(229 days)
The Medela Low Dose Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.
The Medela Low Dose Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is a low dose tip designed to allow for the delivery of fluid to a patient's feeding tube within +/-10%. The Medela Low Dose Enteral Syringe is offered in 1mL and 3mL sizes and intended to connect with devices equipped with ENFit connectors.
The provided document describes the Medela Low Dose Enteral Syringe and its 510(k) submission for substantial equivalence. It is not a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI-driven medical device. Instead, it details the verification and validation testing performed to demonstrate that the device meets established standards and performs comparably to a predicate device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission, which focuses on physical and functional characteristics according to engineering standards rather than diagnostic accuracy or clinical outcomes.
Here's an interpretation of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various nonclinical tests and generally states that "All necessary verification and validation testing has been performed... to assure substantial equivalence." Specific numerical acceptance criteria and reported numerical performance values are not explicitly provided in this summary. However, the tests are based on recognized standards (ISO 7886-1 and AAMI/CN3 (PS):2014, AAMI/CN20 (PS):2014).
| Acceptance Criteria Category (Based on Standards) | Reported Device Performance (Implied by Submission) |
|---|---|
| Syringe Design Verification (ISO 7886-1) | All tests performed; device found to perform satisfactorily, assuring substantial equivalence. |
| - Cleanliness | Pass (implied) |
| - Lubricant | Pass (implied) |
| - Dead Space | Pass (implied) |
| - Fit of Piston in Barrel | Pass (implied) |
| - Slide Force Test | Pass (implied) |
| - Freedom from Air and Liquid Leakage | Pass (implied) |
| - Limits of Alkalinity/Acidity | Pass (implied) |
| - Limits of Extractable Metals | Pass (implied) |
| ENFit Connector Dimensional Analysis (AAMI/CN3 (PS):2014) | All tests performed; device found to perform satisfactorily, assuring substantial equivalence. |
| Additional Connector Testing (AAMI/CN3 (PS):2014 & AAMI/CN20 (PS):2014) | All tests performed; device found to perform satisfactorily, assuring substantial equivalence. |
| - Fluid Leakage | Pass (implied) |
| - Stress Cracking | Pass (implied) |
| - Resistance to Separation from Axial Load | Pass (implied) |
| - Resistance to Separation from Unscrewing | Pass (implied) |
| - Resistance to Overriding | Pass (implied) |
| - Disconnection by Unscrewing | Pass (implied) |
| Biocompatibility Testing | All tests performed; device found to perform satisfactorily, assuring substantial equivalence. |
| - Cytotoxicity | Pass (implied) |
| - Intracutaneous Irritation | Pass (implied) |
| - Sensitization | Pass (implied) |
| Toxicological Risk Assessment | Assessment completed satisfactorily (implied). |
| Verification demonstrating dosing accuracy of the Low Dose syringe (within +/-10%) | Verified to meet the +/-10% accuracy target (implied). |
| Shelf Life Study | Study performed, implying acceptable shelf life confirmed. |
| Low-Dose ENFit connector usability/misconnection risk | Evaluated satisfactorily (implied). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. For engineering verification tests, sample sizes are typically determined by statistical methods for process validation (e.g., AQL, confidence levels) or as specified by the testing standards.
- Data Provenance: The tests are nonclinical, usually conducted in a laboratory setting by the manufacturer, Medela, Inc. This is not clinical data from patients or specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical medical instrument, not a diagnostic tool requiring expert interpretation of results to establish ground truth. "Ground truth" in this context refers to meeting engineering specifications.
4. Adjudication method for the test set
- Not applicable. This isn't a clinical study requiring adjudication of diagnostic findings. Performance is measured against predetermined engineering specifications and 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
- Not applicable. This is a physical medical device (syringe), not an AI-driven diagnostic tool or an imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (syringe), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's performance is defined by the engineering specifications and established national/international standards (e.g., ISO 7886-1 for syringe design, AAMI/CN3 (PS):2014 for connectors, AAMI/CN20 (PS):2014 for connector testing methods) against which the device's physical and functional characteristics are measured. For dosing accuracy, the ground truth is the specified +/-10% deviation.
8. The sample size for the training set
- Not applicable. The device is not learning from a training set. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. 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.