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K Number
K231255
Device Name
NovoFine® Plus
Manufacturer
Novo Nordisk Inc.
Date Cleared
2023-08-25

(116 days)

Product Code
FMI,NOV
Regulation Number
880.5570
Type
Special
Panel
HO
Reference & Predicate Devices
K202005
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

Device Description

NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) summary for the NovoFine® Plus does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a digital health device meets acceptance criteria.

The document is for a hypodermic single lumen needle (NovoFine® Plus), which is a physical medical device, not a digital health device or an AI/software as a medical device (SaMD). Therefore, the concepts of "acceptance criteria" and "study types" as you've described them (e.g., sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable or detailed in this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on:

  • Intended Use, Indications for Use, and Basic Design: Stating they are the same as the predicate.
  • Technological Characteristics: Primarily noting the difference in needle gauge size (29G vs. 32G) and asserting that this difference does not introduce new risks.
  • Performance Testing: Mentioning compliance with ISO standards (ISO 9626 for material/dimensions and ISO 11608-2 for performance) to verify the design against established requirements for such physical devices.
  • Biocompatibility: Confirmation that the new needle meets the same biocompatibility standards as the predicate.

There is no mention of AI, algorithms, or any form of digital health technology that would necessitate the kind of performance studies or ground truth establishment you are asking about.

§ 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).