(115 days)
Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements.
Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is for single use only.
The Regen Spray Applicator (models R-A/NAC) & R-A/NAC3) is a self-contained disposable kit aiding to simultaneous delivery of two non-homogeneous fluids or liguids to a treatment site-as deemed necessary by the clinical use requirements.
The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is comprised of sterile disposable needles, syringe holder, double piston stopper, nozzle, and syringes.
The provided text is a 510(k) summary for a medical device called the "Regen Spray Applicator." It describes the device, its intended use, technological characteristics, and sterilization method, and states that it functions as intended. However, this document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data analysis.
Here's why the requested information cannot be extracted from the given text:
-
No Acceptance Criteria or Reported Device Performance Table: The document explicitly states: "No performance standards have been developed for this type of device." and then generally mentions, "In all instances, the Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) functioned as intended and the performance based on fluids dispensed from the applicator when the syringe plungers are depressing was as expected." This is a qualitative statement, not a quantitative table with specific criteria and results.
-
No Sample Size or Data Provenance for Test Set: Since no formal performance study with a test set is described, this information is absent.
-
No Information on Experts for Ground Truth: As there's no diagnostic or analytical study requiring ground truth establishment by experts, this detail is not present.
-
No Adjudication Method: Related to point 3, no adjudication method is mentioned.
-
No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a "Spray Applicator," which is a delivery mechanism for fluids, not an imaging or diagnostic device that would typically involve human readers for interpretation, hence no MRMC study.
-
No Standalone Performance Study: While it states the device "functioned as intended," it does not provide details of a standalone, algorithm-only performance study with a specific methodology or metrics. The device is a physical tool, not an algorithm.
-
No Type of Ground Truth Used: Not applicable, as there's no diagnostic claim requiring a ground truth.
-
No Sample Size for Training Set: The device is a hardware device; thus, there is no "training set" in the context of an AI/ML algorithm.
-
No Ground Truth Establishment for Training Set: Not applicable for the same reason as point 8.
In summary, the provided document is a 510(k) Pre-Market Notification summary focused on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with quantitative acceptance criteria and empirical results for the new device's functionality.
§ 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).