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K Number
K152597
Device Name
ProteXsure Safety Capsule System
Manufacturer
StarCap Medical LLC ( DBA Prism Medical & Design)
Date Cleared
2016-06-08

(271 days)

Product Code
FMI
Regulation Number
880.5570
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles. This device should only be used when a biohazard Sharps Container is not readily available.

Device Description

The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the ProteXsure Safety Capsule System does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is primarily a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, classifications, and general controls, but it does not include a summary of performance data or acceptance criteria for the device itself.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI.
  6. Information on a standalone algorithm performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of detailed study information would typically be found in the manufacturer's 510(k) submission document itself, which is often much more extensive than the FDA's clearance letter.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).