(237 days)
The Certa Dose™ Pediatric Midazolam 5 mg/mL intramuscular (IM) Syringe is intended for the delivery of midazolam 5 mg/mL for use in pediatric (non-neonatal) patients up to 30kg in weight.
The Certa Dose™ Pediatric Midazolam 5 mg/mL IM Syringe is comprised of (A) a 510(k)-cleared Monoject 1mL Tuberculin Syringe with a regular tip, non-luer lock (K850190), and (B) a plastic overlay which provides barrel markings. The items on the overlay include (1) a zero line, (2) 0.01 mL unit graduation markings, (3) secondary graduation markings at 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.9, 1.0 mL, (4) color bars, and (5) the name of the drug for which the syringe is indicated, midazolam 5 mg/mL.
The provided document is a 510(k) summary for the Certa Dose™ Pediatric Midazolam 5 mg/mL IM Syringe. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria and reported device performance in the format typically used for evaluating the performance of AI/ML devices.
The document focuses on demonstrating substantial equivalence based on:
- Same intended use as the predicate device (delivery of fluid).
- Similar technological characteristics to the predicate, with differences not adversely affecting safety or effectiveness or raising new questions. These differences include drug and device compatibility, color zones and drug-specific barrel markings, and the application of barrel markings via a plastic overlay.
Instead of a typical AI/ML device performance study with acceptance criteria, the document refers to several types of performance testing:
- Human factors testing: This was primarily supported by a previously submitted human factors study for a reference device (Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe, K160589), which included comparative assessments with a standard (non-color coded) 1 mL syringe. The rationale is that critical tasks and design features are highly similar between the epinephrine and midazolam syringes. No specific acceptance criteria or reported performance metrics from this human factors study are detailed in this document, nor is an effect size for human readers with and without AI mentioned (as this is not an AI/ML device in the traditional sense).
- Drug-device compatibility studies: Confirmed that short contact times do not adversely impact drug quality.
- Syringe accuracy testing: Verified that markings are applied correctly and remain accurate.
- Break loose and glide force testing: Assured adequacy for the intended use.
- Biocompatibility testing: Performed per ISO10993-1:2009/(R) 2013, including cytotoxicity and hemocompatibility tests.
- Sterilization validation: Conforms to BS EN ISO 11137-2:2015 and ISO 11137-2:2015.
- Shelf-life testing: Based on the predicate's shelf-life and one-year real-time stability testing for the plastic overlays using the reference epinephrine syringe.
Since the device is a drug-specific syringe with color-coded barrel markings and not an AI/ML diagnostic or predictive system, many of the requested elements for an AI/ML study (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this 510(k) summary.
Therefore, it is not possible to provide a table of acceptance criteria and reported device performance as requested for an AI/ML study. The document serves to establish substantial equivalence for a physical medical device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).