(59 days)
The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Universal Cannula Seal (5-12 mm) is a sterile, single-use (disposable) seal used with da Vinci cannula, obturators, and reducers. The Universal Cannula Seal has an opening that is sized to allow specific diameter ranges of instruments and surgical accessories to pass through to the surgical site while maintaining an air-tight system and an insufflated body cavity. Identical to the predicate seals, the subject seal has an insufflation port with a universal luer fitting and an insufflation lever.
The document describes the Universal Cannula Seal (5-12 mm) and its performance data, but it does not provide specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense with metrics like sensitivity, specificity, or accuracy.
Instead, the document focuses on design verification and validation testing to demonstrate performance and establish substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests, meaning the device met the predefined design input requirements for each test.
Here's a breakdown of the information based on your request, with gaps highlighted where the provided text does not contain the information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Design Verification Tests: | Satisfied (through successful completion of tests): |
| Number of seals per package | Met requirements |
| Single use disposable product | Met requirements |
| Diameter/instrument compatibility markings | Met requirements |
| Position and use of insufflation valve | Met requirements |
| Standard luer fitting attachment | Met requirements |
| Insufflation valve open and close | Met requirements |
| Stopcock rotation | Met requirements |
| No Natural rubber latex | Met requirements |
| Stopcock axial load | Met requirements |
| Depression of seal latches | Met requirements |
| Seal latch strength | Met requirements |
| Installation of seal onto cannula | Met requirements |
| Rotation of seal on cannula | Met requirements |
| Obturator compatibility | Met requirements |
| Torque limits | Met requirements |
| Force limits | Met requirements |
| Flow rate without device | Met requirements |
| Leak test seal without device | Met requirements |
| Leak test seal with compatible devices | Met requirements |
| Seal removal force | Met requirements |
| Reliability/Life Testing: | Met design inputs throughout its intended life of one procedure. |
| Design Validation (General, Functional, Interaction): | Functions in accordance with its intended use (confirmed by animal model and cadaver studies). |
| Human Factors: | No new usability risk scenarios associated with differences to predicate devices. |
| Sterilization: | Complies with applicable FDA Guidance for sterile devices. |
| Biocompatibility: | Successfully completed in accordance with applicable FDA Guidance and international standards (ISO 10993-1). |
| Packaging Verification (Transit & Shelf Life): | Maintains package integrity and product functionality in simulated storage and shipping conditions; retains functionality for the specified shelf life. |
| Overall Safety and Effectiveness | No new issues of safety or effectiveness and no new risks identified. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "a series of bench tests," "tests with an animal model and a cadaver," and "testing was performed." Specific numbers of devices, animals, or cadavers used for these tests are not provided.
- Data Provenance: Not explicitly stated. The document describes bench testing, animal model testing, and cadaver testing. The location or specific context (e.g., country) of where these tests were conducted is not mentioned. It is implied to be prospective testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described (bench, animal, cadaver) relies on objective measurements and functional assessments rather than expert consensus for "ground truth" in the way it might be for a diagnostic AI device.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for establishing ground truth in diagnostic studies. The described tests for the Universal Cannula Seal are functional and performance-based, not involving such adjudication.
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 relevant for diagnostic devices where human readers interpret medical images or data. The Universal Cannula Seal is a surgical accessory, and its evaluation focuses on its physical and functional performance, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical surgical accessory (a cannula seal), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the performance tests was established through objective measurements and predefined engineering and performance specifications. For example:
- Physical dimensions and compatibility with instruments (e.g., "Diameter/instrument compatibility markings," "Obturator compatibility").
- Mechanical properties (e.g., "Stopcock axial load," "Seal latch strength," "Torque limits," "Force limits").
- Functional performance (e.g., "Insufflation valve open and close," "Leak test seal").
- Biological and material compatibility standards (e.g., "No Natural rubber latex," "Biocompatibility testing per ISO 10993-1").
- Successful functioning in a simulated surgical environment (animal model and cadaver studies).
8. The Sample Size for the Training Set
This question is not applicable as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the device is not an AI algorithm.
§ 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.