(112 days)
The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.
The Tools for Surgery™ SIREN SGT™ gastric tube is a clean, non-sterile, single patient use device, comprising a 36 Fr insertion tube portion 109 cm long, a hub containing a suction regulating valve, an extension tube, pinch clamp, and connector. Tubular portions including the hub are flexible polyvinylchloride (PVC). There are multiple apertures in proximity to a rounded distal tip. Line and numeric markings are provided to indicate depth of insertion. The suction regulating valve limits negative pressure applied to the stomach to less than 175 mmHg, and produces an audible signal when the suction pressure in the stomach exceeds ≈160 mmHg.
The document describes the Siren SGT™, a gastric tube used in bariatric and gastric surgical procedures. The provided content is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission usually focuses on demonstrating equivalence through comparison of technical characteristics and performance testing rather than establishing clinical efficacy or a specific "acceptance criteria" measured using clinical outcomes.
Based on the provided information, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to the predicate device (Boehringer Laboratories Gastric Sizing Tube, ViSiGi 3D®, K130483). The performance testing described is intended to show that despite some differences in design, the Siren SGT™ performs comparably and safely for its intended use.
Here's an attempt to extract and organize the information according to your request, acknowledging that a typical "acceptance criteria" table with performance metrics as you might see for a diagnostic AI device isn't explicitly laid out in this type of submission.
Table of Implicit Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)
Since this is a 510(k) submission for a physical medical device, the "acceptance criteria" are not framed in terms of precision, sensitivity, or specificity as they would be for an AI/diagnostic tool. Instead, the criteria revolve around demonstrating equivalent performance to a predicate device. The "reported device performance" refers to the results of the non-clinical tests that show the Siren SGT™ functions as intended and comparably to the predicate.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Functional Equivalence: Device performs intended functions (suction, decompression, drainage, irrigation, sizing) safely and effectively. | Demonstrated through various functional tests: |
- VALVE FUNCTION TEST
- MAXIMAL NEGATIVE PRESSURE TEST: Confirmed the pressure relief valve opens at 103 to 155 mmHg and limits negative pressure to
§ 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.