(202 days)
The ClearPath Upper Gl is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.
The provided document describes a 510(k) premarket notification for the ClearPath Upper GI device, which is an irrigation/evacuation system for endoscopic procedures. The submission is for a modified design of a previously cleared device (K093779).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes performance testing in qualitative terms and asserts equivalence to the predicate device.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Bench Testing | |
| Dimensional compliance | Performed to specifications |
| Strength compliance | Performed to specifications |
| Functional compliance | Performed to specifications |
| Mechanical compliance | Performed to specifications |
| Compliance with endoscopes | Performed to specifications |
| Animal Testing | |
| No dislodgement of tip | Performed as expected |
| Ease of maneuverability/advance | Performed as expected |
| Quality of visibility | Performed as expected |
| Quality of irrigation | Performed as expected |
| No occlusion/interruption to suction | Performed as expected |
| Quality of evacuation (blood, bile, etc.) | Performed as expected |
| Overall Performance | The modified ClearPath Upper GI disposable performed to its specifications and/or was equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for either the bench or animal testing. It refers to "animal testing," implying more than one animal, but no specific count is given.
- Data Provenance: The testing appears to be conducted by the manufacturer, EasyGlide Ltd., which is based in Kfar Truman, Israel. The study type is prospective as it involves new testing performed for this 510(k) submission, referencing "We have performed bench and animal testing to verify..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy). The testing performed seems to be primarily engineering validation (bench tests) and observational assessment by presumably trained personnel during animal studies. No specific number or qualifications of experts for ground truthing are provided.
4. Adjudication Method for the Test Set
Not applicable. The reported studies are primarily performance verification against specifications and observational assessments during animal trials, not diagnostic accuracy studies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an irrigation/evacuation system, not a diagnostic imaging device typically requiring MRMC studies to assess human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently through bench and animal testing against its specifications and the performance of the predicate device. This is not "algorithm only" performance as the device is a physical medical device. The testing aimed to confirm that the modified device itself, when used as intended, meets its design and functional requirements.
7. Type of Ground Truth Used
The "ground truth" in this context is based on:
- Pre-defined specifications for dimensional, strength, functional, and mechanical testing.
- Observational assessment during animal testing for factors like dislodgement, maneuverability, visibility, irrigation quality, and evacuation effectiveness. This observational assessment likely relies on the expertise of veterinary or medical personnel conducting the animal procedures.
- Equivalence to the predicate device (K093779), meaning the performance of the modified device was compared to the expected performance of the predicate.
8. Sample Size for the Training Set
Not applicable. This device is a physical, mechanical system, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.