(99 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 154000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and shap endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, grnecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room enviroument in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The subject IS4000 da Vinci EndoWrist Instruments are to be used with the IS4000 da Vinci Surgical System. The EndoWrist Instruments consist of the housing, shaft, wrist, and tip. The housing contains the connection mechanism to the IS4000 da Vinci Surgical System arm. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. These instruments are reusable and provided non-sterile.
This document describes K150284 for the IS4000 da Vinci EndoWrist® Instruments. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device. Therefore, a full clinical study with acceptance criteria, sample sizes for test and training sets, expert qualifications, and MRMC studies, as typically seen for novel high-risk devices, is not required nor provided in this summary.
The summary focuses on design verification and validation to demonstrate that the modified instruments are as safe and effective as the predicate device.
Here's the information extracted from the provided text, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for modified instruments claiming substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or AUC) are not provided. Instead, the "acceptance criteria" are implied by successful completion of design verification and validation testing, confirming that the new instruments meet design input requirements and perform comparably to the predicate.
| Acceptance Criteria (Implied by Verification/Validation) | Reported Device Performance |
|---|---|
| Instrument reliability and durability | Verified through bench testing. |
| Leakage | Verified through bench testing. |
| Roll, pitch, and yaw range of motion | Verified through bench testing. |
| Jaw close and open positions | Verified through bench testing. |
| Friction | Verified through bench testing. |
| Torque | Verified through bench testing. |
| Instrument insertion | Verified through bench testing. |
| Adequacy of labeling | Verified through bench testing. |
| Software compatibility with IS4000 System software | Verified through software compatibility testing. |
| Instrument data verification with IS4000 System software | Verified through instrument data verification testing. |
| Features meet user needs and intended use (as documented in product requirements) | Validated in representative simulated clinical settings (porcine in vivo and cadaveric tissue models). |
| Safety and efficacy in normal and expected worst-case clinical use | Assessed in representative simulated clinical settings (porcine in vivo and cadaveric tissue models). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state "sample sizes" in terms of number of cases or patients for a test set in a traditional clinical study sense. The testing involved "representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models." The number of porcine or cadaveric models used is not specified.
Data Provence:
- Country of origin: Not specified.
- Retrospective or prospective: The design verification and validation testing are prospective, performed specifically for regulatory submission.
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 in a clinical study context. The validation involved assessing safety and efficacy in simulated clinical settings, which would likely have involved qualified personnel (e.g., engineers, medical professionals familiar with the product) but not specifically "experts" establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical study with a test set requiring adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence through non-clinical performance data (bench testing, simulated use).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a surgical instrument, not an AI algorithm. Its performance is always with a human-in-the-loop (the surgeon).
7. The Type of Ground Truth Used
For the design validation, the "ground truth" was established by the expected functional performance of the instruments in simulated clinical settings (e.g., successful grasping, cutting, suturing, demonstrating intended interaction with tissue) and meeting documented product requirements. This is based on functional performance in controlled, simulated environments rather than diagnostic pathology or long-term clinical outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a physical surgical instrument, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.