5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319

K101743 · Intuitive Surgical, Inc. · NAY · Feb 4, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K101743
• Device Name: 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Flared Cannulae are Intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci SI (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of Insufflation.

Device Story

Intuitive Surgical Flared Cannula (5mm and 8mm models) serves as a port of entry for endoscopic instruments during robotic-assisted surgery. Device consists of a tapered hollow tubular shaft with a flared distal tip and a bowl for attachment to the da Vinci Surgical System (IS2000/IS3000). Includes an integral receptacle for connection to a dispersive electrode grounding pad via a 2-pin connector. Used in clinical settings by surgeons trained on the da Vinci system. Provides a stable access point for instruments; does not maintain insufflation. Benefits include facilitating instrument exchange and electrical grounding during procedures.

Clinical Evidence

No clinical data. Performance demonstrated via bench testing and animal lab tests to confirm design output meets design input requirements and safety/efficacy equivalence to the predicate.

Technological Characteristics

Tapered hollow tubular shaft with flared distal tip and bowl receptacle. Includes 2-pin connector for dispersive electrode grounding pad. Mechanical accessory for robotic surgical systems. No energy source or software.

Indications for Use

Indicated for use as a port of entry during da Vinci surgical procedures that do not require maintenance of insufflation, utilizing the da Vinci S (IS2000) or da Vinci Si (IS3000) systems.

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

• da Vinci Endoscopic Instrument Control System (Model IS1000) and Endoscopic Instruments (K990144)

Submission Summary (Full Text)

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

## FEB - 4 2011

## 510(k) Summary
(As Required by 21 CFR 807.92(c))

| Date: | 09/10/2010 | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | |
| Official Contact: | Meghna Sridharan<br>Sr. Regulatory Engineer<br>Ph: (408) 523- 2487<br>Fax: [phone]<br>[e-mail] | |
| Trade Name: | Intuitive Surgical Flared Cannula<br>• Model # 420262: 5mm Flared Cannula<br>• Model # 420319: 8mm Flared Cannula | |
| Common Name: | Endoscopic Instrument and Accessories | |
| Classification: | Endoscope and Accessories,<br>21 CFR 876.1500, NAY(LFL) | |
| Predicate Device: | Intuitive Surgical, Inc.<br>K990144, da Vinci Endoscopic Instrument<br>Control System (Model IS1000) and Endoscopic<br>Instruments | |
| Device Description: | The Intuitive Surgical Flared Cannula consists of<br>a tapered hollow tubular shaft with a flared<br>distal tip and a bowl with an Integral<br>receptacle. The hollow shaft serves as the port<br>of entry, the bowl is used to attach the<br>cannula to the da Vinci Surgical System and<br>the receptacle allows for attachment of<br>commercially available dispersive electrode<br>grounding pad via a 2-Pin grounding<br>connector | |
| Intended Use: | The Flared Cannulae are Intended to be used<br>with the da Vinci Surgical System (da Vinci S<br>(Model IS2000) or da Vinci SI (Model IS3000)) to<br>serve as a port of entry during da Vinci | |
| Intuitive Surgical, Inc. | Confidential | Page 3-2 |

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

procedures that do not require maintenance of Insufflation.

Technological Characteristics: The subject device is equivalent in Intended use, design and technology as compared to the predicate device.

Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the device Is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new Issues of safety or efficacy.

Summary: on the technical characteristics, Based Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device.

Intuitive Surgical, inc.

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Public Health Service

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

Intuitive Surgical, Inc. % Ms. Meghna Sridharan Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

FEB - 4 2011

Re: K101743

Trade/Device Name: Intuitive Surgical® Flared Cannula Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: January 27, 2011 Received: January 28, 2011

Dear Ms. Sridharan:

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.

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

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Page 2 - Ms. Meghna Sridharan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

AZ
VS
for

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

Enclosure

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K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula

## Indications for Use

510(k) Number if known: K101743

Device Name: Intuitive Surgical Flared Cannula

INDICATION FOR USE:

The Flared Cannuiae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use _ (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Osdoba for mkm

Division Sign-O (Division Sign of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101743