(133 days)
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
The provided text describes the 510(k) premarket notification for the "Irrigation Tubing with CO2 or Air" device, demonstrating its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML medical device submission.
The document pertains to an irrigation tubing device, which is a simple medical device, and not an AI/ML-driven device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of submission.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document mentions "established internal acceptance criteria based on ISO 14971:2012" for risk analysis, and "design verification and validation" for performance. It also lists specific tests conducted. However, it does not provide a table detailing quantitative acceptance criteria (e.g., specific flow rates, leak tolerances) and the corresponding measured performance values.
Partial Information Available:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Flow Performance | Compared directly between subject and predicate device through benchtop testing. (No specific thresholds or measured values provided.) |
| Usability | Evaluation compared handling, setup, and operation directly between subject and predicate device. (No specific metrics or scores provided.) |
| Basic Safety & Performance | Performed in accordance with IEC standards and design verification plan. (No specific pass/fail criteria or results provided.) |
| Risk Analysis | Carried out in accordance with established internal acceptance criteria based on ISO 14971:2012. (No specific risk levels or mitigations detailed here.) |
| Biocompatibility | Evaluation conducted for indirect patient contact. (No specific criteria or pass/fail reported, just that testing was done.) |
| Sterilization | EO sterilization. (Compliance with ISO 11135-1:2014 implied by standard application.) |
| Packaging integrity | Testing performed (ASTM F88, F2096, F1929). (Compliance implied by standard application.) |
| Small-bore connectors | Compliance with ISO 80369-7:2016 implied by standard application. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "benchtop testing" and "usability evaluation" but does not quantify the number of units or test iterations.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For the performance testing bench, it refers to internal testing by KeyMed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. This device is not an AI/ML device that requires expert-established ground truth for performance evaluation in the typical sense. Performance is assessed through engineering and physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not an AI/ML device requiring human adjudication of performance.
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 not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of clinical ground truth for an AI/ML device. For this physical device, "ground truth" would be established through engineering specifications, material properties, and physical measurements against defined standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML 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.