DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES

K131861 · Intuitive Surgical, Inc. · NAY · Mar 28, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K131861
• Device Name: DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures. general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Device Story

da Vinci IS4000 is a software-controlled, electro-mechanical system for minimally invasive surgery. Surgeon console inputs: two master controls and foot pedals; 3D endoscopic visual feedback. System transforms inputs into precise movements of EndoWrist instruments and endoscope via patient side cart (PSC) arms. Vision side cart (VSC) provides electronic/video processing. Used in OR by trained surgeons; assists in grasping, cutting, dissection, suturing, and tissue manipulation. Benefits include enhanced precision and control compared to manual laparoscopy. Instruments are reusable and programmed with specific life cycles.

Clinical Evidence

No human clinical data. Evidence includes bench testing (mechanical/electrical verification, reliability/life testing), cadaver studies (n=10), and live animal models (porcine/canine, n=30 total across specialties). Animal studies demonstrated successful surgical access, procedure completion (e.g., colectomy, Nissen fundoplication, pyeloplasty, nephrectomy, hysterectomy, mitral valve repair), and safety endpoints (no device-related adverse events). Human factors summative validation study (n=15 teams) confirmed safe/effective use by intended users.

Technological Characteristics

Electro-mechanical, software-controlled system. Components: Surgeon Console, Patient Side Cart (PSC), Vision Side Cart (VSC). PSC features four instrument/endoscope arms. EndoWrist instruments provide multi-degree-of-freedom articulation. Connectivity: Networked system components. Sterilization: Reusable instruments/endoscopes. Software: Updated GUI and system control architecture.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Used by trained physicians in operating rooms.

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 Si Surgical System, Model IS3000 (K081137, K090993, K123463)

Submission Summary (Full Text)

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K131861

### 510(k) Summary

| | MAR 28 2014 | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | |
| Contact: | Brandon Hansen<br>Senior Regulatory Manager<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: [e-mail] | |
| Date Summary Prepared: | March 26, 2014 | |
| Trade Name: | <i>da Vinci</i> ® Surgical System, Model IS4000 | |
| Common Name: | Endoscopic instrument control system, endoscopic<br>instruments and accessories | |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories | |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument)<br>GCJ (Laparoscope, General & Plastic Surgery) | |
| Classification Advisory<br>Committee: | General and Plastic Surgery | |
| Predicate Device: | Intuitive Surgical <i>da Vinci</i> ® Si Surgical System, Model<br>IS3000 (K081137, K090993, K123463) | |

## Device Description

The da Vinci Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo

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Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.

Image /page/1/Picture/1 description: The image shows a robotic surgery console. The console has a 3D viewer, hand controls, an armrest, and a foot pedal panel. The console is designed to allow surgeons to perform minimally invasive surgery with greater precision and control.

IS4000 Surgeon Console

The VSC includes the supporting electronic and video processing equipment for the system.

Image /page/1/Picture/4 description: The image shows a medical device cart with several labeled components. The cart includes a touchscreen display mounted on an adjustable arm, a third-party electrosurgical generator, an illuminator, an endoscope controller, and a system core. The cart is on wheels, allowing it to be easily moved around a medical facility. The device appears to be designed for use in endoscopic surgical procedures.

IS4000 Vision Side Cart

The PSC is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system.

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Image /page/2/Picture/0 description: The image shows an IS4000 Patient Side Cart, which is a medical device. The cart has a base, column, helm, boom, and arms. The base is the bottom part of the cart, and the column is the vertical part that supports the boom. The helm is the part that the operator uses to control the cart, and the boom is the horizontal part that extends from the column. The arms are the parts that hold the surgical instruments.

The IS4000 Endoscope is a multi-use device that comprises a 3D camera in a lightweight design (60% lighter as compared to IS3000). The Endoscope can be used laparoscopically (hand-held) at the start of a surgery and then be installed on any arm of the PSC.

