(63 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. This 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 for an expansion of the Indications for Use to include gynecologic laparoscopic surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this pre-market notification.
The da Vinci Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and 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. 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) and 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 provider 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 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.
The provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System, specifically for an expansion of its indications for use to include gynecologic laparoscopic surgical procedures. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically find for a new diagnostic AI device or a device requiring new performance claims.
Instead, the submission argues for substantial equivalence based on the existing device's proven performance in other surgical specialties and a comparison of surgical tasks.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission argues for substantial equivalence based on the device's existing clearance for a "full array of surgical tasks across multidisciplinary surgical specialties" and a "comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures."
Essentially, the "acceptance criteria" here implicitly refer to the established safety and effectiveness of the existing da Vinci system, and the "reported device performance" is its proven ability to perform surgical tasks in general. The document asserts that no new safety or effectiveness issues arise from extending its use to gynecologic procedures.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission relies on a "design analysis and comparison" and "design validation" rather than a clinical trial with a distinct test set of patient data to evaluate performance for the new indication.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no clinical test set in the traditional sense, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
This information is not provided. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. This type of study is more common for diagnostic devices measuring human reader performance. The da Vinci system is a surgical tool, and the submission focuses on its mechanical and functional equivalence for surgical tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. The da Vinci Surgical System is explicitly a "human-in-the-loop" device, as surgeons control the instruments. The concept of "standalone" performance without the human surgeon is not applicable here.
7. The Type of Ground Truth Used
The "ground truth" implicitly used is the established safety and effectiveness profile of the da Vinci Surgical System in its already cleared indications, and the similarity of surgical tasks in gynecologic laparoscopic procedures to those where the device is already cleared. The document states:
- "a comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures with the system."
- "design analysis and comparison, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and design validation confirm that there are no new issues of safety or effectiveness for performing surgical tasks in gynecologic laparoscopic surgical procedures."
This is a form of "comparison to predicate" and "design validation" based on expert surgical knowledge and engineering principles, rather than a quantifiable ground truth derived from pathology or outcomes data in a new clinical study for this specific indication.
8. The Sample Size for the Training Set
This information is not provided. The da Vinci system is a robotic surgery system, not a machine learning algorithm that is "trained" on a dataset in the typical AI sense for image analysis or diagnosis. Its "training" would be more akin to engineering development and refinement based on extensive R&D and clinical experience in other surgical fields.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as the concept of a "training set" and "ground truth" in the AI sense does not directly apply to the approval process described here for a surgical robotic system's expanded indication for use. Its operational "ground truth" is defined by its engineering specifications, safety parameters, and successful performance in prior surgical applications.
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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: K050404
| Date | April 19, 2005 |
|---|---|
| Submitter | Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Mike YramateguiDirector, Regulatory AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390e-mail: mike.yramategui@intusurg.com |
| SubjectDevice | Name: Intuitive Surgical ® da Vinci ® Surgical System and EndoscopicInstrumentsClassification Name: System, Surgical, Computer Controlled Instrument(21 CFR 876.1500)Common Name: Endoscopic Instrument Control System, EndoscopicInstruments and Accessories |
| PredicateDevices | Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments(legally marketed under K990144 / K002489 / K011002 / K011281 /K012833 / K013416 / K021036 / K022574 / K040237 / K040948 /K043153 / K042855 / K050005). |
| DeviceDescription | This 510(k) is being submitted for an expansion of the Indications forUse to include gynecologic laparoscopic surgical procedures. There areno changes in the design, technology, materials, manufacturing,performance, specifications, and method of use for the da Vinci SurgicalSystem associated with this pre-market notification. |
510(k) Section 11, Page 1 of 3
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The da Vinci Surgical System consists of two integrated sub-systems as lollows:
Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While scated 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 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) and 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 provider 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 Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, ondoscopic 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
Device
Description
(continued)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procodures set forth in the Professional Instructions for Use.
