(49 days)
The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.
The subject device 8 mm and 12 mm Assist Cannulas are used as part of a trocar system to establish a port of entry into the surgical site. The 8 mm and 12 mm Assist Cannulas are intended to be used laparoscopically (independently of the da Vinci Systems), but may be used in conjunction with da Vinci systems to assist robotic procedures.
The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation.
This FDA 510(k) clearance letter pertains to medical devices (8 mm and 12 mm Assist Cannulas), not AI/ML software. Therefore, the information typically found for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test sets, expert consensus, MRMC studies, or training set details) is not present in this document.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing relevant to surgical cannulas, such as dimensional measurements, mechanical and functional verification, biocompatibility, and sterilization.
Here's a breakdown of the available information related to performance and testing, framed to align with your request where applicable, but noting the absence of AI/ML-specific details:
Device: 8 mm Assist Cannula; 12 mm Assist Cannula
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Mechanical/Functional Performance | Meets design input requirements; performs as intended. | Performance testing (bench and animal) demonstrates that the subject devices design output meets the design input requirements and that the devices perform as intended. |
| Dimensional Specifications | Specific inner diameters (Funnel Opening, Tube, Tip) and Overall Length as compared to predicate/reference devices. | 8 mm Assist Cannula: Funnel Opening: 1.179", Tube: 0.380", Tip: 0.354". Overall Length: 6.336". |
| 12 mm Assist Cannula: Funnel Opening: 1.179", Tube: 0.564", Tip: 0.564". Overall Length: 6.336". (These dimensions are similar/same to predicate/reference devices as detailed in the comparison table). | ||
| Material Biocompatibility | Evaluated per ISO 10993-1. | All materials have been evaluated for biocompatibility per ISO 10993-1. |
| Sterility | Packaged non-sterile; Steam sterilization compatible. | Packaged non-sterile; Steam sterilization. |
| Use/Disposition | Reusable. | Reusable. |
| Human Factors/Usability | Address known use-related issues, identify use-related risks, and inform user interface design. | Analysis of post-market data (MAUDE database) for predicate/similar devices. Comparative Task Analysis (CTA) to compare user interaction to predicate. Use-Related Risk Analysis (URRA). Formative usability evaluations. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated numerically. The performance data section vaguely mentions "bench and animal" testing. The human factors evaluation refers to "post-market data and the MAUDE database" and "formative usability evaluations." Specific numbers for test units or subjects are not provided.
- Data Provenance:
- Bench and Animal Testing: Implied to be conducted internally or by a testing facility, but no specific country of origin is mentioned. These are typically prospective tests.
- Human Factors Evaluation: "Post-market data and the MAUDE database" is retrospective data from device adverse event reporting. Formative usability evaluations are prospective. No country of origin is specified for these studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document as this is a traditional medical device (surgical cannula) clearance, not an AI/ML device that requires expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. This concept is typically relevant to the establishment of ground truth in AI/ML diagnostic studies through expert review.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance with and without AI assistance for diagnostic tasks, which is not relevant for a surgical cannula.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical surgical tool and does not involve an algorithm.
7. The Type of Ground Truth Used
For the physical device, "ground truth" would correspond to engineering specifications and safe/effective performance. This was established through:
- Design Input Requirements: The pre-defined criteria for the device's function and performance.
- Bench Testing: Direct physical measurements and functional tests against specifications.
- Animal and Cadaver Models: Simulated use to confirm performance in a biological context.
- Biocompatibility Standards: Adherence to ISO 10993-1.
- Sterilization Standards: Confirmation of steam sterilization methods.
- Human Factors Analysis: Identification and mitigation of use-related risks through analysis of historical data and usability assessments.
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train AI/ML algorithms. This device does not use an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML training set 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.