da Vincio SpTM Surgical System, Model SP999: The Intuitive Surgical Endoscopic Instrument Control System (da Vincio Sp™ Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist® Sp™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist® Sp™ Instruments: Intuitive Surgical EndoWrist® Sp™ Instruments are controlled by the da Vincio Sp™ Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use 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 Sp Surgical System. Model SP999 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model SP999 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with a Camera Instrument, EndoWrist Sp Instruments, and Accessories.

AI/ML Overview

Acceptance Criteria and Device Performance Study for da Vinci® Sp™ Surgical System, Model SP999

The provided 510(k) summary outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the da Vinci® Sp™ Surgical System, Model SP999, to its predicate devices. The studies primarily focused on mechanical, electrical, and functional verification, safety, and simulated use in animal and cadaver models.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established qualitatively through various tests to ensure the new device performed equivalently or acceptably compared to the predicate device. The performance was assessed based on the successful completion of surgical tasks and overall system functionality.

Acceptance Criteria Category	Specific Criteria (Implicitly)	Reported Device Performance
Bench Verifications	- Brake forces within specified limits	Patient Cart, Instrument Arm, and Instrument Drives subjected to full design verification to mechanical/electrical specifications.
	- Safety requirements met	Safety verified for Patient Cart, Instrument Arm/EGM, and Instrument Drives. Electrical and Patient safety verified for Camera and Surgical Instruments.
	- Lower-risk mechanical requirements met	Patient Cart confirmed for lower-risk mechanical requirements.
	- Miscellaneous design features verified	Patient Cart confirmed for miscellaneous design features.
	- External testing requirements met	Patient Cart confirmed for external testing.
	- Applied loads within limits	Instrument Arm/EGM confirmed for applied loads.
	- Interfaces met specifications	Instrument Arm/EGM confirmed for interfaces. Equipment interfaces for Camera and Surgical Instruments verified.
	- Mechanical design specifications met	Instrument Arm/EGM confirmed for mechanical design. Mechanical requirements confirmed for Camera and Surgical Instruments.
	- Electrical requirements met	Instrument Arm/EGM confirmed for electrical requirements. Electrical requirements confirmed for Camera and Surgical Instruments.
	- Reliability verified	Instrument Drive confirmed for reliability. Re-use and reliability verified for Surgical Instruments and Accessories.
	- Chassis ground integrity	Instrument Drive confirmed for chassis ground integrity.
	- Mechanical stability of Surgeon Console	Surgeon Console confirmed for mechanical stability.
	- Cosmetic and labeling requirements met	Surgeon Console confirmed for cosmetic and labeling. Labeling confirmed for Camera, Surgical Instruments, and Accessories.
	- Pedal labels and layout specifications met	Foot Pedals confirmed for pedal labels and layout.
	- Pedal reliability sustained	Foot Pedals confirmed for pedal reliability.
	- Mechanical and electrical specifications met for foot pedals	Foot Pedals confirmed for mechanical and electrical specifications. Sensors verified.
	- Mechanical and electrical requirements met for Vision Cart	Vision Cart confirmed for mechanical and electrical requirements.
	- Safety and reliability of Vision Cart	Vision Cart confirmed for safety and reliability.
	- Labeling and cleanability of Vision Cart	Vision Cart confirmed for labeling and cleanability.
	- Camera interface with CCU	CCU confirmed for camera interface.
	- Camera control and video processing functionality	CCU confirmed for camera control and video processing.
	- Vision Cart compatibility	CCU confirmed for Vision Cart compatibility.
	- Safety and reliability of CCU	CCU confirmed for safety and reliability.
	- Noise level of CCU within limits	CCU confirmed for noise level.
	- Mechanical and electrical requirements of CCU	CCU confirmed for mechanical and electrical requirements.
	- Labeling and cleanability of CCU	CCU confirmed for labeling and cleanability.
	- Physical specifications (size, weight, materials) met for Camera	Camera confirmed for physical specifications.
	- Mechanical requirements (force, range of motion, accuracy) met for Camera	Camera confirmed for mechanical requirements.
	- Image quality of Camera	Camera confirmed for image quality.
	- Physical specifications (dimensions, weight, materials) met for Instruments	Surgical Instruments confirmed for physical specifications.
	- Mechanical requirements (force, range of motion, accuracy) met for Instruments	Surgical Instruments confirmed for mechanical requirements.
	- User interface and patient safety for Instruments	Surgical Instruments confirmed for user interface and patient safety.
	- Environmental requirements for Instruments	Surgical Instruments confirmed for environmental requirements.
	- Shipping and storage for Instruments	Surgical Instruments confirmed for shipping and storage.
	- Package and Labeling for Instruments	Surgical Instruments confirmed for package and labeling.
	- Physical specifications (size, weight, materials) met for Accessories	Accessories confirmed for physical specifications.
	- Mechanical and electrical requirements for Accessories	Accessories confirmed for mechanical and electrical requirements.
Cadaver and Animal Validations	- Clinical performance for anatomical access and reach	Successfully demonstrated in 5 cadaver and 6 porcine procedures.
	- Safety and performance in live tissue models	Successfully demonstrated in 6 porcine procedures and 5 cadaver models.
	- Appropriate hemostasis achieved and maintained	Assessed in live animal models.
	- Ability to perform surgical tasks (e.g., dissection, suturing, ligation) with comparable efficacy to predicate	Successful completion of specific success criteria for each procedure performed by 5 independent surgeons for both SP999 and IS3000.
	- Equivalence in surgeon's ability to perform tasks	Surgeons evaluated their ability to perform surgical tasks with both systems through questionnaires, indicating comparable performance.
Human Factors Evaluation	- Use-safety and effectiveness of the system	Validated through a summative validation study with 15 user teams.
	- Identification and assessment of unknown use-related hazards	Assessed during the validation study.
	- Ease of use	Evaluated during the validation study.
	- Effectiveness of user documentation	Assessed during the validation study.
	- Effectiveness of training material	Assessed during the validation study.
Feasibility Study (Human Clinical Cases)	- Safety and effectiveness in human clinical setting	30-day post-operative outcomes on 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies) successfully performed with a functionally equivalent prototype. (Not used for SE determination but supportive evidence).

