(269 days)
The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.
The device is single use for patients who require enteral feeding.
The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.
This document is a 510(k) Premarket Notification from the FDA for a medical device called "ENFit to ENFit Extension Sets." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a physical medical device (extension sets for enteral feeding), not a software or AI-driven diagnostic tool. Therefore, the questions regarding acceptance criteria for a "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training data) are not applicable to this type of device submission.
The "acceptance criteria" for this device are related to its physical performance, safety, and functional equivalence to a legally marketed predicate device, as demonstrated through non-clinical testing and comparison. The "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed.
Here's the information as requested, adapted to the context of a physical medical device:
Acceptance Criteria and Device Performance (adapted for a physical medical device)
The acceptance criteria for this device are established by demonstrating compliance with recognized international standards for medical devices and particularly for enteral feeding connectors, and by showing substantial equivalence to a predicate device in terms of design, intended use, and performance.
1. A table of acceptance criteria and the reported device performance:
The document primarily demonstrates acceptance by adherence to specific ISO standards and by direct comparison to a predicate device. The "reported device performance" is the confirmation that the device met the requirements of these standards.
| Acceptance Criteria (based on ISO Standards & Predicate Comparison) | Reported Device Performance |
|---|---|
| Biocompatibility: |
- Cytotoxicity per ISO 10993-5:2009
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010
- Irritation per ISO 10993-10:2010
- Acute Systemic Toxicity per ISO 10993-11:2017
- Material-mediated Pyrogenicity per 10993-11:2017 | Compliant with Use of International Standard ISO 10993-1: "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." |
| Visual Inspections: - Verification of bonding. | Visual inspection for verification of bonding was performed and met requirements. |
| Enteral Device Performance (per ISO 20695:2020): - Pressure leak testing
- Tensile testing
- Flow rate testing | Found to be in compliance with design and performance requirements when tested according to ISO 20695:2020. |
| ENFit Connector Performance (per ISO 80369-20:2019 & ISO 80369-3:2016): - Fluid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- ENFit dimensional verification | Tested per ISO 80369-20 and met the standards of 80369-3 for all specified connector performance aspects. Evaluated per ISO 80369-3 for ENFit dimensional verification and met requirements. Device is compliant with ISO 80369-3. |
| Risk Analysis (per ISO 14971:2019): - Design Failure Modes and Effects Analysis (DFMEA). | Risk analysis per ISO 14971:2019 was performed, including DFMEA. |
| Usability Analysis (per ISO 62366-1:2015): | Usability analysis per ISO 62366-1:2015 was performed. |
| Substantial Equivalence to Predicate Device (K143018) for: - Indications for Use
- Intended Use
- Environment of Use
- Intended Users
- Patient Population (differences acknowledged but deemed acceptable)
- No Reuse
- Sterility Condition
- ENFit Connector
- Lengths (differences acknowledged but deemed acceptable) | All aspects were deemed "Substantially Equivalent?", with "Yes" indicated for each. Differences in patient population (pediatric and adult vs. neonates and pediatric) and lengths were justified as not impacting safety or performance. |
2. Sample size used for the test set and the data provenance:
For this type of device, "sample size" is typically not referred to in the context of data points for an algorithm's performance, but rather the number of physical devices or batches tested in laboratory settings. The document states "Verification and validation testing was performed with the ENFit Extension Sets" but does not specify the exact number of units tested for each non-clinical test. The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Vesco Medical, to assess the device's compliance with ISO standards. This is prospective testing carried out specifically for regulatory submission. The country of origin of the data is implicitly the country where Vesco Medical conducted its testing (Westerville, Ohio, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized international standards and performance specifications, not through expert consensus on diagnostic images or similar. The "experts" would be the engineers and quality assurance professionals performing and evaluating the non-clinical tests according to the established protocols. Their qualifications would involve expertise in materials science, mechanical engineering, and quality systems for medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. For physical device testing, results are typically quantitative and compared against predefined pass/fail criteria from international 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 is not applicable. MRMC studies are used for evaluating diagnostic performance of AI or imaging systems. This submission is for a physical enteral feeding extension set, not a diagnostic imaging device or AI software. There are no "human readers" interpreting data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on objective performance measurements against established international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993, ISO 14971, ISO 62366-1) and demonstrated functional equivalence to a legally marketed predicate device. There is no "pathology" or "outcomes data" in the typical sense used for diagnostic devices; rather, the device is tested for physical and material integrity, fluid dynamics, and biocompatibility.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are iterative and informed by industry standards and best practices, but there isn't a "training set" of data in the AI sense.
9. How the ground truth for the training set was established:
This is not applicable. Since there is no training set for an AI model, there is no "ground truth" established for it. The design specifications and performance requirements are informed by engineering principles, regulatory standards, and the performance of existing predicate devices.
§ 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.