Bladeless Optical Obturators

K152663 · Intuitive Surgical, Inc. · GCJ · Oct 16, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152663
• Device Name: Bladeless Optical Obturators
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Device Story

Bladeless Optical Obturators facilitate placement of da Vinci Xi Cannulas into body wall during endoscopic procedures. Device consists of shaft, handle, and latches for securing to cannula seal. Handle features opening for insertion of size-compatible endoscope, allowing visualization during insertion. Used in clinical settings by surgeons/physicians. Provides port of entry for endoscopic instruments; enables safe cannula placement via visual guidance. Single-use device available in 8mm and 12mm diameters and standard/long lengths.

Clinical Evidence

Bench testing and animal model validation. Bench testing verified dimensional, mechanical, and labeling requirements (drop test, axial load, diametrical clearance, color differentiation, shaft length). Animal model testing validated latching mechanism and tissue interaction; compatibility testing confirmed maintenance of insufflation with cannulas, seals, and endoscopes.

Technological Characteristics

Single-use bladeless obturator; clear polycarbonate tip; shaft, handle, and latching mechanism. Dimensions: 8mm and 12mm diameters; standard and long lengths. Compatible with da Vinci Xi Cannulas and Cannula Seals. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring a port of entry for endoscopic instruments.

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

• 8MM Trocar Kit (K133845)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Intuitive Surgical, Inc. Vishal Kanani Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

October 16, 2015

Re: K152663

Trade/Device Name: Bladeless Optical Obturators Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 15, 2015 Received: September 17, 2015

Dear Vishal Kanani:

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

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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.

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 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely vours.

Joshua C. Nipper -S

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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# Indications for Use

510(k) Number (if known) K152663

Device Name Bladeless Optical Obturators

Indications for Use (Describe)

The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

| 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)

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## 510(k) Summary

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Vishal Kanani<br>Sr. Regulatory Affairs Specialist<br>Phone Number: 408-523-2035<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | September 15, 2015 |
| Trade Name: | Bladeless Optical Obturator |
| Common Name: | Endoscope and accessories |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | GCJ |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Predicate Device: | K133845 – 8MM Trocar Kit |

## Device Description

The da Vinci Xi Bladeless Optical Obturators are used with the da Vinci Xi Cannulas and da Vinci Xi Cannula Seals to facilitate placement of the Cannula in the body wall. The Bladeless Optical Obturators consist of three components - a shaft, a handle, and two latches that allow the obturator to latch onto the Cannula Seal. The handle has an opening which allows the insertion of a size-compatible endoscope into the Bladeless Optical Obturator. The subject devices are single use devices and are offered in two sizes, 8 mm and 12 mm and in two lengths (standard and long) to match the Cannula lengths and to meet users' needs.

## Intended Use/Indications for Use:

The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Image /page/3/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a sans-serif font. There is a yellow dot above the "I" in "INTUITIVE". Below "INTUITIVE" is the word "SURGICAL" in a smaller font with the registered trademark symbol.

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## Technological Characteristics:

The subject Bladeless Optical Obturators are very similar to the predicate devices, 8 mm Bladeless Obturators (K133845). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate devices. Modifications include the presence of an opening in the handle of the subject device and the change in material of the tip of the obturator, from grav polycarbonate to clear polycarbonate.

## Performance Data:

In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications on the predicate devices. Design verification and design validation testing were conducted on the subject devices to confirm that the design outputs meet design input requirements and that the devices are safe and effective for its intended use.

## Design Verification:

The bench testing summarized in this submission verifies dimensional, mechanical, and labeling requirements for the subject device. Drop test, axial load bearing capacity of the connection between the Obturator and Cannula Seal, maximum diametrical clearance when the Obturator is used with the Cannula, ability to differentiate between colors when used with a size-compatible endoscope, and maximum length of the Obturator shaft past the distal end of the Cannula were tested along with adequacy of labeling required to communicate compatibility of the subject device.

## Design Validation:

The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model were performed to assess the subject device's latching mechanism and verify that the obturator does not catch on tissue. The subject devices' compatibility with the cannulas, cannula seals, and size-compatible endoscopes were tested to ensure they maintain insufflation when used together.

## Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject Bladeless Optical Obturators are substantially equivalent to the predicate 8 mm Bladeless Obturators cleared in K133845.

Image /page/4/Picture/13 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 in smaller font and also in light gray. There is a yellow dot above the word "INTUITIVE".