(45 days)
The ENDOPATH® XCEL® Bladeless Trocar with OPT:VIEW™ Technology has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® XCEL® Blunt Tip Trocar with OPTIVIEW™ Technology has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® XCEL® Dilating Tip Trocar with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® XCEL®. Universal Trocar Stability Sleeve with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are sterile, singlepatient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments ranging from 5 to 12 mm diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW™ Technology, a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
The provided text describes a 510(k) Premarket Notification for the ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology. This submission is focused on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical studies involving human or animal subjects for primary performance evaluation. Therefore, many of the typical acceptance criteria and study components related to AI/ML or diagnostic device performance are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Bench testing was performed to demonstrate that the device performs as intended and is substantially equivalent to the predicate device, ENDOPATH® XCEL® Trocars." The listed performance data points are comparative mechanical and physical property tests rather than clinical outcomes or diagnostic accuracy.
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (vs. Predicate) |
|---|---|
| Drag Force of an Instrument within the Trocar, Peak Force | Demonstrated substantial equivalence |
| Drag Force of an Instrument within the Trocar, Average Force | Demonstrated substantial equivalence |
| Trocar Seal System Durability, demonstrated by Air Leak Performance | Demonstrated substantial equivalence |
| Air Leak Performance While Trocar is Under Torque | Demonstrated substantial equivalence |
| Endoscope Visualization Image Quality | Demonstrated substantial equivalence |
| Ergonomic Force to Attach and Detach Universal Seal Cap | Demonstrated substantial equivalence |
The document does not provide specific quantitative acceptance limits or detailed results for these tests, only a general statement of "demonstrated substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench testing was performed."
- Sample Size: The specific sample sizes for each bench test are not mentioned in the provided text.
- Data Provenance: The data is from bench testing, meaning tests conducted in a laboratory setting on the physical device. It is not from human or animal subjects. The location of the testing is not specified, but it would have been conducted by or for Ethicon Endo-Surgery, LLC. There's no indication of retrospective or prospective data as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a physical device (trocar) and the evaluation is based on mechanical performance and physical properties, not diagnostic accuracy or interpretation by experts. Ground truth in this context would be defined by engineering specifications and measurements, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not Applicable. Since the evaluation is based on objective bench test measurements and engineering criteria, there is no need for an adjudication method typically used for subjective assessments or discrepancy resolution in clinical or diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is typically performed for diagnostic devices, especially those involving image interpretation, to assess how reader performance changes with or without AI assistance. This device is a surgical instrument, and its evaluation did not involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical surgical instrument and does not involve an algorithm or AI component that would have standalone performance.
7. The Type of Ground Truth Used
The ground truth for the bench testing would be engineering specifications, direct physical measurements, and established testing standards. For example, air leak performance would be measured against defined acceptable leakage rates, and drag force against established thresholds or comparative performance of the predicate device.
8. The Sample Size for the Training Set
Not Applicable. This device does not involve a machine learning algorithm, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an algorithm, this question is not relevant.
§ 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.