(154 days)
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si™ Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site™ Port.
The Single-Site™ Wristed Needle Driver instrument is intended to be used with the da Vinci® Si™ Surgical System (IS3000) to perform needle driving and suture tying tasks.
The da Vinci® Single-Site™ Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, semi-rigid blunt obturators (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site™ Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci® Single-Site™ Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing. The da Vinci® Single-Site™ Instruments and Accessories are intended to be used with the existing da Vinci® Si™ Surgical System (IS3000).
The subject device, Single-Site™ Wristed Needle Driver (P/N 428115), is a new addition to the Single-Site™ Instruments and Accessories family. It is a resposable endoscopic instrument used in conjunction with the da Vinci® Si™ Surgical System (IS3000) to handle needles and suture during endoscopic surgical procedures. The distal end configuration of the instrument includes a straight grip and a wrist to enable articulation of the grip.
The provided text describes the regulatory submission for the Intuitive Surgical® Single-Site™ Wristed Needle Driver (K141075) and its performance data, primarily focusing on proving substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study details based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes various tests designed to demonstrate that the device "meets the design input requirements," "operates properly throughout its intended life," and maintains "substantial equivalence" to the predicate device. The performance is reported qualitatively, stating that the device did meet these objectives.
Here's a summary derived from the text:
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Bench Verification: | |
| Design meets physical, mechanical, electrical, user interface, and equipment interface requirements. | Verification testing confirmed that the design of the instrument meets its physical, mechanical, electrical, user interface, and equipment interface requirements. |
| Reliability (Life) Testing: | |
| Instrument operates properly throughout its intended life of five uses, with performance remaining within specification at cycles #1, #5, and #7. | Reliability testing demonstrated that the instrument will operate properly throughout its intended life of five uses. Performance requirements were evaluated during each cycle, and more extensive mechanical measurements confirmed performance remained within specification at cycles #1, #5, and #7. |
| Cadaver and Animal Validations (Design Validation): | |
| Instrument meets product requirements, specifications, and user needs in representative clinical uses (anatomical access, reach, and live tissue performance). | Cadaver and animal models confirmed that the instrument meets product requirements, specifications, and user needs, demonstrating clinical performance for anatomical access and reach, and assessing safety and performance in live tissue models (perfused organs, bleeding, tissue handling, hemostasis). The cadaver model allowed evaluation of vaginal cuff closure, and the live porcine model allowed evaluation of suturing live tissue representative of dense muscular tissue. |
| Equivalence Testing (Cadaver & Animal): | |
| Substantial equivalence to the Single-Site™ Curved Needle Driver (predicate) in terms of safety, performance, suturing task ability, suture line quality, effectiveness, ease of use, and lack of harm during surgical tasks. | Five independent practicing surgeons completed comprehensive sets of suturing tasks in cadaver and porcine models using both the subject and predicate devices. Surgeons' questionnaires and objective assessments (by study observers and independent reviewers) confirmed substantial equivalence in suturing performance, suture line quality, and safety. This included satisfactory performance in full procedures (benign hysterectomy with bilateral salpingo-oophorectomy) in cadavers, vaginal cuff closure in cadavers, and uterine horn hysterotomy closure in porcine models. Evaluations covered tissue bite, number of stitches, distance between stitches, closure completion time, ability to perform suturing tasks, ease of use, and absence of harm. |
| Overall Conclusion: | The device can perform its intended function, perform proposed surgical tasks safely and effectively, and is clinically equivalent in performance and safety to the predicate device. Therefore, it is substantially equivalent to the predicate device. |
Study Details
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Sample sizes used for the test set and the data provenance:
- Bench Verification: 5 test samples. Data provenance is internal laboratory testing ("Bench Testing").
- Reliability (Life) Testing: 8 test samples. Data provenance is internal laboratory testing ("Bench testing").
- Cadaver and Animal Validations (Design Validation):
- Cadaver model: 3 samples. Data provenance is ex-vivo (cadaver).
- Animal model: 2 samples. Data provenance is in-vivo (live animal, specifically porcine).
- Equivalence Testing – Cadaver:
- 5 independent surgeons evaluated 5 cadavers.
- Full procedures: Benign hysterectomy with bilateral salpingo-oophorectomy (n=5).
- Cadaver suturing task: Vaginal cuff closure (n=11).
- Data provenance is ex-vivo (cadaver).
- Equivalence Testing – Animal:
- 5 independent surgeons evaluated 5 animals (porcine).
- Porcine suturing task: Uterine horn hysterotomy closure (n=15, 3 per surgeon).
- Data provenance is in-vivo (live animal, specifically porcine).
All studies appear to be prospective, designed specifically for this regulatory submission. Data provenance indicates a mix of bench, ex-vivo, and in-vivo (animal) models. There is no mention of country of origin for the data, but it is implied to be within the company's testing facilities or affiliated research centers.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Equivalence Testing (Cadaver and Animal): 5 independent practicing surgeons participated. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed beyond "independent practicing surgeons."
- Safety Assessments: Study observers, surgeon participants, and independent reviewers conducted safety assessments. The qualifications of "independent reviewers" are not specified.
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Adjudication method for the test set:
- Equivalence Testing: The document mentions "Surgeons completed questionnaires that evaluated the suturing performance, suture line quality, and safety with the each needle driver; study observers recorded objective assessments of the suture lines quality." For safety, "Study observer, surgeon participant, and independent reviewer assessments" were considered. This suggests a multi-stakeholder assessment, but a formal adjudication method like "2+1" or "3+1" for discordant opinions is not explicitly stated. It seems to be a combination of subjective surgeon feedback and objective observer/reviewer assessments without a formal reconciliation process described.
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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 was not an MRMC study comparing AI performance or human reader improvement with AI assistance. This submission is for a surgical instrument, not an AI-powered diagnostic device. The "multi-reader" aspect involved multiple surgeons evaluating the performance of two different surgical instruments (subject vs. predicate).
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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. Performance tests directly evaluated the instrument itself, often with human operators (surgeons) in simulated or live conditions.
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The type of ground truth used:
- Bench Tests: Design input requirements and specifications served as the ground truth.
- Cadaver and Animal Validations: Product requirements, specifications, and user needs (as assessed by surgeons and observers) served as the ground truth.
- Equivalence Testing: The performance and safety of the predicate device (Single-Site™ Curved Needle Driver) served as the comparative ground truth, along with evaluations of "suture line quality and effectiveness" through Likert scales and objective measurements (tissue bite, number of stitches, distance between stitches, closure completion time). The ability to complete procedures and tasks safely was also a ground truth. This is a form of expert consensus/assessment and objective measurement.
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The sample size for the training set:
- Not applicable. This is a physical surgical instrument, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
§ 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.