(316 days)
Not Found
No
The summary describes a robotic surgical system controlled by a surgeon and a new instrument for that system. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on direct surgeon control and stereo vision, not automated decision-making or learning algorithms.
Yes
The device is described as assisting in the control of various surgical instruments and engaging in procedures such as dissection, ligation, and electrocautery, which are therapeutic interventions.
No
This device is described as assisting in the control of surgical instruments for manipulation of tissue and performing surgical procedures; it is not described as diagnosing specific conditions or diseases.
No
The device description clearly outlines a system comprised of hardware components (Surgeon Console, Patient Side Cart, surgical arms, endoscope, camera, etc.) in addition to any software that controls them. It is not solely software.
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 manipulating tissue during various surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The device description details a surgical system with a surgeon console, patient side cart, robotic arms, and endoscopic instruments. This hardware is used for performing surgical actions, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, urine, tissue samples, or any other biological material for diagnostic purposes. Its function is purely instrumental in performing surgical tasks.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
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, 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 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 (comma separated list FDA assigned to the subject device)
NAY, GEI, GEH
Device Description
This special 510(k) is being submitted for an additional EndoWrist® instrument, the Cardiac Probe Grasper, to be utilized with probes and catheters used endoscopically during cardiac ablation procedures. This submission also includes the related minor labeling changes / clarifications on the da Vinci® Surgical Systems and EndoWrist Instruments. There are no changes in the technology, materials, manufacturing, performance, design, specifications or method of use for the da Vinci Surgical System or the CryoCath SurgiFrost Surgical CryoAblation System.
EndoWrist® Cardiac Probe Grasper
The Cardiac Probe Grasper will be used with the da Vinci Surgical Systems to position and hold probes used during ablative cardiac procedures, and will also facilitate precise and delicate blunt dissection of the pericardial reflections at the superior vena cava (SVC) and inferior vena cava (IVC).
This Intuitive Surgical instrument will be compatible with the previously approved da Vinci Endoscopic Instrument Control Systems Models IS1200 and IS2000.
To address use of the Cardiac Probe Grasper with cardiac ablation probes, an Instructions for Use addendum sheet will be included with the general IFU for instruments that are compatible with the specified probes.
da Vinci® Surgical Systems
The da Vinci Surgical Systems consist of two integrated subsystems as follows: Intuitive Surgical® Endoscopic Instrument Control System:
This sub-system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon is able to view the surgical field and control critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within that field. Movements are controlled by the surgeon through use of Master Tool Manipulators (MTMs), two hand-operated mechanisms residing within the Surgeon Console.
The EndoWrist® endoscopic instruments, stereo endoscope and camera attach to surgical arms located on the Patient Side Cart (PSC). The endoscopic instruments attach to arms known as Patient Side Manipulators (PSM). Another arm, known as the Endoscope Camera Manipulator (ECM), holds the stereo endoscope and camera. Commands from the Surgeon Console are relayed to the PSC, located adjacent to the patient, via various cables. Instrument and endoscope insertions, removals and exchanges are performed by another member of the surgical team 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 the InSite® Vision System, consists of a stereo endoscope, endoscopic camera, and 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 of the surgical field. Additional monitors may be supplied by the user to allow other members of the surgical team to view the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue including: urologic, general laparoscopic, gynecological laparoscopic, general cardiovascular and non-cardiovascular thoracoscopic, thoracoscopically assisted cardiotomy procedures. Cardiac.
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, have 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802, K063220, K062140, K053436, K040690
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section II
:4
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.
| Date | February 8, 2008 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Michael Yramategui |
| Sr. Director, Regulatory & Quality Affairs | |
| Telephone: (408) 523 - 2145 | |
| Fax: (408) 523 - 1390 | |
| E-mail: mike.yramategui@intusurg.com | |
| Subject | |
| Device | Trade Name(s): |
- Intuitive Surgical ® da Vinci ® Surgical System and Endoscopic Instruments
- Intuitive Surgical ® EndoWrist ® Cardiac Probe Grasper
Classification Name:
System, Surgical, Computer Controlled Instrument (21 CFR 876.1500)
Common Name:
Endoscopic Instrument Control System, Endoscopic Instruments and Accessories
Device Class:
Intuitive Surgical ® da Vinci ® Surgical System and Endoscopic Instruments: Class II, NAY, System, Surgical, Computer Controlled Instrument |
510(k) Number: K070947
1
11
| Predicate
Devices | Intuitive Surgical da Vinci® Surgical System and Endoscopic
Instruments
(legally marketed underK990144, K002489, K011002, K013416, K021036,
K022574, K040237, K43153, K043288, K050404, K050369, K050802 and
K063220) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intuitive Surgical EndoWrist® Long Tip Forceps and EndoWrist
Pericardial Dissector
(legally marketed under K990144, K013416, K021036, and K050369) |
| | CryoCath Inc. SurgiFrost® Surgical CryoAblation System
(legally marketed under K062140, K053436 and K040690) |
| Device
Description | This special 510(k) is being submitted for an additional
EndoWrist® instrument, the Cardiac Probe Grasper, to be utilized |
with probes and catheters used endoscopically during cardiac ablation procedures. This submission also includes the related minor labeling changes / clarifications on the da Vinci® Surgical Systems and EndoWrist Instruments. There are no changes in the technology, materials, manufacturing, performance, design, specifications or method of use for the da Vinci Surgical System or the CryoCath SurgiFrost Surgical CryoAblation System.
