(260 days)
The ENFit® Reusable 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 body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
The proposed device with Enfit® connector (1ml-60ml) are standard piston style syringes consisting of syringe barrel with integral EnFit syringe tip, syringe plunger and ring type piston. The proposed device are supplied non-sterile, and reusable. The sizes rang from 1ml to 60ml nominal capacity. The integral syringe tip is a female ENFit connector which is 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.
This is a 510(k) summary for a medical device (ENFit Reusable Enteral Syringe). 510(k) submissions typically demonstrate substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical efficacy studies with acceptance criteria in the manner of AI/software devices. Therefore, the information requested in the prompt, especially related to AI-specific metrics, reader studies, and ground truth establishment, is not applicable or present in this document.
However, I can extract the non-clinical tests performed and mention that these tests serve as the "acceptance criteria" for demonstrating substantial equivalence for this type of device.
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, and the implication that the device met their requirements, serve as the "reported device performance" and "acceptance criteria" for a 510(k) submission. No specific numerical thresholds are provided in this summary, but the successful completion of these tests indicates compliance.
| Acceptance Criteria (Non-Clinical Tests Conducted) | Reported Device Performance |
|---|---|
| A. Finished Device (Performance Testing per ISO 7886-2:2020) | |
| Risk management report in accordance with ISO 14971:2007 | Met (implied by conclusion of SE) |
| Usability testing for ENFit Reusable Enteral Syringe (human factor and usability validation) | Met (implied by conclusion of SE) |
| Appearance | Met (implied by conclusion of SE) |
| Pump Force | Met (implied by conclusion of SE) |
| Short-term Flow Rate Error | Met (implied by conclusion of SE) |
| Syringe Compliance | Met (implied by conclusion of SE) |
| Syringe Design critical dimension | Met (implied by conclusion of SE) |
| B. Reusability | |
| Cleaning Instructions Validation and Use Cycle Parameters Study | Met (implied by conclusion of SE) |
| C. Biocompatibility | |
| ISO 10993-5:2009 (Tests for Vitro Cytotoxicity) | No Cytotoxicity (explicitly stated in comparison table, and implied by conclusion of SE) |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Irritation and Sensitization (explicitly stated in comparison table, and implied by conclusion of SE) |
| ISO 10993-11:2017 (Tests for systemic toxicity) | No Acute Toxicity (explicitly stated in comparison table, and implied by conclusion of SE) |
| D. Shelf Life | |
| Package verification test report | Met (implied by conclusion of SE) |
| Bench test after real-time aging (ISO 80369-3:2016) | |
| Fluid Leakage | Met (implied by conclusion of SE) |
| Sub-atmospheric Pressure Air Leakage | Met (implied by conclusion of SE) |
| Stress Cracking | Met (implied by conclusion of SE) |
| Resistance to Separation from Axial Load | Met (implied by conclusion of SE) |
| Resistance to Separation from Unscrewing | Met (implied by conclusion of SE) |
| Resistance to Overriding | Met (implied by conclusion of SE) |
| Disconnection by Unscrewing | Met (implied by conclusion of SE) |
| Bench test after real-time aging (ISO 7886-1:2017) | |
| Appearance | Met (implied by conclusion of SE) |
| Overall Length of Scale to Nominal Capacity Line | Met (implied by conclusion of SE) |
| Push-button Distance | Met (implied by conclusion of SE) |
| Force Required to Operate Plunger | Met (implied by conclusion of SE) |
| Freedom from Air and Liquid Leakage past Piston | Met (implied by conclusion of SE) |
| Limits for Acidity or Alkalinity | Met (implied by conclusion of SE) |
| Limits for Extractable Metals | Met (implied by conclusion of SE) |
| Tolerance on Graduated Capacity | Met (implied by conclusion of SE) |
| Maximum Dead Space | Met (implied by conclusion of SE) |
| E. Finished Device Performance Test (not related to aging) | |
| Critical Dimension verification | Met (implied by conclusion of SE) |
| Ink Adhesion | Met (implied by conclusion of SE) |
| Bench test (ISO 80369-3:2016) | (These are repeated from the "after real-time aging" section, but without the "after real-time aging" qualifier, suggesting they are also tested in the non-aged state.) |
| Fluid Leakage | Met (implied by conclusion of SE) |
| Sub-atmospheric Pressure Air Leakage | Met (implied by conclusion of SE) |
| Stress Cracking | Met (implied by conclusion of SE) |
| Resistance to Separation from Axial Load | Met (implied by conclusion of SE) |
| Resistance to Separation from Unscrewing | Met (implied by conclusion of SE) |
| Resistance to Overriding | Met (implied by conclusion of SE) |
| Disconnection by Unscrewing | Met (implied by conclusion of SE) |
| Bench test (ISO 7886-1:2017) | (These are repeated from the "after real-time aging" section, but without the "after real-time aging" qualifier, suggesting they are also tested in the non-aged state.) |
| Appearance | Met (implied by conclusion of SE) |
| Overall Length of Scale to Nominal Capacity Line | Met (implied by conclusion of SE) |
| Push-button Distance | Met (implied by conclusion of SE) |
| Force Required to Operate Plunger | Met (implied by conclusion of SE) |
| Freedom from Air and Liquid Leakage past Piston | Met (implied by conclusion of SE) |
| Limits for Acidity or Alkalinity | Met (implied by conclusion of SE) |
| Limits for Extractable Metals | Met (implied by conclusion of SE) |
| Tolerance on Graduated Capacity | Met (implied by conclusion of SE) |
| Maximum Dead Space | Met (implied by conclusion of SE) |
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 does not specify the sample sizes for each non-clinical test conducted. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are material performance tests rather than clinical data.
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 is a physical medical device (syringe), not an AI/software device that requires expert ground truth for classification or diagnosis. Therefore, this information is not applicable and not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/software device or a study involving human interpretation with 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 is a physical medical device. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For these physical device tests, the "ground truth" is defined by the established industry standards (e.g., ISO 14971, ISO 7886-2, ISO 10993 series, ISO 80369-3) and pre-defined specifications for device performance (e.g., freedom from leakage, specific dimensions, resistance to force). The device's performance against these verifiable physical and chemical metrics serves as the ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/software device requiring a training set.
9. How the ground truth for the training set was established
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.