(150 days)
The Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, children, and infants over 10kg 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 esophagectorny 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 Traditional Length GJ 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 surgically-created gastric stoma. The multi-lumen tubing is marked with a graduated scale and held in place by means of an inflatable internal retention balloon and a sliding external bolster. The external tri-port is overmolded onto the tubing and contains three ports: one large port for administering nutrition/medication in the jejunum labeled "JEJUNAL," one large port for gastric decompression/drainage labeled "GASTRIC," and one smaller port housing the balloon fill valve labeled "BAL."
The tri-port component of the Traditional Length GJ Feeding Device is offered in two variations: a legacy model and an ENFit® model designed to ISO 80369-3. Both variations of the device are identical except for the design of the tri-port component configurations.
- The tri-port of the legacy model has two large silicone funnel ports, and a small port to fill 1. the retention balloon. The JEJUNAL and the GASTRIC ports have individual attached silicone straps and plugs intended to independently close each funnel when not in use. The BAL port houses a small, MR conditional balloon fill valve.
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- The tri-port of the ENFit® model has 2 large ports and one small port akin to the legacy model, but with a twist-lock thermoplastic male ENFit® connector housed in each the JEJUNAL and the GASTRIC funnel ports. The ENFit® connectors are compliant to ISO 80369-3. The JEJUNAL and the GASTRIC ENFit® ports have individual attached tethers and plugs intended to independently close each ENFit® port when not in use. The BAL port houses an MR safe balloon fill valve.
Both the legacy and the ENFit® variations of the Traditional Length GJ Feeding Device are offered in different French sizes. The gastric length of both variations of the Traditional Length GJ Feeding Device is adjustable, depending on where the sliding external bolster is placed along the multi-lumen tubing. Various jejunal lengths are available. The distal portion of only the 16Fr and 18Fr jejunal tubing contains an anti-kink design using a metal spring. At the distal end of every tube, a silicone tip is attached to the device through which a non-absorbable suture is attached. The Traditional Length GJ Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
The document provided is a 510(k) summary for a medical device called the "Traditional Length GJ Feeding Device". It describes the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance tests conducted on the Traditional Length GJ Feeding Device. For each test, the general acceptance criterion is that the components and materials "met or exceeded design specifications established by AMT." The reported performance is that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."
Therefore, a table can be constructed as follows:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Testing per AMT Design Specifications | Components met or exceeded design specifications | Met or exceeded design specifications |
| Balloon Assembly Bond Peel/Tear Strength | Met or exceeded design specifications | Met or exceeded design specifications |
| Balloon Burst | Met or exceeded design specifications | Met or exceeded design specifications |
| Fill Valve Blow Out | Met or exceeded design specifications | Met or exceeded design specifications |
| Fill Valve Pullout | Met or exceeded design specifications | Met or exceeded design specifications |
| Flow Rate | Met or exceeded design specifications | Met or exceeded design specifications |
| Leak Test | Met or exceeded design specifications | Met or exceeded design specifications |
| Tensile Test to tear tubing at jejunal holes | Met or exceeded design specifications | Met or exceeded design specifications |
| Tensile Test to tear tubing at gastric holes | Met or exceeded design specifications | Met or exceeded design specifications |
| Minimum Overmold Tri-Port Bond Strength | Met or exceeded design specifications | Met or exceeded design specifications |
| Stoma Pullout | Met or exceeded design specifications | Met or exceeded design specifications |
| Tubing Tensile Test | Met or exceeded design specifications | Met or exceeded design specifications |
| Suture Pullout Tensile Test | Met or exceeded design specifications | Met or exceeded design specifications |
| Gastric Strap Tensile Test | Met or exceeded design specifications | Met or exceeded design specifications |
| Jejunal Strap Tensile Test | Met or exceeded design specifications | Met or exceeded design specifications |
| Testing per ASTM F2528-06 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| Balloon Integrity in Simulated Gastric Fluid | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Balloon volume maintenance | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Balloon size and shaft size | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Balloon concentricity | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Balloon integrity | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Testing per ISO 80369-20 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| Fluid leakage | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Stress cracking | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Resistance to separation from axial load | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Resistance to separation from unscrewing | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Resistance to overriding | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Disconnection by unscrewing | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Testing per ASTM F2052 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| Magnetically induced displacement force | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Testing per ASTM F2213 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| Magnetically induced torque | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Testing per ASTM F2119 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| MR image artifact | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Testing per ASTM F2182 | Conformance to applicable recognized standards | Conformed to applicable recognized standards |
| Radio frequency induced heating | Conformed to applicable recognized standards | Conformed to applicable recognized standards |
| Biocompatibility | Met acceptance criteria for permanent contact with mucosal membrane and breached/compromised surfaces | Met acceptance criteria for permanent contact with mucosal membrane and breached/compromised surfaces |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "various performance tests on the components" and bench tests. However, it does not explicitly state the sample sizes used for these tests. The data provenance is implied to be from bench testing conducted by AMT (Applied Medical Technology, Inc.), the manufacturer. No details about country of origin for the data or whether it's retrospective or prospective are relevant here as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the evaluation involved bench testing and biocompatibility testing, not expert-adjudicated clinical data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
This information is not applicable as the evaluation involved bench testing and biocompatibility testing, which do not typically require adjudication for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. The device is a physical medical device (feeding tube), not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. The device is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance testing cited is the design specifications established by AMT and the requirements of recognized standards (ISO and ASTM standards). For biocompatibility, the ground truth is compliance with the requirements of ISO 10993 series for biological evaluation.
8. The Sample Size for the Training Set:
This information is not applicable as there is no training set for a physical medical device applying for 510(k) clearance based on bench testing.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above (no training set).
§ 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.