(191 days)
The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .
The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution.
The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm.
The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed.
The access adapter is a metal cannula. The distal end of the cannula is curved and can be attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.
The Chait Cecostomy Catheter was subjected to the following tests to assure reliable design and performance: Clinical Trials, Tensile Strength Tests, and Biocompatibility Tests.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text lists the types of tests performed but does not explicitly state specific quantitative acceptance criteria or detailed reported device performance results for each test. It broadly states that the tests "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text for Clinical Trials, Tensile Strength Tests, or Biocompatibility Tests. | The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a catheter which facilitates antegrade colonic flushing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Clinical Trials" but does not provide details on the sample size used, the country of origin, or whether the study was retrospective or prospective.
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)
The text mentions "Clinical Trials" but does not provide any information regarding experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The text mentions "Clinical Trials" but does not specify any adjudication method used.
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
The text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor does it mention any AI assistance. The device described is a physical medical catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The text does not refer to any algorithms or artificial intelligence components for the device. The device is a physical catheter, so this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The text mentions "Clinical Trials" which implies patient outcomes would be part of the evaluation, but it does not specify the type of ground truth used for these trials. For the Tensile Strength and Biocompatibility Tests, the ground truth would be based on established engineering and biological standards, but these details are not provided.
8. The sample size for the training set
The text does not mention a training set as the device described is a physical medical catheter and not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.