The Intuitive Surgical EndoWrist® Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci System (Model 154000) 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).

Device Description

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and Accessories is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vincio Surgical System (Model IS4000). It is intended for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic 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 implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following three configurations to accommodate tissues of various thickness:

2.5 mm staple size single use reload (White Reload) .
. 3.5 mm staple size single use reload (Blue Reload)
4.3 mm staple size single use reload (Green Reload)

Accessories, including cannulae, obturators, a cannula seal, and a cannula reducer, are provided to support the interface of the EndoWrist Stapler 45 with the da Vinci Surgical System (Model IS4000).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EndoWrist® Stapler 45 and Stapler 45 Reloads, based on the provided 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance data in a qualitative manner, focusing on the types of tests conducted rather than specific quantitative acceptance criteria or numerical results. The primary "performance" stated is that the device "is substantially equivalent to the predicate device and that the design output meets the design input requirements."

Acceptance Criteria (Inferred from testing types)	Reported Device Performance
Safe and effective performance in animal survival studies (Small bowel anastomoses, Gastrectomy, Lung Resection, Pneumonectomy)	Demonstrated substantial equivalence to predicate device; passed animal survival studies for specified procedures with given follow-up periods.
Proper staple formation and transection capabilities	X
Compatibility with buttress materials	X
Burst pressure performance	X
Dimensional measurements compliance	Passed
Mechanical and functional verification	Passed
Electrical safety compliance (per IEC standards)	Passed
Electromagnetic compatibility assessment (per IEC standards)	Passed
Safe and effective use by intended users (surgeons, OR staff) in typical and troubleshooting scenarios	The device is safe and effective when used by intended users in the intended use environment, as evidenced by summative usability validation studies.

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

Animal Survival Studies: The document states that these studies involved "side-by-side comparison between subject and predicate devices."
- Small bowel anastomoses: Not specified, but involved both subject and predicate devices.
- Gastrectomy: Not specified, but involved both subject and predicate devices.
- Lung Resection: Not specified, but involved both subject and predicate devices.
- Pneumonectomy: Not specified, but involved both subject and predicate devices.
Staple formation and transection testing: Not specified.
Buttress material compatibility testing: Not specified.
Burst pressure testing: Not specified.
Human Factors and Usability Testing: Not specified for the number of users (surgeons and operating room staff) or the number of scenarios/cases.
Data Provenance: The studies are described as "animal cadaver models" for some tests, and "summative usability validation studies... conducted in a simulated operating room." There is no mention of country of origin, retrospective, or prospective nature for the animal or bench testing data. Usability testing appears prospective given the "simulated operating room" setting.

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

Animal Studies: The report mentions "animal cadaver models" and "various reloads and buttress materials" but does not specify the number of experts or their qualifications for establishing the "ground truth" (e.g., successful anastomosis, proper staple line, lack of leaks). It can be inferred that veterinary or surgical experts would assess the outcomes.
Human Factors/Usability Testing: The "users (surgeons and operating room staff)" likely served as the evaluators of the device's usability, functioning as the "experts" in this context. Their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set:

Not explicitly stated. For the animal studies, it's implied that specific criteria related to surgical outcomes (e.g., successful anastomosis, lack of complications) were assessed. For usability, it's likely a qualitative assessment based on observation and feedback from the participating users.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not conducted. This type of study typically evaluates diagnostic devices where multiple readers interpret cases. The device in question is a surgical stapler, and the performance evaluation focused on its mechanical function and surgical outcomes in animal models and human factors in simulated environments.

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

This question is not applicable as the device is a mechanical surgical instrument, not an AI algorithm. Its performance is always "human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used:

Animal Studies: The ground truth would be based on physiological or anatomical outcomes (e.g., successful healing of anastomoses, absence of leaks, proper lung function) assessed post-procedure or during follow-up. This implicitly relies on expert assessment of biological outcomes.
Bench Testing: Ground truth would be based on engineering specifications and measurements (e.g., staple dimensions, force required for transection, burst pressure).
Human Factors/Usability Testing: Ground truth was user feedback and observations of safe and effective execution of tasks in a simulated environment by surgeons and operating room staff.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. This device is a mechanical surgical stapler, and its development would typically involve iterative design, prototyping, and testing, rather than an AI training/test set paradigm.

