(539 days)
The Intuitive Surgical™ Endoscopic Instrument Control System (hcreinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.
Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels, forceps/pickups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing .
The working ends and elements of the Intuitive Surgical™ Endoscopic Instruments and Accessories are essentially identical in size and shape to the predicate devices referenced and represent standard embodiments of standard surgical tools modified for use with the Intuitive Surgical™ Endoscopic Instrument Control System.
The provided text describes a 510(k) submission for the Intuitive Surgical™ Endoscopic Instrument Control System and Endoscopic Instruments. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study to meet specific quantitative acceptance criteria for device performance. Therefore, many of the requested sections about quantitative acceptance criteria, detailed study design, and advanced statistical analyses (like MRMC) are not explicitly present in the provided document.
Here's an attempt to extract and infer the information based on the given context:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or numerical reported device performance metrics. The core of the submission is based on demonstrating "substantial equivalence" to predicate devices, which is a qualitative assessment rather than a quantitative one against predefined statistical targets.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence (implicit) | "The working ends and elements... are essentially identical in size and shape to the predicate devices" and "essentially identical in terms of shape, size, function and tissue effect." |
| Safety and Effectiveness (implicit) | Confirmed through "Design analysis and comparison as well as in vitro testing" and an "extensive prospectively randomized and concurrently controlled clinical study." The FDA's substantial equivalence determination implies these were met. |
| Intended Use Equivalence (explicit) | The device "is intended to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments... during laparoscopic surgical procedures," which is equivalent to the intended uses of the predicate devices. |
2. Sample size used for the test set and the data provenance
The document states an "extensive prospectively randomized and concurrently controlled clinical study was performed." However, it does not provide the specific sample size for this clinical study or details on the data provenance (e.g., country of origin). The study is prospective, as indicated by "prospectively randomized."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As the study focuses on safety and effectiveness compared to predicate devices in surgical procedures, the "ground truth" would likely be based on clinical outcomes assessed by the operating surgeons and medical staff, rather than a separate panel of experts establishing a ground truth for a diagnostic task.
4. Adjudication method for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes a "prospectively randomized and concurrently controlled clinical study" to demonstrate substantial equivalence in terms of safety and effectiveness. However, it does not explicitly state that this was an MRMC comparative effectiveness study focused on comparing human readers' performance with and without AI assistance. The Intuitive Surgical Endoscopic Instrument Control System is a surgical robotic system, not a diagnostic AI system, so the concept of "human readers" improving with "AI assistance" in the typical diagnostic sense does not directly apply here. The study would have compared clinical outcomes with the new device versus predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this device is explicitly described as an "Endoscopic Instrument Control System" intended "to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments." It is an assistive surgical tool, inherently designed for human-in-the-loop performance, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given it's a clinical study for a surgical instrument, the "ground truth" for safety and effectiveness would implicitly be based on clinical outcomes data (e.g., successful procedure completion, complication rates, recovery times, surgeon's assessment of ease of use and tissue effect) observed and documented during the "prospectively randomized and concurrently controlled clinical study."
8. The sample size for the training set
This information is not applicable and not provided. The device is a surgical instrument control system, not an AI model that requires a training set in the conventional machine learning sense. The "design analysis and comparison" and "in vitro testing" would be validated against engineering specifications and functional requirements, not a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no mention of a training set for an AI model.
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510(k) SUMMARY -- Intuitive Surgical, Inc.
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: TBD
Applicant Information:
| Date Prepared: | January 15, 1999 |
|---|---|
| Name: | Intuitive Surgical, Inc. |
| Address: | 1340 W. Middlefield RoadMountain View, California 94043 |
| Contact Person: | Michael A. Daniel |
| Phone Number: | (650) 237-7036 |
| Facsimile Number: | (650) 526-2060 |
Device Information:
| Classification: | Class I / II Gynecologic Laparoscope and AccessoriesElectrocautery, Endoscope and Accessories |
|---|---|
| Trade Name: | Intuitive Surgical™ Instruments / Accessories:"Resposable" (limited reuse) Endoscopic Instrumentsincluding: Scissors, Scalpels, Forceps, Clip Applier,Electrocautery and accessories, Pick-ups and NeedleDrivers / Holders for use with:The Intuitive Surgical™ Endoscopic Instrument Control System |
| Common Name: | Endoscopic Instruments and Accessories |
| Classification Name: | Endoscope and Accessories, 21 CFR 876.1500Gynecologic laparoscope and Acces. 21 CFR 884.1720 |
.
Predicate Devices:
The Intuitive Surgical™ Endoscopic Instruments and Tools are substantially equivalent in intended use and/or method of operation to the following prodicate deviccs:
- The Intuitive Surgical™ Endoscopic Instrument Control System and selected 2. instruments (K975001).
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Device Description:
The working ends and elements of the Intuitive Surgical™ Endoscopic Instruments and Accessories are essentially identical in size and shape to the predicate devices referenced and represent standard embodiments of standard surgical tools modified for use with the Intuitive Surgical™ Endoscopic Instrument Control System.
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, scalpels, forceps / pick-ups, needle holders, clip appliers, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
Comparison to Predicate Device(s):
The Intuitive Surgical™ Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic instruments cited. Further, the Intuitive Surgical™ Instrument Control System with the additional endoscopic instruments is substantially equivalent to the cleared Intuitive Surgical™ Instrument Control System (K975001).
In Vitro Test Data:
Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited.
Clinical Study Data:
An extensive prospectively randomized and concurrently controlled clinical study was performed to demonstrate substantial equivalence to the predicate devices cited in trans of safety and effectiveness.
Summary:
Based upon the product technical information, intended use, and performance information provided in the pre-market notification, the Intuitive Surgical Endoscopic Instrument Control System has been shown to be substantially equivalent to curvently marketed predicate devices.
Intuitive™ and Intuitive Surgical™ is a registered trademark of Intuitive Surgical, Inc.
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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Casal, Ph.D. Vice President of Clinical, Regulatory and Quality Affairs Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View, California 94043
JUL 11 2000
Re: K990144
Trade Name: Intuitive Surgical™ da Vinci Endoscopic Instrument Control System and Endoscopic Instruments Regulatory Class: II Product Code: NA Y Dated: 18 November 1999 Received: 29 November 1999
Dear Dr. Casal:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the generals controls provisions of the Act and the following limitation:
Any future design changes that affect the operating surgeons ability to personally and immediately intervene in the surgical procedure being to performed will be considered to have a major impact on the device's intended use. Therefore, any design changes that remove the operating surgeon from the immediate vicinity of the patient will require the submission of a traditional or abbreviated 510(k) submission.
The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for
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Page 2 - David Casal, Ph.D.
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
Sincerely yours,
Ala with
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K990144
Intuitive Surgical™ da Vinci™ Endoscopic Instrument Control System Device name: and Endoscopic Instruments
Indications for Use:
The Intuitive Surgical™ Endoscopic Instrument Control System (hcreinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.
Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels, forceps/pickups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing .
Cila with
(Division Sign-Off)
Division of General Res 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use
OR
Over-the Counter Use
(per 21 CFR §801.109
(Optional Format 1-2-96)
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§ 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.