(251 days)
The Intuitive Surgical EndoWrist One Hot Shears Instrument is intended to be used with the da Vinci and da Vinci S Surgical Systems for endoscopic cutting and coagulation of tissue during surgery,
This 510(k) is being submitted for an endoscopic instrument, the EndoWrist One Hot Shears Instrument, to be used with the Intuitive Surgical da Vinci and da Vinci S Surgical Systems. The Intuitive Surgical EndoWrist® instrument family currently consists of resposable endoscopic tools including the predicate EndoWrist® Monopolar Curved Scissors Instrument. The subject Hot Shears instrument has the same intended use as the Monopolar Curved Scissors but is a single-use disposable endoscopic tool.
This Intuitive Surgical instrument will be compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000.
The provided text describes a 510(k) summary for the Intuitive Surgical EndoWrist One Hot Shears Instrument, which is a single-use endoscopic tool intended for cutting and coagulation of tissue during surgery with the da Vinci and da Vinci S Surgical Systems. The submission aims to demonstrate substantial equivalence to a predicate device, the EndoWrist Monopolar Curved Scissors Instrument.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance). Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data section describes the types of studies conducted rather than specific criteria or results.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject device are substantially equivalent to the predicate device cited, and that design output meets the design input requirements." |
| Safety & Effectiveness | "Based upon the technical information, Indications for Use and performance information provided in this pre-market notification, the EndoWrist One Hot Shears Instrument described herein has been shown to be substantially equivalent to the current legally marketed predicate device." |
| Single-Use Indication | The device is assigned only one life by the da Vinci systems, ensuring it cannot be used again after expiration, which is "identical to the manner in which a reusable instrument expires" and ensures its single-use characteristic. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "bench testing" was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. The evaluation is based on comparison to a predicate device and bench testing.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there's no described human-based assessment of a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC study is mentioned. This device is a surgical instrument, not an AI diagnostic tool, so such a study would not be applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a surgical instrument and not an algorithm. Performance assessment is focused on its mechanical and electrical function in conjunction with the surgical system.
7. The Type of Ground Truth Used
The "ground truth" used for proving substantial equivalence is the established performance and safety of the predicate device (EndoWrist Monopolar Curved Scissors Instrument). The new device's performance is compared against the known characteristics and functionality of this already cleared device through "design analysis and comparison, as well as bench testing."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical surgical instrument and does not involve AI algorithms with training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set mentioned for this device.
§ 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.