(137 days)
The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.
The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.
The provided text describes the regulatory clearance of the "Standard Bougie, SB38" device and outlines its characteristics and comparison to a predicate device, along with a list of performance tests conducted. However, it does not provide detailed acceptance criteria or the specific results of those performance tests. The document states that "Standard Bougie SB38 performance testing has been submitted in this 510(k)", and then lists the types of tests. It concludes that "The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device." but does not present the data itself.
Therefore, for aspects requiring specific numerical data, sample sizes, expert qualifications, or details of a study (like an MRMC study or standalone performance), the information is not available in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document only lists the types of performance tests conducted. It doesn't specify the acceptance criteria for each test or the quantitative results achieved by the device against those criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document lists performance tests but does not specify the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/available. The performance tests mentioned (Drainage Flow Rate Verification, Balloon Strength Verification, Balloon Size Verification, Balloon Firmness Verification, Tensile Strength Verification, Reliability Testing) appear to be engineering/mechanical tests rather than studies involving expert assessment of medical outcomes or images. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic device studies does not apply here.
4. Adjudication Method for the Test Set
Not applicable/available. As the tests are engineering/mechanical in nature, an adjudication method (like 2+1, 3+1) is not typically used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention an MRMC comparative effectiveness study. The device is a "bougie," which is a physical medical instrument used as a sizing guide and for other functions during surgery, not a diagnostic imaging or AI device that would typically undergo an MRMC study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.
7. Type of Ground Truth Used
Not explicitly stated, but implied as engineering/physical measurements. For the listed performance tests (e.g., strength, size, flow rate), the ground truth would be based on precise physical measurements and engineering specifications, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical device, this question is not relevant.
§ 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.