(65 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 orally or 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.
NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 100 mL) are standard piston style syringes consisting of a syringe barrel (vented or non-vented) with integral ENFit® syringe tip, syringe plunger, and syringe gasket. They are supplied in sizes ranging from 12 mL to 100 mL nominal capacity, sterile or non-sterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.
NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (0.5 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit® syringe tip that has the additional low dose tip design feature, syringe plunger, and syringe gasket, They are supplied in sizes ranging from 0.5 mL to 6 mL nominal capacity, sterile or nonsterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector with the additional low dose tip design feature designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.
The provided text is a 510(k) summary for NeoMed Oral/Enteral Syringes with ENFit® connectors. It describes performance testing conducted but does not present specific acceptance criteria or quantitative performance data that would allow for a detailed table with reported device performance against those criteria. It lists the types of tests performed.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, or adjudication methods for a test set regarding specific performance metrics.
However, I can extract the information that is present regarding the studies:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided in the document. The document lists the types of performance tests conducted (e.g., Capacity Tolerance, Graduated Scale, Air and Liquid Leakage Testing, Dosing Accuracy Testing, various ENFit® connector resistance tests) but does not state the numerical acceptance criteria or the specific performance results achieved by the device against these criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified for any of the performance tests.
- Data provenance: Not specified. The testing was conducted by the manufacturer, NeoMed, Inc., which is based in Woodstock, GA, USA. The document implies these were bench tests performed during device development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Not specified. The tests mentioned are primarily bench tests (e.g., dimensional verification, leakage, resistance, dosing accuracy) that rely on objective measurements rather than expert interpretation or ground truth establishment in a clinical sense. Human Factors Validation Studies and Usability Studies involved human participants, but the number or qualifications of "experts" to establish ground truth is not relevant in the context you've described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This pertains to clinical studies often involving expert interpretation of medical images or patient outcomes. The listed tests are bench performance tests.
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
- No. An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI/CAD systems that assist human readers in image interpretation, which is not the function of these oral/enteral syringes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a medical syringe, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective measurement/Standards compliance. For tests like dimensional verification, capacity tolerance, leakage testing, and resistance tests, the "ground truth" is defined by the physical or engineering specifications (e.g., ISO standards, internal design specifications) against which the device performance is measured. For dosing accuracy, it would be the actual volume dispensed versus the intended volume.
8. The sample size for the training set
- Not applicable. This device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, it's not a machine learning model.
§ 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.