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

Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

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510(k) Summary

JUL 2 5 2014

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Dawn ChangSr. Regulatory Affairs SpecialistPhone Number: 408-523-2347Fax Number: 408-523-8907Email: dawn.chang@intusurg.com
Date Summary Prepared:	July 24, 2014
Trade Name:	EndoWrist ® Stapler 45 and Stapler 45 Reloads
Common Name:	Endoscope and accessories; Surgical Stapler andimplantable staples
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories21 CRF 878.4750, Implantable Staple
Product Codes:	NAY (Endoscope and accessories)GDW (Implantable Staple)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	Intuitive Surgical EndoWrist ® Stapler 45 System andStapler 45 Reloads (for use with da Vinci ® IS3000 System)and ENDOPATH® ETS Reload (White)

Device Description

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2.5 mm staple size single use reload (White Reload) .
. 3.5 mm staple size single use reload (Blue Reload)
4.3 mm staple size single use reload (Green Reload)

Accessories, including cannulae, obturators, a cannula seal, and a cannula reducer, are provided to support the interface of the EndoWrist Stapler 45 with the da Vinci Surgical System (Model IS4000).

Intended Use:

To resect, transect and/or create anastomoses in surgery.

Indications for Use:

The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vincio 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).

Technological Characteristics:

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (subject devices) are equivalent to the predicate device. EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories (for use with the da Vinci IS3000 System) in terms of technological characteristics and intended use. Modifications to the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories include: (1) an update of the instrument design for compatibility with the da Vinci Surgical System (Model IS4000), (2) inclusion of a thoracic surgery indication with the addition of the Stapler 45 White Reload, and (3) a set of modified accessories to support use with the da Vinci Surgical System (Model IS4000).

Note that the subject devices, the EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories are not compatible with the da Vinci IS3000 System. Similarly, the predicate devices, EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories, are not compatible with the da Vinci IS4000 System.

INTUITIVE
SURGICAL

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Performance Data:

Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Bench testing included dimensional measurements, mechanical and functional verification, as well as electrical safety and electromagnetic compatibility assessment per IEC standards. In addition, staple formation, staple line integrity, and transection performance were evaluated in animal cadaver models with various reloads and buttress materials. The following table provides a quick summary:

Testing	IS4000Stapler	IS3000Stapler
Animal Survival Studies with side-by-side comparison betweensubject and predicate devices
• Small bowel anastomoses (14-day follow-up)	X	X
• Gastrectomy (14-day follow up)	X	X
• Lung Resection (7-day follow up)	X	X
• Pneumonectomy (28-day follow up)	X	*
Staple formation and transection testing	X	X
Buttress material compatibility testing	X	X
Burst pressure testing	X	X

*IS3000 Stapler does not have thoracic (lung) indications

Human Factors and Usability Testing:

Summative usability validation studies were conducted with users (surgeons and operating room staff) for the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories. These studies were conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation studies and the other elements of the human factors engineering program provide evidence that the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are safe and effective when used by the intended users in the intended use environment.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are substantially equivalent to the predicate device, the Intuitive Surgical EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories.

INTUITIVE SURGICAL"

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SERVICES. USA
HEALTH &
OF
HUMAN
DEPARTMENT

Public Health Service

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

July 25, 2014

Intuitive Surgical, Inc. Ms. Dawn Chang Senior Regulatory Specialist 1266 Kifer Rd Sunnyvale, California 94086

K140553 Re: Trade/Device Name: Endowrist stapler 45 and stapler 45 reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories; Surgical Stapler And Implantable Staples Regulatory Class: Class II Product Code: NAY, GDW Dated: June 26, 2014 Received: June 27, 2014

Dear Ms. Chang,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David | David Se -S

for Binita 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140553

Device Name

EndoWrist® Stapler 45, Stapler 45 Reloads, and Accessories

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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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.