(149 days)
The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults.
The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.
The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.
The provided text describes a 510(k) premarket notification for a medical device called the "Bowel Management Device and Irrigation Set." It includes information about the device's intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to predicate devices.
However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
Missing Information:
- Specific Acceptance Criteria Table and Reported Device Performance: While the document states, "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate," it does not provide a table outlining these acceptance criteria or the specific performance metrics achieved by the device against those criteria. It only lists the types of tests performed (e.g., Strap Tensile Testing, Flow Rate Test, Balloon Integrity).
- Detailed Study Information:
- Sample size used for the test set and data provenance: The document mentions "bench tests have been carried out," but does not specify sample sizes (e.g., number of devices tested, number of individual measurements) or the origin of any data (e.g., country, retrospective/prospective).
- Number of experts used to establish ground truth and qualifications: This information is not relevant for the type of bench testing described.
- Adjudication method: Not relevant for bench testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document describes bench testing comparing device performance (mechanical and functional aspects) to a predicate, not a clinical study involving human readers or AI. Therefore, no effect size of human readers improving with/without AI is present.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: For the bench tests, the "ground truth" would be established by the design specifications and performance of the predicate device, but this isn't explicitly detailed as a ground truth methodology.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding performance testing:
- Performance Testing Overview: AMT conducted various performance tests on components.
- Comparison to Predicate: Bench tests were carried out to compare performance to the primary predicate (Cook Chait Cecostomy Catheter, K982500).
- Specific Tests Performed:
- Strap Tensile Testing
- Tube Tensile Testing
- Minimum Overmold Bond Strength
- Stoma Pullout
- 2 Minute Leak Test
- Flow Rate Test
- Testing per ASTM F2528-06 (Balloon Integrity in Simulated Gastric Fluid, Balloon volume maintenance, Balloon size and shaft size, Balloon concentricity, Balloon integrity)
- Testing per ISO 80369-3 (Fluid leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing)
- General Performance Conclusion: "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate."
In summary, while the document states that the device met acceptance criteria based on performance testing comparable to a predicate, it does not provide the granular detail requested in your prompt regarding specific numeric acceptance criteria, detailed study parameters (like sample size or data provenance), or clinical/reader study information typical for AI or diagnostic devices. This document focuses on the engineering and material performance of a physical device for a 510(k) submission.
§ 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.