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K Number
K152050
Device Name
Pencylcap
Manufacturer
B. BRAUN MELSUNGEN AG
Date Cleared
2016-03-02

(223 days)

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

Pencylcap is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Pencylcap," which is a hypodermic single lumen needle. This document does not contain any information about acceptance criteria or performance studies that would typically be associated with an AI/ML medical device.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination for a traditional medical device (like a needle) does not involve the type of performance metrics, clinical studies, or AI-specific evaluations you've requested.

Therefore, I cannot provide the requested information, such as:

  1. Table of acceptance criteria and reported device performance: This document does not specify any performance criteria for the Pencylcap needle or report any specific performance data.
  2. Sample size used for the test set and data provenance: No test sets or data provenance are mentioned.
  3. Number of experts used to establish ground truth and qualifications: No ground truth establishment is described.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-powered device.
  6. Standalone performance study: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory approval notice based on substantial equivalence to existing predicate devices, not a performance study report for an AI/ML algorithm.

§ 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).