available in standard and long versions. The universal seal contains a valve and stopcock to allow for insufflation and the cannula has a fin for attachment to the da Vinci Surgical System and markings for placing the remote center in the body wall. The three components are packaged as a kit, and the obturator and cannula seal also packaged individually.

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# Intended Use:

To provide a port of entry for endoscopic instruments.

## Indications for Use:

The 8 mm Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

# Technological Characteristics:

The 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358) in terms of design, materials, technological characteristics and intended use.

## Performance Data:

Performance test data (bench, animal and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and simulated use in animal and cadaver models.

## Human Factors and Usability Testing:

A summative usability validation study was conducted with users (surgeons and operating room staff) for the 8 mm Trocar. This study was conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation study and the other elements of the human factors engineering program provide evidence that the 8 mm Trocar is safe and effective when used by the intended users in the intended use environment.

#### Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358)

INTUITIVE SURGICAL®