(233 days)
The device is indicated for percutaneous placement of a long term initial placement feeding and/or decompression gastrostomy device.
The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in that it can be the primary source of nutrition for the patient. The indications, complications and contra-indications are identical to those of the predicate Bard device. The actual insertion and placement techniques are also identical. The bolster and connector systems perform the same functions as those performed by the Bard unit. The dilator portion of the over-the-guidewire peg is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. The internal bolster system is comparable to the Bard system in both retention and removal characteristics.
The provided text is a 510(k) summary for a medical device called the "Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy Kit". It outlines the device's description, intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA.
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It focuses solely on the regulatory submission process and the determination of substantial equivalence based on comparison to an existing predicate device, rather than performance testing against specific criteria.
Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is absent from the provided text.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: These are usually quantitative metrics (e.g., tensile strength, flow rate, biocompatibility testing results, shelf-life stability) with defined pass/fail thresholds. The document mainly describes the device and its intended function, stating that its components perform "the same functions" and are "comparable" to the predicate. This is a descriptive comparison, not a report of specific test results against pre-defined acceptance criteria.
- Sample Sizes, Data Provenance, Expert Information, Adjudication, MRMC/Standalone Studies, Ground Truth: These details are typical for clinical performance studies or rigorous engineering verification/validation studies. The 510(k) summary provided here does not include any such study results. It's a regulatory document demonstrating equivalence, not a scientific publication presenting study data.
- Training Set Information: This would be relevant if the device incorporated a machine learning or AI component that required training. This device is a mechanical medical kit (a gastrostomy tube kit), and therefore, a "training set" in the AI context is not applicable.
In summary, the provided K97210Z document is a regulatory submission for a medical device that relies on substantial equivalence to a predicate device, and it does not include the details of performance studies or acceptance criteria that you've requested.
§ 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.