The EndoWrist Instruments come in various configurations such as Graspers, Scissors, and Needle-drivers. A total of 24 8 mm EndoWrist Instruments for the IS4000 are listed in Table 1:

| Monopolar Curved Scissors | Permanent Monopolar<br>Cautery Hook | Permanent Monopolar<br>Cautery Spatula |
|----------------------------------|-------------------------------------|----------------------------------------|
| Maryland Bipolar Forceps | Fenestrated Bipolar Forceps | Curved Bipolar Dissector |
| Micro Bipolar Forceps | Large Needle Driver | Mega SutureCut Needle<br>Driver |
| Black Diamond Micro<br>Forceps | ProGrasp Forceps | Tenaculum Forceps |
| Tip-Up Fenestrated Grasper | Resano Forceps | Small Grasping Retractor |
| Long Tip Forceps | Cardiac Probe Grasper | Large Hem-O-Lok Clip<br>Applier |
| Medium Hem-O-Lok Clip<br>Applier | Small Clip Applier | Dual Blade Retractor |

| Table 1: EndoWrist Instruments for the IS4000 | | | |
|-----------------------------------------------|--|--|--|
|-----------------------------------------------|--|--|--|

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| Atrial Retractor Short Right | Snap-Fit Instrument | Potts Scissors |
|------------------------------|---------------------|----------------|
|------------------------------|---------------------|----------------|

The EndoWrist instruments have a unique articulating design at the distal tip that mimics the human wrist. Each instrument is used to perform a specific surgical task such as grasping, suturing, tissue manipulation and electrocautery. The IS4000 EndoWrist Instruments can only be used with the IS4000 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing. This is identical to the IS3000 instruments.

A number of accessories are required to perform minimally invasive surgery with the IS4000 System including cannulas, obturators, and sterile drapes. Some accessories are modified to interface with the updated IS4000 System and instruments, while others are identical to the accessories used with the predicate IS3000 System. The complete list of IS4000 accessories is listed in Table 2:

| 8 mm Cannula (standard and long) | 8 mm Flared Cannula |
|------------------------------------------|--------------------------------------------------------|
| 8 mm Blunt Obturator (standard and long) | 8 mm Instrument Introducer |
| Arm and Column Drape | Instrument Release Kit |
| Endoscope Sterilization Tray | Tip Cover Accessory (for Monopolar<br>Curved Scissors) |
| SnapFit Scalpel Blade and Paddle Blade | SnapFit Insertion Tool (reusable) |
| 5-8 mm Cannula Seal | Gage Pin |

Table 2: IS4000 Accessories

## Intended Use:

To assist in the accurate control of endoscopic instruments in minimally invasive surgery.

## Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures,

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gynecologic laparoscopic surgical procedures. general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

## Technological Characteristics:

The Intuitive Surgical da Vinci Surgical System, Model IS4000 is equivalent to the predicate device, Model IS3000, in terms of technological characteristics and intended use. Modifications to the IS3000 include an updated Patient Side Cart architecture, design and dimensional changes to the EndoWrist Instruments and endoscope, and updated user interfaces.

## Performance Data:

Performance test data to support substantial equivalence to the predicate device and that the design output meets the design input requirements consist of bench testing, animal/cadaver validation, simulated clinical procedures in live animal, and Human Factor assessment.

## Bench Verification

The bench testing conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and reliability. For the IS4000, the Surgeon Console was not subjected to any bench testing since there was no change made to the hardware. Changes were made to the software, graphical user interface, and cosmetic changes that were tested as part of the overall system. The suites of bench tests are:

| Test | Summary |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Verification - PSC | The purpose of these tests was to verify that the physical,<br>mechanical, electrical, and system level requirements and<br>design specifications were met for each sub-component of<br>the PSC. Sample size varied from 1 to 6 units depending on<br>the test case. Test methods were based on pre-defined test<br>procedures. Objective pass/fail criteria are defined and<br>used. The following PSC sub-components were tested:<br>• Cart Drive<br>• Set-up Structure (SUS)<br>• Set-up Joint (SUJ)<br>• Universal Surgical Manipulator (USM)<br>• PSC Overload Testing |

