(30 days)
The FastracTM Gastric Access Port System is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
The FASTRAC™ Gastric Access Port device is a silicone balloon-type feeding Product designed for percutaneous initial endoscopic placement (via a Pull placement technique, or a Guidewire placement technique) of a long term initial feeding and/or decompression gastrostomy tube. The feeding tube is designed with soft thin silicone tubing, which is wire-reinforced to prevent kinking, and the with volster positions the device at a 90° angle against the abdomen.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Fastrac™ Gastric Access Port System. It details an application for marketing a medical device and its substantial equivalence to a predicate device, rather than a clinical study with acceptance criteria and performance data in the typical sense of a diagnostic or algorithmic device.
Therefore, many of the requested elements for a study proving acceptance criteria (such as sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. This document focuses on demonstrating that the new device meets the same performance requirements and is as safe and effective as its predicate device through design verification, not through an independent clinical study establishing new performance metrics.
Here's a breakdown based on the provided information, addressing what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported device performance metrics in the way a diagnostic algorithm would. Instead, it states that the device meets the "same performance requirements" as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same performance requirements as predicate device | "Design verification data demonstrated that the Fastrac™ Gastric Access Port System meets the same performance requirements and is as safe and effective as the predicate device." |
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: Not specified. The document refers to "design verification data," which typically involves engineering tests, bench testing, and potentially limited animal or human use data from development, but not a formal clinical trial with a defined sample size for statistical evaluation of new performance.
- Data Provenance: Not specified. This would refer to the tests and verification activities performed by the manufacturer (C.R. Bard, Inc. in Billerica, MA).
- Retrospective/Prospective: Not specified, but "design verification" is inherently an integral part of prospective product development and testing.
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)
Not applicable. This is not a study focused on diagnostic accuracy or interpretation by experts. The "ground truth" for a device like this would be its physical and functional characteristics documented by engineers and testing personnel against design specifications, potentially with clinical input on requirements, but not expert adjudication of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" in the sense of cases requiring adjudication of results, as this is a device performance verification, not a diagnostic accuracy study.
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 is not an AI-assisted diagnostic device, nor is it a study involving human readers or comparative effectiveness in that context. It is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its performance is inherent in its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be engineering specifications, material and mechanical test standards, and functional requirements. For example, "ground truth" might be that the silicone tubing must withstand a certain pressure without kinking, or that the bolster maintains a 90° angle, as measured by precise engineering tests, rather than a clinical outcome or expert diagnosis for individual patients.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
§ 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.