(97 days)
The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
This document is a 510(k) premarket notification for the AquaPulse® Irrigation Tubing, submitted by GA Health Company Limited to the FDA. The purpose of this notification is to demonstrate that the AquaPulse® Irrigation Tubing is substantially equivalent to a legally marketed predicate device.
Here's an analysis based on your request, focusing on typical acceptance criteria and study information for medical devices, specifically highlighting what is not present in this 510(k) summary since it's for a relatively simple device where clinical studies are often not required for substantial equivalence.
1. Table of acceptance criteria and reported device performance:
The document summarizes performance testing, but does not provide a detailed table of acceptance criteria and specific performance values with pass/fail results. Instead, it offers a general statement about meeting specifications.
| Performance Characteristic | Acceptance Criteria (Not explicitly stated in detail) | Reported Device Performance |
|---|---|---|
| Flow Performance | Assumed to be comparable to predicate device | "met established specifications" |
| Sterility | Sterility Assurance Level (SAL) of $10^{-6}$ | Achieved $10^{-6}$ SAL via validated EO sterilization cycle |
| EO Residuals | Below maximum levels defined in ANSI/AAMI/ISO 10993-7 | Below maximum levels |
| Shelf Life | Maintain sterile barrier and intended performance for 1 year | Demonstrated through accelerated aging, packaging integrity, and performance tests |
| Biocompatibility | Meet ISO 10993-1 requirements for surface devices with mucosal membrane contact for ≤ 24 hours | Test results indicate biocompatibility |
| Backflow Prevention | Prevent backflow | Diaphragm design allows one-way flow, identical to predicate |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the performance tests (flow, sterility, shelf life, biocompatibility).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of detail is often not included in a 510(k) summary for bench testing.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable (N/A). This document describes testing for a physical medical device (irrigation tubing) where performance is measured objectively (e.g., flow rate, sterility, chemical residue). It does not involve expert-established ground truth like in an AI/imaging device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench testing of device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. An MRMC study is not relevant for this type of device. The study described is a series of bench tests comparing the subject device to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-based device. The "standalone" performance refers to the device's inherent functional characteristics (flow, sterility, etc.) as evaluated in the bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective measurements and established scientific standards. For example:
- Flow Performance: Likely compared to established predicate performance or engineering specifications.
- Sterility: Measured against a Sterility Assurance Level (SAL) of 10^-6.
- EO Residuals: Measured against limits defined by ANSI/AAMI/ISO 10993-7.
- Biocompatibility: Evaluated according to ISO 10993-1 guidelines through biological tests.
8. The sample size for the training set:
- N/A. This device does not use machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- N/A. As there is no training set for an AI/ML model, this question is not applicable.
§ 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.