(148 days)
The Single-Use Introducer is used for patient esophageal intubation to guide the catheters and tubes via the nasal or oral cavity. It is to be used in conjunction with endoscopes to allow visualization of the placement process. The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment.
The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.
The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.
The PatCom Single-Use Introducers are made from single lumen, medical grade polyvinyl chloride plastics. The tubing length is 30cm, with an open tip at one end, and a polycarbonate cone made of 2 halves at the other end.
This device is designed to work in conjunction with endoscopes to make the placement of certain catheters and tubes more pleasant for the patient and easier for the end user. The endoscope is placed inside the introducer and both devices together are guided through the nasal or oral passage into the pharynx, via the visual aid provided by the endoscope. The purpose of the visual aid is to prevent unnecessary aggravation of the nasopharyngeal or oropharyngeal wall. Once the introducer is in its desired position, the endoscope is extracted.
The introducer then functions as an open channel from the mouth or the tip of the nose through to the distal opening end of the introducer, as a guide for the placement of catheters and tubes, especially ones that do not contain their own open lumen for use of guidewires that are standard in the gastrointestinal industry. By feeding the catheters or tubes through the introducer, it again minimizes any possible aggravation of the pharyngeal wall as the catheters and tubes would follow the tunnel created by the introducer.
After the catheter is inserted through the introducer and placed into its proper positioning, the introducer is then extracted out of the nasal or oral cavity along the length of the catheter. Once the entire introducer is exposed, the user grips the 2 halves of the cone and pulls apart the introducer to remove and discard.
This document is a 510(k) premarket notification for a medical device, specifically an "PatCom Single-Use Introducer." It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for a novel AI/software medical device.
Therefore, much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and comparative effectiveness (MRMC) cannot be found in this type of document.
The document primarily describes nonclinical bench testing to demonstrate the device's performance, safety, and effectiveness.
Here's an attempt to answer your questions based on the provided text, indicating where information is not applicable or not present:
1. Table of acceptance criteria and the reported device performance
The document mentions that "Individual verification testing was conducted to verify the performance requirements and specifications of the introducer..." and lists the types of tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for these tests. It only states that "All testing and results were successfully completed."
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Dimensional verification meets specifications | Successfully completed |
| Visual inspection meets quality standards | Successfully completed |
| Kink resistance within acceptable limits | Successfully completed |
| Tensile strength within acceptable limits | Successfully completed |
| Device is as safe and effective as predicate | Demonstrated through testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for nonclinical bench testing.
- Data Provenance: The testing was conducted by H&A Mui Enterprises Inc., o/a Mui Scientific, which is based in Mississauga, Ontario, Canada (manufacturer's address). This is a prospective set of nonclinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device is not an AI/software device that relies on human expert interpretation for "ground truth" in the way clinical diagnostic AI products do. Therefore, information about experts for establishing ground truth is not applicable/not provided. The "ground truth" for nonclinical bench testing is typically defined by engineering specifications and objective measurements against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the "test set" refers to nonclinical bench testing, there is no human adjudication process involved as there would be for subjective clinical assessments. The results are objective measurements.
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. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the nonclinical bench testing, the "ground truth" is based on engineering specifications and objective physical measurements (e.g., dimensions, force required for kinking, tensile strength). There is no "expert consensus" or "pathology" in this context.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/machine learning training set, this question is not relevant to the PatCom Single-Use Introducer.
§ 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.