(38 days)
Not Found
No
The summary describes a robotic surgical system controlled by a surgeon, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
This device directly assists in surgical procedures by controlling instruments for tissue manipulation within a living body.
No
The device description indicates that the system is used for endoscopic manipulation of tissue during surgical procedures, controlling surgical instruments and providing vision for the surgeon. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components, including the Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator, and the Insite Vision System with its components. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist in the control of endoscopic instruments for various surgical procedures on the human body. This involves direct manipulation of tissue in vivo.
- Device Description: The description details a system with a surgeon console, patient side cart, manipulators, and an endoscopic vision system. These components are all related to performing surgical procedures on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body (in vitro) to provide diagnostic information. The system's function is entirely focused on facilitating surgical intervention.
Therefore, this device falls under the category of a surgical robot or instrument control system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Product codes
NAY
Device Description
The da Vinci S Surgical System, Model IS2000 V1.1, consists of three integrated sub-systems as follows: Intuitive Surgical Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of two sub-systems - the Surgeon Console, Model SS2000, and Patient Side Cart, Model PS2000. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique manipulators known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC, Model PS2000). The endoscope is also held in a fixed position (with respect to the patient) by another manipulator. similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC. Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, Model VS2000, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, general laparoscopic, gynecological laparoscopic, general non-cardiovascular thoracoscopic, thoracoscopically assisted cardiotomy.
Indicated Patient Age Range
adult and pediatric use
Intended User / Care Setting
trained physicians 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and comparison, as well as bench testing and risk analysis activities, have been conducted to confirm that the characteristics of the modified device are substantially equivalent to the predicate devices cited.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050369, K021036, K050404 and K050802
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.
0
DEC - 1 2006
Ka63220
7
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.
510(k) Number:
| Date | 19 October 2006 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Jerry Tsutsumi |
| Sr. Regulatory Engineer | |
| Telephone: (408) 523 - 2415 | |
| Fax: (408) 523 - 1390 | |
| e-mail: jerry.tsutsumi@intusurg.com | |
| Subject | |
| Device | Name: Intuitive Surgical® da Vinci® S™ Surgical System (Model IS2000, |
| V1.1) and EndoWrist® Endoscopic Instruments. | |
| Classification Name: System, Surgical, Computer Controlled Instrument | |
| (21 CFR 876.1500) | |
| Common Name: Endoscopic Instrument Control System, Endoscopic | |
| Instruments, and accessories | |
| Predicate | |
| Devices | Intuitive Surgical da Vinci S Surgical System (Model IS2000) and |
| EndoWrist Endoscopic Instruments (legally marketed under K050369, | |
| K021036, K050404 and K050802). | |
| Device | |
| Description | The da Vinci S Surgical System, Model IS2000 V1.1, consists of three |
| integrated sub-systems as follows: | |
| Intuitive Surgical Endoscopic Instrument Control System: The | |
| Endoscopic Instrument Control System is comprised of two sub-systems |
- the Surgeon Console, Model SS2000, and Patient Side Cart, Model
PS2000. While seated at the Surgeon Console, the surgeon controls
critical aspects of the procedure, including movement of the endoscopic
instruments and endoscope, within the operative field. Endoscopic
instrument and camera movements are controlled by the surgeon through
use of the Master Tool Manipulators (MTM), two hand operated
mechanisms residing within the Surgeon Console. |
1
Device Description (continued)
The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique manipulators known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC, Model PS2000). The endoscope is also held in a fixed position (with respect to the patient) by another manipulator. similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, Model VS2000, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
- The Intuitive Surgical Endoscopic Instrument Control System is intended Intended Use to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Surgical System - Model IS2000 V1.1
2
Comparison to Predicate Device
This 510(k) notification is submitted for design modifications to the Endoscopic Instrument Control System, and Vision System.
The modifications to the Vision System Cart (Model VS2000) consist of an optional, enhanced endoscopic camera and Camera Control Units (CCU), and an optional, touch screen display. The touch screen display on the Vision System Cart provides redundant video capabilities as the touch screen display that is currently on the Patient Side Cart (Model PS2000), and the updated endoscopic camera and Camera Control Units provide enhanced vision system performance. An optional still/video capture device (DVD Recorder) will be available and auxiliary control will be provided with the touch screens.
The modifications to the Endoscopic Instrument Control System consist of primarily software modifications to support new features as follows:
Telestration capabilities: instructional controls and Instructional additional controls duplicating some of the Surgeon's Console Left-Side Pod controls (camera calibration and camera set-up functions).
The addition of ECM LED's (Light Emitting Diode's) as fault indicators for User Interface improvements, identical to current PSM LED's functionality. An improved ECM "under-drape Cannula Mount", with a new ECM drape configuration, and ECM cannula sensing for User Interface improvements.
The Surgeon Console is updated with activation of a foot pedal for energy activation of a bipolar and/or a monopolar instrument, with separate bipolar/monopolar connections integrated into the rear IO panel of the Surgeon Console
The user interface design is essentially identical to the predicate device except for minor modifications to accommodate the aforcmentioned changes.
Device operation, functionality, and methods of use for the subject device are identical to the predicate device. The technology, materials, manufacturing methods, and performance are essentially the same for the predicate device as the subject device.
Technological The technological characteristics of the subject devices are essentially the Characteristics same as for the predicate devices.
Performance Design analysis and comparison, as well as bench testing and risk Data analysis activities, have been conducted to confirm that the characteristics of the modified device are substantially equivalent to the predicate devices cited.
3
Based upon the device's general specifications, intended use, and results Conclusion of risk analysis and performance testing provided in this pre-market notification, the da Vinci S Surgical System described herein has been shown to be substantially equivalent to current legally marketed predicate device.
4
Public Health Service
OF HEALTH & HUMAN SERVICES - USA
DEPAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Mr. Michael H. Yramategui Senior Director, Regulatory Affairs and Quality Assurance 950 Kifer Road Sunnyvale, California 94086
DEC - 1 2006
Re: K063220
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: October 20, 2006 Received: October 24, 2006
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
5
Page 2 - Mr. Michael H. Yramategui
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.
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,
Mark N. Molkerson
kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Intuitive Surgical® Endoscopic Instrument Control System Device Namc:
Indications For Use:
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
| (Division Sign-Off) |
Division of General, Res-
and Neurological Devices
| 510(k) Number | LD3220 |
|---|---|
| --------------- | -------- |
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