(221 days)
Wealy ENFit® Disposable 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 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~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed 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 three years.
The provided document is a 510(k) summary for the ENFit® Disposable Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and detailed performance of an AI-powered diagnostic device. Therefore, many of the requested categories (expert ground truth, MRMC study, training set details) are not applicable as this is a medical device for fluid delivery, not an AI diagnostic.
However, I can extract the relevant information regarding acceptance criteria and performance based on the non-clinical tests described.
Here's a breakdown of the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various tests based on international standards (ISO, ASTM, USP). The reported performance is generally stated as "The testing demonstrates the proposed devices conform to the requirements" or "Conforms to the requirement of [standard]". Specific quantitative acceptance criteria are given by referencing clauses within these standards, implying that the device met those quantitative values.
| Acceptance Criteria Category (Referenced Standard/Clause) | Reported Device Performance |
|---|---|
| ISO 80369-3:2016 (Connectors for enteral applications) & ISO 80369-20:2015 (Common test methods): | The testing demonstrates the proposed devices conform to the requirements of ISO80369-3:2016. |
| Fluid Leakage (Annex B) | Conforms |
| Sub-atmospheric pressure Air Leakage (Annex D) | Conforms |
| Stress Cracking (Annex E) | Conforms |
| Resistance to separation from axial load (Annex F) | Conforms |
| Resistance to separation from unscrewing (Annex G) | Conforms |
| Resistance to overriding (Annex H) | Conforms |
| Disconnection by unscrewing (Annex I) | Conforms |
| ISO 7886-1:2017 (Sterile hypodermic syringe for single use): | The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:2017. |
| Appearance (Clause 5) | Conforms |
| Overall Length of Scale to Nominal Capacity Line (Clause 9.3) | Conforms |
| Push-button Distance (Clause 11) | Conforms |
| Force to Operate the Plunger (Clause 13.3) | Conforms |
| Freedom from air and liquid leakage past piston (Clause 13.2) | Conforms |
| Limits for Acidity or Alkalinity (Clause 6.2) | Conforms |
| Limits for Extractable Metals (Clause 6.3) | Conforms |
| Tolerance on graduated capacity (Clause 8) | Conforms |
| Dead Space (Clause 13.1) | Conforms |
| Lubricant (Clause 7) | Conforms |
| Cleanliness (Clause 5) | Conforms |
| Graduated Scale (Clause 9) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Barrel (Clause 11) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Piston/Plunger Assembly (Clause 13) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Biocompatibility Standards (ISO 10993 series): | Conforms to the requirement of ISO 10993 series Standards. No Cytotoxicity, No Irritation to Skin, No significant evidence of sensitization. Biocompatibility testing has demonstrated the biological safety. |
| ISO 10993-5:2009 (Vitro Cytotoxicity) | Conforms |
| ISO 10993-10:2010 (Irritation and skin sensitization) | Conforms |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Conforms |
| ISO 10993-11:2017 (Systemic toxicity) | Conforms |
| Other Tests: | |
| ASTM F 88/F88M-09 (Seal strength of flexible barrier materials) | Conforms |
| USP38-NF33 (Bacterial Endotoxins Limit) | Conforms |
| Product performance after Real-time Aging test | Evaluated properties after aging in support of labeling. |
| Package Integrity after Accelerated Aging test | Evaluated properties after aging in support of labeling. |
| Sterilization (Ethylene Oxide Gas) | Achieves SAL of 10^-6^ (for 3-year shelf life) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test in the non-clinical performance testing. It also does not specify the country of origin of the data (beyond the manufacturer being in China) or whether it was retrospective or prospective, as these are non-clinical hardware tests.
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. This device is an enteral syringe for fluid delivery, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert adjudication.
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
Not applicable. This device is not an AI diagnostic or image analysis tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a medical device like a syringe, "ground truth" is established by adherence to recognized international performance standards (ISO, ASTM, USP). For example, the "ground truth" for fluid leakage would be the acceptable limits defined in ISO 80369-3, and the device passing means it met those objective, standardized measures. For biocompatibility, the ground truth is defined by the toxicological profiles and testing methods in the ISO 10993 series.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have 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.
§ 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.