2. Sample Size and Data Provenance

Test Set for Cadaver and Animal Validations (Comparative Study):
- Sample Size: 5 independent practicing surgeons. Each surgeon performed 7 urologic procedures in a cadaver model and 6 representative procedure steps in a porcine model for each system (SP999 and IS3000), totaling 65 surgical procedures per system. The individual procedures described in the table are the cases.
- Data Provenance: Not explicitly stated, but likely conducted in a controlled lab/testing environment, potentially in the US where the company is based. The data is prospective for this specific study.
Test Set for Cadaver and Animal Validations (Initial SP999 Evaluation):
- Sample Size: 11 procedures (5 cadaver, 6 porcine). The sample size applies to the number of procedures, not necessarily unique animals/cadavers, although it mentions "sample size = 1" in parentheses for the overall system evaluation, which is ambiguous but could imply one animal for each type of procedure or one overall comprehensive animal model.
- Data Provenance: Not explicitly stated, but likely from controlled lab/testing environments.
Test Set for Human Factors Evaluation:
- Sample Size: 15 teams of users (surgeons and patient side assistants). Each team represents one "case" for the human factors study.
- Data Provenance: Conducted in a simulated OR environment. Likely within the US. This is prospective data.
Test Set for Feasibility Study:
- Sample Size: 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies).
- Data Provenance: "OUS feasibility study" (Outside the US), indicating an international origin. This is retrospective for the purpose of the 510(k) submission, as it was conducted with a prototype and submitted as supplementary evidence, not primary for SE.

