(141 days)
Not Found
No
The device description focuses on mechanical components for holding and positioning surgical instruments. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is a holder system that assists in surgical procedures by holding a uterine manipulator and remains external to the patient's body. It does not directly treat or diagnose a disease or condition.
No
The device is described as assisting surgical staff in mounting, positioning, and holding a uterine manipulator during gynecological laparoscopic procedures, and it frees operating room staff. It does not mention analyzing data, diagnosing conditions, or providing information about a patient's health status.
No
The device description clearly outlines physical components such as jointed links, a crossbar, rail clamps, a handle, and a foot pedal, indicating it is a hardware device. There is no mention of software as a primary or standalone component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Probe Holder System is a mechanical device designed to physically hold and position a surgical instrument (a uterine manipulator) during a surgical procedure. It does not interact with or analyze any biological samples.
- Intended Use: The intended use clearly states it's for "mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures." This is a surgical support function, not a diagnostic one.
- Device Description: The description details its mechanical components and how it attaches to an operating table and holds a surgical device. There is no mention of sample collection, analysis, or diagnostic information.
Therefore, the Probe Holder System is a surgical accessory or support device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LKF
Device Description
The Intuitive Surgical Probe Holder System is used to mount, position and hold in position uterine manipulators used in laparoscopic surgical procedures.
The Probe Holder System can be mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Probe Holder System frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures.
The Probe Holder System consists of two attachment mechanisms: one at its distal terminus for mounting the system to the operating room table and the other at the proximal terminus for securely grasping a surgical device. The mechanism at the distal terminus consists of jointed links, a crossbar and rail clamps while that at the proximal end is a simple mechanism for affixing detachable sterile adaptors that securely grasp a surgical device in the desired position. A handle and foot pedal actuated-mechanism facilitates rapid and secure intra-operative re-positioning of the device by the surgeon as needed.
The Probe Holder System remains external to the patient's body at all times and is covered intra-operatively by sterile draping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operating room personnel in an operating room environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
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.
(b)
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.
0
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: mike.yramategui@intusurg.com 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:
1
| Predicate
Devices | Endoboy (K033644)
Geyser, SA |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Zinnanti Uterine Manipulator/Injector (K941458)
Zinnanti Surgical Devices, Chatsworth, CA |
| | Mediflex Flex Arm (Pre-amendments device)
Islandia, NY |
| | Thompson Retractor/Device Holder (Pre-amendments device)
Traverse City, MI |
| Device
Description | The Intuitive Surgical Probe Holder System is used to mount,
position and hold in position uterine manipulators used in
laparoscopic surgical procedures. |
| | The Probe Holder System can be mounted to standard
operating room tables and locked in position allowing surgical
devices to be securely held in position for long periods of time.
Use of the Probe Holder System frees operating room staff for
other activities and reduces fatigue associated with manually
maintaining a device in position during surgical procedures. |
| | The Probe Holder System consists of two attachment mechanisms:
one at its distal terminus for mounting the system to the operating
room table and the other at the proximal terminus for securely
grasping a surgical device. The mechanism at the distal terminus
consists of jointed links, a crossbar and rail clamps while that at the
proximal end is a simple mechanism for affixing detachable sterile
adaptors that securely grasp a surgical device in the desired
position. A handle and foot pedal actuated-mechanism facilitates
rapid and secure intra-operative re-positioning of the device by the
surgeon as needed. |
| | The Probe Holder System remains external to the patient's body at
all times and is covered intra-operatively by sterile draping. |
| 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. |
CONFIDENTIAL
2
| Comparison to
Predicate Device | Based on the comparison of design, technology, materials,
manufacturing, performance, specifications, and method of use, the
Probe Holder System is substantially equivalent to the previously
identified pre-amendment and 510(k) cleared predicate devices. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The technological characteristics of the subject devices are the
equivalent to the predicate devices. |
| Performance Data | Design analysis and testing has been conducted to confirm that basic
functional characteristics of the subject devices are substantially
equivalent to the predicate devices cited, and that design output
meets the design input requirements. |
| Conclusion | Based upon available technical information, intended use and
performance information provided in this pre-market notification,
the Probe Holder System described herein is substantially
equivalent to current legally marketed pre-amendment and 510(k)
cleared predicate devices. |
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
5
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