(303 days)
Not Found
No
The summary describes a computer-assisted surgical system that enhances user control and provides image processing, but it does not mention any features or components related to AI or ML. The focus is on improved user interface and ease-of-use compared to the predicate device.
No.
The da Vinci Si Surgical System is a robotic surgical system designed to assist surgeons in performing complex procedures. While it facilitates surgical tasks that may ultimately result in a therapeutic effect, the device itself is a tool for controlling instruments and is not directly applying therapy.
No
The device is described as an "Endoscopic Instrument Control System" intended "to assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for various surgical procedures. Its purpose is to facilitate surgery, not to diagnose conditions. While it has a Vision System Cart for image processing, this is for guiding the surgical instruments, not for diagnostic interpretation of images.
No
The device description explicitly lists three main hardware components: Surgeon Console, Patient Cart, and Vision System Cart. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, 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 controlling endoscopic instruments for various surgical procedures on patients (urologic, general laparoscopic, gynecological, thoracoscopic, cardiac revascularization). This is a device used in vivo (within a living organism) for surgical intervention.
- Device Description: The description details a computer-assisted device with components like a Surgeon Console, Patient Cart, and Vision System Cart, all geared towards facilitating surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes in this sense.
The device is a surgical robot/instrument control system, not a diagnostic tool that analyzes samples in vitro.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular 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.
Product codes
NAY
Device Description
The Intuitive Surgical da Vinci Si Surgical System, model IS3000 (also known as the Endoscopic Instrument Control System) is a modification of the existing da Vinci S Surgical System, model IS2000. Essentially, the IS3000 is an updated and enhanced version of the existing IS2000 device. The new IS3000 provides a more intuitive user interface and improved ease-of-use.
Overall, the model IS3000 is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The IS3000 consists of the following 3 main components:
- . Surgeon Console (model SS3000) - is the control center for the IS3000 system. While seated at the surgeon console (outside of the sterile field) and as observed through the console's stereo viewer, the surgeon controls critical aspects of the surgical procedures, including movement of the endoscopic instruments and endoscope within the operative field. Instrument and camera movements are controlled by the surgeon through use of 2 handoperated controllers residing in the console, and foot pedals at the console's base. These features allow the surgeon to be as dexterous as in "open" surgery, while operating in a minimally invasive environment. The surgeon at the console also has the option to change the surgical view from full screen mode to a multi-image mode, which displays the 3-dimensional (3-D) image of the operative field.
- Patient Cart (model PS3000) is the operative component of the surgical . system within the sterile field. Its primary function is to support the EndoWrist® instrument arms and camera arm, during surgical procedures.
- . EndoWrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision when operating in a minimally invasive environment. EndoWrist instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures. There are no changes to the EndoWrist Instruments in this submission.
- Vision System Cart (model VS3000) houses the system's image processing equipment and is operated by a person outside of the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The cart is also known as Intuitive Surgical Insite Vision System (Model VS3000) and consists of a stereo endoscope, endoscopic camera and various accessories, including a light source and light guides. The Insite Vision System provides 2 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 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
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)
Performance (bench) testing was conducted on the IS3000. All testing yielded acceptable results and was comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
081137
510(k) Summary
Intuitive Surgical, Inc. da Vinci Si Surgical System; model IS3000
FEB 1 8 2009
General Information
| Trade name | Intuitive Surgical® da Vinci® Si™ Surgical System |
|---|---|
| Product name | Intuitive Surgical da Vinci Si Surgical System |
| Catalog/Model Number | Model IS3000 |
| Common Name | Endoscopic instrument control system, |
| endoscopic instruments and accessories | |
| Classification | Class II |
| 510(k) Owner | Intuitive Surgical, Inc. |
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact Person | Nitya Narayanan |
| International Regulatory Project Manager | |
| nitya.narayanan@intusurg.com | |
| Manufacturer | Product will be manufactured and distributed by |
| Intuitive Surgical, Inc. - mailing and facility address: | |
| Intuitive Surgical, Inc. | |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Establishment | |
| registration number: | 2955842 |
| Owner/Operator | |
| number: | 9028901 |
Summary of Substantial Equivalence
The Intuitive Surgical da Vinci Si Surgical System (model IS3000) does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed computer-controlled surgical instrument systems that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.
