(227 days)
No
The summary describes an electro-mechanical system for controlling endoscopic instruments and does not mention AI or ML capabilities.
No.
The device is described as an "Endoscopic Instrument Control System" designed for "accurate control of selected endoscopic instruments" during surgical procedures. It is a tool for surgeons to use during procedures and does not directly provide therapeutic benefit to the patient.
No.
The "Intended Use" section states that the device is for "accurate control of selected endoscopic instruments" during surgical procedures, indicating primarily a surgical assistance function rather than a diagnostic one.
No
The device description explicitly states it is an "electro-mechanical device consisting of a Surgical Console including 'Master Manipulators', articulated Instrument Control Arms or 'Slave Manipulators' and Limited Reuse Tools or end effectors," indicating it includes significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "accurate control of selected endoscopic instruments... during thoracoscopic and laparoscopic surgical procedures." This describes a surgical tool used in vivo (within the body) for manipulating instruments during surgery.
- Device Description: The description of the system components (Surgical Console, Master Manipulators, Instrument Control Arms, Limited Reuse Tools) aligns with a robotic surgical system, not a device used for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to assist in performing surgical procedures.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System is intended for precise and accurate control of selected tracoscopic and laparoscopic instruments including, rigid laparoscopes, blunt endoscopic dissectors, and endoscopic retractors, during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by trained professionals in operating room environments
The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
Product codes
GCJ
Device Description
The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.
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 professionals in operating room environments
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and in virro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of reproducibility, hysteresis, and functional adequacy. All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Computer Motion AESOP Laparoscope Positioning and Control System, Adronic Devices Endex (originally "Adept") Instrument Positioning Accessory (IPA), US Surgical 3 Auto Suture Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169), Medical Perspectives Corp. Kittner Dissector (K953059)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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JUL 31 1997
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.
510(k) Number: K965001
Applicant Information:
| Date Prepared: | June 20, 1997 |
|---|---|
| Name | Intuitive Surgical, Inc. |
| Address: | 1340 W. Middlefield Road |
| Mountain View, California 94043 415-237-7036 | |
| Contact Person: | Michael A. Daniel |
| Phone Number: | (415) 237-7036 |
| Facsimile Number: | (415) 526-2060 |
Device Information:
| Classification: | Class I / II | Surgical Table and Accessories
Endoscope and Accessories
Gynecologic Laparoscope and Accessories |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Trade Name: | Intuitive Surgical, Endoscopic Instrument Control System
Accessories: "Resposable" (limited reuse) Instruments consisting
of Retractors and Blunt Dissectors | |
| Common Name: | Endoscopic Instrument Control System
Endoscope and Accessories for Minimally Invasive Surgery | |
| Classification Name: | Surgical Table and Accessories, | 21 CFR 878.4960 |
| | Endoscope and Accessories, | 21 CFR 876.1500 |
| | Gynecologic laparoscope and acces. | 21 CFR 884.1720 |
Predicate Devices:
The Innuive Surgical Endoscopic Instrument Control System and Tools are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
- Computer Motion AESOP Laparoscope Positioning and Control System ﻟﺴﻨﺔ
- Adronic Devices Endex (originally "Adept") Instrument Positioning Accessory (IPA) ు
- And various atraumatic Class I Exempt surgical instruments including the US Surgical 3 Auto Suture Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059)
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510(k) SUMMARY
(Continued)
Device Description:
The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.
Intended Use:
The Intuitive Surgical Endoscopic Instrument Control System is intended for precise and accurate control of selected tracoscopic and laparoscopic instruments including, rigid laparoscopes, blunt endoscopic dissectors, and endoscopic retractors, during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by trained professionals in operating room environments
Comparison to Predicate Device(s):
The Intuitive Surgical Endoscopic Instrument Control System and Resposable Tools are substantially equivalent to a combination of the Computer Motion AESOP Laparoscope Posstoning and Control System, the Adept/Andronic Laparoscopic Positioning and Manipulation System and various other Class I Exempt endoscopic instruments in terms of intended use and basic functionality. The Intuitive System is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools. The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects.
In Vitro Test Data:
Design analysis and in virro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of reproducibility, hysteresis, and functional adequacy. All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.
Summary:
Based upon the product technical information provided, intended use, and performance Information provided in this pre-market notification, the Intuitive Surgical Endoscopic Instrument Control System has been shown to be substantially equivalent to currently marketed predicate devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Daniel Vice President, Regulatory/Clinical. Affairs &. Quality Assurance. ........... Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View. California 94304
JUL 3 1 1997
Re: K965001
Trade Name: Intuitive Surgical Endoscopic Instrument Control System Regulatory Class: II Product Code: GCJ Dated: June 30, 1997 Received: July 1, 1997
Dear Mr. Daniel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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. The substantial equivalence determination for the Intuitive Surgical Endoscopic Instrument Control System includes use with rigid endoscopes and the following manual surgical instruments only: (1) the Intuitive™ Retractor, (2) the Intuitive™ Blunt Dissector, (3) the Intuitive™ Kitner, and (4) the Intuitive™ Stablizer manual instrument tips.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such
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Page 2 - Mr. Michael A. Daniel
assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. . . . . . . . . . . . . . .
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, M.D., Ph.D. Director, Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K965001
Intuitive Surgical Endoscopic Instrument Control System Device Name:
Indications For Use ... . .
The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number kg65001
ption Use
OR
Over-The-Counter Use
Prese : phon Use (Pat 21 ChR 801 109) OR
(Optional Format 1-2-96)
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