da Vinci SP® Surgical System, Model SP1098:
The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) 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 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 SPTM Instruments:
Intuitive Surgical® EndoWrist SP™ Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, 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 laparoach. 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 SP1098 is a software-controlled, electromechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 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.

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, threedimensional 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 perform procedures with the system.

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-Z 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 SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The EndoWrist SP 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.

AI/ML Overview

This document describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (referred to as "the device" or "SP1098 system") and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device (Model SP999) and that design output meets design input requirements. The "performance" is generally reported as successful completion of these tests, confirming the device's ability to operate as intended and safely.

Below is a summary of the performance studies conducted and the reported outcomes:

Study Type	Acceptance Criteria (Implied / Reported Outcome)	Reported Device Performance
Bench Performance Testing	General: Design output meets design input requirements; mechanical and electrical specifications are met; components function as intended; image quality, physical specifications, mechanical requirements, equipment interfaces, re-use and reliability, environmental requirements, shipping, storage, package and labeling requirements are met.	SP1098 Patient Cart & Subassemblies: Subjects to full design verification to mechanical/electrical specifications, including brake forces, safety, lower-risk mechanical requirements, miscellaneous design features, external testing, applied loads, interfaces, mechanical design, electrical requirements, and reliability. SP1098 Surgeon Console: Verification testing confirmed modifications (foot pedals) meet electrical and mechanical specifications (mechanical stability, cosmetic/labeling, pedal labels/layout, pedal reliability, sensors). SP1098 Vision Cart: Verification testing confirmed modifications (EnergyShield Monitor addition) meet electrical/mechanical specifications, and design verification performed for EnergyShield Monitor (physical features, layout, equipment interfaces, electrical requirements, safety, environmental, labeling). SP1098 Surgical Instruments & Camera: Testing performed to verify design meets physical/mechanical/user interface/equipment interface requirements (size, weight, materials, force, range of motion, accuracy, electrical/patient safety, image quality, re-use/reliability, environmental, shipping/storage, package/labeling). SP1098 Accessories: Testing performed to verify design meets physical/mechanical/user interface/equipment interface requirements (size, weight, materials, mechanical/electrical, equipment interfaces, re-use/reliability, package/labeling). Overall: "The bench performance testing verified that the design requirements and specifications for the new and/or changed components of the system are met."
Cadaver Testing	Device performance demonstrated for anatomical access and reach in various specific urological procedures (pelvic lymphadenectomy, colectomy, radical prostatectomy, pyeloplasty, total nephrectomy, partial nephrectomy). Specific success criteria for each procedure: Anastomosis complete and acceptable, critical anatomy identified, kidney completely freed, lymph nodes freed, prostate removed, urethrovesical anastomosis complete and acceptable, dissection borders achieved, fine dissection ability, suturing ability, and needle handling.	Nine procedures performed (6 cadaver, 3 porcine). Cadaver specific procedures: Pelvic lymphadenectomy (enables evaluation of pelvic access and precise dissection around vessels), Colectomy (evaluation of range of motion and work volume, instrument/grip strength), Radical Prostatectomy (assessment of deep pelvis access and suturing in confined space), Pyeloplasty (assessment of renal access and suturing small/thin tissues), Total Nephrectomy (evaluation of renal access, fine dissection, instrument strength/range of motion), Partial Nephrectomy (evaluation of fine dissection, suturing delicate tissue, needle handling). Specific performance for the 3 independent surgeons: Anastomosis complete and deemed acceptable upon visual inspection, critical anatomy identified, kidney/lymph nodes completely freed, prostate removed, urethrovesical anastomosis complete and acceptable, dissection borders achieved, hemostasis maintained, 2cm defect removed and closed, renal vein and artery successfully ligated, 3cm length of bladder neck/urethra mobilized. Overall: "The cadaver performance testing validated the users' ability to use the system to accurately control the endoscopic instruments, to reach the necessary target anatomy, and to perform surgical tasks."
Animal (Porcine) Testing	Safety and performance assessed in live tissue models where appropriate, including working with perfused organs, bleeding, normal tissue handling, achieving/maintaining hemostasis. Specific success criteria for each procedure: Anastomosis complete and acceptable, hemostasis maintained, 2 cm diameter defect removed and closed, renal vein and artery successfully ligated, kidney freed, bladder neck/urethra mobilized, lymph node freed.	Live animal specific procedures (porcine): Partial nephrectomy (fine dissection in live tissue, suturing delicate tissue, needle handling), Renal artery ligation/transection/anastomosis (effectively ligating blood vessels, transecting thin tissue, precise suturing/manipulation), Bladder neck dissection/transection/urethrovesical anastomosis (dissecting deep in pelvis, transecting/manipulating/suturing thick tissue, needle handling). Similar successful outcomes as described for cadaver testing. Overall: "The simulated and representative urological procedures in live animals provided validation that the system can safely and effectively complete representative urologic procedures encompassed by the indications for use statement."
Human Factors (HF) Study	Usability risk analysis updated, mitigations implemented, use-related risks identified, previously unknown hazards addressed, safety and effectiveness validated, residual risk at acceptable level, ease of use evaluated, effectiveness of user documentation and training material assessed. Identification and mitigation of use-related risks associated with the SP1098 system.	Formative testing: Conducted on complete system prototypes and individual user interface features; helped identify use-related risks. Summative validation study: Conducted in a simulated operating room; involved 15 surgical teams and 15 prep teams; evaluated high-risk use scenarios and essential tasks, including emergency procedures (e.g., EnergyShield Monitor fault); training materials and user manuals assessed. Data collected included objective performance (observations of task completion, use errors, close calls, difficulties) and subjective feedback (open-ended questions, multiple choice ratings, follow-up interviews). Overall: "The human factors engineering process, culminating in a summative usability validation study, was used to identify and assess the use-related risks associated with the SP1098 system. The safety and usability of the SP1098 were assessed to ensure that residual risk is at an acceptable level, and new hazardous use scenarios identified during testing were assessed according to an accepted risk management process and updated in the usability risk analysis for the SP1098 system."
Substantial Equivalence	The device is substantially equivalent to the predicate device based on intended use, indications for use, technological characteristics, and performance data.	The FDA concluded, "Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories, is substantially equivalent (SE) to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Cadaver and Animal Performance Testing:
- Cadaver Models: 6 cadaver procedures were performed.
- Porcine Models: 3 porcine (live animal) procedures were performed.
- Surgeons: 3 independent practicing surgeons participated. Each performed 7 urologic procedures in cadaver models and 5 representative and simulated procedures in porcine models, totaling 36 surgical procedures.
- Data Provenance: Not explicitly stated, but cadaver and porcine models are used, generally implying controlled laboratory or surgical simulation environments. The participants are "independent practicing surgeons," suggesting their experience is relevant to real-world clinical practice, but the tests themselves were in simulated environments. It's a prospective study in the sense that the device was specifically tested in these models.
Human Factors (HF) Performance Testing:
- Participants: A total of 15 surgical teams (surgeon and patient-side assistant) and 15 prep teams (scrub tech and circulating nurse).
- Data Provenance: The study was conducted in a "simulated operating room environment," involving controlled, prospective testing scenarios.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Cadaver and Animal Performance Testing: The "ground truth" for the success criteria (e.g., "Anastomosis complete and deemed acceptable upon visual inspection," "Critical anatomy identified," "Hemostasis maintained") was implicitly established by the 3 independent practicing surgeons who performed the procedures and evaluated the outcomes. Their qualifications are stated as "independent practicing surgeons," implying they are qualified by their profession and experience to make these assessments.
Human Factors Testing: The "usability risk analysis was developed with feedback from internal functional group experts." The qualifications of these internal experts are not specifically detailed (e.g., years of experience, specific certifications), but they are described as "functional group experts."

