da Vinci Xi Hasson Cone

K153126 · Intuitive Surgical, Inc. · GCJ · Dec 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K153126
• Device Name: da Vinci Xi Hasson Cone
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The da Vinci Xi Hasson Cone is intended to be used in laparoscopic surgery to anchor a port of entry (i.e., cannula) to the patient.

Device Story

The da Vinci Xi Hasson Cone is a cone-shaped accessory for laparoscopic surgery; it anchors a cannula port of entry to the patient's body wall during open (Hasson) surgical techniques. The device increases the effective diameter of the cannula to match the incision contour. It is available in 8 mm and 12 mm & Stapler sizes. Used in clinical settings by surgeons; the device facilitates the insertion of da Vinci Xi EndoWrist instruments and endoscopes. It provides a stable port for robotic-assisted procedures, ensuring secure access to the surgical site.

Clinical Evidence

No clinical data. Evidence consists of bench testing (physical, mechanical, functional, and user interface requirements) and animal/cadaveric validation testing in simulated clinical settings. Human factors evaluation included a usability risk analysis, which determined all risks were tolerable or broadly acceptable.

Technological Characteristics

Cone-shaped mechanical accessory for trocar sleeves. Available in 8 mm and 12 mm & Stapler sizes. Materials and design are similar to the predicate stability cone. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for use in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

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

• Hybrid Trocar System (K101937)

Reference Devices

• Aesculap 10 mm Stability Cone for Trocar Sleeve (K101937)

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

December 9, 2015

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

Re: K153126

Trade/Device Name: da Vinci Xi Hasson Cone Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 26, 2015 Received: October 29, 2015

Dear Mr. 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 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 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 yours,

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

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

#### Indications for Use

510(k) Number (if known) K153126

Device Name da Vinci Xi Hasson Cone

Indications for Use (Describe)

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

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.

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FORM FDA 3881 (8/14)

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Image /page/2/Picture/21 description: The image shows the logo for Intuitive Surgical. The logo is in a light gray color. The word "INTUITIVE" is in all caps and is above the word "SURGICAL", which is also in all caps but in a smaller font size. There is a small yellow circle above the "I" in "INTUITIVE".

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| 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: | October 27, 2015 |
| Trade Name: | da Vinci Xi Hasson Cone |
| Common Name: | Endoscope and Accessories |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories |
| Product Code: | GCJ |
| Classification Advisory Committee: | General and Plastic Surgery |
| Predicate Device: | Hybrid Trocar System (K101937) |

#### Device Description:

The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.

The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.

#### Intended Use:

The da Vinci Xi Hasson Cone is intended to be used in laparoscopic surgery to anchor a port of entry (i.e., cannula) to the patient.

#### Indications for Use:

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

INTUITIVE SURGICAL®

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### Technological Characteristics:

The subject device, da Vinci Xi Hasson Cone, is technologically very similar to the predicate device, Aesculap 10 mm Stability Cone for Trocar Sleeve (cleared under K101937). It has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device.

### Performance Data:

Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing included dimensional measurements, mechanical and functional verification, simulated use in animal models, and human factors assessment.

## Bench Testing:

The da Vinci Xi Hasson Cone, was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the input requirements. The design verification testing included:

- Physical Specifications
- Mechanical Requirements .
- User Interface Requirements
- Functional Requirements ●

# Animal Validation Testing:

Design Validation Testing was performed using animal and cadaveric models to evaluate the performance of the da Vinci Xi Hasson Cone in a simulated clinical setting. The testing summarized in this submission validated general, functional, use and misuserelated, and interaction (compatibility) requirements for the subject device.

# Human Factors Evaluation:

As part of the Usability Engineering Process for the da Vinci Xi Hasson Cone, a Usability Risk Analysis was created to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. All risks were assessed as having "Tolerable" or "Broadly Acceptable" pre-mitigated risk profiles. As a result, no further usability testing was conducted to evaluate the safety and usability of the subject device.

# Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci Xi Hasson Cone is substantially equivalent to its predicate device.

Image /page/4/Picture/18 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. There is a yellow dot above the word "INTUITIVE".