IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories

K170879 · Intuitive Surgical, Inc. · NAY · Sep 21, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170879
• Device Name: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Sep 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material.

Device Story

EndoWrist Stapler instruments are robotic surgical tools used with da Vinci Si and Xi systems; they deliver multiple staggered rows of staples to target tissues followed by tissue transection. Instruments are reusable; reloads are single-use. Accessories include cannulae, obturators, and release kits. Operated by surgeons via the da Vinci console to perform resection, transection, and anastomoses. This submission specifically updates reprocessing instructions for these instruments. No changes to device design, materials, or intended use. Clinical benefit includes precise robotic-assisted tissue management during minimally invasive procedures.

Clinical Evidence

Bench testing only. Evidence includes cleaning validation, thermal disinfection validation, and human factors validation studies. No clinical data or animal studies were required as device design and materials are identical to predicates.

Technological Characteristics

Reusable robotic surgical staplers and accessories. Articulating (wristed) design. Compatible with da Vinci Si and Xi systems. No changes to materials or design from predicates. Sterilization/reprocessing via thermal disinfection and cleaning protocols.

Indications for Use

Indicated for adult and pediatric patients undergoing resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery using da Vinci Si (IS3000) or Xi (IS4000) surgical systems. Compatible with staple line or tissue buttressing materials.

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

• K140553
• K143217
• K152421
• K113706
• K171388

Submission Summary (Full Text)

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

September 21, 2017

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

Re: K170879

Trade/Device Name: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ, GDW Dated: August 24, 2017

Dear Kunal Gunjal:

Received: August 25, 2017

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 comples with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [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.

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

Enclosure

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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) K170879

Device Name

EndoWrist Stapler 45 Instrument and Accessories

#### Indications for Use (Describe)

The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended

to be used with the da Vinci Si Surgical System (Model 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

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)

Image /page/2/Picture/22 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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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) K170879

Device Name

EndoWrist Stapler 45 Instrument and Accessories

#### Indications for Use (Describe)

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

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)

PSC Publishing Sorvices [phone] E

Image /page/3/Picture/21 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in a smaller font, with the registered trademark symbol.

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

| 510(k) Number (if known) | K170879 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IS4000 EndoWrist Stapler 30 Instrument |
| Indications for Use (Describe) | The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material. |

| Type of Use (Select one or both, as applicable) | <span style="text-decoration: underline;"><b>X</b></span> 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."

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# 510(k) Summary (K170879)

This 510(k) applies to da Vinci Si and Xi Stapler Instruments and Accessories that have been cleared through previous 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 1.1 (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/5/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol to the right of the word.

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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 Summary<br>Prepared | September 21, 2017 | | |
| Trade Name | EndoWrist Stapler<br>45 Instrument and<br>Accessories | IS4000 EndoWrist<br>Stapler 30<br>Instrument | Endowrist<br>Stapler Instrument and Accessories |
| Common Name | Endoscope and<br>accessories | Endoscope and<br>accessories | Endoscope and accessories |
| Classification | Class II,<br>21 CFR 876.1500 | Class II,<br>21 CFR 876.1500 | Class II,<br>21 CFR 876.1500 |
| Classification<br>Advisory<br>Committee: | General and Plastic<br>Surgery | General and Plastic<br>Surgery | General and Plastic Surgery |
| Product Codes<br>for Subject<br>Devices<br>(K170879) | NAY, GDW and<br>GCJ | NAY and GDW | NAY and GDW |
| Product Codes<br>for Predicate<br>Devices | NAY, GDW and<br>GCJ | NAY and GDW | NAY and GDW |
| Predicate Devices | K140553<br>(Clearance of<br>Stapler 45<br>instrument and<br>reusable<br>accessories for use<br>with the IS4000<br>system)<br>K143217 (Addition<br>of the 12mm &<br>Stapler Bladeless<br>Obturators for Use<br>with the IS4000<br>System) | K152421<br>(Clearance of<br>Stapler 30<br>instrument for use<br>with the IS4000<br>system) | K113706 and K171388 (use with<br>the IS3000 system) |

| | Table 1.1: da Vinci Si and Xi Stapler Instruments and Accessories |
|--|--------------------------------------------------------------------|

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# Device Description

Table 1.2 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.

| Trade Name | Endowrist Stapler Instrument<br>(used with the IS3000 System) | EndoWrist Stapler 45 Instrument<br>(used with the IS4000 system) | IS4000 EndoWrist Stapler 30 Instrument (used<br>with the IS4000 system) | EndoWrist Stapler Accessories (used with<br>the IS3000 system) | EndoWrist Stapler 45 Accessories (used with<br>the IS4000 system) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Endowrist Stapler Instrument, when used with the compatible Stapler 45 Reloads, delivers multiple rows of staples and transects the tissue along the middle of the staple line. The Endowrist Stapler Instrument is a reusable device while the Stapler 45 reloads (available in various sizes) are single-use/disposable devices | The EndoWrist Stapler 45 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). | IS4000 EndoWrist Stapler 30 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip | EndoWrist Stapler Reusable Accessories consist of a Stapler Cable, Stapler Release Kit, Stapler Cannula, Blunt Obturator, Stapler Cannula Reducer, and Stapler Motor Pack (SMP). | EndoWrist Stapler 45 Accessories mainly consist of:<br><br>Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site<br><br>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.<br><br>"Other" Accessories, include the SRK (Stapler Release Kit). |

Table 1.2: da Vinci Si and Xi Stapler Instruments and Accessories

Image /page/7/Picture/6 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller font, with the registered trademark symbol next to it.

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# Indications for Use:

Table 1.3 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 | Endowrist<br>Stapler and its reusable Accessories | EndoWrist Stapler 45<br>Instrument and Accessories | IS4000 EndoWrist Stapler 30<br>Instrument |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical EndoWrist®<br>Stapler 45 System and Stapler 45<br>Reloads are intended<br>to be used with the da Vinci Si Surgical<br>System (Model 1S3000) for resection,<br>transection and/or creation of<br>anastomoses in General, Gynecologic,<br>and Urologic surgery. The device can<br>be used with staple line or tissue<br>buttressing material (natural or<br>synthetic). | The Intuitive Surgical EndoWrist<br>Stapler 45, Stapler 45 Reloads and<br>other Stapler Accessories (including<br>the bladeless obturators) are intended<br>to be used with the da Vinci Surgical<br>System (Model IS4000) for resection,<br>transection and/or creation of<br>anastomoses in General, Thoracic,<br>Gynecologic, and Urologic surgery.<br>The device can be used with staple line<br>or tissue buttressing material (natural<br>or synthetic). | The Intuitive Surgical EndoWrist® Stapler<br>30 Instrument and Stapler 30 Reloads are<br>intended to be used with the da Vinci<br>Surgical System (Model IS4000) for<br>resection, transection and/or creation of<br>anastomoses in General, Thoracic,<br>Gynecologic, and Urologic surgery. The<br>device is indicated for adult and pediatric<br>use. The devices can be used with staple<br>line or tissue buttressing material. |

| Table 1.3: da Vinci Si and Xi Stapler Instruments and Accessories | |
|-------------------------------------------------------------------|--|
|-------------------------------------------------------------------|--|

# 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.

## Summary:

Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate devices listed in Table 1.1.