(172 days)
The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
This document describes a 510(k) submission for the LIBBE Colonic Nozzle, a device that is substantially equivalent to a previously cleared device. Therefore, a comprehensive study proving the device meets acceptance criteria as would be expected for a novel device is not presented. The information provided focuses on demonstrating substantial equivalence rather than independent performance testing against predefined acceptance criteria.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in terms of specific performance metrics for the LIBBE Colonic Nozzle. Instead, it argues for substantial equivalence to a predicate device, the Libbe Rectal Tube (K962259).
The performance "reported" is primarily a comparison of the new device's characteristics to the predicate device, implying that equivalence in these characteristics constitutes meeting the necessary "performance."
| Feature/Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (LIBBE Colonic Nozzle) |
|---|---|---|
| Intended Use | Same as cleared predicate | "similar" but with differences in dimensions, material & the addition of a bulb shape at the tip |
| Material/Composition | Safe and appropriate for intended use (implicit from predicate) | Semi-rigid plastic (predicate was rigid plastic) ; Biocompatibility tested per ISO 10993 |
| Shape/Design | Effective for colon cleansing (implicit from predicate) | Open tip with slight bulb shape and two small holes; Barbed fitting for tubing attachment (Predicate had smooth, open tip with two small holes; continuous straight tube with smooth wall for connection) |
| Sterility | Non-sterile (explicit for new device, implicit for predicate) | Non-sterile |
| Single Use | Single use (explicit for new device, implicit for predicate) | Single use |
| Biocompatibility | Biocompatible for patient contact | Meets biocompatibility requirements as specified in FDA Guidance G95-1, and tested in accordance with ISO 10993. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No separate test set with a defined sample size for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and biocompatibility testing. The data provenance for the biocompatibility testing (ISO 10993) is not specified in terms of country of origin or whether it was retrospective/prospective outside of the standard testing protocol.
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)
No experts were used to establish ground truth for a test set in the context of device performance, as no such test set is described. The “ground truth” related to safety and effectiveness is largely based on the predicate device's prior clearance and the existing regulatory framework for colonic irrigation systems.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication for performance evaluation.
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
Not applicable. This device is a physical medical device (a nozzle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document relies on the "ground truth" established by the prior clearance of the predicate device (Libbe Rectal Tube K962259) and generally accepted standards for medical device safety and performance, specifically:
- Substantial Equivalence: The primary ground truth is that the predicate device is safe and effective when used as intended.
- Biocompatibility Standards: The device meets ISO 10993, which serves as a recognized standard for evaluating biological effects of medical devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 876.5220 Colonic irrigation system.
(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.