(13 days)
No
The summary describes a surgical robotic system and a specific bipolar dissecting forceps instrument. It focuses on the mechanical control, electrosurgical function, and stereo vision system. There is no mention of AI or ML in the intended use, device description, or performance studies. The modification described is the incorporation of a specific type of bipolar forceps.
Yes
The system is intended to assist in surgical procedures involving manipulation, cutting, and approximation of tissue, and also includes electrocautery, which directly impacts the body for therapeutic purposes.
No
The device is an Endoscopic Instrument Control System and instruments used for surgical procedures such as grasping, cutting, and suturing, and does not perform diagnostic functions.
No
The device description clearly outlines multiple hardware components including the Surgeon Console, Patient Side Cart, manipulators, endoscope, camera, light source, and electrosurgical unit. 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 and instruments used for manipulating tissue during surgical procedures (grasping, cutting, dissecting, suturing, etc.). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a robotic surgical system, endoscopic instruments, and an electrosurgical unit. These are all tools used for performing surgical interventions directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to perform surgical actions on the body.
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, vacuum 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, gynecologic 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
This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical Endoscopic and EndoWrist Instruments to incorporate the functionality of the Everest / Gyrus Bipolar Lyons Dissecting Forceps (a Class II, Electrosurgical cutting and coagulation device and accessories) Product Code GEI, under CFR Section 878.4400.
The Intuitive Surgical EndoWrist PK Dissecting Forceps (P/N 400214 for the da Vinci Surgical System - Model IS1200, and P/N 420214 for the da Vinci S Surgical System - Model IS2000) is an endoscopic instrument with a grasping end effector (or grips) to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control Systems (Model IS1200 and IS2000) and a external electrosurgical unit (ESU) provided by Gyrus Medical. The instrument is a reposable bipolar electrosurgical instrument connected to the ESU via a bipolar electrosurgical cable. The ESU can be activated by a foot pedal attached to the ESU itself, and controls the current flow to the grasping end effector of the device. A current passes from the ESU between the grip jaws then back to the generator, allowing for precise tissue coagulation. The instrument end effectors (or grips) are identical to the Everest Bipolar Lyons Dissecting Forceps, and the identical Gyrus connection cable, Gyrus ESU's and Footswitch are used with the EndoWrist PK Dissecting Forceps.
There are no changes to the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci Surgical System, Model IS1200 and da Vinci S Surgical System, Model IS2000) associated with this pre-market notification. The da Vinci and da Vinci S Surgical Systems consists of two integrated sub-systems as follows:
Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console (SSC) and Patient Side Cart (PSC). 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 arms known as Patient Side Manipulators (PSM), which are located on the PSC. 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 PCS 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 cables. 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 Intuitive Surgical Endoscopic Instrument Control System, also known as Intuitive Surgical Insite® Vision System. 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
Not Found
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)
Design and risk analysis and assessment has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate device without introducing any new issues of safety or effectiveness, and a bench testing has been conducted to confirm that basic functional characteristics 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)
K990144, K012833, K050369, K050802
Reference Device(s)
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
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: |S™ Surgical System,
Model IS2000) and Endoscopic Instruments – Bipolar Forceps is the
predicate devices (legally marketed under K990144, K012833, K050369
and K050802). The Everest (Gyrus) Bipolar Lyons Dissecting Forceps
(legally marketed under K031080) is also cited as a secondary predicate,
due to this submission being a design modification of the Intuitive
Surgical instruments to incorporate features of the Everest / Gyrus
Bipolar Lyons Dissecting Forceps as describe in this submission. |
.
1
Device Description
This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical Endoscopic and EndoWrist Instruments to incorporate the functionality of the Everest / Gyrus Bipolar Lyons Dissecting Forceps (a Class II, Electrosurgical cutting and coagulation device and accessories) Product Code GEI, under CFR Section 878.4400.
