K Number

Device Name

DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES

Manufacturer

INTUITIVE SURGICAL, INC.

Date Cleared

2014-03-28

(277 days)

Product Code

NAY GCJ

Regulation Number

876.1500

Intended 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 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 Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features. The VSC includes the supporting electronic and video processing equipment for the system. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K081137, K090993, K123463

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software-controlled, electro-mechanical surgical system that translates surgeon movements. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical control and visualization aspects.

Therapeutic

No
The da Vinci Surgical System is designed to assist in performing surgical procedures; it does not directly provide therapy. It is a tool for surgeons.

Diagnostic

The device is described as an Endoscopic Instrument Control System, intended to assist in the accurate control of surgical instruments for manipulation of tissue during various surgical procedures. Its function is to facilitate the surgeon's performance of minimally invasive surgery, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "software-controlled, electro-mechanical system" and details multiple hardware components (Surgeon Console, Patient Side Cart, Vision Side Cart, Endoscope, Instruments, Accessories). Performance studies also include bench testing of hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system is designed to assist in the control of surgical instruments for performing various surgical procedures on patients. This involves direct interaction with the patient's body during surgery.
Device Description: The description details a surgical system with a surgeon console, patient side cart, vision side cart, endoscope, and instruments. These components are used for manipulating tissue and providing visualization during surgery.
IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.

The da Vinci Surgical System is a surgical robot designed to assist surgeons in performing procedures on the patient, not for analyzing samples from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

NAY, GCJ

Device Description

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

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

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.

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 Cautery Hook
Permanent Monopolar Cautery Spatula
Maryland Bipolar Forceps
Fenestrated Bipolar Forceps
Curved Bipolar Dissector
Micro Bipolar Forceps
Large Needle Driver
Mega SutureCut Needle Driver
Black Diamond Micro 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 Applier
Medium Hem-O-Lok Clip Applier
Small Clip Applier
Dual Blade Retractor
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 Curved Scissors)
SnapFit Scalpel Blade and Paddle Blade
SnapFit Insertion Tool (reusable)
5-8 mm Cannula Seal
Gage Pin

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic image

Anatomical Site

urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, thoracoscopically-assisted cardiotomy, coronary anastomosis

Indicated Patient Age Range

adult and pediatric use

Intended User / Care Setting

trained physicians in an operating room environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Bench Verification

Design Verification - PSC: Sample size varied from 1 to 6 units depending on the test case. Test methods were based on pre-defined test procedures. Objective pass/fail criteria are defined and used. Tested PSC sub-components: Cart Drive, Set-up Structure (SUS), Set-up Joint (SUJ), Universal Surgical Manipulator (USM), PSC Overload Testing, Audio Intercom Hardware.
Design Verification - VSC: 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. Tested VSC sub-components: Video Processor hardware, Endoscope Controller hardware, 8.5 mm Endoscope, Endoscope adapter.
Instrument Design Verification: 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. Tested: All Instrument types (24), Instrument Electrical Testing, Load Handling, Grip Force Comparison for grasping instruments.
Instrument Reliability/Life Testing: Sample of 9 instruments types (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) subjected to life testing representing worst case for all 24 instruments. A sample size of 4 units of each type was tested. Test instruments were tested up to 8 life cycles to establish a projected life of 5 clinical uses. Each life cycle consisted of cleaning, sterilizing, performance measurements, and simulated surgical use. Objective pass/fail criteria were defined and used.
Accessories Testing:
- Column and Instrument Arm Drapes with sterile adapters: A sample of 5 units of each type was evaluated per the verification protocol. Objective pass/fail criteria were defined and used.
- Reusable trocars: A sample of 4 units of each type of reusable trocar was tested per the verification protocol. Objective pass/fail criteria were defined and used.

Pre-Clinical Verification via cadaver and animal models

Cadaver Study: 10 cadavers (2 male and 8 female). Seven representative procedures were evaluated for surgical access using multiple patient positions and port locations.

Representative Surgical Procedures in Live Animal Models

General laparoscopic surgical procedures (Canine Model): Canine Model (N=4) with weights 25-35 kg. Prospective Study. One investigator.
General laparoscopic surgical procedures (pediatric - Canine Model): Canine Model (N=4) with weights 9-15 kg (representative of pediatric population). Prospective Study. One investigator.
General urologic surgical procedures (pediatric - Porcine Model): Porcine Model (N=4) with weights 25-30 kg. Prospective Study. One investigator.
Urologic surgical procedures (Female Porcine Model): Female Porcine Model (N=4) with weights 50-60 kg. Prospective Study. One investigator.
Gynecologic laparoscopic surgical procedures (Female Porcine Model): Female Porcine Model (N=4) with weights 35-40 kg. Prospective Study. One investigator.
General thoracoscopic surgical and thoracoscopically-assisted cardiotomy procedures (Canine Model): Canine Model (N=9) with weights 28-35 kg. Comparative performance study of da Vinci IS3000 to the IS4000. Two board certified cardio-thoracic surgeons each performed 4 procedures, 2 using the IS3000 and 2 using the IS4000.

