(139 days)
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have ENFit male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.
The provided document is a 510(k) premarket notification for a medical device (NeoMed NeoConnect™ Enteral Syringes with ENFit Connector). It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML powered device, which typically involves metrics like sensitivity, specificity, AUC, or reader performance.
The document describes bench testing for the physical properties and safety of the syringe. These are acceptance criteria for a physical medical device, not an AI algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable to the information provided in this regulatory submission.
However, I can extract the acceptance criteria and related "performance" from the document based on the provided bench testing section.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Risk Management | EN ISO 14971:2012 | Risk Analysis including design, user and process FMEA conducted. |
| Human Factors/Usability | Human Factors and Usability Validation | Design Validation performed. Human Factors Validation Study performed (for ENFit connector). |
| Biocompatibility | ISO 10993-5: Cytotoxicity | Testing conducted. |
| ISO 10993-10: Irritation and sensitization | Testing conducted. | |
| ISO 10993-11: Acute Toxicity | Testing conducted. | |
| Chemical Testing | Extractables and Leachables | Testing conducted. |
| Finished Device Verification | Critical Dimension verification | Verification conducted. |
| Ink Adhesion | Testing conducted. | |
| Capacity Tolerance | Testing conducted. | |
| Graduated Scale | Testing conducted. | |
| Piston Fit in Barrel | Testing conducted. | |
| Air and Liquid Leakage Testing | Testing conducted. | |
| Syringe Tip (ENFit connector) | Enteral Connector Misconnection Assessment | Assessment conducted. |
| ENFit Connector Risk Management Report | Report (including misconnections FMEA) conducted. | |
| Dimensional verification | Verification conducted. | |
| Liquid Leakage Testing | Testing conducted. | |
| Stress Cracking | Testing conducted. | |
| Resistance to separation from axial load | Testing conducted. | |
| Resistance to separation from unscrewing | Testing conducted. | |
| Resistance to overriding | Testing conducted. | |
| Disconnection by unscrewing | Testing conducted. | |
| Sterilization | Ethylene Oxide (EO), 10^-6^ SAL | Sterilization method is EO with 10^-6^ SAL. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The document refers to "Finished Device Verification Testing" and various specific tests but does not disclose the number of units tested.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective bench testing conducted by the manufacturer, NeoMed, Inc. The document implies the tests were performed as part of the device's design validation prior to market submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes testing for a physical medical device (syringe), not an AI/ML algorithm that requires expert-established ground truth for diagnostic or prognostic performance. The "ground truth" for these tests would be the measured physical properties or compliance with engineering standards.
4. Adjudication method for the test set:
- Not Applicable. As above, this is not an AI/ML diagnostic or prognostic test. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or similar tasks, which are not relevant here.
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 for a physical medical device; no AI component is mentioned, and therefore, no MRMC study involving AI assistance would have been performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm or software component described in this device submission.
7. The type of ground truth used:
- Direct Measurement / Standard Compliance. The ground truth for this device's performance is established by direct physical measurements against defined engineering standards (e.g., critical dimensions, leakage rates, strength of connections, biocompatibility testing against ISO standards). This is typical for traditional hardware medical devices.
8. The sample size for the training set:
- Not Applicable. This device does not have a "training set" as it is not an AI/ML product. The design and manufacturing processes are developed based on engineering principles and regulatory standards, not trained on data.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth for a 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.