(85 days)
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
This document is a 510(k) Summary for the Oral/Enteral Syringe with ENFit connector (K211025). It does not contain information about a study proving the device meets acceptance criteria in the manner you describe for AI/imaging devices. Instead, it demonstrates substantial equivalence to a predicate device (K161039) through non-clinical testing.
Here's an analysis of the information provided in the context of your questions, explaining why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
The document provides a list of standards the device complies with, which implicitly serve as acceptance criteria for different aspects of the device's performance. It also states that "dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity." This is a key performance metric and a stated acceptance criterion.
| Acceptance Criteria (Standards and Specific Performance) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use) | Complied |
| ISO 10993-5:2009 (Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity) | Complied (No Cytotoxicity) |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization) | Complied (No Irritation, No Sensitization) |
| ISO 10993-7:2008 (Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals) | Complied |
| ISO 14971:2007 (Medical Devices-Application of Risk Management to Medical Devices) | Complied |
| ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials) | Complied |
| ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Complied |
| ISO 80369-3:2016 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications) | Complied |
| ISO 80369-20:2015 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 20: Common Test Methods) | Complied |
| Dose accuracy: accurate to ±10% when filled with a minimum dose of 20% of overall syringe capacity | Demonstrated (See "Non-Clinical Test Conclusion") |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non clinical tests were conducted," but does not specify the sample sizes for these tests for each standard or the dose accuracy testing. It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these types of details are typically associated with clinical studies involving patient data, not non-clinical device testing.
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)
This question is not applicable to this type of device submission. The "ground truth" concept, especially involving expert consensus and specific qualifications of medical professionals, is relevant for AI/imaging devices interpreting medical images or data. For this physical medical device (an enteral syringe), performance is assessed through objective engineering and biological tests against established international standards, not against expert human interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where multiple experts evaluate ambiguous cases. For non-clinical tests on a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.
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 question is not applicable. MRMC studies are specifically designed for assessing the performance of diagnostic devices, particularly AI-powered ones, and their impact on human reader performance. This submission is for a physical medical device (a syringe), not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This refers to the standalone performance of an algorithm. The device here is a physical syringe, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" is established by the requirements of the referenced international standards (e.g., ISO for sterility, biocompatibility, connector features, and ASTM for material properties) and specific performance specifications (e.g., dose accuracy ±10%). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of a syringe.
8. The sample size for the training set
This question is not applicable. This refers to the training data for an AI algorithm. This submission is for a physical medical device.
9. How the ground truth for the training set was established
This question is not applicable. This refers to establishing ground truth for AI model training. This submission is for a physical medical device.
§ 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.