da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments

K203632 · Intuitive Surgical, Inc. · NAY · Feb 10, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203632
• Device Name: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Feb 10, 2021
• 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 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.

Device Story

da Vinci S/Si and X/Xi EndoWrist instruments are reusable surgical tools with articulating distal tips mimicking human wrists; operated by surgeons via console to perform tissue manipulation (grasping, cutting, suturing, cauterizing). Used in hospital operating rooms. This submission updates reprocessing instructions to include optional automated cleaning and disinfection using washer/disinfectors, replacing or supplementing previous manual/ultrasonic methods. No changes to device design or technological characteristics.

Clinical Evidence

No clinical data. Bench testing only. Cleaning validation (AAMI TIR 12, TIR 30, ST15883-1), thermal disinfection validation (FDA 2002 Guidance), reliability/life testing, and human factors validation (formative and summative testing) demonstrated that instruments remain safe and effective after automated reprocessing.

Technological Characteristics

Reusable articulating EndoWrist instruments; steam sterilization; no changes to materials or design; compatible with automated washer/disinfectors.

Indications for Use

Indicated for adult and pediatric patients (except transoral otolaryngology) for urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures; includes coronary anastomosis via adjunctive mediastinotomy; transoral otolaryngology restricted to benign/malignant T1/T2 tumors and benign base of tongue resection.

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 S and Si Reusable Instruments (K170644)
• da Vinci Xi 8mm Reusable Instruments (K170645)

Submission Summary (Full Text)

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February 10, 2021

Intuitive Surgical, Inc. Kunal Gunjal Sr. Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086

### Re: K203632

Trade/Device Name: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: December 10, 2020 Received: December 11, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Je Hi An. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments (5mm and 8mm) |
| 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, 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. |
| Type of Use (Select one or both, as applicable) | |
| <div><span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
| 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:<br>Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff | |
| [e-mail]<br>"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 (7/17)

Page 1 of 1

PSC Publishing, Services (701)-443-6740 EF

Image /page/2/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and appears to be a bold typeface. The background is white.

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|----------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| mber (if known) | |

510(k) Num K203632

#### Device Name

#### da Vinci Xi (IS4000) 8mm Instruments

#### Indications for Use (Describe)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 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, approxination, 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 pediatic 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)

> 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 (7/17)

Page 1 of 1

PSC Publishing Services (301)-443-6740

Image /page/3/Picture/20 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the text is centered.

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#### K203632 Automated Cleaning/Disinfection Process da Vinci S/Si and X/Xi Reusable Instruments

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|-------------------------------------|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci X (IS4200) 8mm Instruments |

**Indications for Use (Describe)**

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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.

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

| <span style="text-decoration: underline;"><b>Prescription Use</b></span> (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 (7/17)

Page 1 of 1

PSC Publishing Services [phone] EF

Image /page/4/Picture/11 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced.

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| 510(k) Owner | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Sr. Regulatory Affairs Specialist, Regulatory Affairs<br>Phone Number: 408-523-8017<br>Email: [e-mail] |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) |
| Common Name | Endoscope and accessories |
| Classification | Class II,<br>21 CFR 876.1500 |
| Product Codes | NAY |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170644 (Clearance of Reprocessing Instructions for da Vinci S and Si<br>Reusable Instruments) |

## Table 1: da Vinci S/Si (IS2000/IS3000) Reusable Instruments

# INTUÍTIVE

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### Table 2: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

| 510(k) Owner | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Sr. Regulatory Affairs Specialist, Regulatory Affairs<br>Phone Number: 408-523-8017<br>Email: [e-mail] |
| Trade Name | da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Common Name | Endoscope and accessories |
| Classification | Class II,<br>21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170645 (Clearance of Reprocessing Instructions for da Vinci Xi 8mm Reusable Instruments) |

# INTUIT

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### Device Description

Table 3 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.

| Trade Name | da Vinci S/ Si (IS2000/IS3000)<br>EndoWrist Instruments (5mm & 8mm) | da Vinci Xi/X (IS4000/IS4200)<br>Reusable Instruments (8mm) | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | da Vinci S/ Si (IS2000/IS3000) EndoWrist 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 to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | The da Vinci X/Xi (IS4200/IS4000) EndoWrist 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 to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) | da Vinci Xi (IS4000) 8mm Reusable Instruments | da Vinci Xi (IS4200) 8mm Reusable Instruments |
| Indications for Use | 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 T1 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 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 Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4200) 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. |

### Table 3: da Vinci S/Si and X/Xi Reusable Instruments

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### Indications for Use:

Table 4 lists the Indications for Use for the devices impacted by the changes to the reprocessing instructions.

#### Table 4: da Vinci S/Si and X/Xi Reusable Instruments

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Table 5 and Table 6 includes a comparison between the subject devices and predicate devices.

| | Table 5: Comparison of Predicate and Subject Devices (da Vinci S/Si EndoWrist 5mm and 8mm | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| instruments) | | | |
| Characteristic | Subject Device<br>da Vinci IS2000/IS3000 5mm and 8mm<br>Instruments (K203632) | Predicate Device<br>da Vinci IS2000/IS3000 5mm and 8mm<br>Instruments (K170644) | |
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. | |
| Trade Name | da Vinci S/Si (IS2000/IS3000) 5mm/8mm<br>instruments | SAME as subject device | |
| Common Name | Endoscope and accessories | SAME as subject device | |
| Regulation No. | 21 CFR 876.1500 | SAME as subject device | |
| Product Code | NAY | SAME as subject device | |
| Device Class/<br>Regulation Name | Class II | SAME as subject device | |
| Classification<br>Advisory<br>Committee | General and Plastic Surgery | SAME as subject device | |
| Characteristic | Subject Device…