(143 days)
The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura -XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.
This 510(k) is being submitted for a modified EndoWrist® instrument, the EndoWrist Introducer, 5Fr, to be utilized with surgical lasers delivering energy through flexible laser fibers. This submission also includes the product labeling for the new instrument. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the da Vinci Surgical System or the other predicate devices listed.
The Introducer, 5Fr is used with the da Vinci Surgical Systems to hold and position compatible laser fibers used in conjunction with surgical laser systems such as the Laserscope Aura XP or Lisa Laser RevoLix Jr. Laser Systems during indicated surgical procedures. The instrument will also facilitate blunt tissue dissection when the fiber is not present or is retracted into the instrument. The "Introducer, 5Fr" instrument may herein be referred to as the "Introducer" or the "Introducer Instrument".
Similar to currently used minimally invasive endoscopic or laparoscopic surgical instruments, the Introducer Instrument will only hold and position surgical laser fibers and will not directly conduct laser energy.
This Intuitive Surgical instrument is compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000. To address use of the Introducer Instrument with surgical laser systems, a supplemental Instructions for Use sheet is included with each Introducer instrument.
The provided text describes the 510(k) submission for the Intuitive Surgical® EndoWrist® Introducer, 5Fr Instrument. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical trial or performance study would typically be described with quantitative metrics.
Instead, this submission focuses on establishing substantial equivalence to predicate devices through design analysis, comparison, and bench testing, rather than a clinical performance study with specific quantitative acceptance criteria for the device's function.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.
Acceptance Criteria and Device Performance Study for Intuitive Surgical® EndoWrist® Introducer, 5Fr
The provided document, a 510(k) summary (K072627), does not detail specific quantitative acceptance criteria or a clinical study proving the device meets performance metrics in the format typically used for direct measurement of diagnostic or therapeutic efficacy. Instead, it establishes substantial equivalence to predicate devices.
The "Performance Data" section states: "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." This implies that the 'acceptance criteria' were related to maintaining the functional characteristics of the predicate device and meeting internal design input requirements through engineering verification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain functional characteristics of predicate devices (e.g., proper manipulation, holding, and positioning of instruments). | "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited..." The device functions as an "Introducer, 5Fr" to hold and position compatible laser fibers and facilitate blunt tissue dissection. The "distal tip lumen was modified to accept a laser fiber and a laser fiber sheath, and the distal tip will no longer accept the cautery accessories, but is now shaped to facilitate blunt dissection of tissue when the laser is not activated." It is compatible with the da Vinci and da Vinci S Endoscopic Instrument Control Systems. |
| Meet design input requirements. | "...and that design output meets the design input requirements." |
| Compatibility with da Vinci Surgical Systems. | "This Intuitive Surgical instrument is compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000." |
| Retention of manufacturing, material, and sterilization processes. | "There is no change in the instrument technology, materials, manufacturing or sterilization processes, common instrument requirements or compatibility with the da Vinci Surgical Systems." |
| Elimination of cautery function components. | "The cautery function has been removed, as the Introducer Instrument is intended to only hold and position compatible laser fibers. Consequently, all electrical contacts, wiring and other components related to the cautery function have been removed." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "bench testing" but does not specify a quantitative sample size for any test set.
- Data provenance is not mentioned, but given the nature of a 510(k) submission for a medical device manufacturer based in Sunnyvale, California (USA), it is highly likely that testing was conducted internally or by contractors within the USA. The testing appears to be prospective (new tests performed for this submission) rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The study described is an engineering and comparative analysis, not one involving expert review for ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This type of adjudication is typically used in studies involving subjective interpretation (e.g., image reading), which is not the nature of the "design analysis and bench testing" 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 device is an surgical instrument (an "Introducer"), not an AI or diagnostic imaging device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical surgical instrument, not an algorithm. The "da Vinci Surgical Systems" themselves are computer-controlled, but this submission is for a specific instrument attachment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this engineering assessment appears to be the established functional performance and design specifications of the predicate devices, along with internal engineering design input requirements.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI-based device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.