4. Adjudication Method for the Test Set

Cadaver and Animal Performance Testing: The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the surgical outcomes. The success criteria imply a direct assessment by the performing surgeons. It might be assumed that for critical assessments like "acceptable upon visual inspection," the surgeons' professional judgment served as the "adjudication."
Human Factors Testing: "The SP1098 usability risk 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." This suggests an iterative process where identified issues were reviewed and addressed, but a specific "adjudication method" for individual use errors is not detailed. Objective performance data and subjective feedback were collected and presumably interpreted by human factors experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a surgical system, not an AI-assisted diagnostic or interpretation tool for "readers." The performance studies focused on the surgical system's ability to perform procedures, safety, and usability.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a surgical system that requires a human surgeon for operation (human-in-the-loop). It is not a standalone algorithm. The "standalone" aspect that could be considered is the system's electromechanical function and software control, which were tested via bench performance without direct human interaction for some aspects, but the overall product is user-dependent.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For Cadaver and Animal Testing: The ground truth was based on the expert assessment and visual inspection of the surgical outcomes by "independent practicing surgeons" against predefined success criteria (e.g., "Anastomosis complete and deemed acceptable," "Kidney completely freed," "Hemostasis maintained"). No mention of pathology or long-term outcomes data for these specific tests.
For Human Factors Testing: The ground truth for identifying usability issues and risks was based on observations of user performance (objective data) and user feedback (subjective data) during simulated scenarios, interpreted by human factors experts.

