(101 days)
The Micro Transgastric-Jejunal Feeding Device is inchildren and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.
The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon.
The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
The provided text does not contain specific acceptance criteria with numerical targets. Instead, it describes various performance tests conducted on the Micro Transgastric-Jejunal Feeding Device to demonstrate conformance to applicable recognized standards and comparability to the predicate device.
Therefore, I cannot populate a table of acceptance criteria with reported device performance or describe a study that proves the device meets specific numerical acceptance criteria.
However, I can extract information about the types of tests performed and the general conclusion regarding device performance.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted, specific numerical acceptance criteria and reported device performance are not provided in the document. The text broadly states that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."
Therefore, the table would look like this, indicating the lack of specific data in the provided document:
| Acceptance Criteria (Specific Numerical Targets) | Reported Device Performance (Specific Numerical Results) |
|---|---|
| Not specified in the document | Not specified in the document; generally stated as "met all acceptance criteria and performed comparable to or better than the primary predicate." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document mentions "various performance tests on the components" and lists types of tests, but does not provide the number of units or samples tested for each.
- Data Provenance: The tests were conducted internally by AMT ("AMT conducted various performance tests") and are bench tests. The document does not specify a country of origin for the data or whether it's retrospective or prospective, though bench testing is inherently prospective for the specific tests performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable for performance bench testing. Ground truth, in the context of expert review, is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) where human experts determine the correct outcome. The tests described are physical performance tests (e.g., strength, flow rate).
4. Adjudication Method for the Test Set:
- Not applicable for performance bench testing. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers or experts when establishing ground truth. This is not relevant to objective physical performance measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "F. Clinical Study: Clinical testing was NOT performed." MRMC studies involve human readers and clinical cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. The device is a physical medical device (a feeding tube), not an algorithm or software. The document explicitly states: "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."
7. The Type of Ground Truth Used:
- For the performance testing, the "ground truth" would be the physical measurement standards and design specifications established by AMT and defined by the listed ISO and ASTM standards. The device's performance was compared against these established technical benchmarks.
8. The Sample Size for the Training Set:
- Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As a physical device, there is no "training set" or "ground truth for a training set" in the context of AI/ML.
Summary of Device Performance Study (as described):
The manufacturer, Applied Medical Technology, Inc. (AMT), conducted various bench tests on the components of the Micro Transgastric-Jejunal Feeding Device. These tests aimed to demonstrate conformance to applicable recognized standards and to compare the device's performance to its primary predicate (AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit, K123716).
Tests performed included:
- Testing per AMT Design Specifications:
- Balloon Assembly Bond Peel/Tear Strength
- Balloon Burst
- Fill Valve Blow Out
- Fill Valve Pullout
- Flow Rate
- Leak Test
- Tensile Test to remove jejunal interlock
- Tensile Test to remove gastric interlock
- Tensile Test to tear tubing at jejunal hole
- Tensile Test to tear tubing at gastric hole
- Minimum Overmold External Bolster Bond Strength
- Stoma Pullout
- Tubing Tensile Test
- Gastric Strap Tensile Test
- Jejunal Strap Tensile Test
- Testing per ASTM F2528-06 (Standard for Gastrostomy and Jejunostomy Feeding Tubes):
- Balloon Integrity in Simulated Gastric Fluid
- Balloon volume maintenance
- Balloon size and shaft size
- Balloon concentricity
- Balloon integrity
- Testing per ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications):
- Fluid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- Testing per ASTM F2052 (Magnetic Resonance Safety):
- Magnetically induced displacement force
- Testing per ASTM F2119 (Magnetic Resonance Safety):
- MR image artifact
- Testing per ASTM F2182 (Magnetic Resonance Safety):
- Radio frequency induced heating
- Biocompatibility Testing following ISO 10993 standards (Parts 1, 3, 5, 6, 7, 10, 11, 12, 17) for permanent contact with mucosal membranes and breached/compromised surfaces.
Conclusion of the study: The document states that the Micro Transgastric-Jejunal Feeding Device "meets all the acceptance criteria and performed comparable to or better than the primary predicate." No animal studies or clinical studies were performed. The specific numerical data from these tests that support this conclusion are not included in the provided text.
§ 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.