(253 days)
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2. general 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 (except for transoral otolaryngology surgical procedures). 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 510(k) is being submitted to request an expansion of the Indications for Use to include transoral otolaryngology surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification. The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) consists of two integrated sub-systems as follows: A Surgeon Console and a Patient Side Cart. 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. The 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 Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM), which is also located on the PSC. 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 individual positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical Systems, 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 surgeon located at the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
The provided 510(k) summary (K090993) is for an expansion of the Indications for Use for the Intuitive Surgical da Vinci Surgical Systems to include transoral otolaryngology surgical procedures. Since this is an expansion of indication for an existing device, the study is focused on demonstrating substantial equivalence rather than meeting specific performance criteria.
Therefore, the structure for acceptance criteria and device performance table, and sections related to algorithm performance, training data, ground truth establishment, and MRMC studies are not directly applicable in the conventional sense for this submission. The 510(k) summary focuses on comparing the surgical tasks involved in the new indication to those already cleared for the device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this 510(k) is for an expansion of indications for an already cleared device (Intuitive Surgical da Vinci Surgical Systems), the acceptance criteria are not in the form of numerical performance metrics for an AI algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing treatment methods and the lack of new safety or effectiveness issues.
| Acceptance Criterion (Implied) | Reported Device Performance/Justification |
|---|---|
| Feasibility of use for Transoral Otolaryngology Surgical Procedures | A multicenter retrospective clinical study confirmed the feasibility of the device for transoral otolaryngology surgical procedures. |
| Efficacy in Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study confirmed the efficacy of the device in these procedures. Historical controls demonstrated substantial equivalence of robotic-assisted transoral procedures to alternative methods (Open surgery, transoral surgery, chemoradiation). |
| Safety in Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study confirmed the safety of the device for this indication. The submitter concludes no new issues of safety or effectiveness are raised. |
| Functional Assessment for Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study included functional assessment of patients undergoing these procedures. |
| Equivalence of Surgical Tasks with Existing Indications | A comparison of surgical tasks involved in transoral otolaryngology procedures confirmed "there are no new tasks above and beyond those for which the da Vinci Surgical System... is currently used." |
| No Changes to Device Design/Technology | Stated that "There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the Intuitive Surgical Endoscopic Instrument Control Systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical value within the 510(k) summary. It refers to a "multicenter retrospective clinical study" that included "transoral otolaryngology surgical patients." The exact number of patients or cases is not provided.
- Data Provenance:
- Country of Origin: Not specified in the summary.
- Retrospective or Prospective: Retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This submission does not involve an AI algorithm with a defined "ground truth" established by experts in the typical sense. The clinical study's "ground truth" would be derived from patient outcomes, surgical observations, and comparison to standard treatments.
- Number of Experts: Not applicable/not specified. The study involved a clinical assessment implicitly by the treating physicians and researchers.
- Qualifications of Experts: The study was conducted by "trained physicians in an operating room environment," as indicated in the Intended Use statement common to the da Vinci system.
4. Adjudication Method for the Test Set
Not applicable as this is a clinical outcomes study for an existing surgical device's indication expansion, not a diagnostic or AI performance study requiring expert adjudication of image annotations or classifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study measuring the effectiveness of human readers with or without AI assistance. It's a clinical study to support an expanded indication for a surgical robot.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The da Vinci Surgical System is a human-controlled robotic surgical system; it's not an autonomous algorithm. The study assesses the system's performance with a human surgeon.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the clinical outcomes and observations from the surgical procedures performed using the da Vinci system.
- Type of Ground Truth: Clinical outcomes (feasibility, efficacy, safety, functional assessment) from actual patient surgeries, compared to historical controls for alternative treatment methods (Open surgery, transoral surgery, and chemoradiation treatment).