8. The Sample Size for the Training Set

Not explicitly stated for an AI/algorithm context. This device is a robotic surgical system, not a machine learning model that undergoes "training" in the traditional sense with a distinct training dataset. Its development likely involved iterative design and testing using various models and prototypes, which could be seen as its "training" or development phase.

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

Not applicable in the context of an AI training set for this type of medical device. The "ground truth" for the device's design and engineering development (analogous to a training set in ML) would have been established through engineering specifications, design input requirements, and previous historical data/knowledge from predicate devices (e.g., da Vinci SP999, da Vinci Xi IS4000). These requirements and the "truth" of their fulfillment were then verified through the detailed bench, cadaver, animal, and human factors testing described.

Summary

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May 31, 2018

Intuitive Surgical, Inc. Elaine Lee Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K173906

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: April 26, 2018 Received: April 27, 2018

Dear Elaine Lee:

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 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 (SP1098).

Please note that the above labeling limitations are required by Section 513(i)(1)(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.

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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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

William H. Maisel -S

William H. Maisel. MD. MPH Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173906

Device Name

da Vinci SP® Surgical System, Model SP1098, EndoWrist SP™ Instruments, and Accessories

Indications for Use (Describe)

da Vinci SP® Surgical System, Model SP1098:

The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) 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 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 SPTM Instruments:

Intuitive Surgical® EndoWrist SP™ Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, 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 laparoach. 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (7/17)

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Elaine LeeSenior Regulatory EngineerPhone Number: 408-523-8887Fax Number: 408-523-8907Email: Elaine.Lee@intusurg.com
Date Summary Prepared:	May 29, 2018
Trade Name:	da Vinci SP® Surgical System, Model SP1098,EndoWrist SPTM Instruments, and Accessories
Common Name:	Endoscopic instrument control system, endoscopicinstruments and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	da Vinci SP Surgical System, Model SP999, EndoWrist SPInstruments, and Accessories (K131962)
Reference Device:	Intuitive Surgical da Vinci Xi Surgical System, ModelIS4000 (K131861, K152892, K161271)

Device Description

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Image /page/4/Picture/2 description: The image shows three pieces of medical equipment against a white background. The first piece of equipment is a surgical console with a large, gray viewing hood and robotic arm controls. The second piece of equipment is a robotic surgical arm with multiple joints and a base. The third piece of equipment is a medical cart with a monitor, shelves, and drawers.

Surgeon Console, Model SS1098

Patient Cart, Model PS1098

Vision Cart, Model VS1098

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

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The following EndoWrist SP Instruments and accessories are listed for use with the da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

Fenestrated Bipolar Forceps .
. Maryland Bipolar Forceps
. Medium-Large Clip Applier (a.k.a. ML Clip Applier)
Monopolar Cautery Instrument .
Monopolar Curved Scissors (a.k.a. MCS) ●
Needle Driver ●
. Round Tooth Retractor
Cadiere Forceps ●
EndoWrist SP Camera, 0° (a.k.a. Camera Instrument) ●

Accessories for the SP1098 da Vinci SP Surgical System:

SP Cannula, Circular, 25 x 100 mm (a.k.a. Cannula) .
. SP Obturator, Circular, 25 x 100 mm (a.k.a. Obturator)
EntryGuide Kit C.6.6.6, 25 x 100 mm (a.k.a. Entry Guide and Cannula . Seal)
Instrument Sheath .
Camera Sheath
MCS Tip ●
Cautery Hook Tip ●
Cautery Spatula Tip .
Bipolar Cautery Cord .
EnergyShield Monopolar Cautery Cord
Instrument Arm Drape (a.k.a. Drape) ●

Intended Use:

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

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Indications for Use:

da Vinci SP® Surgical System, Model SP1098

The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) 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 Vinci SP® Surgical System, Model SP1098, 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.

