(323 days)
The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).
The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.
The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.
The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.
Here's a breakdown of the acceptance criteria and study information for the ClearPath Tubing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on establishing substantial equivalence to predicate devices for the ClearPath Tubing, which is an irrigation tube for gastrointestinal endoscopic procedures. As such, the "acceptance criteria" are more related to functional performance and safety demonstration rather than specific quantitative metrics often seen with diagnostic devices.
| Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Leak detection | Tubing functions as intended |
| Tubing does not deteriorate | Tubing functions as intended |
| No visible degradation | Tubing functions as intended |
| Equivalent Indications for Use | Identical to predicate devices (K092429, K103239) |
| Equivalent Technology | Identical to predicate device (K091305) - simple tubing with peristaltic pump and check valve |
| Equivalent Environment of Use | Identical to all predicate devices |
| Equivalent Materials | Identical to K091305 or tested per ISO 10993 |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical study with a defined sample size of patients or cases. The performance testing appears to be primarily engineering or bench testing focused on the physical integrity and function of the tubing itself. This type of testing typically involves a number of manufactured units but not a patient-centric test set.
- Sample Size: Not specified in terms of patient/case count. The testing focused on manufactured tubing units.
- Data Provenance: Not applicable in the context of patient data. The tests are likely internal laboratory tests.
3. Number of Experts and Qualifications
This information is not applicable. The device is an irrigation tube, and its performance testing as described focuses on physical properties (leakage, degradation) rather than diagnostic performance requiring expert interpretation.
4. Adjudication Method
This information is not applicable. There's no mention of a human-in-the-loop diagnostic study or a need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. This type of study is more common for diagnostic devices where AI assistance could impact human interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. The ClearPath Tubing is a physical medical device (irrigation tube), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's performance acceptance is based on the satisfactory results of engineering tests (leak detection, material integrity, visible degradation) rather than clinical outcomes, pathology, or expert consensus on a diagnosis. The primary "ground truth" for regulatory approval is demonstrating substantial equivalence to predicate devices through functional and design similarities.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML-based system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted, there is no training set for this type of 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.