(172 days)
The ClearPath is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water) and feces.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
The ClearPath's main purpose is to improve procedure reliability and decrease colonoscopy procedures cancellation rate by enabling intra-procedural cleaning of a poorly prepared colon.
The ClearPath utilizes a suction / irrigation head for the purpose of irrigating or cleaning the colon and enabling the rapid evacuation of large amounts of water and feces.
The ClearPath is composed of two major units:
- . The disposable Irrigator and
- . the reusable Control cabinet.
The disposable Irrigator is attached to a standard colonoscope by means of silicon bands and does not hinder colonoscope functionality nor affects the procedure sequence in any way.
The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.
The provided document describes the ClearPath device, an external uterine monitor for intra-procedural colon cleaning. The information primarily focuses on substantial equivalence to predicate devices based on technical specifications and indications for use, rather than a clinical study evaluating its effectiveness.
However, based on the information provided, here's a breakdown regarding acceptance criteria and the "study" that proves the device meets them, recognizing that this "study" is more accurately described as performance testing for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are implicitly defined by the performance specifications of the predicate device, specifically the Olympus (KeyMed) OFP-1 endoscopic flushing pump (K000948). The ClearPath device aims to be "equal or less than" these specifications, which indicates non-inferiority in performance for certain parameters.
| Performance Parameter | Acceptance Criteria (Predicate: Olympus OFP-1, K000948) | Reported Device Performance (ClearPath ACE-1000) | Meets Acceptance Criteria? |
|---|---|---|---|
| Air / Water pressure | 52 Psi | Up to 30 Psi | Yes (Equal or less than) |
| Flow rate | Up to 300 ml/min | Up to 300 ml/min | Yes (Equal or less than) |
| Suction specifications (Vacuum) | Approximately 0.5 Bar (Standard wall suction) | Approximately 0.5 Bar (Standard wall suction) | Yes (Equal or less than) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "testing to demonstrate that the operating performance specifications of the ClearPath is equivalent to the predicates for flow rate, irrigation and vacuum pressures."
- Sample Size: The document does not specify the sample size (e.g., number of devices tested, number of measurements taken). It refers to "testing" in a general sense for technical specifications.
- Data Provenance: This testing appears to be internal engineering or lab testing. There is no information provided regarding country of origin, retrospective or prospective nature, or if it involved human subjects or real-world clinical data. It is likely bench testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of performance testing. The "ground truth" for the technical specifications (pressure, flow rate, suction) would be established by calibrated measurement devices and engineering standards, not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable as this was technical performance testing against established specifications, not a subjective evaluation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted for this device. The purpose of the submission was to demonstrate substantial equivalence based on technical performance and indications for use, not to prove clinical effectiveness or improvement in human reader performance. This device is an instrument for cleaning during a procedure, not a diagnostic or interpretation aid.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone "study" (i.e., standalone performance testing) was performed. The device's performance (pressure, flow, suction) was measured independently without human intervention directly influencing the measurement of these parameters. This testing focused on the device's technical capabilities as described in the table above.
7. Type of Ground Truth Used:
- The ground truth for the performance testing was based on established engineering specifications and measurements from the predicate device (Olympus OFP-1 endoscopic flushing pump) and general industry standards for such devices (e.g., standard wall suction levels).
8. Sample Size for the Training Set:
- Not applicable. This device is a mechanical instrument, 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.