(27 days)
The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit. The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash. The ClearJet is composed of two major units: - . A disposable Irrigator and - . A Control cabinet It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.
The ClearJet is an endoscope accessory intended to improve visualization during endoscopic procedures by providing irrigation through the working channel of an endoscope. The 510(k) summary reports that the device's performance was evaluated through comparative flow and pressure testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operate within predicate specifications | Confirmed to operate within predicate specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The testing described is comparative flow and pressure testing, likely performed on the device itself rather than human or animal subjects. Thus, there's no mention of sample size for a test set derived from patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for this device's performance was established through objective engineering measurements (flow and pressure testing) against predicate specifications, not expert interpretation of clinical data.
4. Adjudication Method
Not applicable. There was no clinical data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The device is an accessory for irrigation, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The ClearJet is a physical medical device (an endoscope accessory), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply.
7. Type of Ground Truth Used
The ground truth used was the specifications of the predicate devices for flow and pressure. The ClearJet's performance was compared against these objective engineering parameters.
8. Sample Size for the Training Set
Not applicable. The ClearJet is a physical medical device, not an AI or machine learning algorithm 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 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.