(247 days)
The proposed device 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 setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.
The propsoed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
This document describes the non-clinical testing performed to demonstrate that the ENFit Enteral Syringe meets its acceptance criteria and is substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with several international standards. The specific acceptance criteria are defined within these standards. Below is a table summarizing the tests described and the reported outcome of compliance.
| Individual Test (Standard Clause) | Standard Defining Requirement | Requirement / Acceptance Criteria (Derived from Standard) | Reported Device Performance |
|---|---|---|---|
| Connector Tests (from ISO 80369-3:2016) | AAMI/CN3 (PS):2014 | Specified in Clause 6.2 (Fluid Leakage) | Complies with ISO 80369-3:2016 requirements |
| Fluid Leakage | AAMI/CN3 (PS):2014 | Specified in Clause 6.3 (Stress Cracking) | Complies with ISO 80369-3:2016 requirements |
| Stress Cracking | AAMI/CN3 (PS):2014 | Specified in Clause 6.4 (Resistance to separation from axial load) | Complies with ISO 80369-3:2016 requirements |
| Resistance to separation from axial load | AAMI/CN3 (PS):2014 | Specified in Clause 6.5 (Resistance to separation from unscrewing) | Complies with ISO 80369-3:2016 requirements |
| Resistance to separation from unscrewing | AAMI/CN3 (PS):2014 | Specified in Clause 6.6 (Resistance to overriding) | Complies with ISO 80369-3:2016 requirements |
| Resistance to overriding | AAMI/CN3 (PS):2014 | Specified in Clause 6.7 (Disconnection by unscrewing) | Complies with ISO 80369-3:2016 requirements |
| Disconnection by unscrewing | |||
| Syringe Tests (from ISO 7886-1:1993) | ISO 7886-1:1993 | Specified in Clause 5 (Cleanliness) | Complies with ISO 7886-1:1993 requirements |
| Cleanliness | ISO 7886-1:1993 | Specified in Clause 6 (Limits for acidity or alkalinity) | Complies with ISO 7886-1:1993 requirements |
| Limits for acidity or alkalinity | ISO 7886-1:1993 | Specified in Clause 7 (Limits for extractable metals) | Complies with ISO 7886-1:1993 requirements |
| Limits for extractable metals | ISO 7886-1:1993 | Specified in Clause 8 (Lubricant) | Complies with ISO 7886-1:1993 requirements |
| Lubricant | ISO 7886-1:1993 | Specified in Clause 9 (Tolerance on graduated capacity) | Complies with ISO 7886-1:1993 requirements |
| Tolerance on graduated capacity | ISO 7886-1:1993 | Specified in Clause 10 (Graduated scale) | Complies with ISO 7886-1:1993 requirements |
| Graduated scale | ISO 7886-1:1993 | Specified in Clause 11 (Barrel) | Complies with ISO 7886-1:1993 requirements |
| Barrel | ISO 7886-1:1993 | Specified in Clause 12 (Piston/plunger assembly) | Complies with ISO 7886-1:1993 requirements |
| Piston/plunger assembly | ISO 7886-1:1993 | Specified in Clause 14.1 (Dead space) | Complies with ISO 7886-1:1993 requirements |
| Dead space | ISO 7886-1:1993 | Specified in Clause 14.2 (Freedom from air and liquid leakage past piston) | Complies with ISO 7886-1:1993 requirements |
| Freedom from air and liquid leakage past piston | |||
| Biocompatibility Tests (from ISO 10993 series) | ISO 10993-5:2009 | No Cytoxicity | No Cytoxicity |
| Tests for Vitro Cytotoxicity | ISO 10993-10:2010 | No Irritation to Skin | No Irritation to Skin |
| Tests for irritation and skin sensitization | ISO 10993-10:2010 | No significant evidence of sensitization | No significant evidence of sensitization |
| ISO 10993 series | Conforms to requirements of ISO 10993 series Standards | Conforms to requirements of ISO 10993 series Standards | |
| Sterilization & Packaging Tests | ISO 10993-7:2008 | Acceptable Ethylene oxide sterilization residuals | Complies with ISO 10993-7:2008 |
| Ethylene oxide sterilization residuals | ASTM F 88/F88M-09 | Seal strength of flexible barrier materials meets standard | Complies with ASTM F 88/F88M-09 |
| Seal strength (packaging) | ASTM F1140/F1140-13 | Internal pressurization failure resistance meets standard | Complies with ASTM F1140/F1140-13 |
| Internal pressurization failure resistance (packaging) | USP37-NF32 | Bacterial Endotoxins within limits | Complies with USP37-NF32 |
| Bacterial Endotoxins Limit | - | Achieves SAL of 10^-6 for sterilization | Achieves SAL of 10^-6 |
| Sterilization Assurance Level (SAL) | - | Maintained sterility during shelf life of five years | Sterility maintained after accelerated aging tests |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes (number of units tested) for each non-clinical test. However, it indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016... using the test methods provided in ISO 80369-20..." and similarly for syringe testing. These standards often specify minimum sample sizes for different tests.
The data provenance is from non-clinical (bench) testing performed on the proposed device. The device manufacturer is Jiangsu Caina Medical Co., Ltd. located in Jiangyin, Jiangsu, China. The report is a summary of these tests. This is retrospective in the sense that the tests were completed prior to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the information provided pertains to non-clinical (bench) testing of a medical device (enteral syringe). "Ground truth" and "experts" typically refer to human interpretation or pathology results in diagnostic or clinical studies. For physical device testing, the "ground truth" is defined by the technical specifications and requirements within the cited international standards (e.g., ISO, ASTM, USP).
4. Adjudication method for the test set
This section is not applicable as adjacency methods are used in clinical studies with human readers, not in non-clinical bench testing. The compliance is determined by whether the device's physical and performance characteristics meet the quantitative and qualitative requirements of the listed 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 section is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic or screening tools, often involving artificial intelligence. This document describes the non-clinical testing of a physical medical device (enteral syringe).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. "Standalone performance" in this context refers to the performance of an algorithm without human intervention, typically in AI/software as a medical device. This document is about a physical medical device.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is compliance with established international and national standards and their specified test methods and acceptance criteria. This includes:
- Performance Specifications: Defined by standards like ISO 80369-3, ISO 7886-1 for connector and syringe function (e.g., fluid leakage, tolerance on graduated capacity).
- Biocompatibility Standards: Defined by ISO 10993 series for biological safety (e.g., cytotoxicity, irritation, sensitization).
- Sterilization and Packaging Standards: Defined by ISO 10993-7, ASTM F 88/F88M-09, ASTM F1140/F1140-13, USP37-NF32 .
8. The sample size for the training set
This section is not applicable. "Training set" refers to data used to train machine learning models. This document describes the non-clinical testing of a physical medical device.
9. How the ground truth for the training set was established
This section is not applicable.
§ 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.