(65 days)
The Monoject™ Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in sizes of 1mL and 3mL. The device specific for low dose applications incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.
This document is a 510(k) premarket notification for the Monoject™ Enteral Feeding Syringe with ENFit Connector. As such, it details the non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study proving the device meets specific performance criteria against a ground truth.
Therefore, many of the requested sections related to clinical studies, expert-established ground truth, and human reader performance will not be applicable or available from this document.
Here's an analysis of the provided information based on your request:
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a non-clinical evaluation for a medical device (enteral feeding syringe), the "acceptance criteria" are based on the requirements of recognized industry standards. The "device performance" is reported as conformity to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined in AAMI /CN3 (PS):2014) | Test Method (Defined in ISO 80369-20) | Reported Device Performance |
|---|---|---|
| Fluid Leakage (Clause 6.2) | Annex C | Conforms to requirements |
| Stress Cracking (Clause 6.3) | Annex E | Conforms to requirements |
| Resistance to separation from axial load (Clause 6.4) | Annex F | Conforms to requirements |
| Resistance to separation from unscrewing (Clause 6.5) | Annex G | Conforms to requirements |
| Resistance to overriding (Clause 6.6) | Annex H | Conforms to requirements |
| Disconnection by unscrewing (Clause 6.7) | Annex I | Conforms to requirements |
| Dimensional analysis for low dose ENFit connector | - (AAMI /CN3 (PS):2014 Table B.2) | Conforms to criteria |
| Dosing Accuracy of low dose tip ENFit connector | - | Verified |
| Biocompatibility | - | Demonstrated biological safety |
| Stability | - | Properties maintained after accelerated aging (supports labeling) |
| ISO 7886-1 Sterile Hypodermic Syringes (Part 1) | - | Conforms to requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of syringes tested for fluid leakage). It generally states that "Testing performed on the Monoject™ Enteral Feeding Syringes with low dose tip ENFit Connectors included the items listed below..."
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Covidien, based in Mansfield, MA, USA. The data is thus internally generated non-clinical test data. It is neither retrospective nor prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For non-clinical device testing verifying compliance with standards, "experts" in the sense of clinical specialists establishing a "ground truth" are not relevant. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO and AAMI standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is assessed directly against the objective criteria of the specified standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission for an enteral feeding syringe, which is a physical medical device. It does not involve AI, image analysis, or human readers, so an MRMC comparative effectiveness study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not a software device or an algorithm.
7. Type of Ground Truth Used
The "ground truth" for these tests is the set of objective, measurable requirements specified in the following international and industry standards:
- AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications.
- ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
- ISO 7886-1, Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use.
- Biocompatibility standards (not explicitly listed, but implied by "Biocompatibility testing has demonstrated the biological safety").
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The relevant "ground truth" for non-clinical performance evaluation is established by international and industry consensus standards.
§ 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.