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| Test | Summary |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Audio Intercom Hardware |
| Design Verification - VSC | The purpose of these tests was to verify the sub-components of the VSC met the functional requirements as defined in the applicable Functional Specification Documents. Sample size was 1 unit except for the Endoscope and Endoscope adapter where 4 to 5 units were tested. Test methods were based on pre-defined test procedures. Objective pass/fail criteria were defined and used. The following VSC sub-components were tested: Video Processor hardware Endoscope Controller hardware 8.5 mm Endoscope Endoscope adapter |
| Instrument Design Verification | The purpose of these tests was to verify the IS4000 instruments met the physical, mechanical, and electrical requirement and specifications. Instrument compatibility to software parameters and user interface specifications were also verified. Samples sizes up to 5 units for all 24 instruments were used. For load handling and grip forces verification, worst case representative instruments were tested. The following design verification tests were performed: All Instrument types (24) Instrument Electrical Testing Load Handling Grip Force Comparison for grasping instruments |
| Test | Summary |
| Instrument Reliability/Life<br>Testing | The purpose of this test was to confirm the instruments met<br>the projected life of each re-usable instrument. A sample of<br>9 instruments types was subjected to life testing<br>representing worst case for all 24 instruments. A sample<br>size of 4 units of each type was tested. Test instruments<br>were tested up to 8 life cycles to establish a projected life of<br>5 clinical uses. Each life cycle consisted of cleaning,<br>sterilizing, performance measurements, and simulated<br>surgical use. Objective pass/fail criteria were defined and<br>used. The following instruments were evaluated: |
| | • Monopolar Curved Scissors |
| | • Maryland Bipolar Forceps |
| | • Large Needle Driver |
| | • Black Diamond Micro Forceps |
| | • Mega SutureCut Needle Driver |
| | • ProGrasp Forceps |
| | • Tenaculum Forceps |
| | • Permanent Cautery Hook |
| | • Small Clip Applier |
| Accessories Testing | • The purpose of this test was to confirm that Column and<br>Instrument Arm Drapes with sterile adapters met the<br>specifications and requirements for maintenance of<br>sterility. A sample of 5 units of each type was evaluated<br>per the verification protocol. Objective pass fail criteria<br>were defined and used. |
| | • Reusable trocars were tested for physical, mechanical,<br>and interface requirements. A sample of 4 units of each<br>type of reusable trocar was tested per the verification<br>protocol. Objective pass/fail criteria were defined and<br>used. |

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## Pre-Clinical Verification via cadaver and animal models

The IS4000 system was evaluated for surgical access for seven representative procedures using multiple patient positions and port locations involving 10 cadavers (2 male and 8 female) and one 20 kg porcine model. Test cases validated requirements across all system components associated with system set-up, positioning, docking, transporting and procedure specific requirements for achieving external access and internal surgical

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targets. Specifically, the protocol focused on the IS4000 system's ability to safely and effectively:

- . Maneuver the PSC and USMs into proper surgical position for the target procedure
- . Reach and attach the USMs to the ports
- Maintain adequate external clearance between the system and its surroundings at . all times (e.g., during transport, roll-up, and intraoperative use)
- Reach the internal surgical targets with the instruments and endoscope .
- Maximize patient access .

| Procedure/<br># of cases | Port<br>Location | Port<br>Spacing | Work<br>Volume | Body Wall<br>Type | Patient<br>Position | Working<br>Distance |
|-----------------------------------------------------------|------------------------------------------------|-----------------|---------------------|-------------------|------------------------------------------|---------------------|
| Low Anterior<br>Resection/ 2<br>(cadaver) | Anterior<br>Transverse/<br>Anterior<br>Oblique | 8-11 cm | > 3k cm³ | Abdomen | Trendelenburg<br>Right roll<br>Lithotomy | 3-15 cm |
| Gastric Bypass/ 3<br>(cadaver) | Anterior<br>Transverse | 8-11 cm | Between<br>1-3k cm³ | Thick<br>Abdomen | Reverse<br>Trendelenburg<br>Lithotomy | 4-12 cm |
| Hysterectomy/ 3<br>(cadaver) | Anterior<br>Transverse | 8-11 cm | > 3k cm³ | Abdomen | Trendelenburg<br>Lithotomy | 3-15 cm |
| Mitral Valve<br>Repair/ 1<br>(cadaver) | Lateral,<br>Anterior,<br>Coronal | 2-8 cm | <1k cm³ | Ribs | Supine,<br>Left roll right<br>arm down | 2-8 cm |
| Cardiac<br>Revascularization/<br>1 (cadaver) | Lateral,<br>Anterior,<br>Coronal | 5-8 cm | Between<br>1-3k cm³ | Ribs | Supine, drop<br>Left shoulder | 2-8 cm |
| Nephrectomy w/<br>partial<br>Ureterectomy/ 3<br>(cadaver) | Anterior,<br>Lateral,<br>Sagittal | 5-11 cm | Between<br>1-3k cm³ | Abdomen | Lateral<br>decubitus, flex | 2-9 cm |
| Pediatric/ 2<br>(small porcine<br><20 kg) | Variable | 2-5 cm | Between<br>1-3k cm³ | Abdomen | Variable | 2-10 cm |

