(91 days)
The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older).
It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors' offices.
The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices. The Pathfinder® CR System consists of the following main components: Suction Adapter (CR, Adapter), Foot Pedal (Suction Controller), Suction Tubing (Tubing).
The provided FDA 510(k) summary for the Neptune Medical Pathfinder® CR System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, and non-clinical functional and performance testing. It explicitly states that "No clinical testing was applicable to this submission" and "No animal testing was applicable to this submission." Therefore, the document does not contain information about a study with acceptance criteria of the type requested, which would typically involve human-in-the-loop performance or standalone algorithm performance.
However, based on the provided text, I can infer the "acceptance criteria" are related to successful functional and performance testing and biocompatibility, rather than a clinical performance study with metrics like sensitivity, specificity, or AUC.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The document describes several non-clinical functional and performance tests. While specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values, the overall conclusion states that the device "successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness."
To provide a table as requested, I'll interpret the successful completion of each test as meeting an implicit acceptance criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Biocompatibility: | |
| Meets ISO 10993 requirements for patient-contacting materials (Suction Adapter) | Testing demonstrated that the material used in the Suction Adapter meets the requirements of the applicable ISO 10993 standard. Tests included Cytotoxicity, Sensitization, Irritation Reactivity, Acute Systemic Toxicity, and Material Mediated Pyrogenicity. |
| Functional and Performance Testing: | It's important to note that specific PASS/FAIL criteria or numerical results for these tests are not provided in this summary. The summary states that these activities "successfully demonstrated that the device correctly performs as designed." |
| Dimensional Measurements | Successfully demonstrated (implied by overall conclusion). |
| Adapter Scope Installation | Successfully demonstrated (implied by overall conclusion). |
| Endoscope Trackability | Successfully demonstrated (implied by overall conclusion). |
| Device Trackability | Successfully demonstrated (implied by overall conclusion). |
| System Flow Rate | Successfully demonstrated (implied by overall conclusion). Includes specifications for maximum suction pressure of (-)0.5 Bar / (375mmHg). |
| Adapter Tubing Installation and Removal | Successfully demonstrated (implied by overall conclusion). |
| Adapter Tensile Integrity | Successfully demonstrated (implied by overall conclusion). |
| Adapter Cantilever Integrity | Successfully demonstrated (implied by overall conclusion). |
| Adapter Scope and Cantilever Seal | Successfully demonstrated (implied by overall conclusion). |
| Adapter Torque | Successfully demonstrated (implied by overall conclusion). |
| Foot Pedal Cyclic and Actuation Force | Successfully demonstrated (implied by overall conclusion). |
| Foot Pedal Tubing Installation and Removal | Successfully demonstrated (implied by overall conclusion). |
| Simulated Use | Successfully demonstrated (implied by overall conclusion). |
| Sterility & Shelf Life: | |
| Sterilization effective for Suction Adapter | Ethylene Oxide (EO) used as the method of Sterilization. Neptune Medical is responsible for its sterilization. |
| Shelf life validation | Proposed shelf life of 6 months from the date of manufacture. (Implies satisfactory validation was performed, though details aren't provided). |
| Substantial Equivalence: | |
| As safe, as effective, and performs as well as predicates | "Differences in design and technology do not raise any unanswered questions of safety or effectiveness and the intended use remains unchanged." Concluded to be substantially equivalent to Pathfinder Endoscope Overtube (K211301) and Pure-Vu EVS System (K232922) based on bench testing and biocompatibility. |
Regarding the specific questions about evaluation studies:
2. Sample size used for the test set and the data provenance:
- Not applicable / Information not provided. This document details non-clinical (bench) testing, not a clinical study involving a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert review of a "test set" to establish ground truth is described, as there was no clinical study.
4. Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication method is described.
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:
- No. The document explicitly states, "No clinical testing was applicable to this submission." This device is a mechanical system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical system, not an algorithm. The testing described is functional performance testing of the device itself.
7. The type of ground truth used:
- Bench Test Specifications / Engineering Requirements. For the functional tests, the "ground truth" would be the engineering specifications and design requirements against which the device's performance was measured. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set:
- Not applicable. This pertains to algorithm development. This device is a mechanical system.
9. How the ground truth for the training set was established:
- Not applicable. This pertains to algorithm development. This device is a mechanical system.
§ 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.