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 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: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point; "Other" Accessories, include the SRK (Stapler Release Kit).

AI/ML Overview

This FDA 510(k) summary (K170879) describes the reprocessing instructions for existing Intuitive Surgical EndoWrist Stapler instruments and accessories. It does not include detailed acceptance criteria or a study demonstrating device performance against specific acceptance criteria for the functionality of the staplers. Instead, the 510(k) focuses on validating the reprocessing instructions for these already cleared devices, ensuring they can be safely reprocessed for multiple uses without compromising their safety or effectiveness.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as the document is not about the initial performance of a new device in terms of its clinical efficacy, but rather about the validation of its reprocessing procedures.

However, I can provide information relevant to the reprocessing validation that is present in the document.

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

Acceptance Criteria (for Reprocessing)	Reported Device Performance (for Reprocessing)
Cleaning Validation	Performance test data demonstrates that the subject device is substantially equivalent to the predicate device.
Thermal Disinfection Validation	Performance test data demonstrates that the subject device is substantially equivalent to the predicate device.
Human Factors Validation	Performance test data demonstrates that the subject device is substantially equivalent to the predicate device.

Note: The document states "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" for these tests. Specific quantitative acceptance limits or failure rates for the reprocessing validation are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in this 510(k) summary for the reprocessing validation tests.
Data Provenance: Not specified in this 510(k) summary. The context implies it would be internal testing by Intuitive Surgical, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here relates to the effectiveness of reprocessing, established through laboratory testing and human factors studies, not clinical interpretation by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers. This document describes validation testing of reprocessing instructions.

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

Not applicable. This document is not about AI assistance or clinical efficacy; it pertains to the validation of reprocessing instructions.

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

Not applicable. This document is not about an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the reprocessing validation, the "ground truth" would be established by:

Cleaning Validation: Objective measurements of residual soil/bioburden after reprocessing.
Thermal Disinfection Validation: Objective measurements demonstrating inactivation or removal of microorganisms.
Human Factors Validation: Observation and assessment of users' ability to correctly follow the reprocessing instructions.

8. The sample size for the training set

Not applicable. This document describes validation testing, not a machine learning model's training.

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

Not applicable. This document describes validation testing, not a machine learning model's training.

Study Information (from document):

The document states: "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."

This indicates that multiple studies were conducted to specifically validate the reprocessing instructions. The detailed methodology and results of these studies (e.g., specific protocols, microbial challenges, residual limits, human factors study design) are not provided in this summary but would have been submitted as part of the full 510(k) application. The conclusion is that these studies demonstrated substantial equivalence to the predicate device in terms of reprocessing effectiveness and safety.

Summary

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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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

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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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black, and the background is white. The letters "FDA" are faintly visible in the background, suggesting the image may be related to the Food and Drug Administration.

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 PRAStaff@fda.hhs.gov

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

FORM FDA 3881 (8/14)

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)

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

FORM FDA 3881 (8/14)

PSC Publishing Sorvices (101) 443-6340 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
	Indications for Use	Expiration Date: January 31, 2017See 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)	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.

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

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

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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.1266 Kifer RoadSunnyvale, CA 94086
Contact	Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com
Date SummaryPrepared	September 21, 2017
Trade Name	EndoWrist Stapler45 Instrument andAccessories	IS4000 EndoWristStapler 30Instrument	EndowristStapler Instrument and Accessories
Common Name	Endoscope andaccessories	Endoscope andaccessories	Endoscope and accessories
Classification	Class II,21 CFR 876.1500	Class II,21 CFR 876.1500	Class II,21 CFR 876.1500
ClassificationAdvisoryCommittee:	General and PlasticSurgery	General and PlasticSurgery	General and Plastic Surgery
Product Codesfor SubjectDevices(K170879)	NAY, GDW andGCJ	NAY and GDW	NAY and GDW
Product Codesfor PredicateDevices	NAY, GDW andGCJ	NAY and GDW	NAY and GDW
Predicate Devices	K140553(Clearance ofStapler 45instrument andreusableaccessories for usewith the IS4000system)K143217 (Additionof the 12mm &Stapler BladelessObturators for Usewith the IS4000System)	K152421(Clearance ofStapler 30instrument for usewith the IS4000system)	K113706 and K171388 (use withthe 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(used with the IS3000 System)	EndoWrist Stapler 45 Instrument(used with the IS4000 system)	IS4000 EndoWrist Stapler 30 Instrument (usedwith the IS4000 system)	EndoWrist Stapler Accessories (used withthe IS3000 system)	EndoWrist Stapler 45 Accessories (used withthe 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:Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical siteObturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point."Other" Accessories, include 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	EndowristStapler and its reusable Accessories	EndoWrist Stapler 45Instrument and Accessories	IS4000 EndoWrist Stapler 30Instrument
Indications for Use	The Intuitive Surgical EndoWrist®Stapler 45 System and Stapler 45Reloads are intendedto be used with the da Vinci Si SurgicalSystem (Model 1S3000) for resection,transection and/or creation ofanastomoses in General, Gynecologic,and Urologic surgery. The device canbe used with staple line or tissuebuttressing material (natural orsynthetic).	The Intuitive Surgical EndoWristStapler 45, Stapler 45 Reloads andother Stapler Accessories (includingthe bladeless obturators) are intendedto be used with the da Vinci SurgicalSystem (Model IS4000) for resection,transection and/or creation ofanastomoses in General, Thoracic,Gynecologic, and Urologic surgery.The device can be used with staple lineor tissue buttressing material (naturalor synthetic).	The Intuitive Surgical EndoWrist® Stapler30 Instrument and Stapler 30 Reloads areintended to be used with the da VinciSurgical System (Model IS4000) forresection, transection and/or creation ofanastomoses in General, Thoracic,Gynecologic, and Urologic surgery. Thedevice is indicated for adult and pediatricuse. The devices can be used with stapleline 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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.