(60 days)
This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.
The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.
This document describes a 510(k) premarket notification for a medical device called the "14Fr Colon Decompression Set (CDSG) / Marcon Colon Decompression Set (CDSM)". This is a Class II device (21 CFR § 876.5980, Gastrointestinal Tube and Accessories). The application aims to demonstrate substantial equivalence to a predicate device (Cook Colon Decompression Set, K900035, cleared March 7, 1990).
The provided text does not contain information about a study proving that an AI-driven device meets acceptance criteria. This document describes a traditional medical device (colon decompression sets) and its equivalence with a predicate device based on manufacturing, material, and design comparisons, along with performance testing relevant to its physical function and safety.
Therefore, I cannot provide the requested information regarding AI acceptance criteria, study details, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone AI performance, or ground truth establishment for AI.
The document discusses non-clinical performance testing of the device itself (not an AI component). Here’s what is mentioned regarding acceptance criteria and performance data for the described device:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "Performance testing included simulated use, dimensional testing, resistance to collapse, flow rate, tensile strength testing, dimensional and leakage tests, MR safety testing, radiopacity and shelf life testing." And "The results of the non-clinical testing demonstrates that the Colon decompression sets met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness."
However, specific quantitative acceptance criteria and their corresponding reported performance values for each test are not provided in this regulatory letter. The letter confirms that the tests were performed and the device met the requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the performance tests (simulated use, dimensional, resistance to collapse, flow rate, tensile strength, leakage, MR safety, radiopacity, shelf life).
- Data Provenance: Not explicitly stated, but typically, these tests are conducted by the manufacturer (Cook Ireland Ltd.) in controlled laboratory settings. There is no mention of country of origin for the "data" as it pertains to patient data; it's product performance data.
- Retrospective or Prospective: These are laboratory performance tests on the manufactured device, not clinical studies on patients. Therefore, the terms "retrospective" or "prospective" do not directly apply in the context of clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for this device's performance is established by direct physical measurements, engineering specifications, and established biocompatibility standards, not by expert interpretation of medical images or clinical outcomes in the same way an AI device's ground truth would be.
4. Adjudication method for the test set:
- Not applicable for the type of performance testing described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based ground truth establishment, not for direct physical property measurements of a device.
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 not an AI product, and no MRMC study involving human readers or AI assistance is mentioned or relevant to its 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For the performance testing: The "ground truth" is defined by engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1, FDA's biocompatibility guidance), which are measured directly.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.