5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT

K112584 · Intuitive Surgical, Inc. · NAY · Sep 29, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K112584
• Device Name: 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Sep 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The da Vinci Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. The Intuitive Surgical Harmonic™ Curved Shears Instrument is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

Device Story

Device delivers ultrasonic energy for soft tissue transection and coagulation; consists of reusable instrument housing and disposable Harmonic ACE™ or Harmonic™ Curved Shears insert (shaft and grip assembly). Used with da Vinci Surgical Systems (IS1200, IS2000, IS3000) and Ethicon Endo-Surgery Generator/Hand Piece. Operated by surgeons in clinical settings. Ultrasonic energy enables precise cutting and hemostasis; minimizes thermal injury to surrounding tissue. Output is mechanical ultrasonic vibration at the distal tip. Benefits include controlled bleeding and reduced thermal damage during soft tissue surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Ultrasonic energy delivery system; 5mm and 8mm diameter configurations; reusable housing with disposable insert (shaft/grip assembly); connects to Ethicon Endo-Surgery Generator; compatible with da Vinci IS1200, IS2000, and IS3000 systems.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in patients undergoing procedures using da Vinci Surgical Systems (IS1200, IS2000, IS3000).

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

• Harmonic ACE™ Curved Shears (K093217)
• Harmonic™ Curved Shears Instrument (K042855)

Submission Summary (Full Text)

{0}------------------------------------------------

Intuitive Surgical Inc.

Special 510(k): Device Modification

510(K) SUMMARY (per 21 CFR 807.92)

K112584

SEP 2 9 2011

| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086<br>Ph: [phone]<br>Fax: [phone] |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Official Contact: | Brandon Hansen<br>Sr. Regulatory Affairs Manager |

September 2, 2011 Date Summary Prepared:

#### Device Name:

| Trade Name: | da Vinci Harmonic ACE™ Curved Shears 5mm Harmonic ACE™ Curved Shears 8mm Harmonic ACE™ Curved Shears Disposable Harmonic ACE™ Insert Intuitive Surgical Harmonic™ Curved Shears Instrument 5mm Harmonic™ Curved Shears Instrument 8mm Harmonic™ Curved Shears Instrument Disposable Harmonic™ Curved Shears Insert |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Endoscopic Instrument |
| Classification Name: | Endoscope and Accessories<br>(21 CFR 876.1500, Product Code NAY) |

Predicate Device:

Intuitive Surgical, Inc. K093217, Harmonic ACE™ Curved Shears

Intuitive Surgical, Inc. K042855, Harmonic™ Curved Shears Instrument

Device Description:

The Intuitive Surgical Harmonic ACE™ Curved Shears is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical System. The distal end is the Disposable Harmonic ACE™ Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic

{1}------------------------------------------------

ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The Intuitive Surgical Harmonic™ Curved Shears Instrument is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical Systems. The distal end is the Disposable Harmonic™ Curved Shears Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical Systems and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The da Vinci Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in coniunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

The Intuitive Surgical Harmonic™ Curved Shears Instrument is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in coniunction with the da Vinci Surqical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

The subject device Harmonic ACE™ Curved Shears is identical in technological characteristics as compared

Indications For Use:

Technological Characteristics:

P.2/3

{2}------------------------------------------------

to the predicate device.

The subject device Harmonic™ Curved Shears Instrument is identical in technological characteristics as compared to the predicate device.

Performance Data:

Summary:

Performance testing was not required for this labeling change.

The Harmonic ACE™ Curved Shears is substantially equivalent in indications for use and technological characteristics as compared to the predicate device.

The Harmonic™ Curved Shears Instrument is substantially equivalent in indications for use and technological characteristics as compared to the predicate device.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.

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

Intuitive Surgical, Inc. % Ms. Kim T. Servance 1266 Kifer Road Sunnyvale, California 94086 2 9 2311

Re: K112584

Trade/Device Name: da Vinci Harmonic ACE™ Curved Shears Intuitive Surgical Harmonic" Curved Shears Instrument Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class H Product Code: NA Y Dated: September 02, 2011 Received: September 06, 2011

Dear Ms. Servance:

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

{4}------------------------------------------------

Page 2 - Ms. Kim T. Servance

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 (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for D

Mark N. Molkerson

DE

CLN

DIK

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## 6. INDICATION FOR USE

K112584 510(k) Number if known:

Device Name: da Vinci Harmonic ACE ™ Curved Shears Intuitive Surgical Harmonic™ Curved Shears Instrument

### INDICATIONS FOR USE:

## da Vinci Harmonic ACE™ Curved Shears

The da Vinci Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. .

### Intuitive Surgical Harmonic™ Curved Shears Instrument

The Intuitive Surgical Harmonic™ Curved Shears Instrument is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

Prescription Use × (Per 21 CFR 801 Subpart D) C)

AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle - Director
Birector Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number. K112584