(148 days)
The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.
The EndoFLIP® Gastric Tube is a simple single lumen tube which acts as a support bougie for a 43 Fr lumen and may be used to aid in the EndoFLIP® catheter, K092850 and K 102214, deployment. It may also be used for drainage, suction or irrigation as it is open at both ends and features a number of side-holes at the distal end. A connector is supplied to push-on the proximal end to aid attachment to a suction system. The tube is 75 cm long and markings are provided at 20 cm and 70 cm from the distal end. The EndoFLIP® Gastric Tube is supplied non-sterile and is single patient use, disposable. An alcohol swab is provided to wipe down the tube exterior prior to use.
The Crospon Ltd. EndoFLIP® Gastric Tube EF-900 is a single-lumen tube intended for use in bariatric surgical procedures as a support bougie, for stomach decompression, gastric fluid drainage and removal, and to aid deployment of other EndoFLIP® catheters.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Age Testing | Meets performance specifications, does not raise safety/efficacy issues. |
| Kink Test | Meets performance specifications, does not raise safety/efficacy issues. |
| Biocompatibility | |
| ISO 10993-1 Testing | Meets ISO 10993-1 standards for materials in contact with the patient. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a separate test set or sample size for the performance testing mentioned (age testing, kink test, biocompatibility). The testing appears to be conducted on the device itself as part of product validation.
Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering/material tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of performance testing described. The acceptance criteria relate to physical and material properties, not clinical diagnostic accuracy or similar evaluations that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human expert review process for the performance criteria. The testing involves objective measurements against established engineering and biocompatibility standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a surgical tool, not an imaging or diagnostic device that would typically undergo such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone or algorithm-only performance study was conducted. The device is a physical instrument, not an AI or software-based system.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be established by engineering specifications, international standards (e.g., ISO 10993-1), and internal performance specifications. For example, the biocompatibility ground truth is conformity to ISO 10993-1. For age and kink testing, the ground truth is likely predefined thresholds for durability and functionality under specified conditions.
8. Sample Size for the Training Set
This information is not applicable. The device is a medical instrument and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.