Date: April 18, 2008
510(k) Notification INTUITIVE SURGICAL, INC.
1
Substantially Equivalent Devices
| Manufacturer | Substantially equivalent device | 510(k) |
|---|---|---|
| Intuitive Surgical, Inc. | ||
| Sunnyvale, CA | da Vinci S Endoscopic Instrument | |
| Control System (Model IS2000, V1.1), | ||
| Endoscopic instruments and | ||
| accessories | K050369 | |
| K063220 |
Device Description
The Intuitive Surgical da Vinci Si Surgical System, model IS3000 (also known as the Endoscopic Instrument Control System) is a modification of the existing da Vinci S Surgical System, model IS2000. Essentially, the IS3000 is an updated and enhanced version of the existing IS2000 device. The new IS3000 provides a more intuitive user interface and improved ease-of-use.
Overall, the model IS3000 is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The IS3000 consists of the following 3 main components:
- . Surgeon Console (model SS3000) - is the control center for the IS3000 system. While seated at the surgeon console (outside of the sterile field) and as observed through the console's stereo viewer, the surgeon controls critical aspects of the surgical procedures, including movement of the endoscopic instruments and endoscope within the operative field. Instrument and camera movements are controlled by the surgeon through use of 2 handoperated controllers residing in the console, and foot pedals at the console's base. These features allow the surgeon to be as dexterous as in "open" surgery, while operating in a minimally invasive environment. The surgeon at the console also has the option to change the surgical view from full screen mode to a multi-image mode, which displays the 3-dimensional (3-D) image of the operative field.
- Patient Cart (model PS3000) is the operative component of the surgical . system within the sterile field. Its primary function is to support the EndoWrist® instrument arms and camera arm, during surgical procedures.
- . EndoWrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision when operating in a minimally invasive environment. EndoWrist instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures. There are no changes to the EndoWrist Instruments in this submission.
2
- Vision System Cart (model VS3000) houses the system's image processing � equipment and is operated by a person outside of the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The cart is also known as Intuitive Surgical Insite Vision System (Model VS3000) and consists of a stereo endoscope, endoscopic camera and various accessories, including a light source and light guides. The Insite Vision System provides 2 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 2-D) of the surgical field for the surgeon's reference.
Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular 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.
3
Bench/Animal/Clinical Testing
Performance (bench) testing was conducted on the IS3000. All testing yielded acceptable results and was comparable to the predicate device.
The IS3000 complies with applicable portions of the following technical standards, or FDA-recognized consensus standards:
| UL/IEC 60601-1:1988, Amendment A1: 1991-11, Amendment A2: 1995
| Medical Electrical Equipment - Part 1: General requirements for safety |
|---|
| IEC 60601-1-1:2000, Medical Electrical Equipment - Part 1: |
| General requirements for safety; Collateral standard: |
| Safety requirements for medical electrical systems |
| IEC 60601-1-2:2001, Medical Electrical Equipment - Part 1-2: |
| General requirements for safety; Collateral standard: |
| Electromagnetic compatibility - requirements and tests |
| IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1: |
| General requirements for safety; Collateral standard: |
| Programmable electrical medical systems |
| IEC 60601-2-2:1998, Medical Electrical Equipment - Part 2-2: |
| Particular requirements for the safety of high frequency surgical equipment |
| IEC 60601-2-18:1996, Amendment A1: 2000 |
| Medical Electrical Equipment - Part 2: |
| Particular requirements for the safety of endoscopic equipment |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Ms. Karen Uyesugi VP, Clinical and Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K081137
Trade/Device Name: da Vinci Si Surgical System IS3000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: December 23, 2008 Received: January 5, 2009
Dear Ms. Uyesugi:
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. Drue, 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.
EB 1 8 2009
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.
5
Page 2 - Ms. Karen Uyesugi
Enclosure
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 A. Millken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): K081137
Device Name: Intuitive Surgical® da Vinci Si Surgical System (IS3000)
Indications For Use: The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 and cryogenic ablation probes and accessories during urologic surqical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular 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 × (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)
Neil RP Ogale for MXM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K081137