The Intuitive Surgical EndoWrist PK Dissecting Forceps (P/N 400214 for the da Vinci Surgical System - Model IS1200, and P/N 420214 for the da Vinci S Surgical System - Model IS2000) is an endoscopic instrument with a grasping end effector (or grips) to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control Systems (Model IS1200 and IS2000) and a external electrosurgical unit (ESU) provided by Gyrus Medical. The instrument is a reposable bipolar electrosurgical instrument connected to the ESU via a bipolar electrosurgical cable. The ESU can be activated by a foot pedal attached to the ESU itself, and controls the current flow to the grasping end effector of the device. A current passes from the ESU between the grip jaws then back to the generator, allowing for precise tissue coagulation. The instrument end effectors (or grips) are identical to the Everest Bipolar Lyons Dissecting Forceps, and the identical Gyrus connection cable, Gyrus ESU's and Footswitch are used with the EndoWrist PK Dissecting Forceps.
There are no changes to the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci Surgical System, Model IS1200 and da Vinci S Surgical System, Model IS2000) associated with this pre-market notification. The da Vinci and da Vinci S Surgical Systems consists of two integrated sub-systems as follows:
Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console (SSC) and Patient Side Cart (PSC). 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 arms known as Patient Side Manipulators (PSM), which are located on the PSC. 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 PCS 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 cables. Instrument and
SPECIAL 510(k) Section II, Page 2 of 4
2
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 Intuitive Surgical Endoscopic Instrument Control System, also known as Intuitive Surgical Insite® Vision System. 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.
Intended 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, vacuum 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, gynecologic 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.
Comparison to The Intuitive Surgical EndoWrist PK Dissecting Forceps incorporates the functionality of the Everest / Gyrus Bipolar Lyons Dissecting Forceps (a Predicate Class II, Electrosurgical cutting and coagulation device and accessories) Device device in a modification to the Intuitive Surgical EndoWrist Bipolar Forceps instrument as cleared under K012833. There are no changes in design, technology, materials, manufacturing, performance, the specifications, and method of use for the Intuitive Surgical Endoscopic Instrument Control Systems. Technological The technological characteristics of the subject device (Intuitive Surgical EndoWrist PK Dissecting Forceps). are the same as the predicate devices Characteristics Intuitive Surgical EndoWrist BipolarForceps, and Everest / Gyrus Bipolar Lyons Dissecting Forceps).
SPECIAL 510(k) Section II, Page 3 of 4
3
| Performance
Data | Design and risk analysis and assessment has been conducted to confirm
that basic functional characteristics are substantially equivalent to the
predicate device without introducing any new issues of safety or
effectiveness, and a bench testing has been conducted to confirm that
basic functional characteristics are substantially equivalent to the
predicate devices cited, and that design output meets the design input
requirements. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based upon the information provided in this pre-market notification, the
Intuitive Surgical EndoWrist PK Dissecting Forceps described herein is
shown to be substantially equivalent to current legally marketed predicate
device(s), and the results of the design control process confirm that the
design input meets the design output requirements and that that there
are no new issues of safety or effectiveness. |
. . . . . . . . . . . . .
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a sense of movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18 2006
Intuitive Surgical, Inc. % Mr. Mike Yramategui Senior Director, RA/QA 950 Kifer Road Sunnyvale, California 94086
Re: K061260
Trade/Device Name: Intuitive Surgical® EndoWrist® PK Dissecting Forceps For use with Intuitive Surgical® Endoscope Instrument Control System Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: May 3, 2006 Received: May 5, 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
5
Page 2 - Mr. Mike Yramategui
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hukutolermer no
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section III
Indications for Use
1061260 510(k) Number (if known):
Device Name:
Intuitive Surgical® EndoWrist® PK Dissecting Forceps For use with Intuitive Surgical® Endoscopic Instrument Control System
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, vacuum 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, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with mediastinotomy to perform coronary anastomosis during cardiac adjunctive 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)
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)
Device Evaluation (ODE)
Hehert temen mo
Division of General. Restorative. and Neurological Dev
510(k) Number L061260
Intuitive Surgical® Endoscopic Instrument Endowrist® PK Dissecting Forceps
Section III, Page 1 of 1
1