(215 days)
The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.
The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:
- Is composed on non-porous plastic material that allows for air flow
- Has minimal contact points with the endoscope or medical/surgical instruments
- Fits a wide variety of devices: 4.9mm -15mm outer diameter
- Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.
The Endoscope Tip Protector is available both non-sterile and sterile.
Based on the provided text, the Acceptance Criteria and Device Performance for the Endoscope Tip Protector are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Attachment and Detachment Force | The Endoscope Tip Protector must be able to be attached and detached with minimal force. | PASS |
| Scope Protection | The Endoscope Tip Protector must reduce the impact force to the endoscope compared to without protection. | PASS |
| Transport Protection | The Endoscope Tip Protector must remain on the endoscope during transport. | PASS |
| Longevity of Hold on Endoscope | The Endoscope Tip Protector must remain on the endoscope for at least 7 days. | PASS |
| Irritation and Skin Sensitization | Must meet ISO 10993-10: 2010. | PASS |
| Cytotoxicity | Must meet ISO 10993-5:2009. | PASS |
| Sterility | The Endoscope Tip Protector must have a sterile version. | PASS |
| Packaging Validation | Sterile Packaging must meet ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1886/F1886M-16. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each test (e.g., number of endoscope tip protectors tested, number of cycles for transport or attachment/detachment). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. It summarily states "Proposed Endoscope Tip Protector" and "PASS" for each criterion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for this device's testing. The tests appear to be physical and biological performance tests rather than subjective evaluations requiring expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
There is no mention of an adjudication method, as the tests outlined are objective performance metrics (e.g., force, time, compliance with standards) rather than interpretations.
5. If a multi-reader multi-case (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:
This is not applicable. The device is a physical endoscope tip protector, not an AI-assisted diagnostic tool or system that would involve human readers or comparative effectiveness studies of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As noted above, the device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests appears to be defined by industry standards (ISO 10993-10, ISO 10993-5, ASTM standards) and defined physical/mechanical performance requirements (e.g., "minimal force," "reduce impact force," "remain on the endoscope for at least 7 days"). These are objective, measurable criteria rather than subjective interpretations requiring expert consensus or clinical outcomes data in the traditional sense.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this type of 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.