(282 days)
The AMSure® Enteral Feeding Syringe with ENFit Tip 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 settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in adults only.
The AMSure® Enteral Feeding Syringes with ENFit Tip are standard piston style syringes consisting of a syringe barrel with ENFit syringe nozzle, syringe plunger, syringe stopper and protective cap. The devices are made with polypropylene and polyisoprene rubber. The plunger can be linearly pulled and pushed along the inside wall of the barrel, allowing the syringe to take in and expel fluid through the nozzle at the front end of the barrel. The integral syringe nozzle has a female ENFit connector designed to be 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. The Enteral Feeding Syringes with ENFit Tip have a capacity of 60mL for single-use. The devices are provided either sterilized by EtO or non-sterile.
The provided document is a 510(k) premarket notification for a medical device, specifically an "AMSure® Enteral Feeding Syringe with ENFit Tip." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies and acceptance criteria for a novel AI/software device.
Therefore, the specific information requested, such as acceptance criteria table with reported device performance for an algorithm, sample sizes for test/training sets for an AI model, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets, are not applicable to this type of medical device submission.
The "studies" and "acceptance criteria" discussed in this document refer to traditional medical device testing, primarily non-clinical, to ensure the physical and biological safety and performance of the syringe itself.
However, I can extract the information that is present concerning the non-clinical testing performed on the AMSure® Enteral Feeding Syringe with ENFit Tip, which serves a similar purpose to demonstrating a device meets its intended performance.
Here's the relevant information based on the provided text, re-interpreting "acceptance criteria" and "study" in the context of a physical medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists various performance characteristics that were tested. For a 510(k) submission, "acceptance criteria" typically refers to established standards (e.g., ISO standards) or pre-defined thresholds that the device must meet to be considered safe and effective and substantially equivalent to its predicate. The document states a general conclusion that the device "passed all acceptance criteria" without specifying the exact numerical criteria or individual results for each test.
| Test Category | Specific Test (where listed) | Acceptance Criteria (General, based on passing relevant standards) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Meets ISO 10993-5 standards | Passed |
| Sensitization | Meets ISO 10993-10 standards | Passed | |
| Irritation | Meets ISO 10993-10 standards | Passed | |
| Syringe Tip (ENFIT) per ISO 80369-3 | Dimensional analysis | Meets ISO 80369-3 standards | Passed |
| Enteral Connector Misconnection assessment | Prevents misconnection as per ISO 80369-3 | Passed | |
| Fluid leakage | Within acceptable limits as per ISO 80369-3 | Passed | |
| Stress Cracking | Meets ISO 80369-3 standards | Passed | |
| Resistance to separation from axial load | Meets ISO 80369-3 standards | Passed | |
| Resistance to separation from unscrewing | Meets ISO 80369-3 standards | Passed | |
| Resistance to overriding | Meets ISO 80369-3 standards | Passed | |
| Disconnection by unscrewing | Meets ISO 80369-3 standards | Passed | |
| Dose accuracy | Meets ISO 80369-3 standards | Passed | |
| Syringe per ISO 7886-1 | Appearance performance | Meets ISO 7886-1 standards | Passed |
| Capacity Tolerance | Meets ISO 7886-1 standards | Passed | |
| Graduated Scale | Meets ISO 7886-1 standards | Passed | |
| Critical Dimension | Meets ISO 7886-1 standards | Passed | |
| Freedom from air and liquid leakage | Meets ISO 7886-1 standards | Passed | |
| Tolerance on graduated capacity | Meets ISO 7886-1 standards | Passed | |
| Dead space | Meets ISO 7886-1 standards | Passed | |
| Piston/plunger assembly (Piston sliding, Piston Fit in Barrel) | Meets ISO 7886-1 standards | Passed | |
| Silicone oil quantity | Meets ISO 7886-1 standards | Passed | |
| Chemical (Limits for acidity or alkalinity, Limits for extractable metals) | Meets ISO 7886-1 standards | Passed | |
| Ink adhesion | Meets ISO 7886-1 standards | Passed | |
| Additional Testing | Stability testing | Ensures performance over time | Passed |
| Sterilization validation | Meets sterilization standards (e.g., EtO efficacy) | Passed | |
| Package testing | Ensures package integrity and sterility | Passed | |
| Dose accuracy testing (additional) | Confirms accurate fluid delivery | Passed | |
| Risk management | Demonstrates identified risks are mitigated | Passed | |
| Usability testing (for cleaning instructions) | Confirms clear and effective cleaning instructions | Passed | |
| Cleaning validation for reprocessing | Validates cleaning procedure per FDA guidance for 8 uses/washes | Passed | |
| Performance testing following 8 uses and washes within 24 hours | Maintains performance after reprocessing | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document for the non-clinical tests. Sample sizes for physical device testing typically refer to the number of physical devices subjected to each test. The provenance would be the manufacturing site (Amsino International Inc. in Pomona, CA). The tests are prospective in nature, as they are performed on new devices to demonstrate compliance.
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 not applicable as the device is a physical enteral feeding syringe, not an AI/software device requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device requiring 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
This is not applicable as the device is a physical enteral feeding syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical enteral feeding syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For manufacturing quality and performance testing of a physical device, the "ground truth" is typically defined by established engineering specifications, recognized national/international standards (e.g., ISO, ASTM), and regulatory guidance documents (e.g., FDA guidance). Device performance is measured against these objective criteria.
8. The sample size for the training set
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set and associated ground truth.
§ 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.