3. Number of Experts and Qualifications for Ground Truth

For Cadaver and Animal Validations (Comparative Study):
- Number of Experts: 5 independent practicing surgeons.
- Qualifications: "independent practicing surgeons." Specific experience or specialization is only noted as "urologic surgical procedures." Given the procedures (pyeloplasty, nephrectomy, prostatectomy, lymphadenectomy), they are likely urologists with relevant surgical experience.
For Cadaver and Animal Validations (Initial SP999 Evaluation):
- Number of Experts: Not explicitly stated. Procedures were performed by "clinical development engineers." These are likely internal experts with specialized knowledge of the device and surgical procedures, but their clinical credentialing as surgeons isn't mentioned for this specific evaluation phase (they are performing the initial tests, not the comparative reader study).
For Human Factors Evaluation:
- Number of Experts/Users: 15 surgical urologists and 15 patient side assistants.
- Qualifications: Surgical urologists with varying experience (2 - 30 years in surgical practice, 13 - 1000 robotic surgical cases). Patient side assistants also varied in experience (55 - 40,000 cases, 0 - 9000 robotic patient side cases).
For Feasibility Study:
- Number of Experts/Users: Not explicitly stated for each case, but implies trained surgeons performed the procedures.
- Qualifications: Unspecified, but performing "human clinical cases" implies they were qualified surgeons.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method like "2+1" or "3+1" for establishing ground truth for the test sets. Instead, success criteria for each procedure were defined, and the performance against these criteria was observed and evaluated by the participating surgeons themselves (in the comparative study) or by clinical development engineers (in the initial evaluation). For human factors, objective performance data, use-errors, close calls, and subjective feedback were collected.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was a MRMC comparative effectiveness study done? Yes, a comparative study was conducted where five independent practicing surgeons (multiple readers) performed a comprehensive set of urologic surgical procedures (multiple cases) using both the SP999 (subject) and the IS3000 (predicate) systems.
Effect size of how much human readers improve with AI vs without AI assistance: This study does not evaluate AI assistance. The da Vinci system is a robotic surgical system that assists surgeons, but the context here is comparing a new version of the robotic system (SP999) against an older version (IS3000), not comparing human readers with and without AI assistance for interpretation tasks (e.g., radiology). The goal was to prove the substantial equivalence of the new robotic system, not to quantify improvement in human diagnostic performance with AI. The effect measured was the ability of surgeons to successfully complete defined surgical tasks with both systems. The document implies no statistically significant difference or inferiority of the new system compared to the predicate was found, as it concluded substantial equivalence. Specific quantitative improvements of surgeons using one system over the other are not detailed.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a surgical system that requires human interaction, not a standalone diagnostic algorithm. The da Vinci system is not an AI algorithm operating independently; it is a human-controlled, electro-mechanical system.

7. Type of Ground Truth Used

Bench Verifications: Engineering specifications, design requirements, and industry standards as the ground truth for mechanical, electrical, and functional performance.
Cadaver and Animal Validations: Defined "success criteria" for each surgical procedure (e.g., "Anastomosis complete with no visible gaps," "Kidney completely freed"). The completion of these criteria by the surgeons or engineers served as the ground truth for performance. Tissue examination and physiological responses (e.g., hemostasis) in live animals also contribute to this.
Human Factors Evaluation: Observational data (user's ability to complete tasks, identified use-errors, close calls, difficulties) and subjective feedback (ratings, interviews) were used to assess safety, usability, and effectiveness, with the "ground truth" being defined safe and effective operation based on risk analysis.
Feasibility Study: 30-day post-operative outcomes on human patients. This is outcome data, serving as a form of ground truth for safety and effectiveness in a human clinical setting.

8. Sample Size for the Training Set

The document does not identify a distinct "training set" in the context of an algorithm or machine learning. The da Vinci system is a robotic system, and its development involves iterative design, testing, and feedback, rather than traditional machine learning training. The information provided describes verification and validation studies.

9. How the Ground Truth for the Training Set Was Established

Since there is no identified "training set" for an algorithm in the machine learning sense, this question is not applicable. The development of the da Vinci SP999 system involved engineering design and testing, where the "ground truth" for each component and system feature was established by engineering specifications, regulatory standards, and clinical input from experienced surgeons guiding the design process. Formative testing and an earlier clinical investigation provided feedback that led to design iterations and improvements.

Summary

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K131962 Page 1 of 11

510(k) Summary

1999 - 1999 - 1999

	APR 17 2014
510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Michael YramateguiPrincipal Regulatory EngineerPhone Number: 408-523-2145Fax Number: 408-523-8907Email: Mike.Yramategui@intusurg.com
Date Summary Prepared:	April 15, 2014
Trade Name:	da Vinci® Sp™ Surgical System, Model SP999, EndoWrist® Sp™Instruments, and Accessories
Common Name:	Endoscopic instrument control system, endoscopic instruments andaccessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Devices:	K112208, K122532: Intuitive Surgical da Vinci Single-SiteInstruments and AccessoriesK050005: Intuitive Surgical Monopolar Curved Scissors, Model400179; Tip Cover Accessory Model 400180K050369: Intuitive Surgical da Vinci Surgical System, ModelIS2000K081137: Intuitive Surgical da Vinci Si Surgical System, ModelIS3000K082497: Intuitive Surgical EndoWrist One Hot ShearsInstrumentK112263: Intuitive Surgical Monopolar Curved Scissors TipCover AccessoryK123463: Intuitive Surgical da Vinci Si Surgical SystemSmartPedals

