da Vinci Xi EndoWrist Instruments and Accessories

K170645 · Intuitive Surgical, Inc. · NAY · Sep 11, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170645
• Device Name: da Vinci Xi EndoWrist Instruments and Accessories
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Sep 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Reusable surgical instruments and accessories for da Vinci Xi (IS4000) system; includes EndoWrist instruments (articulating tips for grasping, cutting, suturing, cauterizing), cannulae, obturators, cautery cords, and Hasson cones. Devices facilitate minimally invasive surgery by providing access and tissue manipulation capabilities. Operated by trained physicians in OR. This submission updates reprocessing instructions for cleaning and thermal disinfection. No changes to device design, materials, or intended use. Benefits include standardized, validated reprocessing protocols to ensure device safety and performance across multiple uses.

Clinical Evidence

No clinical data. Evidence consists of bench testing: cleaning validation (qualitative/quantitative endpoints per AAMI TIR 12:2010 and TIR 30:2011), thermal disinfection validation (6-log10 reduction of vegetative organisms including P. aeruginosa, S. aureus, E. coli, and Klebsiella-Enterobacter), and human factors validation (preliminary evaluation, usability risk analysis, formative testing, and validation testing).

Technological Characteristics

Reusable surgical instruments, cannulae, obturators, and cautery cords. Materials and design identical to predicates. Sensing/actuation via da Vinci Xi system interface. Cautery cords provide electrical connectivity for electrosurgery. Thermal disinfection and cleaning processes validated per FDA/AAMI standards.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Used by trained physicians in operating rooms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• da Vinci Endowrist Instruments and Accessories (K131861)
• da Vinci Xi Instruments Family (K150284)
• da Vinci Xi Instruments Family (K150837)
• Monopolar and Bipolar Cautery Cord (K133167)
• da Vinci Xi Hasson Cone (K153126)

Submission Summary (Full Text)

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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.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Regulatory Affairs Specialist, Regulatory Affairs<br>Phone Number: 408-523-8017<br>Fax Number: 408-523-8907<br>Email: [e-mail] | | | |
| Date<br>Summary<br>Prepared | August 14, 2017 | | | |
| Trade Name | da Vinci Xi<br>EndoWrist<br>Instruments and<br>Accessories | Monopolar and<br>Bipolar Cautery<br>Cord | da Vinci Xi Hasson Cone | |
| Common<br>Name | Endoscope and<br>accessories | Monopolar/<br>Bipolar<br>Electrosurgical<br>Cord | Endoscope and accessories | |
| Classification | Class II,<br>21 CFR<br>876.1500 | Class II,<br>21 CFR<br>878.4400 | Class II,<br>21 CFR 876.1500 | |
| Product Codes | NAY, GCJ | GEI | GCJ | |
| Classification<br>Advisory<br>Committee: | General and<br>Plastic Surgery | General and<br>Plastic Surgery | General and Plastic Surgery | |
| Predicate<br>Devices | K131861<br>(Clearance of<br>da Vinci<br>Endowrist<br>Instruments and<br>Accessories for<br>use with the<br>IS4000 system)<br><br>K150284<br>(Addition of 6<br>additional<br>instruments to<br>the da Vinci Xi<br>Instruments<br>Family)<br><br>K150837<br>(Addition of<br>Small Clip<br>Applier and<br>Long Bipolar<br>Grasper<br>Instruments to<br>the da Vinci Xi<br>Instruments<br>Family) | K133167 | K153126 | |
| Trade Name | da Vinci Xi<br>EndoWrist<br>Instruments | da Vinci Xi<br>Accessories | Monopolar and<br>Bipolar Cautery Cord | da Vinci Xi Hasson Cone |
| Device<br>Description | The <i>da Vinci Xi EndoWrist</i><br>Instruments<br>(8mm), have an<br>articulating<br>design at their<br>distal tips that<br>mimics the<br>human wrist.<br>Each instrument<br>is used to<br>perform one or<br>more specific<br>surgical tasks<br>e.g., grasping,<br>suturing,<br>cutting,<br>cauterizing, or<br>tissue<br>manipulation. | <i>da Vinci Xi</i><br>Accessories mainly<br>consists of:<br><b>Cannulae</b> , which<br>are essentially<br>hollow tubes that<br>provide a path for<br>instruments to<br>access the surgical<br>site<br><b>Obturators</b> , which<br>provide a means of<br>initially inserting the<br>seal and cannula<br>assemblies through<br>the body wall by<br>providing a fitted tip<br>that extends beyond<br>the cannula's most<br>distal point.<br><br>"Other"<br>Accessories, include<br>an instrument<br>release kit (IRK), an<br>Insertion tool and<br>Instrument<br>introducer. These<br>accessories have<br>simple geometries<br>with no long narrow<br>lumens | The <b>Monopolar and<br/>Bipolar Cautery<br/>Cords</b> are accessories<br>to electrosurgical<br>instruments where<br>monopolar or bipolar<br>electrosurgical cutting<br>and coagulation is<br>desired during surgery.<br>The Monopolar and<br>Bipolar Cautery Cords<br>are insulated cords<br>with an instrument-<br>mating connector on<br>one end and generator-<br>mating connector on<br>the other end. | The Hasson Cone, is a cone-shaped device<br>which is intended to be used in endoscopic<br>surgery to assist in establishing a port of entry<br>through the abdominal wall for Intuitive<br>Surgical <i>da Vinci Xi EndoWrist</i> Instruments,<br>endoscopes, and compatible accessories. The<br>Hasson Cone is available in two sizes; 8 mm<br>and 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 and<br>Accessories | Monopolar and Bipolar Cautery Cords | da Vinci Xi Hasson Cone |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical Endoscopic<br>Instrument Control System (da Vinci<br>Surgical System, Model IS4000) is<br>intended to assist in the accurate<br>control of Intuitive Surgical<br>Endoscopic Instruments including rigid<br>endoscopes, blunt and sharp<br>endoscopic dissectors, scissors,<br>scalpels, forceps/pick-ups, needle<br>holders, endoscopic retractors,<br>electrocautery and accessories for<br>endoscopic manipulation of tissue,<br>including grasping, cutting, blunt and<br>sharp dissection, approximation,<br>ligation, electrocautery, suturing, and<br>delivery and placement of microwave<br>and cryogenic ablation probes and<br>accessories, during urologic surgical<br>procedures, general laparoscopic<br>surgical procedures, gynecologic<br>laparoscopic surgical procedures,<br>general thoracoscopic surgical<br>procedures and thoracoscopically-<br>assisted cardiotomy procedures. The<br>system can also be employed with<br>adjunctive mediastinotomy to perform<br>coronary anastomosis during cardiac<br>revascularization. The system is<br>indicated for adult and pediatric use. It<br>is intended to be used by trained<br>physicians in an operating room<br>environment in accordance with the<br>representative, specific procedures set<br>forth in the Professional Instructions<br>for Use. | The Monopolar and Bipolar Cautery Cords<br>are intended for connecting<br>monopolar/bipolar electrosurgical<br>instruments to an electrosurgical generator<br>to provide transmission of high frequency<br>current from the electrosurgical generator<br>to the surgical instrument. | The da Vinci Xi Hasson Cone has<br>applications in laparoscopic surgery to<br>establish a port of entry for Intuitive<br>Surgical da Vinci Xi EndoWrist<br>Instruments, endoscopes, or compatible<br>accessories. |

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 [e-mail]

"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)

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.

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."

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 [e-mail]

"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 [phone] 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.*

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 [e-mail]

"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 [phone] 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-

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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 [phone] or [phone] 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 [phone] or [phone] 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