Human Factors

Summative usability validation study: 15 teams of users (surgeons and OR team). 15 surgeons from different surgical specialties (urology, gynecology, general surgery and thoracic) from novice (200 cases) participated. Also, fifteen OR staff (5 circulating nurses, 9 scrub nurse/tech, and 1 physician's assistant) provided OR support during the sixteen study sessions. Training materials and user manuals were incorporated in the validation study. Conducted in a simulated OR, involved typical workflow scenarios and troubleshooting scenarios. Data collected included objective performance data (observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered) and subjective feedback (open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Verification: 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.
- Key Results: The physical, mechanical, electrical, and system level requirements and design specifications were met for each sub-component. Instruments met physical, mechanical, and electrical requirements and specifications. Instrument compatibility to software parameters and user interface specifications were also verified. Instruments met projected life. Drapes and trocars met specifications and requirements.
Pre-Clinical Verification via cadaver and animal models: Evaluated 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.
- Key Results: The IS4000 system could 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, Reach internal surgical targets with instruments and endoscope, Maximize patient access.
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.
- General laparoscopic surgical procedures (Canine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events. Normal vital signs and absence of device-related adverse events during post-op period.
  - Success Criteria Effectiveness: Ileocolic anastomosis intact and looking healthy at day of euthanasia. Normal eating and bowel movements over post-op period.
  - Key Results: Surgical time ranged from 30-65 minutes, shorter times noted with each subsequent case. No conversion to open surgery. Estimated blood loss was 10 ml in all cases. 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. Ileocolic anastomoses were intact and functional. One unanticipated splenic injury occurred with port placement but was repaired. No device-related adverse events.
- General laparoscopic surgical procedures (pediatric - Canine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events. Normal vital signs and absence of device-related adverse events during postoperative period.
  - Success Criteria Effectiveness: Fundoplication wrap intact and looking healthy at day of euthanasia. Normal eating over post-op period.
  - Key Results: Surgery time ranged from 48-68 min. No animal required conversion to open surgery. Estimated blood loss average was 13.8 ml. All wraps were found to be intact with no abnormalities noted in the surrounding tissue. One animal sustained a splenic injury during takedown of the gastro-colic ligament, controlled with standard surgical techniques, and was felt to be related to surgical error.
- General urologic surgical procedures (pediatric - Porcine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events. Normal vital signs and absence of device-related adverse events during intra-operative and post-op periods.
  - Success Criteria Effectiveness: Normal passage of urine throughout the survival period. Normal peristalsis of ureter at day of euthanasia. No stricture of ureter at day of euthanasia. Normal eating and bowel movements over post-op period.
  - Key Results: Surgical time range from 50-62 minutes. No conversions to an open procedure. Estimated blood loss average was 15 ml. 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. Ureteral anastomoses were intact and functional with no evidence of stricture. No device-related adverse events.
- Urologic surgical procedures (Female Porcine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events. Normal vital signs and absence of device-related adverse events during intra-operative and post-op periods.
  - Success Criteria Effectiveness: Successful organ removal. Normal eating and bowel movements over post-op period.
  - Key Results: Surgical time range from 35-42 minutes. No conversions to an open procedure. Successful removal of kidney in all animals. Estimated blood loss average 12.5ml. All four animals survived for 25-28 days with normal vital signs and absence of device-related adverse events. One splenic injury during port placement controlled with local measures. No device-related adverse events.
- Gynecologic laparoscopic surgical procedures (Female Porcine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events. Normal vital signs and absence of device-related adverse events during intra-operative and post-op periods.
  - Success Criteria Effectiveness: Successful organ removal. Normal eating and bowel movements over post-op period.
  - Key Results: Surgical time range from 29-55 minutes; shorter time noted with each subsequent case. No conversion to an open procedure. Estimated blood loss average 10ml. Successful removal of uterus in all animals. All four animals survived for 21 days with normal vital signs and absence of device-related adverse events. All vaginal cuffs were found to be intact with no abnormalities. No leaks observed in trans-vaginal air leak testing. No device-related adverse events.
- General thoracoscopic surgical and thoracoscopically-assisted cardiotomy procedures (Canine Model):
  - Success Criteria Safety: Ability to perform procedure without intraoperative adverse events.
  - Success Criteria Effectiveness: Placing a cardioplegia catheter. Simulating pacemaker lead placement. Closing a leaflet defect. Perform an annuloplasty with a flexible band. Intra-operative valve leak test as surrogate for assessment of mitral regurgitation.
  - Key Results: Total surgical time for all steps was 67-93 minutes for the IS3000 and 76-101 minutes for the IS4000. Times for specific steps (cardioplegia catheter, lead placement, annuloplasty completion) were comparable between IS3000 and IS4000. All animals had measures for mitral valve regurgitation that were equal to pre-operative measures, and all changes were acceptable to surgeons. One animal in the IS4000 group died intra-operatively due to a non-device-related acute onset pulmonary complication. No device-related adverse events.
Human Factors: A summative usability validation study conducted with 15 teams of users (surgeons and OR team) in a simulated OR.
- Key Results: The Model IS4000 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. Use-related risks were identified and mitigated to acceptable levels of residual risk.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, K090993, K123463)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.