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Device Description

Image /page/1/Picture/3 description: The image shows three components of the da Vinci surgical system. The first component is the surgeon console, where the surgeon sits and controls the robotic arms. The second component is the patient cart, which holds the robotic arms that perform the surgery. The third component is the vision cart, which provides the surgeon with a high-definition 3D view of the surgical site.

Surgeon Console. Model SS999

Patient Cart, Model PS999

Vision Cart, Model VS999

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Sp Instruments and Camera Instrument 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 Vision Cart includes the supporting electronic and video processing equipment for the system.

The Patient Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Sp Instruments can be attached to and detached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instrument and up to three surgical instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an obturator, a seal, an entry guide, disposable tips for selected instruments, instrument sheaths, and a drape are needed to

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perform procedures with the system. Cleaning tools are also provided for cleaning the instruments.

The EndoWrist Sp Instruments come in various configurations such as graspers, scissors, and needle drivers. The EndoWrist Sp instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The EndoWrist Sp Instruments can be used only with the SP999 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The SP999 Camera Instrument is a reusable endoscope that provides a stereo image of the surgical site. Like the instruments, the distal end includes multiple joints that provide the flexibility needed for use with a single-port system.

The following EndoWrist Sp Instruments and accessories are listed for use with the da Vinci Sp Surgical System, Model SP999:

EndoWrist Sp Instruments:

Fenestrated Bipolar Forceps
. Maryland Bipolar Forceps
Medium-Large Clip Applier (a.k.a. ML Clip Applier) .
Monopolar Cautery .
Monopolar Curved Scissors .
Needle Driver .
. Camera Instrument (a.k.a. da Vinci Sp Camera)

Accessories for the SP999 da Vinci Sp Surgical System:

Cannula, 25 x 100 mm (a.k.a. Cannula) .
Entry Guide Kit, 25 x 100 mm (a.k.a. Entry Guide and Cannula Seal) .
Obturator, 25 x 100 mm (a.k.a. Obturator) .
Instrument Sheath .
Camera Sheath .
Monopolar Curved Scissors Tip .
Cautery Hook Tip .
. Cautery Spatula Tip
. Patient Arm Drape (a.k.a. Drape)

Cleaning Accessories for the SP999 da Vinci Sp Surgical System:

. Water Brush, Camera
Water Brush, Instrument .
Water Clamp, Instrument .

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Intended Use:

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

Indications for Use:

da Vincio SpTM Surgical System, Model SP999

The Intuitive Surgical Endoscopic Instrument Control System (da Vincio SpTM Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist® Sp™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist® Sp™ Instruments

Intuitive Surgical EndoWrist® Sp™ Instruments are controlled by the da Vincio Sp™ Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use 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 Sp Surgical System, Model SP999 is equivalent to the predicate device, Model IS3000, in terms of technological characteristics and intended use. The SP999 is designed for single incision laparoscopic procedures similar to the IS3000 when the IS3000 was cleared with specific instrumentation in K112208 and K122532 for single incision laparoscopic procedures. The SP999 includes a new Patient Cart architecture, design and dimensional changes in the EndoWrist Sp Instruments and endoscope, design of a new multichannel cannula system, and modifications to the Surgeon Console foot pedals.

The predicate Patient Cart has four systems of setup joints used to position three Instrument Arms (each housing one instrument drive for an instrument) and one Camera Arm (housing one instrument drive for the endoscope). In contrast, the new Patient Cart has only one system of setup joints used to position a single Instrument Arm that houses four independent instrument drives (three for surgical instruments and one for the Camera Instrument).

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The predicate EndoWrist instruments of the IS3000 are hinged-wrist joints. The EndoWrist Sp instruments have joggle joints in combination with snake-like wrist joints. This instrument design allows the instrument tip to be oriented with the same degrees of freedom as the predicate instruments. The EndoWrist Sp camera has the same design as the instruments, including both a wrist joint and joggle joints. The predicate endoscope is rigid, lacking any joints.

