The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).

The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric 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.

The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps(pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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

S2000/IS3000 5mm and 8mm Instruments can be used only with the da Vinci S (IS2000) and Si (IS3000) Surgical Systems. Most instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips.

The Harmonic ACE Curved Shears Instrument (5mm/8mm) consists of a proximal reusable instrument housing and a distal disposable insert. The reusable instrument housing, when assembled with the disposable insert, is attached to the da Vinci IS2000/IS3000 System and delivers ultrasonic energy for transection (cutting) and coagulation of tissue.

The Endowrist Stabilizer is a reusable instrument similar to the da Vinci S/ Si EndoWrist Instruments. It is mounted on a PSM arm and is positioned, controlled, and held in place by the da Vinci IS2000/IS3000 System.

da Vinci S/ Si Accessories mainly consist of: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point; "Other" Accessories include PK Cables, instrument release kit (IRK), Blade Protectors and Insertion tools (used with the Snap-FitTM Scalpel Instrument), a Blank Cartridge (used with the Endopass Delivery instrument), cannula mounts, light guide cable and cannula gage pins. These accessories have simple geometries with no long narrow lumens.

The Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an integral electrical receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci S/Si Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-pin grounding connector.

The 8.5 mm Endoscope Cannula is made of stainless steel components and is used to establish a port of entry for the 8.5mm Endoscope and provide an outlet for insufflation and/or smoke evacuation.

The Endoscope Alignment Target is used during stereo endoscope set-up to align the left and right images from the endoscope to provide a stereo image to the console surgeon. It does not have any long narrow lumens.

AI/ML Overview

The provided document describes a 510(k) premarket notification for changes to the reprocessing instructions for various da Vinci S/Si EndoWrist Instruments and Accessories, not a new device or an AI-powered device. Therefore, the information typically requested for AI/machine learning device studies (such as sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable here as this submission focuses on the effectiveness of the reprocessing instructions rather than the diagnostic or therapeutic performance of the instruments themselves.

The study presented focuses entirely on the validation of the revised reprocessing instructions.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Cleaning Validation	Efficacy of cleaning process in reprocessing instructions in accordance with: - FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) - AAMI TIR 12:2010 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities) - AAMI TIR 30: 2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) - Qualitative visual inspection - Quantitative endpoints	Cleaning Efficacy test evaluated the cleaning process for the devices using qualitative visual inspection and quantitative endpoints, demonstrating compliance with standards.
Thermal Disinfection Validation	Efficacy of disinfection process in reprocessing instructions in accordance with: - FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) - FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (February 7, 2002) - Quantitative endpoint: 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group)	Thermal disinfection efficacy testing evaluated the efficacy of the disinfection process, achieving a quantitative endpoint of 6-log10 reduction of typical vegetative organisms.
Human Factors Testing	Usability, effectiveness, and use safety of the Reprocessing Instructions, evaluated through: - Preliminary Evaluation - Usability Risk Analysis (URA) - Design Team Participation - Formative Testing - Validation Testing with representative end users	The Reprocessing Instructions underwent a rigorous Human Factors testing process, including preliminary evaluation, URA, design team participation, formative testing, and validation testing, assessing usability, effectiveness, and safety.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the devices tested for cleaning and thermal disinfection. It states that "devices within the product family that represent the greatest challenge for the cleaning process" and "devices within the product family that represent significant challenges to the disinfection step" were used. For Human Factors testing, "representative end users" were involved, but no number is given.
Data Provenance: The studies were conducted by Intuitive Surgical, Inc. as part of their 510(k) submission. The nature of these validation studies (e.g., cleaning, disinfection, human factors) implies they were prospective experiments or evaluations designed specifically for this submission. The country of origin of the data is not specified but would typically be where the manufacturer conducts its testing (likely the US, given the FDA submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not explicitly stated. For cleaning and thermal disinfection, the "ground truth" and acceptance criteria are based on established regulatory guidance and industry standards (FDA guidance, AAMI TIRs). For Human Factors, "Human Factors Engineers" participated in the design and evaluation, and "representative end users" participated in validation testing. No specific number or individual qualifications are provided beyond these roles.

4. Adjudication method for the test set:

No specific adjudication method (e.g., 2+1, 3+1) is mentioned as relevant for these types of validation studies. The assessments for cleaning and disinfection are based on objective measures against defined standards (visual inspection, quantitative reduction of microorganisms). The Human Factors studies involved direct observation and feedback during usability testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This submission is for changes to reprocessing instructions for surgical instruments, not an AI or imaging device that would typically involve human "readers." The concept of improving human readers with AI assistance is not applicable here.

