(217 days)
Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.
The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel.
The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes.
The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.
The provided text is a 510(k) Summary for the Endoscopic Seal. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparisons, rather than providing details of a clinical study with acceptance criteria and device performance metrics in the way you've outlined for a typical AI/software device.
Therefore, for aspects related to clinical performance, ground truth, expert involvement, and AI-specific studies (MRMC, standalone), the information is not applicable as this device is a physical medical device (an endoscopic seal), not an AI/software as a medical device (SaMD).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various bench tests conducted to demonstrate the safety and performance of the Endoscopic Seal. It does not explicitly state "acceptance criteria" in a quantitative format for most tests, but rather implies that the device "meets the requirements" or is "identical to the predicated device."
| Performance Test / Element of Comparison | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical Tests: | ||
| Seal Leaks (ASTM F1929) | Meets standard requirements | Tested, presumably met |
| Seal Strength (ASTM F88) | Meets standard requirements | Tested, presumably met |
| Seal Integrity (ASTM F1886) | Meets standard requirements | Tested, presumably met |
| Accelerated Aging (ASTM F1980-16) | Meets standard requirements for sterile barrier systems | Tested, presumably met |
| Small-bore connectors (ISO 80369-20) | Meets common test methods | Tested, presumably met |
| Fastness of connection | Identical to predicated device | Identical to predicated device |
| Smoothness | Identical to predicated device | Identical to predicated device |
| Sealing performance (Leakage) | Identical to predicated device | Identical to predicated device (tested "together with subject device" for predicate) |
| Biocompatibility Tests: | ||
| Cytotoxicity (ISO 10993-5: 2009) | Meets standard requirements | Meets requirements of ISO 10993-5 |
| Sensitization (ISO 10993-10:2010) | Meets standard requirements | Meets requirements of ISO 10993-10 |
| Skin irritation (ISO 10993-10:2010) | Meets standard requirements | Meets requirements of ISO 10993-10 |
| Material-Mediated Pyrogenicity (ISO 10993-11: 2017) | Meets standard requirements | Meets requirements of ISO 10993-11 |
| Acute Systemic Toxicity (ISO 10993-11: 2017) | Meets standard requirements | Meets requirements of ISO 10993-11 |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The tests are bench tests on the device hardware itself, not clinical data.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and the "ground truth" is established by adhering to established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is a physical device.
5. If a multi-reader multicase (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 is a physical device, not an AI/software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and biocompatibility testing, the "ground truth" is defined by the acceptance criteria and methodologies specified in the cited ASTM and ISO international standards. Successful completion of these tests according to the standards serves as the evidence of compliance.
8. The sample size for the training set:
- Not Applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a training set for an 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.