(453 days)
The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.
The Applied Medical Technology, Inc. G-Tube Balloon Gastrostomy Feeding Device (AMT G-Tube) is made of silicone elastomer and is designed for enteral feeding in a gastrostomy tract. The device can be used as a replacement device through a mature stoma tract or for initial placement in a supported stoma tract. The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. On the shaft near the end is located a balloon which, when properly inflated acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration. The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.
Here's a breakdown of the acceptance criteria and study information for the AMT G-Tube Balloon Gastrostomy Feeding Device, based on the provided FDA 510(k) summary:
This device is not an AI/ML powered device, therefore, sections 2-6 and 8-9 do not apply.
Acceptance Criteria and Reported Device Performance
Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied/Stated) | Reported Device Performance (Summary) | Basis for Acceptance (Study Type) |
|---|---|---|---|---|
| Biocompatibility | ISO 10993-1, -3, -5, -6, -7, -10, -11 | Met acceptance criteria for permanent contact (>30 days) with mucosal membrane and breached/compromised surfaces. | Met all applicable biocompatibility requirements. | Bench Testing |
| Sterilization | ANSI/AAMI/ISO 11135-1:2014 | Sterility Assurance Level (SAL) of $10^{-6}$. | Validated to confirm a SAL of $10^{-6}$. Sterilization processing complies. | Bench Testing |
| ISO 10993-7 | Compliance with Ethylene Oxide Sterilization Residuals. | Complied with ISO 10993-7. | Bench Testing | |
| Shelf Life | ASTM F1980 | Evaluation of performance after simulated 3-year accelerated aging of packaging. Evaluation of performance of 50A durometer 18Fr TGJ assemblies after four years of accelerated aging. Evaluation of performance of 50A durometer 18Fr TGJ sprung tubing after four-year accelerated aging simulation. | Validated shelf life of three years. | Bench Testing |
| Bench Testing | AMT Design Specifications | Balloon Assembly Bond Peel/Tear Strength: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing |
| Balloon Burst: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Fill Valve Blow Out: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Fill Valve Pullout: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Flow Rate: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Leak Test: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Tubing Tensile Test to determine strength (at gastric holes): (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Minimum Overmold Bond Strength: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Stoma Pullout: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Tubing Cyclic and Tensile Test: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Main Strap Tensile Test: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Side Strap Tensile Test: (Specific values not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| ASTM F2528-06 | Balloon Integrity in Simulated Gastric Fluid: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | |
| Balloon volume maintenance: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Balloon size and shaft size: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Balloon concentricity: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Balloon integrity: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| ISO 80369-3 | Dimensional Verification: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | |
| Missed Connection Testing: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| ISO 80369-20 | Fluid leakage: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | |
| Stress cracking: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Resistance to separation from axial load: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Resistance to separation from unscrewing: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Resistance to overriding: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| Disconnection by unscrewing: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | ||
| ISO 11607-1:2019 and ISO 11607-2:2019 | Packaging for terminally sterilized medical devices: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | |
| EN 1615:2000, EN 1618:1997 | Leak Testing: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing | |
| Safety - Pyrogenicity | USP 41-National Formulary (NF) 36: 2018 | Pyrogenicity testing: (Specific requirements not provided, but implied to be met) | Met or exceeded all acceptance criteria. | Bench Testing |
Study Information
1. A table of acceptance criteria and the reported device performance:
See table above.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided document does not specify the sample sizes for the individual bench tests or the country of origin/provenance for the data. The studies performed were bench testing, meaning they were conducted in a laboratory setting rather than with human subjects, therefore, provenance like "country of origin" is less relevant than for clinical data. The tests are prospective in nature, as they are specifically designed to evaluate the performance of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This section is not applicable as the studies described are bench tests (biocompatibility, sterilization, shelf life, and various physical performance tests) and do not involve expert review or establishment of ground truth in the context of diagnostic interpretation. The "ground truth" for these tests is the objective measurement against established engineering, material, and safety standards (e.g., a specific tensile strength, absence of pyrogens, a confirmed SAL).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers/experts, typically in diagnostic studies. The studies performed were bench tests against pre-defined engineering and safety standards.
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:
This section is not applicable. The device is a physical medical device (gastrostomy feeding tube), not an AI/ML powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical medical device and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the various performance tests (biocompatibility, sterilization, shelf life, and bench tests) is based on established industry standards, design specifications, and objective laboratory measurements. For instance, a confirmed Sterility Assurance Level ($10^{-6}$) is an objective measurement against a standard, not an expert consensus or pathology report. Similarly, meeting specific tensile strength, flow rate, or leak test criteria are objective measurements against defined engineering specifications.
8. The sample size for the training set:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set.
9. How the ground truth for the training set was established:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set and its associated ground truth establishment.
§ 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.