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

No, a standalone (algorithm-only) performance study was not done. The device in question (surgical instruments) is not an algorithm. The "performance" being evaluated is the effectiveness of the reprocessing instructions for cleaning and disinfecting physical medical devices, and the usability of these instructions by human users.

7. The type of ground truth used:

Cleaning and Thermal Disinfection: Ground truth is established by adherence to recognized industry standards and regulatory guidance documents (e.g., FDA guidance, AAMI TIRs) for sterility, cleanliness, and disinfection efficacy, which include quantitative microbiological reduction targets.
Human Factors: Ground truth is established by the usability, effectiveness, and safety of the instructions as determined through detailed ergonomic and human factors analyses and validation studies with representative users, aiming to identify and mitigate potential use errors.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device, so there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an algorithm.

Summary

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Public Health Service

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

September 11, 2017

Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K170644

Trade/Device Name: Da Vinci S/Si Endowrist Instruments and Accessories, Harmonic Ace Curved Shears (5mm & 8mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 14, 2017 Received: August 15, 2017

Dear Kunal Gunjal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.

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

Enclosure

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7 510(k) Summary (K170644)

This 510(k) applies to multiple instruments and accessories that have been cleared through a number of 510(k) Premarket Notifications. It concerns the Reprocessing Instructions provided to users for reprocessing of instruments and accessories intended for multiple usage. For ease of review, the subject devices have been listed in Tables 7.1 and 7.2 (which is structured based on the device and the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.

510(k) Owner	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact	Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared	August 14, 2017
Trade Name	da Vinci S/ SiEndoWristInstruments(5mm & 8mm)	Harmonic ACECurved Shears(5mm & 8mm)	EndowristStabilizer
Common Name	Endoscope andaccessories	Endoscope andaccessories	Cardiovascular SurgicalInstrument
Classification	Class II,21 CFR876.1500	Class II,21 CFR876.1500	Class II,21 CFR 876.1500
Product Codes	NAY	NAY	NAY
ClassificationAdvisoryCommittee:	General andPlastic Surgery	General andPlastic Surgery	General and Plastic Surgery
PredicateDevices	K050369 (usewith IS2000SurgicalSystem), withadditionalindicationsunder K081137(use withIS3000System),K090993(TORSindication) andK123329(updated TORSindication)	K093217 (usewith IS2000 andIS3000 SurgicalSystems)	K060391 (use with IS2000Surgical SystemK081137 (use with IS3000System)

Table 7.1: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System

Image /page/2/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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Changes to Reprocessing Instructions

K170644

510(k) Owner	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact	Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared	August 14, 2017
Trade Name	da Vinci S/ Si Accessories	Flared Cannula (5mm & 8mm)	8.5 mm Endoscope Cannulaand 8.5 mm EndoscopeAlignment Target
Common Name	Endoscope and accessories	Endoscope and accessories	Endoscope and accessories
Classification	Class II, 21 CFR 876.1500	Class II, 21 CFR 876.1500	Class II, 21 CFR 876.1500
Product Codes	NAY	NAY	NAY
Classification Advisory Committee:	General and Plastic Surgery	General and Plastic Surgery	General and Plastic Surgery
Predicate Devices	K050369 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication)	K101743 (use with IS2000 and IS3000 Surgical Systems)	K080155 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication)

Table 7.2: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System

Device Description

The da Vinci IS2000 (S) and IS3000 (Si) Surgical Systems are used in conjunction with reusable Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci S and da Vinci Si Instruments and Accessories. Tables 7.3 and 7.4 list the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.

Image /page/3/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol.

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Trade Name	da Vinci S/ Si EndoWristInstruments (5mm & 8mm)	Harmonic ACE Curved Shears(5mm & 8mm)	Endowrist Stabilizer
Device Description	S2000/IS3000 5mm and 8mmInstruments can be used onlywith the da Vinci S (IS2000)and Si (IS3000) SurgicalSystems. Most instrumentshave a unique articulatingdesign at their distal tips thatmimics the human wrist.While seated at the SurgeonConsole of the SurgicalSystem, the surgeon canprecisely control movementsof the endeffectors/instrument tips.	The Harmonic ACE CurvedShears Instrument (5mm/8mm)consists of a proximal reusableinstrument housing and a distaldisposable insert. The reusableinstrument housing, whenassembled with the disposableinsert, is attached to the daVinci IS2000/IS3000 Systemand delivers ultrasonic energyfor transection (cutting) andcoagulation of tissue.	The Endowrist Stabilizer is areusable instrument similar to theda Vinci S/ Si EndoWristInstruments. It is mounted on aPSM arm and is positioned,controlled, and held in place by theda Vinci IS2000/IS3000 System.

