(166 days)
The OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.
The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope.
The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected.
The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button.
The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.
The provided text is a 510(k) summary for the Olympus Endoscopic Flushing Pump (OFP-2). It details the device description, indications for use, and a summary of testing, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance during a clinical study.
Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not explicitly present in the provided document.
However, I can extract the information that is available regarding the device's performance verification, validation, and general testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for the OFP-2's flushing performance (e.g., flow rate thresholds, cleaning efficacy metrics). Instead, it states that "The performance of the OFP-2 and its accessories was verified and validated" and demonstrates substantial equivalence to predicate devices. The study detailed is primarily a summary of testing focused on safety, biocompatibility, and sterilization, rather than a clinical performance study with specific acceptance criteria for clinical outcomes.
| Acceptance Criteria Category | Reported Device Performance (as per available information) |
|---|---|
| Intended Use | Shares the same intended use as predicate devices (OFP-1, AFU-100, UWS-1) |
| Method of Operation | Utilizes the same method of operation as predicate devices (OFP-1, AFU-100, UWS-1, with minor variations like foot switch being optional for AFU-100 and electro-magnetic pump for UWS-1). The OFP-2 uses a peristaltic pump head. |
| Biocompatibility | Established by subjecting water container, a tube, and Instrument Channel Adapter to ISO 10993-5 (MEM elution test) and ISO 10993-10 (Intracutaneous Injection Test, Kligman Maximization Test). (No specific performance metrics or pass/fail criteria are detailed, only that it was "established".) |
| Electrical Safety | Conforms to IEC 60601-1:1988, EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 No. 601.1-M90, IEC 60601-1-1, IEC 60601-2-18. (No specific performance metrics are detailed, only adherence to standards.) |
| Sterilization Effectiveness | Effectiveness of steam sterilization on the water container was validated. Robustness of the water container when subjected to steam sterilization over its expected useful life was validated. (No specific performance metrics or pass/fail criteria are detailed, only that it was "validated".) |
| Risk Management | Performed to ISO 14971, including device hazard analysis. (Compliance statement, not performance metric.) |
| Flushing Capability | Designed to transfer water from a bottle to an endoscope to wash blood, feces, and other organic matter; aid in filling GI tract with water for trans-endoscopic ultrasound probes. (Functional description, not a tested performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" in the context of clinical performance evaluation (e.g., number of patients, procedures, or images). The testing described relates to material and electrical safety.
- Sample Size: Not specified for biocompatibility (e.g., number of units tested, number of animals for in-vivo tests) or electrical safety (e.g., number of units tested).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests mentioned (biocompatibility, electrical safety, sterilization) are likely laboratory-based evaluations rather than clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided as the document does not describe a clinical study requiring expert assessment of a "test set" for ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the document does not describe a clinical study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance
This information is not applicable/provided. The OFP-2 is an endoscopic flushing pump, not an AI-powered diagnostic device. No MRMC study was mentioned, nor is AI relevant to its function as described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/provided. The OFP-2 is a mechanical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the safety and performance verification that was done:
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and the results of specific laboratory tests (e.g., L929 MEM elution, Intracutaneous Injection, Kligman Maximization). The "ground truth" here is the pass/fail determination based on standard biological response.
- Electrical Safety: Ground truth is established by compliance with specified IEC, EN, UL, and CAN/CSA standards.
- Sterilization Effectiveness: Ground truth is established by validated steam sterilization protocols and durability testing of the water container over its expected life.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a mechanical pump, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided 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.