(239 days)
The U&U ENFit Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
The U&U ENFit Enteral Syringes are standard piston style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 1 mL to 60 mL nominal capacity. The integral syringe tip is a female connector which is compatible only with enteral access devices having 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 (U&U ENFit Enteral Syringe). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial or a comprehensive performance study for an AI/diagnostic device would.
Based on the information given, here's an analysis of the "acceptance criteria" and "study" as they pertain to this type of regulatory submission:
For a Medical Device like a Syringe:
The "acceptance criteria" are generally derived from recognized international standards and ensure the device performs as intended and is safe for its stated use. The "study" refers to the non-clinical tests performed to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several tests derived from ISO standards, implying that meeting these standards constitutes the acceptance criteria. The performance is reported as "Conforms" to these standards.
| Acceptance Criteria (Stated as "Test Items") | Reported Device Performance |
|---|---|
| Physical Performance | |
| Diameter | Conforms |
| Maximum Dead Space | Conforms |
| Freedom Liquid and air leakage past piston | Conforms |
| Force required to Operate plunger | Conforms |
| Tolerance on graduated capacity (Dose accuracy) | Conforms |
| Syringe Tip (ISO 80369-3 female connector) | |
| Fluid Leakage by pressure decay | Conforms |
| Fluid Leakage by falling drop positive pressure decay | Conforms |
| Stress Cracking | Conforms |
| Resistance to separation from axial load | Conforms |
| Resistance to separation from unscrewing | Conforms |
| Resistance to overriding | Conforms |
| Low Dose Tip Misconnection Analysis | Conforms |
| Low Dose Dimension Analysis | Conforms |
| Biocompatibility | |
| ISO10993 Part 1: Evaluation and testing | Conforms |
| ISO10993 Part 5: Tests for in vitro cytotoxicity | Conforms |
| ISO10993 Part 7: Ethylene oxide sterilization residuals | Conforms |
| ISO10993 Part 10: Tests for irritation and delayed-type hypersensitivity | Conforms |
| ISO10993 Part 11: Tests for systemic toxicity | Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of syringes) used for each specific non-clinical test. It is typical for these types of tests to use a statistically relevant number of samples, but the exact numbers are not provided in this summary.
- Data Provenance: The tests were performed on the "subject device" (U&U ENFit Enteral Syringe) by the manufacturer or accredited testing facilities. The country of origin for the device is China (both U&U Medical Technology Co., Ltd and U&U (HONGKONG) Medical Technology Co., Limited). The data would be considered prospective in the sense that the tests were conducted specifically for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for non-clinical performance and biocompatibility testing of a medical device like a syringe. The "ground truth" is established by the predefined parameters and methodologies outlined in the international standards (e.g., ISO 7886-1, ISO 80369-3, ISO 10993 series). The "experts" would be the personnel at the testing lab carrying out these standardized tests, who are qualified to perform and interpret results according to the standards, rather than clinical experts establishing a medical ground truth.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for evaluating diagnostic devices where expert consensus is needed to establish a "true" diagnosis or condition. For syringe performance, the results are objectively measured against the criteria defined by the ISO 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. An MRMC study is relevant for evaluating diagnostic tools, particularly those involving human interpretation (e.g., radiologists reading images) where AI might assist. This submission is for a physical medical device (syringe) and does not involve AI or human "readers" in that context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This question pertains to AI/algorithm performance. The U&U ENFit Enteral Syringe is a physical, non-AI medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics of the syringe is the objective, measurable criteria defined by the international standards (ISO 7886-1, ISO 80369-3, ISO 10993 series). These standards prescribe specific test methods and acceptable ranges for various physical and material properties (e.g., force to operate, leakage, dimensional tolerances, cytotoxicity).
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product, not an algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
§ 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.