Table 7.3: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System

Table 7.4: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System

TradeName	da Vinci S/ Si Accessories	Flared Cannula (5mm &8mm)	8.5 mm Endoscope Cannula and 8.5 mmEndoscope Alignment Target
DeviceDescription	da Vinci S/ Si Accessories mainly consist of:Cannulae, which are essentially hollow tubesthat provide a path for instruments to access thesurgical siteObturators, which provide a means of initiallyinserting the seal and cannula assembliesthrough the body wall by providing a fitted tipthat extends beyond the cannula's most distalpoint."Other" Accessories include PK Cables,instrument release kit (IRK), Blade Protectorsand Insertion tools (used with the Snap-FitTMScalpel Instrument), a Blank Cartridge (usedwith the Endopass Delivery instrument),cannula mounts, light guide cable and cannulagage pins. These accessories have simplegeometries with no long narrow lumens.	The Flared Cannulaconsists of a taperedhollow tubular shaft witha flared distal tip and abowl with an integralelectrical receptacle. Thehollow shaft serves as theport of entry, the bowl isused to attach the cannulato the da Vinci S/SiSurgical System and thereceptacle allows forattachment ofcommercially availabledispersive electrodegrounding pad via a 2-pingrounding connector.	The 8.5 mm Endoscope Cannula is madeof stainless steel components and is used toestablish a port of entry for the 8.5mmEndoscope and provide an outlet forinsufflation and/or smoke evacuation.The Endoscope Alignment Target is usedduring stereo endoscope set-up to align theleft and right images from the endoscope toprovide a stereo image to the consolesurgeon. It does not have any long narrowlumens.

Indications for Use:

Tables 7.5 through 7.7 list the Indications for Use for the devices impacted by the changes to the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.

Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".

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Trade Name	da Vinci S/ Si EndoWrist Instruments (5mm&8mm) and Accessories	Harmonic ACE Curved Shears (5mm& 8mm)
Indications for Use	The Intuitive Surgical Endoscopic InstrumentControl System is intended to assist in theaccurate control of Intuitive Surgical EndoscopicInstruments including rigid endoscopes, blunt andsharp endoscopic dissectors, scissors, scalpels,ultrasonic shears, forceps/pick-ups, needleholders, endoscopic retractors, stabilizers,electrocautery and accessories for endoscopicmanipulation of tissue, including grasping,cutting, blunt and sharp dissection,approximation, ligation, electrocautery, suturing,and delivery and placement of microwave andcryogenic ablation probes and accessories, duringurologic surgical procedures, general laparoscopicsurgical procedures, gynecologic laparoscopicsurgical procedures, transoral otolaryngologysurgical procedures restricted to benign andmalignant tumors classified as TI and T2, and forbenign base of tongue resection procedures,general thoracoscopic surgical procedures, andthoracoscopically assisted cardiotomy procedures.The system can also be employed with adjunctivemediastinotomy to perform coronary anastomosisduring cardiac revascularization. The system isindicated for adult and pediatric use (except fortransoral otolaryngology surgical procedures). Itis intended to be used by trained physicians in anoperating room environment in accordance withthe representative, specific procedures set forth inthe Professional Instructions for Use.	The Intuitive Surgical da Vinci Harmonic ACE™Device is intended for soft tissue incisions whenbleeding control and minimal thermal injury aredesired. It is designed to be used in conjunction withthe da Vinci Surgical Systems (Model IS1200, IS2000and IS3000) and the Ethicon Endo-Surgery Generator300 (Model GEN04) and Hand Piece (Model HP054).

Table 7.6: EndoWrist Stabilizer Instrument used with the da Vinci S/Si (IS2000/IS3000) System