The following table shows the types of procedures used to set-up and deploy the system:

## Representative Surgical Procedures in Live Animal Models

A series of six evaluations in which surgeons performed complete procedures on live animal models were conducted covering the range of specialties listed in the indication statement. Each study included clinical endpoints to assess safety and effectiveness of the IS4000 system that were appropriate for the procedure being performed. The evaluations for five of the six specialties involved surviving the animal models for a minimum of 21 days.

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# General laparoscopic surgical procedures

| Right Colectomy | Canine Model (N=4) with weights 25-35 kg |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prospective Study | |
| No. of Investigators: | One (trained on system 4-6 weeks prior to use) |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.<br>Normal vital signs and absence of device-related adverse events<br>during post-op period. |
| Success Criteria<br>Effectiveness: | Ileocolic anastomosis intact and looking healthy at day of euthanasia.<br>Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Fenestrated Bipolar Forceps, Tip-Up Grasper, 30° down endoscope,<br>Monopolar Curved Scissors, EndoGIA® Ultra-Universal stapler,<br>Endopouch® specimen retrieval bag, and LigaClips. |
| Findings: | 1. Surgical time ranged from 30-65 minutes shorter times noted with each subsequent case.<br>2. There was no conversion to open surgery.<br>3. Estimated blood loss was 10 ml in all cases. |
| Adverse Events: | 1. Unanticipated splenic injury with placement of port. Splenic injury was repaired and procedure continued without further incident.<br>2. There were no device-related adverse events. |
| Postmortem Assessment<br>Protocol: | 1. Animals were euthanized and the operative site examined grossly for intactness of the ileoclic anastomosis and tissue health.<br>2. Blood samples collected for hematology and chemistry analysis.<br>3. Histopathology if needed on abnormal tissue as determined by Veterinary Pathologist. |
| Postmortem findings: | 1. All four animals survived for 26 days with normal vital signs and absence of device-related adverse events intra-operatively and during the post-operative period.<br>2. One animal presented with intermittent inappetance, moderate weight loss and clinical pathology results indicative of ongoing inflammation.<br>3. The ileocolic anastomoses were intact and functional at the end of the survival period. In the animal with irregular clinical observations, solid feces were found distal to the anastomosis with surrounding tissue inflammation (not device-related) at the end of the survival period.<br>4. All animals had a loop of small bowel covering the staple line, as observed during the post-survival evaluation surgery. This did not cause obstruction of the anastomosis in any of the animals. All other animals were free of clinically significant variances in observations or clinical pathology. |

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# General laparoscopic surgical procedures (pediatric)

:

| Nissen Fundoplication | Canine Model (N=4) with weights 9-15 kg (representative of |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prospective Study | pediatric population) |
| No. of Investigators: | One |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.<br>Normal vital signs and absence of device-related adverse events<br>during postoperative period. |
| Success Criteria<br>Effectiveness: | Fundoplication wrap intact and looking healthy at day of euthanasia.<br>Normal eating over post-op period. |
| Instrumentation Used: | Monopolar Curved Scissors, Fenestrated Bipolar Grasper, Tip-Up<br>Grasper, 30° down endoscope, Large Needle Drivers |
| Findings: | 1. Surgery time ranged from 48-68 min. |
| | 2. No animal required conversion to open surgery. |
| | 3. Estimated blood loss average was 13.8 ml. |
| | 4. Moderate weight loss occurred in all four animals during the<br>course of the study, and ranged from a 1.1-1.7 kg decrease. |
| | 5. All animals retained good appetites and were clinically healthy<br>throughout the duration of the survival period with no<br>observations of vomiting, regurgitation, or other Gl upset, and no<br>reported loss of body condition. The weight loss was likely due<br>to decreased caloric intake as a result of the post-operative<br>dietary change to canned food/gruel to accommodate GI tract<br>changes from the Nissen fundoplication. |
| Adverse Events: | 1. One animal sustained a splenic injury during takedown of the<br>gastro-colic ligament using the Monopolar Curved Scissors.<br>Bleeding was controlled by applying standard surgical<br>techniques of pressure to the puncture site with a 4x4 gauze and<br>monopolar electro-cautery. Hemostasis was achieved and this<br>event had no impact on the clinical outcome for the animal. This<br>was felt to be related to surgical error rather than instrumentation<br>as the scissor was under the command of the surgeon and not a<br>result of motions from the system. |
| Postmortem Assessment<br>Protocol: | 1. Animals were euthanized and the operative site examined grossly<br>for intactness of fundal wrap and tissue health. |
| | 2. Blood samples collected for hematology and chemistry analysis. |
| | 3. Histopathology if needed on abnormal tissue as determined by<br>Veterinary Pathologist. |
| Postmortem Findings: | 1. In the post-survival evaluation surgeries on Day 24, all wraps<br>were found to be intact with no abnormalities noted in the<br>surrounding tissue. |
| | 2. One slight adhesion was noted at a port site in one animal. |

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## General urologic surgical procedures (pediatric)

| Pyeloplasty<br>Prospective Study | Porcine Model (N=4) with weights 25-30 kg |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. of Investigators: | One |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.<br>Normal vital signs and absence of device-related adverse events during intra-operative and post-op periods. |
| Success Criteria<br>Effectiveness: | Normal passage of urine throughout the survival period.<br>Normal peristalsis of ureter at day of euthanasia.<br>No stricture of ureter at day of euthanasia.<br>Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Maryland Bipolar Forceps, Large Needle Driver |
| Findings: | 1. Surgical time range from 50-62 minutes.<br>2. There were no conversions to an open procedure.<br>3. Estimated blood loss average was 15 ml. |
| Adverse Events: | 1. One animal was noted to have thickened port sites with some purulent material expressed. Peritoneal wounds on this animal had healed normally.<br>2. There were no device-related adverse events. |
| Postmortem Assessment<br>Protocol: | 1. Animals were euthanized and the operative site examined grossly for intactness of the pyeloplasty, presence or absence of intra-peritoneal fluid, peristaltic activity.<br>2. Blood samples collected for hematology and chemistry analysis.<br>3. The anastomotic segment was explanted and histopathology performed by Veterinary Pathologist. |
| Postmortem Findings: | 1. All four animals survived for 26 days with normal vital signs and absence of device-related adverse events intra-operatively and during the post-operative period. All animals were free of clinically significant variances in observations or clinical pathology.<br>2. The ureteral anastomoses were intact and functional at the end of the survival period. There was no evidence of stricture as evidenced by the successful passage of a 6F dilator.<br>3. All animals were found to have 20cc clear abdominal fluid at euthanasia. This was the same finding prior to beginning the |

## Urologic surgical procedures

| Radical Nephrectomy<br>Prospective Study | Female Porcine Model (N=4) with weights 50-60 kg | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| No. of Investigators: | One (trained on system 6 weeks prior to study) | | |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.<br>Normal vital signs and absence of device-related adverse events<br>during intra-operative and post-op periods. | | |
| Success Criteria<br>Effectiveness: | Successful organ removal.<br>Normal eating and bowel movements over post-op period | | |

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| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Fenestrated Bipolar<br>Forceps, Laparoscopic EndoGIA Ultra-Universal stapler, |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Findings: | 1. Surgical time range from 35-42 minutes. |
| | 2. There were no conversions to an open procedure. |
| | 3. Successful removal of kidney in all animals. |
| | 4. Estimated blood loss average 12.5ml. |
| Adverse Events: | 1. One splenic injury during port placement controlled with local<br>measures. |
| | 2. There were no device-related adverse events. |
| Postmortem Assessment<br>Protocol: | 1. Animals were sedated and the operative site palpated for pain<br>and swelling and then euthanized. All port sites healed. |
| | 2. Blood samples collected for hematology and chemistry analysis. |
| | 3. Histopathology performed by Veterinary Pathologist on<br>abnormal tissue if needed. |
| Postmortem Findings: | 1. All four animals survived for 25-28 days with normal vital signs<br>and absence of device-related adverse events intra-operatively<br>and during the post-operative period. |
| | 2. No inappetance or other GI disturbances were reported, and all<br>animals remained in good condition throughout the duration of<br>the survival period. |
| | 3. None of the animals showed any signs of pain reaction. |