The predicate Surgeon Console has a view pedal that activates control of endoscope position and camera-focusing function. The SP999 Surgeon Console has a modified view pedal and a new arm pedal. The view pedal performs two functions, a Camera Control mode to move the articulating joints on the endoscope without movement of the instruments, and an Adjust mode to facilitate re-centering of the instruments' range of motion. The arm pedal is used to re-orient the instruments and camera as a group, pivoting around the single port. This mode (Relocate mode) can be used to move the instruments and camera to a different surgical quadrant.

Performance Data:

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

Bench Verifications -

The SP999 Patient Cart and subassemblies were subjected to full design verification to mechanical and electrical specifications. A summary of the design verification testing for the Patient Cart, the Instrument Arm (or Entry Guide Manipulator, EGM), and the Instrument Drives is described below:

Patient Cart	Brake forces
	Safety
	Lower-risk mechanical requirements
	Miscellaneous design features
	External testing
Instrument Arm/EGM	Applied loads
	Interfaces
	Mechanical design
	Electrical requirement
	Safety
Instrument Drive	Mechanical
	Chassis ground
	Reliability

The SP999 Surgeon Console has many of the same functional requirements as the IS3000 Surgeon Console. The main hardware modification to the SP999 Surgeon Console is to the foot

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pedals. Verification testing was performed to confirm that the modifications meet electrical and mechanical specifications.

Surgeon Console	Mechanical stabilityCosmetic and labeling requirements
Foot Pedals	Pedal labels and layoutPedal reliabilityMechanical and electrical specificationsSensors

Engineering design verification was performed on the SP999 Vision Cart and the SP999 Camera Control Unit (CCU). A summary of the design verification testing for the Vision Cart and CCU is described here:

Vision Cart	Mechanical and electrical requirementsSafety and reliabilityLabeling and cleanability
Camera Control Unit (CCU)	Camera interfaceCamera control and video processingVision Cart compatibilitySafety and reliabilityNoise levelMechanical and electrical requirementsLabeling and cleanability

Testing was performed on each instrument type to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the design verification testing for the SP999 surgical instruments and camera is described below:

Camera	Physical specifications (size, weight, materials)
	Mechanical requirements (force, range of motion, accuracy)
	Equipment interfaces (mechanical, electrical, cleaning, software)
	Electrical and Patient safety
	Image quality
	Labeling
Surgical Instruments	Physical specifications (dimensions, weight, materials)
	Mechanical requirements (force, range of motion, accuracy)
	Equipment interfaces (mechanical, electrical, cleaning, software)
	User interface and patient safety
	Re-use and reliability
	Environmental requirements
	Shipping and storage
	Package and Labeling

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A summary of the design verification testing for the SP999 accessories is described below:

Accessories Including	Physical specifications (size, weight, materials)
Cannula, Obturator,	Mechanical and electrical requirements
Entry Guide,	Equipment interfaces
Instrument Sheath,	Re-use and reliability
Camera Sheath, Tip	Labeling and packaging
Covers, Drapes

Cadaver and Animal Validations -

Cadaver models were used to demonstrate clinical performance for anatomical access and reach. Live animal models were used to assess safety and performance in cases where a live tissue model was appropriate. These models replicate factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensure that appropriate hemostasis is achieved and maintained. Eleven procedures were performed (5 cadaver, 6 porcine) to evaluate and validate the performance of the overall SP999 system (sample size = 1). Procedures were chosen on the basis of the types of surgical tasks that are performed, and which EndoWrist instruments are needed for the tasks. These procedures were performed by clinical development engineers:

