(245 days)
The 24 hour use Endoscopy 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 Endoscopy Irrigation Tubing is intended for 24-hour use and then discarded. The endoscopy irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The endoscopy irrigation tubing is individually packed in sealed package, sold as a sterile device. The endoscopy irrigation tubing is designed to be attached 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.
The provided text describes the 510(k) premarket notification for the "Endoscopy Irrigation Tubing" device. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance criteria through a rigorous clinical trial or AI model validation.
Therefore, many of the requested sections related to AI model validation, ground truth establishment, expert consensus, MRMC studies, and effect sizes cannot be directly extracted from this document, as the device is not an AI/ML-driven diagnostic tool. The document describes a medical device (tubing) and its physical and chemical properties and basic performance.
However, I can extract information related to the acceptance criteria and the type of study done to prove the device meets these criteria as described for this specific type of medical device submission.
Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (Endoscopy Irrigation Tubing), the "acceptance criteria" are related to its physical and functional equivalence to the predicate device and its compliance with relevant standards. The "performance" is demonstrated through bench testing and compliance with various material and sterilization standards.
| Acceptance Criteria (Related to Substantial Equivalence and Safety/Performance) | Reported Device Performance (as per submission) |
|---|---|
| Functional/Technical Equivalence | |
| Product Code: OCX | Same as predicate device (OCX) |
| Regulation No.: 876.1500 | Same as predicate device (876.1500) |
| Regulatory Classification: Class II | Same as predicate device (Class II) |
| Regulation Description: Endoscope and accessories | Same as predicate device |
| Indications for Use (24-hour use, irrigation via sterile water bottle, GI endo procedures, with irrigation pump) | Same as predicate device. |
| Compatibility with GI endoscopes and irrigation pumps | Model A: ENDOGATOR™ EGP-100 Irrigation Pump, OLYMPUS® OFP Pump, OLYMPUS® AFU-100 Pump and ERBE EIP2® Pump. Model B: Olympus® OFP, OFP-2, OFP-3 and OPF-3 Plus Irrigation Pump. (Note: Predicate lists Olympus® OFP, Endo Status™ EGA-500 and Endogator® EGP-100. Manufacturer states "Substantial Equivalent" for compatibility.) |
| Single Use, Disposable (24-hour use) | Same as predicate device (24-hour use then discard). |
| Backflow Prevention Design | Diaphragm in the connector allowing one-way pressurized water flow. Similar to predicate. |
| Supplied Sterile | Yes, individually packed in sealed package. |
| Packaging | Irrigation tubing packaged in a sealed pouch. |
| Manufacturing Method: Injection molding and Extrusion | Same as predicate. |
| Biocompatibility/Material Safety | |
| Materials: Polycarbonate (PC), Polyvinyl Chloride (PVC), Polypropylene (PP), Polytetrafluoroethylene(PTFE), Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS), Silicone, Polyformaldehyde Resin(POM) | Wider range than predicate (Polycarbonate and Polyvinyl Chloride). Biocompatibility tests conducted and all passed with acceptable results per ISO 10993-1:2018. Cytotoxicity, sensitization and intracutaneous reactivity tests performed. |
| Sterilization & Shelf-Life | |
| Sterilization Method: EO gas | Validated EO sterilization cycle per ISO 11135 and ISO 10993-7 (EO residual). |
| Shelf Life: Minimum 1 year (predicate) | Claimed 3 years. Validated through accelerated aging testing (ASTM F1980-21) and packaging requirements met (ISO 11607-1, ISO 11607-2). |
| Performance (Functional) | |
| Flow Performance | Bench testing performed on Endoscopy Irrigation Tubing to support substantial equivalence. Performance data demonstrated the proposed device met established specifications (details of specific flow rates/pressures not provided in this summary but implied as equivalent or meeting internal specs). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text. The "Performance Test" states "bench testing was performed" but does not give sample sizes for devices tested.
- Data Provenance: The tests are analytical bench tests, not clinical data from patients. The manufacturer is Zhejiang Chuangxiang Medical Technology Co., LTD., located in Hangzhou, Zhejiang Province, P.R. China. The data would originate from their internal testing or contracted labs. It is not retrospective or prospective in the clinical sense.
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 medical device (tubing), not a diagnostic or AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is established by compliance with engineering standards, material properties, and functional specifications defined by recognized standards (e.g., ISO, ASTM) and internal quality control.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is a medical device, not an AI/ML algorithm or clinical study requiring adjudication of interpretations. The "test set" involves laboratory measurements and comparisons to predicate device specifications.
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:
- Not Applicable. This device is a passive medical tube. There is no AI component, and no human reader interpretation is involved or enhanced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Standard Compliance: The "ground truth" for this device's acceptance is based on meeting pre-defined physical, chemical, and functional specifications derived from engineering standards (e.g., flow rate requirements, material biocompatibility limits, sterilization efficacy) and demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a bench testing and material characterization ground truth.
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. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.