DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100

K101077 · Intuitive Surgical, Inc. · GCJ · Feb 4, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K101077
• Device Name: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · 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 da Vinci® Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging.

Device Story

Endoscopic imaging system for minimally invasive surgery; provides real-time visible light and near-infrared (NIR) fluorescence imaging. Input: optical signals captured via 12mm endoscopes and 3D HD stereoscopic camera head. Transformation: system processes optical inputs to display standard visible light and NIR fluorescence overlays; utilizes IndoCyanine Green (ICG) fluorescence imaging agent for contrast. Output: visual assessment of vessels, blood flow, and tissue perfusion displayed to surgeon. Used in OR by surgeons to assist in intra-operative tissue assessment. Benefits: enables real-time visualization of perfusion, potentially aiding surgical decision-making during minimally invasive procedures.

Clinical Evidence

Bench testing only. Verification and validation testing performed to evaluate device requirements and specifications against the da Vinci Si Surgical System and SPY Scope Intra-operative Imaging System. Results demonstrated that all components met design and performance criteria.

Technological Characteristics

Endoscopic imaging system; 12mm endoscopes (0 or 30 degree); 3D HD stereoscopic camera head; NIR-optimized illuminator; ICG fluorescence imaging kit. Connectivity: integrates with existing video processor unit. Energy: standard endoscopic illumination. Sterilization: not specified.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring endoscopic visible light and near-infrared fluorescence imaging for visual assessment of vessels, blood flow, and tissue perfusion.

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

• Intuitive Surgical da Vinci SI Surgical System: Model IS3000 (K081137)
• Novadaq Spy Scope Intra-operative Operating System (K091515)

Submission Summary (Full Text)

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KI017 page (1) of (2)

FEB - 4 2011 INTUITIVE

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SURGICAL

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

April 16, 2010

Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086

- Official Contact: Karen Uyesuai Vice President, Clinical and Regulatory Affalrs Ph: 408-523-8918 Fax: [phone] [e-mail]
Trade Name: Intuitive Surgical da Vinci® Fluorescence Imaging Vislon System

Common Name: system, surgical, computer controlled Instrument

Product Code: NAY (GCJ/IZI)

Classification: endoscope and accessories, 21 CFR 876. 1500

Predicate Devices: Intuitive Surgical da Vinci� SI Surgical System: Model IS3000 (K081137) Novadaq Spy Scope Intra-operative Operating System (KO91515)

Device Description: The Intultive Surgical da Vinci® Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible ilght and near-Infrared fluorescence Imaging during minimally invasive surgery. The Intuittve Surgical da Vincl® Fluorescence Imaging Vision System is a variation of the Intultive Surgical da Vincle SI Surgical System: Model IS3000 (K081137) with the following modified/additional components:

- 12mm endoscopes (0 degree or 30 degree) optimized for NIR . fluorescence Imaging In addition to VIS Imaging,
- A 3D High Definition stereoscopic camera head optimized for NIR . fluorescence imaging In addition to VIS Imaging,
- A new illuminator for use with the existing video processor unit, and ◆
- A Fluorescence Imaging Klt (IndoCyanine Green (ICG) fluorescence ● Imaging agent, aqueous solvent, and syringe trays)

Intuitive Surgical, Inc.

Confidential

page 5-2 of 55

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K151077

ge (2) of (2)

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N T II I T I V F SURGICAL

Intended Use/Indications for Use: The da Vincle Fiuorescence Imaging Vision System is Intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vincl® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging.

Technological Characteristics: The da Vinci® Fluorescence Imaging Vision System is equivalent to the predicate devices in terms of its indications for use, design, technology and performance specifications.

Performance Data: Verification and validation were performed on the da Vincle Fluorescence Imaging Vision System to evaluate the device requirements/specifications and to demonstrate that they are substantially equivalent to the predicate devices (da Vinct®Si Surgical System: Model IS3000 and SPY Scope Intra-operative Imaging System).

The results of verification and validation tests demonstrate that the da Vincle Fluorescence imaging Vision System components met their design and performance criteria and are substantlally equivalent to the predicate devices.

Summary: Based on the Indications for use, design, technological characteristics and performance data the da Vincl® Fluorescence Imaging Vision System Is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Intuitive Surgical, Inc. % Ms. Karen Uyesugi Vice President, Clinical and Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

FEB - 4 201

Re: K101077

Trade/Device Name: da Vinci® Fluorescence Imaging Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, NAY, IZI Dated: January 10, 2011 Received: January 11, 2011

Dear Ms. Uyesugi:

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

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Page 2 - Ms. Karen Uyesugi

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 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/MedicalDevices/Safety/ReportalProblem/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,

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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## 510(k) Number if known: K101077

Device Name: da Vinci® Fluorescence Imaging Vision System

## INDICATION FOR USE:

The da Vinci® Fluorescence Imaging Vision System is intended to provide realtime endoscopic visible and near-infrared fluorescence imaging. The da Vinci® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-the-Counter Use (Per 21 CFR 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel R. Dyke
Signature

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101077

Confidential