PROBE HOLDER SYSTEM

K071405 · Intuitive Surgical, Inc. · LKF · Oct 9, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K071405
• Device Name: PROBE HOLDER SYSTEM
• Applicant: Intuitive Surgical, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Oct 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Probe Holder System is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

Device Story

Probe Holder System; mechanical device for mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgery. System attaches to standard operating room tables; features jointed links, crossbar, and rail clamps at distal end; proximal end uses sterile adaptors to grasp surgical devices. Surgeon uses handle and foot pedal-actuated mechanism for intra-operative re-positioning. Device remains external to patient; covered by sterile drapes. Reduces staff fatigue; maintains device position for extended periods; frees staff for other tasks.

Clinical Evidence

Bench testing only. Design analysis and testing conducted to confirm functional characteristics are equivalent to predicate devices and meet design input requirements.

Technological Characteristics

Mechanical positioning system; jointed links, crossbar, rail clamps, and foot pedal-actuated mechanism. External use only; sterile drape coverage. No electronic or software components described.

Indications for Use

Indicated for use by trained operating room personnel to assist in mounting, positioning, and holding a uterine manipulator during gynecological laparoscopic surgical procedures.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• Endoboy (K033644)
• Zinnanti Uterine Manipulator/Injector (K941458)
• Mediflex Flex Arm (Pre-amendments device)
• Thompson Retractor/Device Holder (Pre-amendments device)

Submission Summary (Full Text)

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Page 8 of 78

OCT - 9 2007

Ko71405

# Section II

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## May 18, 2007 Date ースの出品を持つ。 1972年 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 Intuitive Surgical, Inc. Submitter 950 Kifer Road Sunnyvale, CA 94086 ER Number 2955842 の回出した。 A H H H H H S A S - A M M F F A C - A M M F F C - F - F - F - F - F - F - F - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Michael Yramategui Contact Sr. Director, Regulatory & Quality Affairs Telephone: (408) 523 - 2145 Fax: (408) 523 - 1390 E-mail: [e-mail] Trade Name(s): Subject Device Probe Holder System Classification Name: Endoscope and Accessories (GCJ, §876.1500) Cannula, manipulator/injector, uterine (LKF,unclassified) Common Name: Holder, Manipulator, Positioner, Arm Device Class: Probe Holder System Class II (GCJ); Unclassified (LKF)

#### 510(k) Number:

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| Predicate<br>Devices | Endoboy (K033644)<br>Geyser, SA |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Zinnanti Uterine Manipulator/Injector (K941458)<br>Zinnanti Surgical Devices, Chatsworth, CA |
| | Mediflex Flex Arm (Pre-amendments device)<br>Islandia, NY |
| | Thompson Retractor/Device Holder (Pre-amendments device)<br>Traverse City, MI |
| Device<br>Description | The Intuitive Surgical Probe Holder System is used to mount,<br>position and hold in position uterine manipulators used in<br>laparoscopic surgical procedures. |
| | The Probe Holder System can be mounted to standard<br>operating room tables and locked in position allowing surgical<br>devices to be securely held in position for long periods of time.<br>Use of the Probe Holder System frees operating room staff for<br>other activities and reduces fatigue associated with manually<br>maintaining a device in position during surgical procedures. |
| | The Probe Holder System consists of two attachment mechanisms:<br>one at its distal terminus for mounting the system to the operating<br>room table and the other at the proximal terminus for securely<br>grasping a surgical device. The mechanism at the distal terminus<br>consists of jointed links, a crossbar and rail clamps while that at the<br>proximal end is a simple mechanism for affixing detachable sterile<br>adaptors that securely grasp a surgical device in the desired<br>position. A handle and foot pedal actuated-mechanism facilitates<br>rapid and secure intra-operative re-positioning of the device by the<br>surgeon as needed. |
| | The Probe Holder System remains external to the patient's body at<br>all times and is covered intra-operatively by sterile draping. |
| Intended<br>Use | The Probe Holder System is intended to assist the surgical staff in<br>mounting, positioning and holding a uterine manipulator during<br>gynecological laparoscopic surgical procedures. It is intended for<br>use by trained operating room personnel in an operating room<br>environment. |

CONFIDENTIAL

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______________________________________________________________________________________________________________________________________________________________________________

| Comparison to<br>Predicate Device | Based on the comparison of design, technology, materials,<br>manufacturing, performance, specifications, and method of use, the<br>Probe Holder System is substantially equivalent to the previously<br>identified pre-amendment and 510(k) cleared predicate devices. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The technological characteristics of the subject devices are the<br>equivalent to the predicate devices. |
| Performance Data | Design analysis and testing has been conducted to confirm that basic<br>functional characteristics of the subject devices are substantially<br>equivalent to the predicate devices cited, and that design output<br>meets the design input requirements. |
| Conclusion | Based upon available technical information, intended use and<br>performance information provided in this pre-market notification,<br>the Probe Holder System described herein is substantially<br>equivalent to current legally marketed pre-amendment and 510(k)<br>cleared predicate devices. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a simple, stylized manner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2007

Intuitive Surgical, Inc. % Mr. Michael Yramategui Sr. Director, Regulatory & Quality Affairs 950 Kifer Road Sunnyvale, California 94086

Re: K071405

Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LKF Dated: September 6, 2007 Received: September 7, 2007

Dear Mr. Yramategui:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Michael Yramategui

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark McMullen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section III

## Indications for Use

510(k) Number (if known): Ko71405

Intuitive Surgical® Endoscopic Instrument Control System Device Name:

Indications For Use:

The Probe Holder System is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Milken

al. Restorative, Division of Ge and Neurologica

510(k) Number

Page 1 of 1

Intuitive Surgical® Inc. Probe Holder System

CONFIDENTIAL

Traditional 510(k) Section III, Page 1 of 1