(45 days)
The Monoject™ 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, either orally or enterally, into the gastrointestinal system of a patient. The oral/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 all age groups.
The Monoject™ Enteral Syringes with ENFit Connector are provided in sizes of 1mL to 60mL, sterile or non-sterile. The device (sizes 6mL to 60mL) incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector. The device specific for low dose applications (sizes 1mL & 3mL) incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.
The provided document is a 510(k) summary for the Monoject™ Enteral Syringe with ENFit Connector. It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria for an AI or diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established) are not applicable to this type of device and submission.
However, I can extract the relevant acceptance criteria and reported performance from the non-clinical testing described:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Defined in AAMI /CN3 (PS):2014 & ISO 80369-20 | Acceptance Criteria Defined in AAMI /CN3 (PS):2014 | Reported Device Performance |
|---|---|---|
| Dimensional Analysis (ENFit and Low Dose Tip ENFit connector) | Conform to criteria in Table B.2 of AAMI /CN3 (PS):2014 | The analysis demonstrates the proposed devices conform to the criteria in Table B.2 of AAMI /CN3 (PS):2014. |
| Fluid Leakage (using ISO 80369-20 Annex C) | Clause 6.2 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20 (which incorporates AAMI /CN3 (PS):2014 requirements). |
| Stress Cracking (using ISO 80369-20 Annex E) | Clause 6.3 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20. |
| Resistance to separation from axial load (using ISO 80369-20 Annex F) | Clause 6.4 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20. |
| Resistance to separation from unscrewing (using ISO 80369-20 Annex G) | Clause 6.5 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20. |
| Resistance to overriding (using ISO 80369-20 Annex H) | Clause 6.6 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20. |
| Disconnection by unscrewing (using ISO 80369-20 Annex I) | Clause 6.7 of AAMI /CN3 (PS):2014 | The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20. |
| Biocompatibility | Demonstrated biological safety | Testing has demonstrated the biological safety of the proposed devices. |
| Stability (Accelerated Aging) | Support the labeling claims | Stability testing evaluated the properties of the enteral syringes after accelerated aging in support of the labeling. |
| Dosing Accuracy (Direct Oral Administration & Low Dose Syringe design) | Not explicitly stated but implied to meet functional requirements. | Verification of the Enteral Syringes to demonstrate the direct oral administration Dosing Accuracy and Low Dose Syringe design Dosing Accuracy. |
| Risk Assessment (Misconnection of ENFit Tip and Low Dose Tip ENFit connector) | Risk associated with misconnection assessed. | The risk associated with the misconnection of the ENFit tip and Low Dose Tip ENFit connector has been assessed. |
| ENFit Syringe Tip and Low dose Tip Usability Testing | Implied to meet usability requirements. | ENFit Syringe Tip and Low dose Tip Usability Testing. |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test.
Data provenance is internal testing performed by Covidien for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical device performance study based on engineering and material standards, not expert clinical interpretation of data.
4. Adjudication method for the test set:
Not applicable. This is a non-clinical device performance study based on engineering and material 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 non-AI medical device (syringe).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device (syringe).
7. The type of ground truth used:
For most tests (Fluid Leakage, Stress Cracking, Resistance to separation, Resistance to overriding, Disconnection by unscrewing, Dimensional Analysis), the "ground truth" is defined by established engineering and material standards (AAMI /CN3 (PS):2014 and ISO 80369-20). For biocompatibility, it's safety standards. For stability, it's product integrity after aging. For dosing accuracy and usability, it's functional performance.
8. The sample size for the training set:
Not applicable. This is a non-AI medical device (syringe).
9. How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device (syringe).
§ 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.