(59 days)
The Articulating Xenoscope is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The Articulating Xenoscope™ System contains two separate functioning components. First is the single-use, sterile Articulating Xenoscope™ Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 30° articulating tip, 10 cm or 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.
This submission is a 510(k) premarket notification for the Xenocor Articulating Xenoscope Laparoscope, which is an endoscope and accessories (21 CFR 876.1500; product codes GCJ, HET, GCQ). The new device is compared to the predicate device, K161838 - Xenocor®, Xenoscope™ Laparoscopic System.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes several verification and functional/safety tests. For each test, the document states that "All data met pre-determined acceptance criteria" or "All devices tested passed." However, the specific quantitative acceptance criteria are generally not explicitly stated in the summary, nor are the detailed quantitative results of the tests. Instead, it refers to the acceptance criteria being the same as the predicate device.
| Test Category | Acceptance Criteria (as described) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1 and 2016 FDA guidance for "External communicating device, direct tissue contact, duration ≤ 24 hours." Same protocol and acceptance criteria as the predicate device. | All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Systemic Injection, Material Mediated Pyrogenicity) passed. |
| Shaft Bend Strength Testing | Functionality confirmed after bending the shaft. Same protocol and acceptance criteria as the predicate device. | All devices tested passed. |
| Accelerated Aging | Mechanical functionality after 1-year shelf life. Visual examination of heat shrink materials and ≥ 30° articulation in both X and Y axis. Same protocol and acceptance criteria as the predicate device. | All devices were mechanically functional after 1-year shelf life testing. |
| Software Validation | The software for the Xenobox and the subject device has not changed. | Not applicable, as software is unchanged from the predicate. |
| Packaging | Packaging and its configuration were not affected by the changes. | Not applicable, as packaging is unchanged. |
| Design Validation | Intended users (trained surgeons) evaluating the Articulating Xenoscope™ using the same study protocol and acceptance criteria as the predicate. | Evaluated by 10 physicians. All acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility: The sample size for biocompatibility tests is not explicitly stated, but it follows ISO 10993-1 and FDA guidance, which typically involve specific numbers of samples for each test (e.g., cell cultures, animal models).
- Shaft Bend Strength Testing: "All devices tested passed." The specific number of devices tested is not mentioned.
- Accelerated Aging: "All devices were mechanically functional." The specific number of devices tested is not mentioned.
- Design Validation: The device was "evaluated by 10 physicians" for the subject device. The provenance of the data (country of origin, retrospective/prospective) is not specified, but design validation studies are typically prospective and conducted in a controlled environment (e.g., simulation labs).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Design Validation: "10 physicians" were used to evaluate the device. Their specific qualifications (e.g., specialty, years of experience) are not provided beyond being "trained surgeons" and "intended users."
- For other tests (biocompatibility, mechanical testing), the "ground truth" is typically defined by standardized testing protocols and established scientific principles, rather than expert consensus on a test set.
4. Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the test sets. For design validation, it states that "the subject device was evaluated by 10 physicians," implying individual evaluations against predetermined criteria, rather than a group consensus approaching a "ground truth" in the clinical sense. For the other tests, acceptance criteria are typically objective and measurable, not requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The design validation involved "trained surgeons" evaluating the device, which is a human evaluation, but it's not a comparative effectiveness study with an AI component as typically understood in medical imaging contexts. The Xenocor Articulating Xenoscope Laparoscope is a hardware device for visualization, not an AI diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not directly applicable as the Xenocor Articulating Xenoscope Laparoscope is not an AI algorithm but a medical device for visual inspection during surgery. There is no "standalone algorithm performance" to assess.
7. The Type of Ground Truth Used:
- Biocompatibility, Shaft Bend Strength, Accelerated Aging: The "ground truth" is defined by adherence to international standards (ISO 10993-1), FDA guidance, and internal quality procedures which set objective pass/fail criteria. These are essentially engineering and material science standards and not clinical "ground truth" derived from patient outcomes or pathology.
- Design Validation: The "ground truth" for design validation is functional performance and usability as assessed by "trained surgeons" against predetermined criteria. This is a form of expert clinical opinion/assessment of device performance characteristics.
8. The Sample Size for the Training Set:
- This concept of a "training set" is not applicable to the Xenocor Articulating Xenoscope Laparoscope. This is a hardware device, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no 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.