(158 days)
ENFit Oral/Enteral Syringe is indicated for use as a dispenser, a measuring device, and an oral/enteral 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.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 100ml. 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 5ml, 6ml, 12ml, 20ml, 30ml, 35ml, 50ml, 60ml and 100ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 5ml and 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 Side connector ENFit syringe range from 10ml to 100ml; and central connector ENFit syringe range from 0.5ml to 100ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. The sterile syringes are provided with transparent barrel, and the non-sterile syringes are provided with transparent/ amber color barrel.
This document describes the premarket notification (510(k)) for the ENFit Oral/Enteral Syringe manufactured by Jiangsu Caina Medical Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K161039).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with recognized international standards for medical devices and specific tests. The reported device performance is indicated by the statement of compliance with these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 80369-3:2016 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications) | Complied |
| ISO 7886-1:2017 (Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use) | Complied |
| ISO 80369-20:2015 (Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods) | Complied |
| ISO 10993-5:2009 (Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity) | Completed, did not show any adverse effect |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization) | Completed, did not show any adverse effect |
| ISO 10993-7:2008 (Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals) | Implied compliance (for EO sterilized devices) |
| ISO 14971:2007 (Medical Devices-Application of Risk Management to Medical Devices) | Implied compliance |
| ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials) | Implied compliance |
| ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Implied compliance |
| Sterility Assurance Level (SAL) | 10^-6 (for sterile devices) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test. The testing was conducted to verify compliance with international standards, which typically involve specific sample size requirements. The data provenance is from non-clinical tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for a physical medical device (syringe) and does not involve the use of AI, image analysis, or diagnostic interpretation requiring expert ground truth establishment in the traditional sense. The "ground truth" here is compliance with engineering and biological safety standards, which are evaluated by accredited laboratories and regulatory bodies, not by "experts" establishing a diagnostic truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a study requiring adjudication of expert opinions. Device performance is determined by objective physical and chemical testing.
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 MRMC study was done. This device is an ENFit Oral/Enteral Syringe, a physical device, and not an AI-powered diagnostic tool. Therefore, human readers or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is defined by adherence to established international and national standards for medical devices, specifically:
- Engineering and Performance Standards: ISO 80369-3, ISO 7886-1, ISO 80369-20, ASTM F88/F88M-15, ASTM F1929-15.
- Biological Safety Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-7 (EO sterilization residuals).
- Quality Management Standards: ISO 14971 (Risk Management).
Compliance with these standards, demonstrated through non-clinical laboratory testing, serves as the "ground truth" for the device's safety and effectiveness for its intended use.
8. The Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 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.