(327 days)
The Disposable Lens Cleaning Sheath is an endoscope accessory that uses saline solution and carbon dioxide to remove debris from the lens surface of endoscopes used within the thoracic and abdominal cavities, including female reproductive organs.
The Disposable Lens Cleaning Sheath is an endoscope accessory that uses saline solution and carbon dioxide to remove debris from the lens surface of endoscopes used within the thoracic and abdominal cavities, including female reproductive organs.
The subject device is a single use disposable device and is provided to the user sterile. The subject devices consist of an insertion section, main body section, and water/CO2 gas tube section.
The subject devices are used in combination with flexible endoscope and rigid endoscope.
Upon use the device is attached to the compatible endoscope, water source, and gas source to remove debris from the objective lens surface of the endoscope by spraying saline solution and CO2 gas.
The provided text is a 510(k) summary for a medical device called the "Disposable Lens Cleaning Sheath." It describes the device, its intended use, and the non-clinical testing performed to demonstrate its safety and effectiveness. However, it does not contain information about acceptance criteria and device performance in the context of a clinical study or a study involving human readers or expert ground truth.
The document focuses on non-clinical performance and a comparison to a predicate device. Therefore, I cannot extract the specific information requested in the prompt, such as:
- A table of acceptance criteria and reported device performance (in a clinical/expert setting).
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states the following, which is relevant to your request about testing:
Acceptance Criteria and Device Performance (Non-Clinical):
The document mentions that:
- "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
- "Performance testing including sterilization validation, shelf life, and mechanical performance / bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended."
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, based on summary in the document):
| Test Category | Acceptance Criteria (Implicit from "performs as intended" and standard compliance) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Compliance with ISO 11137-1:2006 (Methods VDmax25) | Validated according to ISO 11137-1:2006 |
| Shelf Life Testing | Compliance with ASTM F1980-07 for accelerated aging; expectation of longer stability through real-time aging. | Demonstrated stability based on accelerated aging |
| Mechanical Performance | Device performs as intended for each item below | Confirmed to perform as intended |
| - Insertion/Removal | Inserts and removes from endoscope | Performed as intended |
| - Trocar Insertion | Inserts into trocar | Performed as intended |
| - Gas Feeding Operation | Gas feeding functionality | Performed as intended |
| - Spray Feeding Operation | Spray feeding functionality | Performed as intended |
| - Debris Removal | Effective in removing debris | Performed as intended (Inspection of removing the debris) |
| - Insertion Section Durability | Durable | Performed as intended |
| - Main Body Fixing Strength | Secure fixing of main body | Performed as intended |
| - Package Inspection | Package integrity and quality | Performed as intended |
| Biocompatibility Testing | Compliance with FDA Guidance "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1," including cytotoxicity, sensitization, and irritation. | Demonstrated biocompatibility according to FDA guidance |
| Risk Analysis | In accordance with ISO 14971:2007 (in-house acceptance criteria) | Carried out and informed design verification tests |
Regarding the other specific points you requested:
- Sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, training set sample size, and ground truth for training set: This information is not available in the provided document. The document describes non-clinical testing for a device, not a diagnostic algorithm or AI system that would typically involve such studies. The device is a "Disposable Lens Cleaning Sheath," an accessory for endoscopes, which implies mechanical and material performance testing rather than diagnostic accuracy studies.
§ 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.