(23 days)
The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter 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, scalpels, 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 and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
This special 510(k) is being submitted for a modification of Intuitive Surgical® Endoscopic Instruments to include the EndoPass Endoscopic Delivery Instrument. The EndoPass Endoscopic Delivery Instrument is similar to the Clip Applier instrument originally cleared by FDA in 2000 (K990144).
The EndoPass Endoscopic Delivery Instrument is used with the Intuitive Surgical® Endoscopic Instrument Control System, also known as the da Vinci Surgical System. The da Vinci Surgical Systemconsists 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 describes a 510(k) premarket notification for a medical device called the "EndoPass Endoscopic Delivery Instrument." This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device evaluations.
Therefore, many of the requested details, such as specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, and effect sizes of AI assistance, are not applicable or not provided in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (explicitly stated) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K990144) in terms of: | "The Intuitive Surgical® EndoPass Endoscopic Delivery Instrument described herein is essentially identical in terms of shape, function, activation, and use to the predicate Class II endoscopic instrument cited." |
| - Shape | "essentially identical" |
| - Function | "essentially identical" |
| - Activation | "essentially identical" |
| - Use | "essentially identical" (The primary difference noted is the type of delivery: predicate delivered surgical clips, subject device delivers general accessories like suture, needles, clamps.) |
| Design input requirements met | "Design analysis and comparison, as well as in vitro testing, confirm that basic functional characteristics are substantially equivalent to the predicate device cited, and that design output meets the design input requirements." "the results of the design control process confirm that the design output meets the design input requirements." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission does not describe a clinical study or a test set in the context of AI/ML performance evaluation. The "testing" mentioned is in vitro testing for functional characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of expert consensus for AI/ML validation, is not relevant to this submission. The evaluation is based on engineering design analysis and in vitro functional testing.
4. Adjudication method for the test set:
- Not applicable / Not provided. No test set requiring expert adjudication is described.
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:
- No. This is not an AI/ML device, and no MRMC study or human-in-the-loop performance evaluation is described. The device is a surgical instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used:
- Not applicable / Not provided in the AI/ML sense. The "ground truth" for this submission is the performance and characteristics of the legally marketed predicate device, against which the new device's functional equivalence and safety are compared, primarily through design analysis and in vitro testing.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set for an AI/ML model, there is no need to establish ground truth for it.
Summary of the Study:
The "study" described in K040948 is not a clinical trial or an AI/ML performance evaluation. It is a special 510(k) submission for a modification to an existing device (Endoscopic Instruments) to include a new component (EndoPass Endoscopic Delivery Instrument).
The study relies on:
- Design analysis and comparison: A detailed comparison of the new EndoPass instrument's design, shape, function, activation, and use against the predicate device (a clip applier).
- In vitro testing: Functional characteristics were evaluated in vitro to confirm substantial equivalence to the predicate device and that the design output met design input requirements.
The primary objective was to demonstrate substantial equivalence to an already legally marketed predicate device (K990144) as mandated by the 510(k) process for Class II medical devices.
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OC 7
Section II
MAY = 5 2004
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 | April 9, 2004 |
|---|---|
| Submitter | Intuitive Surgical950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Mike YramateguiDirector, Regulatory AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390e-mail: mike.yramategui@intusurg.com |
| New Device | Name: EndoPass Endoscopic Delivery InstrumentClassification Name: System, Surgical, Computer Controlled InstrumentCommon Name: Endoscopic Instrument, Delivery Instrument |
| PredicateDevices | Intuitive Surgical® Endoscopic Instrument Control System and IntuitiveSurgical® Endoscopic Instruments and accessories(legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 /K022574) |
| DeviceDescription | This special 510(k) is being submitted for a modification of IntuitiveSurgical® Endoscopic Instruments to include the EndoPass EndoscopicDelivery Instrument. The EndoPass Endoscopic Delivery Instrument issimilar to the Clip Applier instrument originally cleared by FDA in 2000(K990144). |
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Device Description (continued)
The EndoPass Endoscopic Delivery Instrument is used with the Intuitive Surgical® Endoscopic Instrument Control System, also known as the da Vinci Surgical System. The da Vinci Surgical Systemconsists 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 Intuitive Surgical® Endoscopic Instrument Control System Intended Use (hereinafter referred to as the " da Vinci Surgical 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 for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
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| Intended Use(continued) | Intuitive Surgical® Endoscopic Instruments including scissors, scalpels,forceps/pick-ups, needle drivers and electrocautery are intended forendoscopic manipulation of tissue, including: grasping, cutting, blunt andsharp dissection, approximation, ligation, electrocautery and suturing. |
|---|---|
| Comparison toPredicateDevice | The Intuitive Surgical® EndoPass Endoscopic Delivery Instrumentdescribed herein is essentially identical in terms of shape, function,activation, and use to the predicate Class II endoscopic instrument citedThe primary difference is that the predicate device is intended to deliverand apply a surgical clip to ligate vessels; the subject device is intended todeliver general accessories, such as suture, needles and clamps, to thesurgical site under the direct control of the console surgeon. |
| TechnologicalCharacteristics | The technological characteristics of the subject devices are the same as orthe predicate devices. |
| PerformanceData | Design analysis and comparison, as well as in vitro testing, confirm thatbasic functional characteristics are substantially equivalent to thepredicate device cited, and that design output meets the design inputrequirements. |
| Conclusion | Based upon the product technical information, intended use, andperformance information provided in this pre-market notification, theIntuitive Surgical® EndoPass Endoscopic Delivery Instrument describe isherein has been shown to be substantially equivalent to the current legallymarketed predicate device, and the results of the design control processconfirm that the design output meets the design input requirements. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized graphic of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K040948
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument, EndoPass Endoscopic Delivery Instrument
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: April 9, 2004 Received: April 12, 2004
Dear Mr. Yramategui
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becaren broker is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimeres pro. to 1125 2012 11:45 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). and Costiete . I've (110) that the device, subject to the general controls provisions of the Act. The I ou may, aroney animas 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 r your de rise to such additional controls. Existing major regulations affecting your device can may or balyeet to decir was a 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 or carf i 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.
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Page 2 - Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma reter nations on. The FDA finding of substantial equivalence of your device to a legally premated 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 (301) 594-4659. 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,
Muriam C. Provost
Fed Celia M. Witten, Ph.D., M.D. I)irector Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040948
Device Name: Intuitive Surgical® Endoscopic Instrument, EndoPass Endoscopic Delivery Instrument
Indications For Use:
The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter 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, scalpels, 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 and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Prescription Use X (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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_Ko40948
§ 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.