ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS

K140553 · Intuitive Surgical, Inc. · NAY · Jul 25, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140553
• Device Name: ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jul 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

EndoWrist Stapler 45 is a reusable surgical stapler system designed for use with the da Vinci Surgical System (Model IS4000). It utilizes single-use cartridges (reloads) containing implantable staples in 2.5mm, 3.5mm, or 4.3mm sizes. The device is operated by a surgeon via the da Vinci console to perform tissue resection, transection, and anastomosis creation. It places multiple staggered rows of staples while simultaneously cutting tissue along the center of the staple line. Accessories include cannulae, obturators, seals, and reducers to facilitate interface with the robotic system. Used in OR settings for General, Thoracic, Gynecologic, and Urologic procedures. The system provides precise, robotically-assisted stapling, potentially improving surgical outcomes through controlled tissue manipulation and consistent staple line formation.

Clinical Evidence

Bench, animal, and cadaver testing performed. Bench testing included dimensional, mechanical, functional, electrical safety, and EMC assessments per IEC standards. Animal studies (small bowel anastomosis, gastrectomy, lung resection, pneumonectomy) compared subject and predicate devices, evaluating staple formation, staple line integrity, and transection performance. Burst pressure and buttress material compatibility were also verified. Summative usability validation studies were conducted in simulated OR environments with surgeons and staff, confirming safe and effective use.

Technological Characteristics

Reusable robotic surgical stapler system. Components: EndoWrist Stapler 45, single-use staple reloads (2.5mm, 3.5mm, 4.3mm), and accessories (cannulae, obturators, seals). Designed for exclusive use with da Vinci IS4000 system. Mechanical stapling and cutting principle. Electrical safety and EMC per IEC standards. Sterilization method not specified.

Indications for Use

Indicated for use with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. Compatible with staple line or tissue buttressing material (natural or synthetic).

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads (for use with da Vinci IS3000 System)
• ENDOPATH® ETS Reload (White)

Submission Summary (Full Text)

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### 510(k) Summary

## JUL 2 5 2014

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Chang<br>Sr. Regulatory Affairs Specialist<br>Phone Number: 408-523-2347<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | July 24, 2014 |
| Trade Name: | <i>EndoWrist</i> ® Stapler 45 and Stapler 45 Reloads |
| Common Name: | Endoscope and accessories; Surgical Stapler and<br>implantable staples |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories<br>21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)<br>GDW (Implantable Staple) |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Predicate Device: | Intuitive Surgical <i>EndoWrist</i> ® Stapler 45 System and<br>Stapler 45 Reloads (for use with <i>da Vinci</i> ® IS3000 System)<br>and ENDOPATH® ETS Reload (White) |

## 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).

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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).

### 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 | IS4000<br>Stapler | IS3000<br>Stapler |
|-----------------------------------------------------------------------------------------------|-------------------|-------------------|
| Animal Survival Studies with side-by-side comparison between<br>subject 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 [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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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)

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).

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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