(30 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 gastrontestinal 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 describes a 510(k) premarket notification for the AquaPulse® Irrigation Tubing. This is not a medical device that uses AI or machine learning.
Therefore, most of the requested information regarding acceptance criteria and study proving device performance related to AI/ML (e.g., sample size for training/test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for AI) is not applicable to this submission.
Here's a breakdown of the applicable information based on the provided text, and an explanation of why other aspects are not present:
Analysis of the Provided Document for Device Acceptance Criteria and Study
The provided document is a 510(k) premarket notification for a medical device called "AquaPulse® Irrigation Tubing." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as would be required for a completely new device or a device with new technology (like AI/ML).
The core of this submission revolves around bench testing and biocompatibility testing to show that the modified device is as safe and effective as its predicate. It does not involve artificial intelligence or machine learning components.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing specifications, material properties, sterilization, and basic functional performance, rather than diagnostic accuracy or predictive power. The document summarizes these in comparison to a predicate device to establish substantial equivalence.
| Specification | Predicate Device Characteristic | Subject Device Characteristic | Substantial Equivalence (Acceptance) |
|---|---|---|---|
| Product Code | OCX | OCX | Identical (Met) |
| Regulatory Classification | 2 | 2 | Identical (Met) |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical (Met) |
| Regulation Description | Endoscope and accessories | Endoscope and accessories | Identical (Met) |
| Compatibility | Olympus® OFP, Endo Status™ EGA-500 and Endogator® EGP-100 Irrigation Pump | Olympus® OFP, Endo Status™ EGA-500 and Endogator® EGP-100 Irrigation Pump | Identical (Met) |
| Intended Use | The 24 hour use AquaPulse® Irrigation Tubing... is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. | The 24 hour use AquaPulse® Irrigation Tubing... is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. | Identical (Met) |
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | Identical (Met) |
| Single Use, Disposable | 24-hour use then discard | 24-hour use then discard | Identical (Met) |
| Material | Polycarbonate and Polyvinyl Chloride | Polycarbonate and Polyvinyl Chloride (Material not Made with DEHP) | Substantial Equivalent (Met - notes specific material detail) |
| Packaging | Irrigation tubing is packaged in a sealed pouch | Irrigation tubing is packaged in a sealed pouch | Identical (Met) |
| Manufacturing Method | Injection molding and extrusion | Injection molding and extrusion | Identical (Met) |
| Backflow Prevention Design | Diaphragm in the connector allow pressurized water passing through in one-way but not the other way | Diaphragm in the connector allow pressurized water passing through in one-way but not the other way | Identical (Met) |
| Sterilization | EO gas | EO gas | Identical (Met) |
| Shelf Life | 1 year | 3 years | Substantial Equivalent (Met - based on accelerated aging test) |
Reported Device Performance:
- Flow Performance: "The bench testing was performed to support substantial equivalence such as verification tests on flow performances of modified devices. The performance data demonstrated that the subject devices met established specifications and it demonstrated substantial equivalence to the previously cleared predicate devices." (Section 9)
- Sterilization: "The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10⁻⁶. EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals." (Section 10)
- Shelf Life: "The modified devices have a three (3) year shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test and performance test were conducted after accelerated aging test. The test result can imply that the modified device can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life." (Section 11)
- Biocompatibility: "The test result shows that the modified devices are biocompatible" in accordance with ISO 10993-1 for surface devices with mucosal membrane contact for limited duration (not more than 24 hours). (Section 12)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of units tested. For bench tests, it typically refers to a number of manufactured units subjected to specific physical and chemical tests (e.g., flow rate, material composition, sterilization validation samples, accelerated aging samples, biocompatibility samples). The document states "The test result shows that the modified devices are biocompatible" and "The performance data demonstrated that the subject devices met established specifications," implying samples were tested, but not the specific quantity.
- Data Provenance: Not explicitly stated as "country of origin of the data." These are likely lab/bench test results generated by the manufacturer (GA Health Company Limited, Hong Kong, CHINA) or a contracted testing facility.
- Retrospective or Prospective: Not applicable. These are laboratory/bench test results of physical properties and performance, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device does not generate diagnostic interpretations or clinical assessments that would require human expert ground truth establishment. The "ground truth" for this device's performance is established by meeting engineering specifications through bench testing and validated laboratory methods (e.g., flow rate measurements, sterility testing, chemical analysis for residuals, biocompatibility assays).
4. Adjudication Method for the Test Set
- Not applicable. As no expert interpretation or human assessment of results requiring consensus was involved, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is designed to evaluate the impact of a diagnostic AI system on human reader performance. This device is an irrigation tubing, not a diagnostic imaging or AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is hardware and does not contain an algorithm.
7. The Type of Ground Truth Used
- Functional/Performance Specifications & Regulatory Standards: The "ground truth" here is adherence to engineering design specifications, validated sterilization parameters (SAL 10⁻⁶, EO residuals), biocompatibility standards (ISO 10993-1), and demonstrated performance equivalence (flow rate, shelf life) to the predicate device. This is based on objective measurements rather than clinical outcomes or expert review of images/data.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model.
§ 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.