8. Sample Size for the Training Set
Not applicable. The da Vinci Surgical System is a physical device, and this submission is for an expanded indication, not an AI algorithm that requires a training set in the machine learning sense. The device itself has been developed and refined over many years and multiple previous 510(k) clearances.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
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Section II - 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | December 14, 2009 |
|---|---|
| Submitter | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Karen UyesugiVP, Clinical and Regulatory AffairsTelephone: (408) 523 - 8918Fax: (408) 523 - 1390e-mail:karen.uyesugi@intusurg.com |
| Subject Device | Name: Intuitive Surgical® da Vinci, da Vinci S® and da Vinci Si®Surgical Systems and EndoWrist Instruments and Accessories. |
| Classification Name: System, Surgical, Computer ControlledInstrument (21 CFR 876.1500). | |
| Common Name: Endoscopic Instrument Control System,Endoscopic Instruments and Accessories | |
| Predicate Devices | Intuitive Surgical da Vinci Surgical Systems (Models IS1200,IS2000, IS3000) and EndoWrist Instruments and Accessories(legally marketed under: K990144 / K002489 / K011002 / K011281/ K012833 / K013416 / K021036 / K022574 / K040237 / K040948 /K042855 / K043153 / K043288 / K050005 / K050369 / K050404 /K050802 / K060391 / K061260 / K063220 / K081137). |
| Device Description | This 510(k) is being submitted to request an expansion of theIndications for Use to include transoral otolaryngology surgicalprocedures. There are no changes in the design, technology,materials, manufacturing, performance, specifications, or methodof use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification.The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) |
| consists of two integrated sub-systems as follows: | |
| Device | A Surgeon Console and a Patient Side Cart. While seated at theSurgeon Console, the surgeon controls critical aspects of the |
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| Description(continued) | procedure, including movement of the endoscopic instruments andendoscope within the operative field. The endoscopic instrumentand camera movements are controlled by the surgeon through useof the Master Tool Manipulators (MTM); two hand-operatedmechanisms residing within the Surgeon Console. The endoscopicinstruments are held in a fixed position with respect to the patientby either two (or optionally three) unique arms known as PatientSide Manipulators (PSM), which are located on the Patient SideCart (PSC). The endoscope is also held in a fixed position (withrespect to the patient) by another arm, similar to the PSM, knownas the Endoscope Camera Manipulator (ECM), which is alsolocated on the PSC. Commands from the Surgeon Console arerelayed to the PSC, which is located immediately adjacent to thepatient, via cables. Instrument and endoscope changes areperformed by another individual positioned adjacent to the PSC. |
|---|---|
| Intuitive Surgical Stereo View Endoscopic System: The | endoscopic vision system used with the da Vinci SurgicalSystems, also known as Intuitive Surgical Insite® Vision System,consists of a stereo endoscope, endoscopic camera, and variousaccessories, including a light source and light guides. The InsiteVision System provides two independent images that are relayedto the surgeon located at the Surgeon Console, where they arefused to form a 3-D (or alternatively a 2-D image) image of thesurgical field. |
| Intended Use | The Intuitive Surgical Endoscopic Instrument Control Systems (daVinci, da Vinci S, and da Vinci Si Surgical Systems ModelsIS1200, IS2000, IS3000) are intended to assist in the accuratecontrol of Intuitive Surgical EndoWrist Instruments andAccessories including rigid endoscopes, blunt and sharpendoscopic dissectors, scissors, scalpels, ultrasonic/harmonicshears, forceps/pick-ups, needle holders, endoscopic retractors,stabilizers, electrocautery and accessories for endoscopicmanipulation of tissue, including grasping, cutting, blunt and sharpdissection, approximation, ligation, electrocautery, suturing,delivery and placement of microwave ablation probes andaccessories, during urologic surgical procedures, generallaparoscopic surgical procedures, gynecologic laparoscopicsurgical procedures, transoral otolaryngology surgical proceduresrestricted to benign and malignant tumors classified as T1 and T2,general thoracoscopic surgical procedures, and thoracoscopicallyassisted cardiotomy procedures. The system can also beemployed with adjunctive mediastinotomy to perform coronaryanastomosis during cardiac revascularization. The system isindicated for adult and pediatric use (except for transoralotolaryngology surgical procedures). It is intended for use by |
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trained physicians in an operating room environment Intended Use accordance with the representative, specific procedures set forth (continued) in the Professional Instructions for Use.
Comparison to Predicate Device
There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the Intuitive Surgical Endoscopic Instrument Control Systems. The expansion of the labeling to include transoral otolaryngology surgical procedures is based on the da Vinci, da Vinci S Surgical Systems (Models IS1200, IS2000, IS3000) and EndoWrist instruments and accessories being currently cleared for performing a full array of surgical tasks across multidisciplinary surgical specialties, and on a comparison of surgical tasks performed in cleared procedures to those performed in transoral otolaryngology surgical procedures.
The technological characteristics of the subject device are the Technological same as for the predicate device cleared to performed similar Characteristics surgical tasks in other specialties. A list of surgical tasks involved in completing the typical array of transoral otolaryngology surgical procedures confirms there are no new tasks above and beyond those for which the da Vinci Surgical System (IS1200, IS2000, IS3000) is currently used.
A multicenter retrospective clinical study has been conducted to Clinical Data confirm the feasibility, efficacy, safety and functional assessment undergoing transoral otolaryngology surgical patients in Historical controls demonstrate substantial procedures. equivalence of robotic assisted transoral procedures to alternative methods of treatment (Open surgery, transoral surgery and chemoradiation treatment).
- upon the information provided in this pre-market Conclusion Based notification, the Intuitive Surgical Endoscopic Instrument Control Systems' (Models IS1200, IS2000, IS3000) use in transoral otolaryngology surgical procedures is substantially equivalent to existing treatment methods of otolaryngology procedures (Open and transoral surgery). The use of the da Vinci Surgical Systems do not raise any new issues of safety or effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle with its wings spread, possibly representing freedom or protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. % Ms. Usha S. Kreaden Senior Director, Clinical Affairs 1266 Kifer Road Sunnyvale, California 94086
DEC 1 6 2009
Re: K090993
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control Systems Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: December 01, 2009 Received: December 02, 2009
Dear Ms. Kreaden:
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 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); medical device reporting (reporting of medical
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Page 2 - Ms. Usha S. Kreaden
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
For
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section III - Indications for Use
510(k) Number (if known): K090993
Intuitive Surgical® Endoscopic Instrument Control Systems Device Name:
Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2. general 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 (except for transoral otolaryngology surgical procedures). 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 Kldal for xxx
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090993
§ 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.