EndoWrist® Cardiac Probe Grasper
The Cardiac Probe Grasper will be used with the da Vinci Surgical Systems to position and hold probes used during ablative cardiac procedures, and will also facilitate precise and delicate blunt dissection of the pericardial reflections at the superior vena cava (SVC) and inferior vena cava (IVC).
This Intuitive Surgical instrument will be compatible with the previously approved da Vinci Endoscopic Instrument Control Systems Models IS1200 and IS2000.
To address use of the Cardiac Probe Grasper with cardiac ablation probes, an Instructions for Use addendum sheet will be included with the general IFU for instruments that are compatible with the specified probes.
2
12
Device Description (continued)
da Vinci® Surgical Systems
The da Vinci Surgical Systems consist of two integrated subsystems as follows: Intuitive Surgical® Endoscopic Instrument Control System:
This sub-system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon is able to view the surgical field and control critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within that field. Movements are controlled by the surgeon through use of Master Tool Manipulators (MTMs), two hand-operated mechanisms residing within the Surgeon Console.
The EndoWrist® endoscopic instruments, stereo endoscope and camera attach to surgical arms located on the Patient Side Cart (PSC). The endoscopic instruments attach to arms known as Patient Side Manipulators (PSM). Another arm, known as the Endoscope Camera Manipulator (ECM), holds the stereo endoscope and camera. Commands from the Surgeon Console are relayed to the PSC, located adjacent to the patient, via various cables. Instrument and endoscope insertions, removals and exchanges are performed by another member of the surgical team 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 the InSite® Vision System, consists of a stereo endoscope, endoscopic camera, and 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 of the surgical field. Additional monitors may be supplied by the user to allow other members of the surgical team to view the procedure.
Intended Use
EndoWrist® Cardiac Probe Grasper
EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
3
Intended Use (continued) The Cardiac Probe Grasper is an addition to the EndoWrist Instrument family, and there are no changes to be made in the intended use of the device.
da Vinci® Surgical Systems
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 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 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.
This minor labeling change is a clarification within the currently cleared indications for use, and does not alter the intended use of the device.
EndoWrist® Cardiac Probe Grasper Comparison to Predicate The design of the predicate devices' distal end effectors, or Device grips, was modified in order to better grasp and manipulate cardiac ablation probes. There will be no change in the instrument technology. materials. manufacturing or sterilization processes, requirements or compatibility with the da Vinci Surgical Systems.
4
| Comparison to
Predicate
Device
(continued) | Labeling modification for the Cardiac Probe Grasper will
consist of new box labeling and a supplement to the Instrument
Instructions For Use describing the use of the instrument with
specified cardiac ablation probes. |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | da Vinci® Surgical Systems, CryoCath CryoAblation System |
| | There are no changes in the design, technology, materials,
manufacturing, performance, specifications, or method of use
for either the Intuitive da Vinci Surgical Systems or the
SurgiFrost® Surgical CryoAblation System. |
| | The only modification consists of an update to the Indication
statement which provides a clarification of tasks that can be
performed with the da Vinci Surgical Systems to add delivery
and placement of cryogenic ablation probes. There will be no
modifications to CryoCath SurgiFrost labeling. |
| | The use of the da Vinci Surgical System to deliver and place
the SurgiFrost probe is equivalent to the currently cleared
practice of using conventional minimally invasive surgical
instruments. This change does not impact the operational
characteristics or change the intended use of either device. |
| Technological
Characteristics | The technological characteristics of the subject devices are the
same as the predicate devices. |
| Performance
Data | Design analysis and comparison, as well as bench testing, have
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 the technical information, intended use and
performance information provided in this pre-market notification,
the EndoWrist® Cardiac Probe Grasper instrument and the da
Vinci Surgical Systems described herein have been shown to be
substantially equivalent to current legally marketed predicate
devices. |
14
5
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the top and left side of the caduceus.
FEB 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. c/o Mr. Michael Yramategui Senior Director, Regulatory Affairs 950 Kifer Rd. Sunnyvale, CA 94086
Re: K070947
Trade/Device Name: Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments; Intuitive Surgical® EndoWrist® Cardiac Probe Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II (two) Product Code: NAY, GEI, GEH Dated: December 10, 2007 Received: December 11, 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.
6
Page 2 - Mr. Michael Yramategui
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. 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) 276-0120. 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,
Blommor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section III
Indications for Use
510(k) Number (if known): K070947
Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments Device Name: Intuitive Surgical® EndoWrist® Cardiac Probe Grasper
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, 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 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.
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)
E. Mcd
(Division Sign-Off)
Division of Cardiovascular Devices
Koloqui