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

The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

Device Description

The da Vinci Xi EndoWrist Instruments (8mm), have an articulating design at their distal tips that mimics the human wrist. Each instrument is used to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.

da Vinci Xi Accessories mainly consists 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 an instrument release kit (IRK), an Insertion tool and Instrument introducer. These accessories have simple geometries with no long narrow lumens.

The Monopolar and Bipolar Cautery Cords are accessories to electrosurgical instruments where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generator-mating connector on the other end.

The Hasson Cone, is a cone-shaped device which is intended to be used in endoscopic surgery to assist in establishing a port of entry through the abdominal wall for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, and compatible accessories. The Hasson Cone is available in two sizes; 8 mm and 12 mm & Stapler.

AI/ML Overview

The provided 510(k) summary (K170645) is for changes to the reprocessing instructions for da Vinci Xi Instruments and Accessories, Monopolar and Bipolar Cautery Cords, and da Vinci Xi Hasson Cones. It focuses on validating that the updated instructions effectively clean and disinfect the devices and are usable by healthcare personnel.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria Type	Acceptance Criteria (from standards/guidance)	Reported Device Performance
Cleaning Efficacy	Efficacy of the cleaning process (as described in the Reprocessing Instructions) with qualitative visual inspection and quantitative endpoints. Specific contaminants and reduction levels are implied by references to AAMI TIR 30: 2011.	Cleaning validation testing was performed on devices representing the greatest challenge. The cleaning process was evaluated using qualitative visual inspection and quantitative endpoints. (The document states this was done and implies success by concluding substantial equivalence without reporting specific quantitative results.)
Thermal Disinfection Efficacy	Efficacy of the disinfection process (as described in the Reprocessing Instructions) using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group).	Thermal disinfection efficacy testing was performed on devices representing significant challenges. The process was evaluated using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group). (Similar to cleaning, the document states this was done and implies success.)
Human Factors/Usability	The Reprocessing Instructions should be useable, effective, and safe. (Implicitly, the instructions should lead to successful cleaning and disinfection without significant user error).	A rigorous Human Factors testing process was completed, including: Preliminary Evaluation, Usability Risk Analysis (URA), Design Team Participation, Formative Testing, and Validation Testing. This validation study assessed usability, effectiveness, and use safety. (The document states this was done and implies success.)

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

Sample Size for Cleaning and Disinfection Validation: The document states that testing was performed "using 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." However, specific sample sizes (number of devices tested, number of cycles) are not provided.
Sample Size for Human Factors Testing: Not explicitly stated. It mentions "representative end users" for validation testing but does not quantify them.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of validation studies for reprocessing, they would typically be prospective laboratory-based studies conducted in a controlled environment.

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

For Cleaning and Disinfection: The "experts" are the methodologies and acceptance criteria outlined in the referenced standards and guidance documents (FDA Guidance, AAMI TIR 12, AAMI TIR 30). The ground truth is established by these pre-defined scientific criteria for microbial reduction and cleanliness. There isn't information on human experts establishing ground truth beyond the scientific rigor of adhering to these standards.
For Human Factors: "Human Factors Engineers participated in design meetings" and "representative end users" were involved in validation testing. No specific number or explicit qualifications (e.g., "nurses with 5+ years of experience reprocessing surgical instruments") are provided for these individuals.

4. Adjudication Method for the Test Set:

Cleaning and Disinfection: The adjudication method is based on pre-defined scientific and quantitative acceptance criteria from the referenced standards. For cleaning, it involves qualitative visual inspection and quantitative endpoints. For disinfection, it specifically requires a 6-log10 reduction of vegetative organisms. There is no mention of a human consensus or committee method like 2+1 or 3+1.
Human Factors: The Usability Risk Analysis (URA) conducted for Reprocessing likely involved identifying potential use errors and assessing their severity. The "Validation Testing" likely involved observing users and documenting issues or successful completion of tasks, but the specific adjudication method (e.g., how "usability" or "effectiveness" was formally judged) is not detailed beyond stating it "assessed the usability, effectiveness, and use safety."