Procedure	Subject	Surgical Tasks Evaluated in Procedure
Pelviclymphadenectomy	Cadaver	Enables evaluation of pelvic access and ability to precisely dissect aroundvessels.
Colectomy	Cadaver	Requires access to multiple quadrants of the body, allowing evaluation of thesystem's range of motion and ability to work in a large work volume. Instrumentand grip strength during retraction can also be assessed.
Prostatectomy	Cadaver	Allows assessment of the ability to access the deep pelvis in a male model andsuture in a confined space.
Pyeloplasty	Cadaver	Enables assessment of renal access and the ability to precisely suture small/thintissues.
Nephrectomy	Cadaver	Enables evaluation of renal access, fine dissection ability during renal hilumdissection, and instrument strength and range of motion during mobilization ofthe kidney.
Renal hilumdissection & renalartery anastomosis	Porcine	Enables evaluation of fine dissection in live tissue and suturing of delicate tissue.Additionally, allows evaluation of needle handling in a variety of orientations.
Renal artery & veinligation/ transection	Porcine	Enables evaluation of the ability to effectively ligate blood vessels and to transectthin tissue.
Ureter dissection,transection, &anastomosis	Porcine	Enables assessment of the ability to dissect and transect live tissue, as well asprecisely suture and manipulate small anatomy.
Cystic artery & ductdissection	Porcine	Enables evaluation of precise dissection and safe grasping of live tissue.
Bladder neckdissection,transection, &anastomosis	Porcine	Allows assessment of the ability to dissect deep in the pelvis as well as totransect, manipulate, and suture thick tissue. Additionally, enables evaluation ofneedle handling in a variety of orientations.

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K131962 Page 8 of 11

Bladder and uterinehorn amputation andclosure	Porcine	Enables evaluation of the ability to transect, manipulate, and suture thick tissue.
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For comparison to the predicate, five (5) independent practicing surgeons participated in a study completing a comprehensive set of urologic surgical procedures using both the SP999 (subject) and the IS3000. With each system, each surgeon performed seven urologic procedures in a cadaver model and six representative procedure steps in a porcine model, for a total of 65 surgical procedures performed with each system. The order that the procedures were performed was randomized. Success criteria for each procedure are listed in Table 2. In addition, surgeons completed questionnaires that evaluated their ability to perform surgical tasks with the two systems.

Procedure	Subject	Surgical Tasks Evaluated in Procedure
Left pyeloplastyRight pyeloplasty	CadaverCadaver	During a pyeloplasty, the surgeon requires access to the ureter and renal hilumand requires precise control of instruments to effectively suture the anastomosis.Success Criteria: Anastomosis complete with no visible gaps where leakingcould occur
Left totalnephrectomyRight totalnephrectomy	CadaverCadaver	During a nephrectomy, the surgeon requires sufficient range of motion tocircumferentially dissect the kidney and needs precise control of instruments tosafely dissect around blood vessels.Success Criteria: Kidney completely freed from all surrounding tissues
Prostatectomy	Cadaver	During a radical prostatectomy, the surgeon accesses a broad range of anatomyfrom the urachus to the distal urethra, deep in the pelvis. In addition, removingthe lymph nodes requires access to the right and left pelvic walls. The surgeonalso requires precise control of instruments to enable safe dissection aroundblood vessels and effective suturing.Success Criteria: Prostate completely removed, no leaking of anastomosiswhen bladder is filled with water (~120mL)
Left pelviclymphadenectomyRight pelviclymphadenectomy	CadaverCadaver	Success Criteria: Lymph nodes freed from vessels, anatomic landmarks todefine dissection boundaries visualized
Ureterskeletonization,transection, andanastomosis(Pyeloplasty)	Porcine	Success Criteria: Anastomosis complete with no visible leaks of urine
Renal hilumdissection	Porcine	Success Criteria: Renal artery and renal vein sufficiently dissected toenable ligation
Partial nephrectomy	Porcine	Success Criteria: Defect closed such that hemostasis is maintainedfollowing removal of the Bulldog clamp
Total nephrectomy	Porcine	Success Criteria: No blood leaks following ligation of the renal arteryand renal vein, entire kidney freed from allattachments
Bladder neckmobilization,division, andanastomosis	Porcine	Success Criteria: No leaking from anastomosis when bladder filledwith water (~100-120mL or until full)
Pelviclymphadenectomy	Porcine	Success Criteria: Lymph node freed from surrounding tissue

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Clinical Validation -

No clinical testing was provided with this submission using the subject device.

Human Factors Evaluation -

A human factors (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 SP999 Human Factors Hazard Analysis was developed with feedback from internal functional group experts, using cognitive walk-through, experience from prior products, and internal testing to identify use-related risks. This human factors hazard analysis was updated throughout the design process as formative testing was conducted, system design was iterated, new use errors were identified, and new mitigations were implemented. Formative testing was conducted both on complete system prototypes and on individual features of the user interface design. Those tests, along with information about the use of previous da Vinci Surgical Systems (Models IS 1200, IS2000, and IS3000), helped identify use-related risks for the SP999 system. Additionally, an earlier version of the SP999 was used in a clinical investigation, which provided valuable usability feedback that led to the current design iteration.