Summary

K131861

510(k) Summary

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

Device Description

INTUITIVE SURGICAL

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

INTUÍTIVE 1. 10. 10. 10. 20

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 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
Cautery Hook | Permanent Monopolar
Cautery Spatula |
|----------------------------------|-------------------------------------|----------------------------------------|
| Maryland Bipolar Forceps | Fenestrated Bipolar Forceps | Curved Bipolar Dissector |
| Micro Bipolar Forceps | Large Needle Driver | Mega SutureCut Needle
Driver |
| Black Diamond Micro
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
Applier |
| Medium Hem-O-Lok Clip
Applier | Small Clip Applier | Dual Blade Retractor |

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

INTUITIVE SURGICAL

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

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
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:

INTUITIVE SUNGICAL®

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

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
Testing	The purpose of this test was to confirm the instruments met
the projected life of each re-usable instrument. A sample of
9 instruments types was subjected to life testing
representing worst case for all 24 instruments. A sample
size of 4 units of each type was tested. Test instruments
were tested up to 8 life cycles to establish a projected life of
5 clinical uses. Each life cycle consisted of cleaning,
sterilizing, performance measurements, and simulated
surgical use. Objective pass/fail criteria were defined and
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
Instrument Arm Drapes with sterile adapters met the
specifications and requirements for maintenance of
sterility. A sample of 5 units of each type was evaluated
per the verification protocol. Objective pass fail criteria
were defined and used.
	• Reusable trocars were tested for physical, mechanical,
and interface requirements. A sample of 4 units of each
type of reusable trocar was tested per the verification
protocol. Objective pass/fail criteria were defined and
used.

I N T U I T | V E
Surgical"

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

INTUITIVE SURGICAL"

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/

of cases | Port

Location | Port
Spacing | Work
Volume | Body Wall
Type | Patient
Position | Working
Distance |
|-----------------------------------------------------------|------------------------------------------------|-----------------|---------------------|-------------------|------------------------------------------|---------------------|
| Low Anterior
Resection/ 2
(cadaver) | Anterior
Transverse/
Anterior
Oblique | 8-11 cm | > 3k cm³ | Abdomen | Trendelenburg
Right roll
Lithotomy | 3-15 cm |
| Gastric Bypass/ 3
(cadaver) | Anterior
Transverse | 8-11 cm | Between
1-3k cm³ | Thick
Abdomen | Reverse
Trendelenburg
Lithotomy | 4-12 cm |
| Hysterectomy/ 3
(cadaver) | Anterior
Transverse | 8-11 cm | > 3k cm³ | Abdomen | Trendelenburg
Lithotomy | 3-15 cm |
| Mitral Valve
Repair/ 1
(cadaver) | Lateral,
Anterior,
Coronal | 2-8 cm | 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®

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®

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 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

Page 2 - Mr. Brandon Hansen

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803}, please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar 2014.03.28 16:00:30 -04'00'

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

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K131861

Device Name

da Vinci Surgical System, Model IS4000, and EndoWrist® Instruments, and Accessories

Indications for Use (Describe)

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, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general thoracoscopic surgical procedures and thoracoscopicallyassisted 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 Professions for Use.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Long H. Chen
[FDA Signature Image]
for BSA
(Division Sign-Off)		510 (k) Number: K131861
Division of Surgical Devices
FORM FDA 3881 (1/14)	Page 1 of 2