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 510(k) is for updated reprocessing instructions for existing surgical instruments and accessories, not for an AI-powered diagnostic or interpretive device. Therefore, the concept of "human readers improving with AI assistance" is not applicable to this submission.

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

No, this is not applicable. This submission is not for an algorithm or AI-based device. It is about the physical instruments and the instructions for their handling. The performance evaluated here is the efficacy of the reprocessing instructions by humans using those instructions, not an algorithm's standalone performance.

7. The Type of Ground Truth Used:

Expert Consensus/Standardized Criteria:
- For cleaning validation, the ground truth is based on the efficacy criteria and test methods outlined in AAMI TIR 12:2010 and AAMI TIR 30:2011, as well as FDA guidance. This represents an expert consensus on what constitutes adequate cleaning for medical devices.
- For thermal disinfection validation, the ground truth is a quantitative microbial reduction target (6-log10 reduction of specific vegetative organisms) established by FDA guidance and industry standards.
- For human factors testing, the ground truth is the successful and safe completion of reprocessing tasks by representative users, and the absence of critical use errors, as determined through usability testing methodologies guided by regulatory recommendations.

8. The Sample Size for the Training Set:

Not Applicable. This submission is not for a machine learning or AI device that requires a training set. The "training" here refers to the development and refinement of the reprocessing instructions themselves through formative testing and design team participation, not a data-driven model.

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

Not Applicable. As there is no training set in the context of machine learning, this question does not apply. However, if interpreted as how the "truth" for developing the reprocessing instructions was established, it would be through a combination of:
- Knowledge of the device design and materials (the "design and materials of the subject devices" are identical to predicates, K170645).
- Adherence to recognized standards and guidance documents for reprocessing (AAMI TIRs, FDA Guidance).
- Iterative design and testing processes (Formative Testing) informed by Human Factors best practices and risk analysis. The "ground truth" for these iterations would be identifying potential issues and refining instructions to overcome them.

Summary

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7 510(k) Summary (K170645)

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 Table 7.1 (which is structured based on the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.

Image /page/0/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray capital letters, with a yellow dot above the "I". Below that, the word "SURGICAL" is in smaller, gray capital letters, with the registered trademark symbol to the right.

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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
DateSummaryPrepared	August 14, 2017
Trade Name	da Vinci XiEndoWristInstruments andAccessories	Monopolar andBipolar CauteryCord	da Vinci Xi Hasson Cone
CommonName	Endoscope andaccessories	Monopolar/BipolarElectrosurgicalCord	Endoscope and accessories
Classification	Class II,21 CFR876.1500	Class II,21 CFR878.4400	Class II,21 CFR 876.1500
Product Codes	NAY, GCJ	GEI	GCJ
ClassificationAdvisoryCommittee:	General andPlastic Surgery	General andPlastic Surgery	General and Plastic Surgery
PredicateDevices	K131861(Clearance ofda VinciEndowristInstruments andAccessories foruse with theIS4000 system)K150284(Addition of 6additionalinstruments tothe da Vinci XiInstrumentsFamily)K150837(Addition ofSmall ClipApplier andLong BipolarGrasperInstruments tothe da Vinci XiInstrumentsFamily)	K133167	K153126
Trade Name	da Vinci XiEndoWristInstruments	da Vinci XiAccessories	Monopolar andBipolar Cautery Cord	da Vinci Xi Hasson Cone
DeviceDescription	The da Vinci Xi EndoWristInstruments(8mm), have anarticulatingdesign at theirdistal tips thatmimics thehuman wrist.Each instrumentis used toperform one ormore specificsurgical taskse.g., grasping,suturing,cutting,cauterizing, ortissuemanipulation.	da Vinci XiAccessories mainlyconsists of:Cannulae , whichare essentiallyhollow tubes thatprovide a path forinstruments toaccess the surgicalsiteObturators , whichprovide a means ofinitially inserting theseal and cannulaassemblies throughthe body wall byproviding a fitted tipthat extends beyondthe cannula's mostdistal point."Other"Accessories, includean instrumentrelease kit (IRK), anInsertion tool andInstrumentintroducer. Theseaccessories havesimple geometrieswith no long narrowlumens	The Monopolar andBipolar CauteryCords are accessoriesto electrosurgicalinstruments wheremonopolar or bipolarelectrosurgical cuttingand coagulation isdesired during surgery.The Monopolar andBipolar Cautery Cordsare insulated cordswith an instrument-mating connector onone end and generator-mating connector onthe other end.	The Hasson Cone, is a cone-shaped devicewhich is intended to be used in endoscopicsurgery to assist in establishing a port of entrythrough the abdominal wall for IntuitiveSurgical da Vinci Xi EndoWrist Instruments,endoscopes, and compatible accessories. TheHasson Cone is available in two sizes; 8 mmand 12 mm & Stapler.