A summative validation study conducted with 15 teams of users (surgeons and patient side assistants). This study was conducted in a simulated OR and involved preoperative preparation and simulated surgical procedures, as well as emergency procedures that involved safety critical tasks. Training materials and user manuals were developed in concert with the product hardware and software, and were assessed in the validation study. The goals of human factors validation testing were to:

Validate risk mitigations to ensure use-safety and effectiveness of the system .
Assess any previously unknown use-related hazards, or identify and assess any hazards . resulting from implemented mitigations
. Evaluate ease of use
Assess effectiveness of user documentation (i.e., User Manual and Instructions for Use) .
Assess effectiveness of training material .

A total of 15 user teams participated in the study, each team consisting of a surgical urologist and a patient side assistant. Surgeon participants exhibited a wide range of age (34 - 65 years), years in surgical practice (2 - 30 years), and robotic surgical experience (13 - 1000 cases). Patient side

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K131962 Page 10 of 11

assistants also varied in age (26 - 52 years), experience (55 - 40.000 cases), and robotic patient side experience (0 - 9000 cases). Participants underwent the training a user would be provided for the SP999 system on the first day. The testing sessions were conducted in a simulated operating room environment which included overhead operating room lighting, an adjustable patient table, and accessory equipment (e.g. anesthesia equipment, energy equipment, insufflator, etc.). Participants were asked to use sterile technique within the surgical field. In addition to the normal use situation of performing the necessary surgical tasks to complete the procedures, imposed scenarios were interjected to test use scenarios that may not occur during normal operation of the system, such as responding to a non-recoverable system fault. Data collected included both 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 SP999 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 factors engineering process, culminating in a usability validation study, was used to identify and assess the use-related risks associated with the SP999. The safety and usability of the SP999 were assessed to ensure residual risk is at acceptable levels, and that new hazardous use scenarios identified during testing were assessed according to an accepted risk management process and updated in the Human Factor Hazard Analysis for the SP999.

Feasibility Study

The 510(k) also included information with thirty (30) day post-operative outcomes on 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies) successfully performed with a functionally equivalent prototype version of the SP999 system as part of an OUS feasibility study. The clinical data were not used to demonstrate substantial equivalence to the predicate device, but served to supplement the animal and cadaver testing and provided further evidence that the new design of the SP999 is safe and effective in a human clinical setting.

Conclusion :

Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci® Sp™ Surgical System, Model SP999, EndoWrist Sp™ Instruments, and Accessories, is substantially equivalent (SE) to the predicate devices. 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

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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 animal were adequate to establish SE to the predicate.

This review did not compare human clinical performance between the da Vinci® Sp™ Surgical System, Model SP999, EndoWrist Sp™ Instruments, and Accessories and its predicates. This review did not assess user training although a training program was described as part of the human factors assessment.

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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three overlapping wings or strokes, giving the impression of movement or flight. The logo is black and white.

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

April 17, 2014

Intuitive Surgical Incorporated Mr. Mike Yramategui Principal Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K131962

Trade/Device Name: da Vinci Sp Surgical System, EndoWrist Sp Instruments, and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: March 14, 2014 Received: March 18, 2014

Dear Mr. Yramategui:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:

The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological procedures with the da Vinci EndoWrist Sp Instruments and the da Vinci Sp Surgical System (SP999).

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Page 2 - Mr. Mike Yramategui

Please note that the above labeling limitations are required by Section 513(i)(I)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (Part 801), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/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 Industry and Consumer Education 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 vours.

Christy L. Foreman -S

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration

Enclosure

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510(k) Number if known: K131962

Device Name: SP999 da Vincio Sp™ Surgical System

INDICATIONS FOR USE:

da Vincio SpTM Surgical System, Model SP999

The Intuitive Surgical Endoscopic Instrument Control System (da Vincio Sp™ Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist® Sp™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist® Sp™ Instruments

Intuitive Surgical EndoWrist® Sp™ Instruments are controlled by the da Vincito Sp™ Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Prescription Use X AND/OR Over-the-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

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.