DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK

K130726 · Intuitive Surgical, Inc. · NAY · Jun 7, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130726
• Device Name: DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jun 7, 2013
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vincio Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

Device Story

da Vinci Single-Site Instruments and Accessories are semi-rigid shaft instruments and cannulae designed for use with the da Vinci Si Surgical System (IS3000). The system enables robotic-assisted single-incision surgery. The subject device adds a Permanent Cautery Hook to the existing instrument line, modifying the previous Monopolar Cautery instrument to improve assembly and reduce manufacturing costs. Instruments are used by surgeons in an operating room to perform tissue manipulation, grasping, cutting, dissection, and cautery. The surgeon operates the system via a console, translating hand movements into robotic instrument actions. The device benefits patients by facilitating complex procedures through a single incision, potentially reducing trauma compared to traditional multi-port laparoscopy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and animal testing demonstrating that the modified instrument design meets design input requirements and performs equivalently to the predicate.

Technological Characteristics

Semi-rigid shaft instruments, fixed-shape curved cannulae, accessory cannulae, and blunt obturators. Includes a Single-Site Port for multi-instrument insertion. Features a modified Permanent Cautery Hook. System is used with the da Vinci Si Surgical System (IS3000).

Indications for Use

Indicated for trained physicians in operating room environments to perform endoscopic tissue manipulation, grasping, cutting, dissection, approximation, clip-ligation, electrocautery, and suturing during single-incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo-oophorectomy. Not indicated for general laparoscopic abdominal or gynecological surgery.

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

• Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories (K112208/K120215/K122532)

Submission Summary (Full Text)

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Intuitive Surgical, Inc.

# 510(k) Summary [As Required by 21 CFR 807.92(c)]

**JUN 07 2013**

K 130726 Special 510(k)

510(k) Owner: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086

Melissa S. Gonzalez Official Contact: Sr. Regulatory Affairs Specialist 408-523-8684 (phone) 408-523-8907 (fax) [e-mail]

Date Summary Prepared: March 14, 2013

Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories Trade Name:

Common Name: Endoscope and accessories

Product Code: NAY, GCJ

Endoscope and Accessories, 21 CFR 876.1500 Classification:

## Predicate Devices:

- Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories . (K112208/K120215/K122532)
#### Device Description:

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), and a Single-Site Port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.

The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).

Single-Site Instruments and Accessories

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### Intended Use:

The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vincio Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

The indications for use are unchanged from the predicate.

### Technological Characteristics:

The only change to the cleared da Vinci Single-Site Instruments and Accessories is the addition of the Single-Site Permanent Cautery Hook. The Single-Site Permanent Cautery Hook is a modified version of the cleared Single-Site Monopolar Cautery instrument that incorporates a permanently attached cautery hook, as well as design elements from the Single-Site Gen2 instruments cleared under K120215. The modified instrument design is intended to improve ease of assembly and reduce manufacturing costs. The Single-Site Permanent Cautery Hook is equivalent to the predicate Single-Site Monopolar Cautery instrument in terms of its technological characteristics, and the intended use is identical.

### Performance Data:

Bench and animal testing demonstrated that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The differences do not raise any different issues of safety or effectiveness as compared to the predicate devices.

#### Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the Permanent Cautery Hook is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

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

### June 7, 2013

Intuitive Surgical, Inc. % Ms. Melissa Gonzalez Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K130726

Trade/Device Name: Intuitive Surgical da Vinci Single-Site Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: May 2, 2013 Received: May 6, 2013

Dear Ms. Gonzalez: .

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions s 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act. the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:

The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectorny, benign hysterectomy, and salpingo-oophorectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000).

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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### Page 2 - Ms. Melissa Gonzalez

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeline.

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (Part 801), please contact 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/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

### Barbara A. Zimmerman for

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intuitive Surgical, Inc.

Special 510(k)

510(k) Number if known:

Device Name: da Vinci® Single-Site™ Instruments and Accessories

### INDICATIONS FOR USE:

The Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (1S3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

Prescription Use X

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-Off)

Division of Surgical Devices

510(k) Number K130726

Single-Site Instruments and Accessories