Trade Name	EndoWrist Stabilizer Instrument- For use with the daVinci S IS2000 System)	EndoWrist Stabilizer Instrument- For use with the da Vinci Si IS3000System)
Indications for Use	The Intuitive Surgical Endoscopic Instrument ControlSystem is intended to assist in the accurate control ofIntuitive Surgical Endoscopic Instruments includingrigid endoscopes, blunt and sharp endoscopic dissectors,scissors, scalpels, ultrasonic shears, forceps/pickups,needle holders, endoscopic retractors, stabilizers,electrocautery and accessories for endoscopicmanipulation of tissue, including grasping, cutting, bluntand sharp dissection, approximation, ligation,electrocautery, suturing, and delivery and placement ofmicrowave ablation probes and accessories duringurologic surgical procedures, general laparoscopicsurgical procedures, gynecologic laparoscopic surgicalprocedures, general noncardiovascular thoracoscopicsurgical procedures and thoracoscopically assistedcardiotomy procedures. The system can also beemployed, with adjunctive mediastinotomy to performcoronary anastomosis during cardiac revascularization.The system is indicated for adult and pediatric use. It isintended for use by trained physicians in an operatingroom environment in accordance with the representativespecific procedures set forth in the ProfessionalInstructions for Use.	The Intuitive Surgical Endoscopic Instrument Control System (IntuitiveSurgical® da Vinci Si Surgical System Model IS3000) is intended to assistin the accurate control of Intuitive Surgical Endoscopic Instrumentsincluding rigid endoscopes, blunt and sharp endoscopic dissectors,scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders,endoscopic retractors, stabilizers, electrocautery and accessories forendoscopic manipulation of tissue, including grasping, cutting, blunt andsharp dissection, approximation, ligation, electrocautery, suturing, anddelivery and placement of microwave and cryogenic ablation probes andaccessories during urologic surgical procedures, general laparoscopicsurgical procedures, gynecological laparoscopic surgical procedures,general cardiovascular and non-cardiovascular thoracoscopic surgicalprocedures, and thoracoscopically assisted cardiotomy procedures. Thesystem is indicated for adult and pediatric use. The system can also beemployed, with adjunctive mediastinotomy to perform coronaryanastomosis during cardiac revascularization. It is intended for use bytrained physicians in an operating room environment in accordance withthe representative specific procedures set forth in the ProfessionalInstructions for Use.

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Trade Name	Flared Cannula (5mm & 8mm)
Indications for Use	The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures thatdo not require maintenance of insufflation.

Table 7.7: Flared Cannula (5mm & 8mm) used with the da Vinci S/Si (1S2000/IS3000) System

Technological Characteristics:

The technological characteristics of the subject devices are identical to the predicate devices.

Performance Data:

Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Verification, design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.

Cleaning Validation

The cleaning validation testing summarized in this submission validates the efficacy of the cleaning process in the Reprocessing Instructions in accordance with the following standards and guidance documents:

FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for 0 reprocessing in health care facilities: A guide for medical device manufacturers
AAMI TIR 30: 2011 A compendium of processes, materials, test methods, and ● acceptance criteria for cleaning reusable medical devices

Cleaning validation testing was performed using devices within the product family that represent the greatest challenge for the cleaning process. The Cleaning Efficacy test evaluated the cleaning process (as described in the Reprocessing Instructions) for the devices using qualitative visual inspection and quantitative endpoints.

Thermal Disinfection Validation

The disinfection validation testing summarized in this submission validates the efficacy of the disinfection process in the Reprocessing Instructions in accordance with the following guidance documents:

Image /page/6/Picture/18 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a small yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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K170644
FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and ● Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff", document issued on February 7, 2002.

Efficacy of the thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use. The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e., 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.

Human Factors Testing

The Reprocessing Instructions underwent a rigorous Human Factors testing process. This process included:

Preliminary Evaluation: A preliminary evaluation was completed to better understand . the users, uses, and use environment.
. Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
Design Team Participation: Human Factors Engineers participated in design meetings 0 and played a significant role in the visual design and content development.
0 Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
. Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.

This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.

Summary:

Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate devices listed in Tables 7.1 and 7.2.

Image /page/7/Picture/17 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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Changes to Reprocessing Instructions

Traditional 510(k)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

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

510(k) Number (if known) K170644

Device Name

da Vinci S/Si EndoWrist Instruments (5mm & 8mm) and Accessories

Indications for Use (Describe)

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, lisation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiae revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (8/14)

Page 1 of 1

600000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Image /page/8/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray.

{9}------------------------------------------------

Changes to Reprocessing Instructions

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below.

510(k) Number (if known)

K170644

Device Name

Harmonic ACE Curved Shears Instrument (5mm & 8mm)

Indications for Use (Describe)

The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publiching Sarvices (301)-403-4740 17

Image /page/9/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, light gray sans-serif font, with the registered trademark symbol next to it.

{10}------------------------------------------------

Changes to Reprocessing Instructions

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170644

Device Name Flared Cannula (5mm & 8mm)

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

Image /page/10/Picture/23 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol. The text is light gray against a white background.

{11}------------------------------------------------

Changes to Reprocessing Instructions

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K170644

Device Name

EndoWrist Stabilizer Instrument

Indications for Use (Describe)

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

Image /page/11/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

{12}------------------------------------------------

Changes to Reprocessing Instructions

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K170644

Device Name

Endowrist Stabilizer Instrument

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

EP PSC Publishing Services (301) 443-6740

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.