Comparison of Technological Characteristics with the Predicate Device:

The da Vinci SP Surgical System, Model SP1098 is equivalent to the predicate device, Model SP999 (K131962), in terms of technological characteristics, and has identical indications for use. Like the Model SP999, the Model SP1098 is designed for use in single incision laparoscopic procedures.

The Model SP1098 is a modification of the Model SP999 (K131962). The Vision Cart, Surgeon Console, and Patient Cart were modified to incorporate the latest mechanical, electrical, and user interface technology of the cleared multi-port da Vinci Xi Surgical System, Model IS4000 (K131861, as modified by K152892 and K161271). An integrated monopolar energy monitor was also added to the Vision Cart. Modifications were also made to the EndoWrist SP Instruments and Accessories to improve manufacturability, robustness/reliability, cleaning ability, and ease of use while enhancing safety and maintaining the same ability to perform surgical tasks. In order to accommodate the modified instruments and to improve ease of use, the Instrument Arm and Instrument Drives were updated as well.

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Attribute	Subject DeviceSP1098 da Vinci SP Surgical System,Instruments, and Accessories	Predicate DeviceSP999 da Vinci SP Surgical System,Instruments, and Accessories (K131962)
Device types	System Carts:• Surgeon Console• Vision Cart, including theEnergyShield Monitor• Patient CartInstruments:• Fenestrated Bipolar Forceps• Maryland Bipolar Forceps• Medium-Large Clip Applier• Monopolar Cautery Instrument• Monopolar Curved Scissors• Needle Driver• Round Tooth Retractor• Cadiere ForcepsEndoscope:• Camera InstrumentAccessories:• Cannula• Entry Guide• Cannula Seal• Obturator• Instrument Sheath• Camera Sheath• Energy Shield Monopolar CauteryCord• Drape• MCS Tip	SAME types of system carts as subjectdevice.SAME types of available instrumentsand endoscope as subject device.Note: The SP999 instruments did notinclude a Round Tooth Retractor orCadiere Forceps; however, the SP999Fenestrated Bipolar Forceps is thepredicate device for these newinstruments.SAME types of accessories as subjectdevice, plus the AEM (Active ElectrodeMonitor).Note: The Active Electrode Monitor andMonopolar Cautery Cord used with theSP999 system were third-party devices.
Common Name	Endoscopic instrument control system,endoscopic instruments and accessories	SAME as subject device
Attribute	Subject DeviceSP1098 da Vinci SP Surgical System,Instruments, and Accessories	Predicate DeviceSP999 da Vinci SP Surgical System,Instruments, and Accessories (K131962)
RegulationNumber & Name	21 CFR 876.1500Endoscope and Accessories	SAME as subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	SAME as subject device
Product Code(s)	NAY (System, Surgical, ComputerControlled Instrument)	SAME as subject device
Classification	Class II	SAME as subject device
Intended Use	To assist in the accurate control ofendoscopic instruments in minimallyinvasive surgery.	SAME as subject device
Principles ofOperation	Facilitates accurate movement of surgicalinstruments and an endoscope through asingle surgical port by using amaster/slave servomechanism thatincorporates servo drive and system-levelmotor control.	SAME as subject device
Prescription Use	Physician use only	SAME as subject device
Where Used	Hospital	SAME as subject device

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Performance Data:

Performance test data (bench, animal, 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. For some components or subassemblies that are identical to those in the Model SP999 or the Model IS4000. design verification relied on previous testing.

Bench Performance Testing

The SP1098 (da Vinci SP) 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, and the Instrument Drives is described below:

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

The SP1098 Surgeon Console is identical to the IS4000 (da Vinci Xi) Surgeon Console except for modifications to the foot pedals. Verification testing was performed to confirm that the modifications meet electrical and mechanical specifications, as summarized below:

Item	Testing
Surgeon Console	Mechanical stability
	Cosmetic and labeling requirements
Foot Pedals	Pedal labels and layout
	Pedal reliability
	Mechanical and electrical specifications
	Sensors

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The SP1098 Vision Cart is identical to the IS4000 Vision Cart except for the addition of the EnergyShield Monitor. Verification testing was performed to confirm that this modification meets electrical and mechanical specifications, and design verification testing was performed for the EnergyShield Monitor, as summarized below:

