(234 days)
No
The document describes a robotic surgical system with image processing capabilities, but there is no mention of AI or ML being used for any function, such as image analysis, surgical guidance, or fault diagnosis. The described functions are based on direct control and viewing.
No
The device, specifically the da Vinci Connect and da Vinci OnSite accessories, are described as intending to facilitate communication and fault diagnosis for the da Vinci S Surgical System, which is a computer-assisted device for surgery. Neither the accessories nor the surgical system itself are directly applying therapy; rather, they assist a surgeon in performing therapeutic procedures.
Yes
The da Vinci OnSite is specifically intended for "diagnosing faults with the da Vinci S Surgical System."
No
The device description clearly outlines multiple hardware components (Surgeon Console, Patient Side Cart, InSite Vision System) that are integral to the device's function. While software is undoubtedly involved in controlling these components and processing data, the device is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The da Vinci S Surgical System with its accessories (Connect and OnSite) is a surgical system designed to facilitate complex surgery using a minimally invasive approach. It involves robotic arms, instruments, and a vision system to assist the surgeon during the procedure.
- Intended Use: The intended uses described are for surgical assistance, remote proctoring, viewing surgical procedures, and diagnosing faults with the surgical system itself. None of these involve testing samples taken from the human body.
- Device Description: The description details the components of a surgical system (Surgeon Console, Patient Side Cart, Vision System) and their roles in performing surgery. It does not mention any components or processes related to analyzing biological samples.
Therefore, the da Vinci S Surgical System and its accessories, as described, fall under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.
The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.
Product codes
NAY
Device Description
The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive environment. The surgeon has the option to change the surgical view from full screen mode to a multi-image mode, which displays an optional 3-dimensional High Definition (3-D HD), 3-D, or 2-D standard definition image of the operative field.
The Patient Side Cart (PSC, Model PS2000): The operative component of the surgical system within the sterile field. Its primary function is to support the endoscopic instrument arms and camera arm, during surgical procedures. Endoscopic instruments are held in a fixed position (with respect to the patient) by unique Patient Side Manipulators (PSM), and the endoscope is held by the Endoscope Camera Manipulator (ECM). The PSM's 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, via a cable.
InSite ® Vision System (Model VS2000): Houses the system's image processing equipment and is operated by a person outside the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The 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 image (or alternatively a 2-D) of the surgical field for the surgeon's reference.
Mentions image processing
Yes
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
da Vinci Connect: trained Surgical proctors.
da Vinci OnSite: trained Intuitive Surgical Customer Service personnel.
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
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.
Key Metrics
Not Found
Predicate Device(s)
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
081207
510(k) SUMMARY
DEC 1 9 2008
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
5 December 2008 Date Submitter Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 ER Number 2955842 9028901 Owner/Operator James Farnworth Contact Director, Regulatory Affairs Direct: 408-523-8687 Fax: 408-523-1390 james.farnworth@intusurg.com Name: Intuitive Surgical® da Vinci® S" Surgical System, Model IS2000, Subject with da Vinci Connect™, da Vinci OnSite™ Device Classification Name: System, Surgical, Computer Controlled Instrument (2 CFR 876.1500) Common Name: Endoscopic Instrument Control System, Endoscopic Instruments, and accessories Predicate Devices Intuitive Surgical da Vinci S Surgical System (Model IS2000) with Endoscopic and EndoWrist Instruments (legally marketed under K050369 and K063220). The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and Device Description da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive
510(k) Number:
1
| Device
Description
(continued) | environment. The surgeon has the option to change the surgical view from
full screen mode to a multi-image mode, which displays an optional 3-
dimensional High Definition (3-D HD), 3-D, or 2-D standard definition
image of the operative field. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Patient Side Cart (PSC, Model PS2000): The operative component of
the surgical system within the sterile field. Its primary function is to
support the endoscopic instrument arms and camera arm, during surgical
procedures. Endoscopic instruments are held in a fixed position (with
respect to the patient) by unique Patient Side Manipulators (PSM), and the
endoscope is held by the Endoscope Camera Manipulator (ECM). The
PSM's 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, via a cable. |
| | InSite ® Vision System (Model VS2000): Houses the system's image
processing equipment and is operated by a person outside the sterile field
during surgery. The cart provides space for an optional touch screen
monitor, as well as ancillary surgical equipment. The 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 image (or alternatively a 2-D)
of the surgical field for the surgeon's reference. |
| Indications for
Use | da Vinci Connect: |
| | The da Vinci Connect is an accessory to the da Vinci S Surgical System
and is intended for use by trained Surgical proctors to communicate and to
provide surgical advice to the operating surgeon when using the da Vinci
S Surgical System, Model IS2000. In addition, the Remote Proctor
Interface can be used to view surgical procedures related to the use of the
da Vinci S Surgical System, Model IS2000. |
| | da Vinci OnSite: |
| | The da Vinci OnSite is an accessory to the da Vinci S Surgical System
and is intended for use by trained Intuitive Surgical Customer Service
personnel to obtain da Vinci S Surgical System information for the
purpose of diagnosing faults with the da Vinci S Surgical System, Model
IS2000. |
| Comparison to
Predicate Device | This 510(k) notification is being submitted for minor design
modifications to the Surgeon Console and Vision System Cart of the
Endoscopic Instrument Control System, Model IS2000. |
| | • da Vinci Connect allows a skilled remote proctoring surgeon to |
2
provide advice to the console surgeon via audio, video or using instructional telestration, during a surgical procedure.
- da Vinci OnSite allows trained Intuitive Surgical, Inc. Customer . Support personnel to obtain system information for the purpose of debugging and diagnosing problems with the system.
Minor hardware modifications to the Surgeon Console (SS2000) to support da Vinci Connect and da Vinci OnSite consists of:
Comparison to Predicate Device (continued)
- . Router,
- Workgroup Bridge, .
- . Antenna,
- Rear Service Panel Modification to allow connection to hospital ethernet .
Minor hardware modifications to the Vision System Cart (VS2000) to support da Vinci Connect and da Vinci OnSite consists of:
- . a da Vinci Connect PC (also known as "Proctor PC") mounted on the Vision System Cart, with customized software.
- a Uninterruptable Power Supply (UPS) with a battery backup, connected . to an existing Medical Grade Isolation Transformer, for the Proctor PC only.
- . Rear Panel modification, two (2) additional User Video Input connections, and an Ethernet connector.
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 device are essentially the Characteristics same as for the predicate device.
- 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.
- Conclusion The da Vinci S Surgical System (Model IS2000) is a sophisticated computer assisted device designed to facilitate complex surgery using a minimally invasive approach. The indications for use, remains unchanged from the predicate device. The Intuitive Surgical da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite does not raise any new safety or effectiveness issues and is substantially equivalent to, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2008
Director, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Intuitive Surgical, Inc.
% Mr. James Farnworth
Re: K081207
Trade/Device Name: Intuitive Surgical® da Vinciço Sm Surgical System, Model IS200, with da Vinci Connect™, da Vinci Onsite™
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: December 5, 2008 Received: December 8, 2008
Dear Mr. Farnworth:
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. James Famworth
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K081207
Device Name: Intuitive Surgical da Vinci S Surgical System, Model IS2000 with da Vinci OnSite and da Vinci Connect
Indications For Use:
Indications For Use - da Vinci Connect:
The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.
Indications For Use - da Vinci OnSite:
The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.
Prescription Use × (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)
Neill R. Oglin Cor mem
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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