# Gynecologic laparoscopic surgical procedures

| Hysterectomy<br>Prospective Study | Female Porcine Model (N=4) with weights 35-40 kg |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. of Investigators: | One (trained on system 2 weeks prior to study) |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.<br>Normal vital signs and absence of device-related adverse events<br>during intra-operative and post-op periods. |
| Success Criteria<br>Effectiveness: | Successful organ removal.<br>Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Fenestrated Bipolar<br>Forceps, Mega SutureCut Needle Driver, |
| Findings: | 1. Surgical time range from 29-55 minutes; shorter time noted with<br>each subsequent case.<br>2. There was no conversion to an open procedure.<br>3. Estimated blood loss average 10ml.<br>4. Successful removal of uterus in all animals. |
| Adverse Events: | There were no device-related adverse events. |
| Postmortem Assessment<br>Protocol: | 1. Animals were euthanized and the vaginal cuff closure assessed.<br>A trans-vaginal leak test was performed.<br>2. Blood samples collected for hematology and chemistry analysis.<br>3. Histopathology performed by Veterinary Pathologist on<br>abnormal tissue if needed |

·

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| Postmortem Findings: | 1. All four animals survived for 21 days with normal vital signs and<br>absence of device-related adverse events intra-operatively and<br>during the post-operative period.<br>2. All vaginal cuffs were found to be intact with no abnormalities<br>noted in the surrounding tissue.<br>3. There were no leaks observed in the trans-vaginal air leak<br>testing. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### General thoracoscopic surgical and thoracoscopically-assisted cardiotomy procedures .

| Mitral Valve Repair | Canine Model (N=9) with weights 28-35 kg |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prospective Study | Comparative performance study of da Vinci IS3000 to the<br>IS4000 |
| No. of Investigators: | Two board certified cardio-thoracic surgeons each performed<br>4 procedures, 2 using the IS3000 and 2 using the IS4000. |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events. |
| Success Criteria<br>Effectiveness: | 1. Placing a cardioplegia catheter.<br>2. Simulating pacemaker lead placement.<br>3. Closing a leaflet defect.<br>4. Perform an annuloplasty with a flexible band.<br>5. Intra-operative valve leak test as surrogate for assessment of<br>mitral regurgitation. |
| Instrumentation Used: | Large Needle Driver, Resano Forceps, Atrial Retractor Short Right,<br>Monopolar Curved Scissors |
| Procedural Steps: | 1. Placing a cardioplegia catheter.<br>2. Simulating pacemaker lead placement. .<br>3. Closing a leaflet defect.<br>4. Perform an annuloplasty with a flexible band. |
| Findings: | 1. Total surgical time for all steps was 67-93 minutes for the<br>IS3000 and 76-101 minutes for the IS4000.<br>2. Time to cardioplegia catheter averaged 8.71 minutes for the<br>1S3000 and 8.12 minutes for the IS4000.<br>3. Time for lead placement averaged 13.25 minutes for the IS3000<br>and 13.5 minutes for the IS4000.<br>4. Time to completion of annuloplasty averaged 14.74 minutes for<br>the IS3000 and 14.57 minutes for the IS4000.<br>5. All animals had measures for mitral valve regurgitation that were<br>equal to pre-operative measures. All changes were acceptable to<br>surgeons. |
| Adverse Events: | *One animal (D955) in the IS4000 group died intra-operatively due<br>to a non-device-related adverse event, an acute onset pulmonary<br>complication leading to bronchial obstruction with reduced O₂<br>exchange. This animal was excluded from the study, and another<br>animal (D999) added to the study. |
| | There were no device-related adverse events. |
| Postmortem Assessment<br>Protocol: | None as animals were euthanized during the procedures to simulate<br>bypass machine. |

·

t

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The results of the animal testing demonstrate that the IS4000 Surgical System can be used to safely and effectively perform procedures from all of the specialties listed in the indications for use statement.