Item	Testing
Vision Cart	Mechanical and electrical requirements
	Safety
EnergyShield® Monitor	Physical specifications (physical features, layout)
	Equipment interfaces (mechanical, electrical, cleaning)
	Electrical requirements
	Electrical safety
	Environmental requirements
	Labeling

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 SP1098 surgical instruments and camera is described below:

Item	Testing
Camera	Physical specifications (size, weight, materials)Mechanical requirements (force, range of motion,accuracy)Equipment interfaces (mechanical, electrical, cleaning,software)Electrical and patient safetyImage qualityLabeling
Surgical Instruments	Physical specifications (dimensions, weight, materials)Mechanical requirements (force, range of motion,accuracy)Equipment interfaces (mechanical, electrical, cleaning,software)User interface and patient safetyRe-use and reliabilityEnvironmental requirementsShipping and storagePackage and labeling

A summary of the design verification testing for the SP1098 accessories is described below:

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Item	Testing
Cannula, Obturator,	Physical specifications (size, weight, materials)
EntryGuide™ Kit,	Mechanical and electrical requirements
Instrument Sheath,	Equipment interfaces
Camera Sheath, MCS	Re-use and reliability
Tip, EnergyShield®	Package and labeling
Monopolar Cautery Cord,
Instrument Arm Drape

Cadaver and Animal Performance Testing -

Cadaver models were used to demonstrate device 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 use, including working with perfused organs, bleeding, normal tissue handling, and ensuring that appropriate hemostasis is achieved and maintained. Nine procedures were performed (6 cadaver, 3 porcine) to evaluate and validate the performance of the overall SP1098 system. Procedures were chosen on the basis of the types of surgical tasks that are performed, and which EndoWrist SP instruments are needed for the tasks.

Procedure	Subject	Performance Evaluated in Procedure
Pelvic lymphadenectomy	Cadaver	Enables evaluation of pelvic access and ability to preciselydissect around vessels.
Colectomy (Right and Left)	Cadaver	Requires access to multiple quadrants of the body, allowingevaluation of the system's range of motion and ability to workin a large work volume. Instrument and grip strength duringretraction can also be assessed.
Radical Prostatectomy	Cadaver	Allows assessment of the ability to access the deep pelvis in amale model and suture in a confined space.
Pyeloplasty	Cadaver	Enables assessment of renal access and the ability to preciselysuture small/thin tissues.
Total Nephrectomy	Cadaver	Enables evaluation of renal access, fine dissection abilityduring renal hilum dissection, and instrument strength andrange of motion during mobilization of the kidney.
Partial Nephrectomy	Cadaver	Enables evaluation of fine dissection ability around vascularstructures, suturing of delicate tissue, and evaluation of needlehandling in a variety of orientations.
Partial nephrectomy (renalhilum dissection andclamping, specimenresection, and defect closure)	Porcine	Enables evaluation of fine dissection in live tissue andsuturing of delicate tissue. Additionally, allows evaluation ofneedle handling in a variety of orientations.
Renal artery ligation,transection, and anastomosis	Porcine	Enables evaluation of the ability to effectively ligate bloodvessels and to transect thin tissue, as well as precisely sutureand manipulate small anatomy.
Bladder neck dissection,transection, andurethrovesical anastomosis	Porcine	Allows assessment of the ability to dissect deep in the pelvisas well as to transect, manipulate, and suture thick tissue.Additionally, enables evaluation of needle handling in avariety of orientations.

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Three (3) independent practicing surgeons participated in a study using the SP1098 system to perform a set of urologic procedures. Each surgeon performed seven urologic procedures in a cadaver model and five representative and simulated procedures in a porcine model, for a total of 36 surgical procedures performed. The order that the procedures were performed was randomized. Success criteria for each procedure are listed below. In addition, surgeons completed questionnaires that evaluated their ability to perform surgical tasks with the SP1098 system.

