(151 days)
The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
New standard ISO-80369-1 is pushing feeding tube manufacturers to transition current extension set designs to incorporate enteral only connectors. Most enteral feeding devices currently on the market utilize luer slip or catheter tip connectors to connect enteral giving sets and syringes to enteral receiving sets. Standard luer slip and catheter tip connectors raise risk levels for patients as devices outside of the enteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369 series was developed to help reduce the possibility of misconnections across different medical fields.
The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989. This extension set remains identical to our previously marketed device, but includes Enfit connectors. However, launching a enteral extension sets with Enfit connectors will not be simultaneous across all manufacturers and distributors. Therefore, transition adapters are necessary for a limited time.
As the new Enfit connectors are not backwards compatible with current luer and bolus connections currently used for enteral products, AMT has designed several transition adapter configurations to help users make the switch to the new connections. AMT estimates that there will be a time of at least a year and possibly up to three years where users and distributors will still have access to enteral devices with luer / bolus connectors. The transition adapters AMT has designed in this 510(k) will allow users to use their old giving/receiving sets until the market is flushed of old inventory.
The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5 separate components. The five configurations include:
• Male Enfit to Male Luer Adapter
• Female Enfit to Female Luer Adapter
• Female Enfit to Y-Port (Bolus/Luer) Adapter
• Female Enfit to Bolus Adapter
• Male Enfit to Christmas-tree Adapter
These 5 transition adapter configurations will allow AMT to offer users with options for all of the common enteral connectors currently on the market. All components and materials have been previously cleared in 510(k)s for similar use. It is planned to include these transition adapters kitted with enteral devices previously cleared through the 510(k) process, as well as selling the adapters as stand-alone items.
This document is a 510(k) summary for the AMT Enteral Transition Adapters, which is a medical device subject to FDA review. The focus of this document is on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical or AI-based context.
Therefore, much of the requested information regarding acceptance criteria, study design for performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details (which are typically relevant for AI/algorithm-driven devices or clinical trials) is not applicable to this type of regulatory submission for a physical medical device.
However, I can extract the relevant performance testing information and present it in the requested format where possible, noting the limitations of the document's scope.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance values for each criterion. Instead, it lists the types of performance tests conducted. The "Conclusions" section states that the device is "substantially equivalent ... in testing criteria," implying that the device met the criteria for these tests, likely aligned with the predicate device or relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Tensile strength | Met (Device is substantially equivalent in testing criteria) |
| Fluid leakage | Met (Device is substantially equivalent in testing criteria) |
| Stress cracking | Met (Device is substantially equivalent in testing criteria) |
| Resistance to separation from axial load | Met (Device is substantially equivalent in testing criteria) |
| Resistance to separation from unscrewing | Met (Device is substantially equivalent in testing criteria) |
| Resistance to overriding | Met (Device is substantially equivalent in testing criteria) |
| Disconnection from unscrewing | Met (Device is substantially equivalent in testing criteria) |
| Flow testing | Met (Device is substantially equivalent in testing criteria) |
| Incompatibility with other connectors (ISO 80369-1) | Met (Enfit connectors will not misconnect to other connectors in the 80369 series) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "various performance tests on all components," but does not provide specific sample quantities for each test.
- Data Provenance: Not specified, but given it's a 510(k) submission for a physical device, testing would typically be conducted in a laboratory setting by the manufacturer (Applied Medical Technology, Inc.) in the USA (Brecksville, OH). The tests would be prospective in nature, performed on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical adapter, not an AI or diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., diagnosis, abnormality detection). The performance tests listed are engineering and mechanical evaluations.
4. Adjudication method for the test set
- Not Applicable. As per point 3, this is not a clinical or AI performance study requiring adjudication of expert interpretations.
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
- Not Applicable. This is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- For the performance tests listed (tensile strength, fluid leakage, etc.), the "ground truth" would be established by engineering specifications, material science standards, and mechanical test methods defined by ISO or other relevant industry standards (e.g., ISO 80369-1 for connector incompatibility). Test results are compared against predefined pass/fail criteria from these standards.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device, not an AI system.
§ 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.