Table 7.1: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) System

Image /page/1/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. There is a yellow dot above the "I" in Intuitive. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font size and also in a light gray color.

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Device Description

The da Vinci IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Xi Instruments and Accessories. Table 7.2 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.

Table 7.2: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) System

Image /page/2/Picture/6 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font, with the registered trademark symbol to the right of the word.

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Indications for Use:

Table 7.3 lists the Indications for Use for the devices impacted by the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.

Trade Name	da Vinci Xi EndoWrist Instruments andAccessories	Monopolar and Bipolar Cautery Cords	da Vinci Xi Hasson Cone
Indications for Use	The Intuitive Surgical EndoscopicInstrument Control System (da VinciSurgical System, Model IS4000) isintended to assist in the accuratecontrol of Intuitive SurgicalEndoscopic Instruments including rigidendoscopes, blunt and sharpendoscopic dissectors, scissors,scalpels, forceps/pick-ups, needleholders, endoscopic retractors,electrocautery and accessories forendoscopic manipulation of tissue,including grasping, cutting, blunt andsharp dissection, approximation,ligation, electrocautery, suturing, anddelivery and placement of microwaveand cryogenic ablation probes andaccessories, during urologic surgicalprocedures, general laparoscopicsurgical procedures, gynecologiclaparoscopic surgical procedures,general thoracoscopic surgicalprocedures and thoracoscopically-assisted cardiotomy procedures. Thesystem can also be employed withadjunctive mediastinotomy to performcoronary anastomosis during cardiacrevascularization. The system isindicated for adult and pediatric use. Itis intended to be used by trainedphysicians in an operating roomenvironment in accordance with therepresentative, specific procedures setforth in the Professional Instructionsfor Use.	The Monopolar and Bipolar Cautery Cordsare intended for connectingmonopolar/bipolar electrosurgicalinstruments to an electrosurgical generatorto provide transmission of high frequencycurrent from the electrosurgical generatorto the surgical instrument.	The da Vinci Xi Hasson Cone hasapplications in laparoscopic surgery toestablish a port of entry for IntuitiveSurgical da Vinci Xi EndoWristInstruments, endoscopes, or compatibleaccessories.

Table 7.3: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) 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. Design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.

Image /page/3/Picture/11 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray capital letters, with a yellow dot above the "U". Below that, the word "SURGICAL" is also in gray capital letters, but in a smaller font size.

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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 reprocessing in health care facilities: A guide for medical device manufacturers
o 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:

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 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 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.
o Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.

Image /page/4/Picture/20 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.

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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 nonelinical 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 Table7.1.

Image /page/5/Picture/5 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the yellow dot adds a touch of color.

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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)

K170645

Device Name

da Vinci Xi Instruments and Accessories

Indications for Use (Describe)

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

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)

PSC Publishing Sarvices (301)-40-4740 10

Image /page/6/Picture/25 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 smaller font size, with the registered trademark symbol next to it.

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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)

K170645

Device Name Monopolar and Bipolar Cautery Cords

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/7/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font in all caps, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, sans-serif font, also in all caps. The logo is simple and modern.

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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)

K170645

Device Name da Vinci Xi Hasson Cone

Indications for Use (Describe)

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

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/8/Picture/24 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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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: K170645

Trade/Device Name: Da Vinci Xi Endowrist Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ, GEI 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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

Image /page/9/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

If you desire specific advice for your device on our labeling regulation (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

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.