Procedure	Subject	Success Criteria
Left pyeloplasty	Cadaver	Anastomosis complete and deemed acceptable upon visual inspection.
Right pyeloplasty	Cadaver	Critical anatomy identified.
Left total nephrectomy	Cadaver	Kidney completely freed from all surrounding tissues. Critical anatomy identified.
Right total nephrectomy	Cadaver	Kidney completely freed from all surrounding tissues. Critical anatomy identified.
Prostatectomy	Cadaver	Prostate is removed. Urethrovesical anastomosis is complete and deemed acceptable upon visual inspection. Critical anatomy identified.
Left pelvic lymphadenectomy	Cadaver	Lymph nodes freed from vessels. Critical anatomy identified and dissection borders achieved.
Right pelvic lymphadenectomy	Cadaver	Lymph nodes freed from vessels. Critical anatomy identified and dissection borders achieved.
Pyeloplasty	Porcine	Ureter anastomosis is complete and deemed acceptable upon visual inspection. Hemostasis is maintained.
Partial nephrectomy	Porcine	2 cm diameter defect is removed. Defect is closed such that hemostasis is maintained.
Total nephrectomy	Porcine	Renal vein and artery successfully ligated. Entire kidney freed from all attachments. Hemostasis is maintained.
Bladder neck mobilization, division, and anastomosis	Porcine	3 cm length of bladder neck/urethra mobilized. Anastomosis is complete and deemed acceptable upon visual inspection. Hemostasis is maintained.
Pelvic lymphadenectomy	Porcine	Lymph node freed from surrounding tissue. Hemostasis is maintained.

Clinical Studies -

No clinical testing was provided with this submission using the subject device to support substantial equivalence.

Human Factors Performance Testing -

A human factors (HF) engineering process was followed in accordance with the following:

. ANSI/AAMI/IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices
FDA, 2016, Applying Human Factors and Usability Engineering to Medical . Devices - Guidance for Industry and Food and Drug Administration Staff

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The SP1098 usability risk 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 usability risk 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 the da Vinci Xi Surgical System (Model IS4000), with which the SP1098 shares some design features, helped identify use-related risks for the SP1098 system.

A summative validation study was conducted to evaluate high-risk use scenarios and essential tasks that were not assessed in previous usability validations. This study was conducted in a simulated operating room and involved preoperative preparation and simulated surgical procedures, as well as emergency procedures that involved safetycritical 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 .
Assess effectiveness of training material .

A total of 15 surgical teams (surgeon and patient-side assistant) and 15 prep teams (scrub tech and circulating nurse) participated in the study. Participants underwent the training a user would be provided for the SP1098 system on the first day. The testing sessions were conducted in a simulated operating room environment. 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 interiected to test use scenarios that may not occur during normal operation of the system, such as responding to an EnergyShield Monitor 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 human factors engineering process, culminating in a summative usability validation study, was used to identify and assess the use-related risks associated with the SP1098

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system. The safety and usability of the SP1098 were assessed to ensure that residual risk is at an acceptable level, and new hazardous use scenarios identified during testing were assessed according to an accepted risk management process and updated in the usability risk analysis for the SP1098 system.

Consensus Standards and FDA Guidance Documents Used in Performance Testing:

. AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
AAMI/ANSI/IEC 60601-2-2:2009, Medical Electrical Equipment Part 2-2: . Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgery Equipment and High Frequency Surgical Accessories
. IEC 60601-2-18:2009, Medical Electrical Equipment - Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment
. IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance
. IEC 60825-1:2007, Safety of Laser Products - Part 1: Equipment Classification and Requirements
. ANSI/AAMI/IEC 62366-1:2015, Medical devices - Application of Usability Engineering to Medical Devices
IEC 62304:2015, Medical Device Software Software Life Cycle Processes ●
AAMI/ANSI/ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical . Devices - Part 1: Evaluation and Testing within a Risk Management Process
. ISO 10993-7:2008. Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
. ISO 17665-1:2006, Sterilization Of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
AAMI/ANSI/ISO 11137-1:2006/(R)2010, Sterilization of Health Care Products -. Radiation - Part 1
ASTM D4169-16, Standard Practice for Performance Testing of Shipping . Containers and Systems
. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015.
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for . General Surgery. Guidance for Industry and Food and Drug Administration Staff, issued August 15, 2016.

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Applying Human Factors and Usability Engineering to Medical Devices. . Guidance for Industry and Food and Drug Administration Staff, issued February 3, 2016.

Conclusion:

Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories, is substantially equivalent (SE) to the predicate device. This SE determination is based on performance testing that included: bench, cadaver, and animal testing with simulated and representative urological procedures. The bench performance testing verified that the design requirements and specifications for the new and/or changed components of the system are met. The cadaver performance testing validated 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 and representative urological procedures in live animals provided validation that the system can safely and effectively complete representative urologic 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.

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.