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| Comparison toPredicateDevice | There are no changes in the design, technology, materials, manufacturing,performance, specifications, and method of use for the da Vinci SurgicalSystem. The expansion of the labeling to include gynecologiclaparoscopic surgical procedures is based on the da Vinci Surgical Systemand endoscopic instruments being currently cleared for performing a fullarray of surgical tasks across multidisciplinary surgical specialties, and acomparison of surgical tasks performed in cleared procedures to thoseperformed in gynecologic laparoscopic surgical procedures with thesystem. Additionally, a comparison of endoscopic instruments availableon the da Vinci® Surgical System with predicate instruments cleared forgynecologic laparoscopic surgical procedures demonstrates substantialequivalence to existing laparoscopic instruments cleared for gynecologicindications. | |||
|---|---|---|---|---|
| TechnologicalCharacteristics | The technological characteristics of the subject device are the same as forthe predicate device (da Vinci Surgical System) cleared to performsimilar surgical tasks in other specialties. The primary differencebetween the subject device and the predicate devices cleared for use ingynecologic laparoscopic surgical procedures is that the subject deviceprovides computerized robotic assistance to precisely manipulate andmove the instruments and the predicate devices are hand operatedlaparoscopic instruments. | |||
| PerformanceData | Design analysis and comparison, has been conducted to confirm thatbasic functional characteristics are substantially equivalent to thepredicate devices cited, and design validation confirm that there are nonew issues of safety or effectiveness for performing surgical tasks ingynecologic laparoscopic surgical procedures. | |||
| Conclusion | Based upon the information provided in this pre-market notification, theda Vinci Surgical System described herein has been shown to besubstantially equivalent to current legally marketed predicate devices,and the results of the risk analysis and design validation confirm that thethere are no new issues of safety or effectiveness. |
.... ...
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road SUNNYVALE CA 94086
Re: K050404 K050404
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories ﻠﺴﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ Regulatory Class: II Product Code: HET Dated: February 16, 2005
Received: February 17, 2005
Dear Mr. Yramategui:
Deal Mr. Tranatogal.
We have reviewed your Section be startielly equivalent (for the indications for use stated in We have reviewed your Section 5 U(K) premantially equivalent (for the indications for use stated in
above and have determined the device is substantially interstate commerce above and have determined the devices marketed in interstate commerce price to
the enclosure) to legally marketed predicate devices marketed in interstate commerce price that the enclosure) to legally marketed predical Devices inianced an memors, or to devices that have been
May 28, 1976, the enactment date of the Medical Food Drus, and Cosmetic May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that
reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmence reclassified in accordance with the provisions of the Posts of the may, therefore, market the do not require approval of a premarket approvation (The Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Actives pr device, subject to the general controls provisions of the Act. The general contraction, labeling,
include requirements for annual registration, lisenties Include requirements for and adulteration.
APR 2 1 2005
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into eliment on the transmiss regulations affecting your regulations affecting your Approval), it may be subject to such adonoist controls. Date 8 105.
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Code of Federal Regulations Provide in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuation isqurvalies with other menuments of the Act or any
FDA has made a determination the your device complies. You must comply with all FDA has made a determination that your device compless. You must comply with all the
Federal statutes and regulations administered by other Federal and listing (1 CFF Part Federal statutes and regulations administed by other recordisting (21 CFR Part 807); Labeling
Act's requirements, including, but not limited to registration and listing (21 C Act's requirements, including, but not implex to registration the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quality (21 CFR Part 801); good manutacturing practice tequirements as sol secure of the provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radiation regulation (21 CFR Pull 020); 21 CFR 1000-1050.
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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:___________ Intuitive Surgical® Endoscopic Instrument Control System
Indications For Use:
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the The Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic
accurate control of Intuitive Surgical Endoscopic Instruments during room accurate control of millilive Surgical Endoscopic metranicis and 1997 in the surgical procedures. This intended for use by trainou pryolance in and proposedures 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 In Vitro Diagnostic Devices (OIVD)
Nancy C. Broadon
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.