(31 days)
The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized.
The Olympus Flushing Pump is peristaltic pump which facilitates direct washing of debris from the observation site during endoscopic examinations. The peristaltic pump and associated tubing allow irrigation water to be controlled and directed to the observation site to remove blood, faeces or other organic matter that may be obstructing the endoscopic view.
The provided text describes a 510(k) submission for the Olympus Flushing Pump OFP-1, specifically focusing on a modification to the Auxiliary Water Irrigation Tube. This is a special 510(k) as stated in section 8, meaning the performance testing is focused on validating the changes, which are a material change and sterilization of the tubing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatibility of new PVC tubing | "Biocompatibility testing of the PVC tubing" - Implied successful, as substantial equivalence was granted. |
| Sterilization | Validation of Gamma Sterilization Process for tubing | "Validation of the Gamma Sterilization Process" - Implied successful. |
| Packaging Integrity | Validation of Irrigation Tube Packaging | "Validation of the Irrigation Tube Packaging" - Implied successful. |
| Functional Performance | Performance testing of the new irrigation tube | "Performance testing of the new irrigation tube has demonstrated that the OFP fulfills prospectively defined performance criteria and that the modified system meets user needs." - Implied successful. |
| Intended Use | Device continues to operate as intended | "The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized." - Intended Use remains unchanged, implies device still supports it. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each of the validation activities (biocompatibility, sterilization, packaging, performance testing). Given this is a modification to a previously cleared device, the testing would be focused on the new components/processes.
The provenance of the data is not explicitly stated. However, the sponsor is KeyMed (Medical & Industrial) Ltd. in the United Kingdom, suggesting the testing might have been conducted there or by a contract research organization. The study type is retrospective in the sense that it's a validation of a modified product against established performance criteria, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing focuses on engineering and material validation rather than clinical ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the validation (biocompatibility, sterilization, packaging, and functional performance of a tube), adjudication by experts, as typically seen in clinical studies, would not be applicable. The adjudication would be against pre-defined engineering and regulatory standards.
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
No, an MRMC comparative effectiveness study was not done. This device is an endoscopic flushing pump, not an AI-powered diagnostic tool. The submission is for a material and sterilization modification to an existing mechanical device. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not conducted. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus, pathology) is not applicable to this submission. The "ground truth" here is based on:
- Engineering Standards and Specifications: For functional performance of the flushing tube (e.g., flow rate, pressure, durability).
- Biocompatibility Standards: ISO 10993 series for the PVC tubing.
- Sterilization Standards: ISO 11137 series for gamma sterilization.
- Packaging Standards: Relevant standards for sterile medical device packaging.
8. The Sample Size for the Training Set
There is no training set. This is a mechanical device modification, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this 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.