## Human Factors

A Human Factor (HF) engineering process was followed in accordance with FDA guidelines for medical devices:

- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk . Management, 2000
- Draft Guidance for Industry and Food and Drug Administration Staff Applying . Human Factors and Usability Engineering to Optimize Medical Device Design, 2011

The HF process focused primarily on identifying and mitigating use-related risks to safe levels while also providing a user friendly product. For the 1S4000 system, an extensive HF process was followed documenting many user research, design iteration, and formative evaluations prior to usability validation testing. A summative usability validation study was conducted with 15 teams of users (surgeons and OR team). This study was conducted in a simulated OR and involved representative typical workflow scenarios as well as troubleshooting scenarios that involved safety-critical tasks. Training materials and user manuals were developed in concert with the product hardware and software, and were incorporated in the validation study. The study assessed the following:

- ensure intended users could perform essential and high risk tasks in the expected t use environments in a safe and effective manner;
- validate that use-related risks have been mitigated to acceptable levels of residual . risk;
- assess the overall ease of use and usability of the IS4000 Surgical System; .
- this study evaluated whether the design introduced any previously unknown use-. related risks.

Fifteen surgeons from different surgical specialties (urology, gynecology, general surgery and thoracic) from novice (<20 cases) to very experienced (>200 cases) participated in the study. In addition, fifteen OR staff (5 circulating nurses, 9 scrub nurse/tech, and 1 physician's assistant) provided OR support during the sixteen study sessions. Each participant received one-half day of hands-on training prior to conducting testing. A simulated OR environment was provided to perform pre-operation set-up tasks (e.g., docking, draping, power on), intraoperative tasks (e.g., installing and activating instruments, instrument exchange, manipulating instruments), and post-operative tasks (e.g., undocking, cleaning, sorting for reprocessing). Data collected included both

INTUITIVE SURGICAL®

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objective performance data and subjective feedback from participants. Objective performance data included observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered. Subjective feedback included open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews.

The Model 1S4000 da Vinci Surgical System has been assessed and found to be safe and effective for its intended uses, by the intended users, in its intended use environment. The Human Factor engineering process, culminating in a usability validation study, was to identify and assess the use-related risks associated with the IS4000 Surgical System. The safety and usability of the IS4000 Surgical System was assessed to ensure residual risk is at acceptable levels, and that the use-safety of the system has not diminished in comparison to the IS3000 Surgical System.

### Summary:

Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci Surgical System, Model IS4000, is substantially equivalent (SE) to the predicate device, the Intuitive Surgical da Vinci Si Surgical System, Model IS3000. This SE determination is based on bench testing including reliability testing, animal/cadaver validation, simulated clinical procedures in live animals, and Human Factors assessment. The bench/reliability testing verified that the design requirements and specifications for the new and/or changed components of the system are met. The animal/cadaver validation demonstrated the users' ability to use the system to accurately control the endoscopic instruments, to reach the necessary target anatomy, and to perform surgical tasks. The simulated clinical procedures in live animals provided clinical validation that the system can safely and effectively complete representative surgical procedures encompassed by the indications for use statement. Finally, the Human Factors assessment provided further assurance that risks due to user errors are identified and mitigated.

This SE determination did not require clinical data for the following reasons:

- The indications for use are within the scope of the predicate device (da Vinci . IS3000).
- The changes to the device hardware and software were such that bench testing, . animal/cadaver validation, and simulated clinical procedures in live animals were adequate to establish SE to the predicate.

This review did not compare human clinical performance between the IS4000 System to the IS3000 System. This review did not assess user training, although a training program was described as part of the human factors assessment. Finally, because there were no human clinical data, user learning curve was not assessed for the new model.

1 N T U I T I V E SURGICAL®

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Image /page/15/Picture/0 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 wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

### 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

March 28, 2014

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

Re: K131861

Trade/Device Name: da Vinci Surgical System, Model IS4000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: June 19, 2014 Received: June 24, 2013

Dear Mr. Hansen:

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 requi…