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K Number
K980082
Device Name
J-TIP NEEDLESS INJECTOR
Manufacturer
NATIONAL MEDICAL PRODUCTS, INC.
Date Cleared
1998-03-04

(54 days)

Product Code
KZE
Regulation Number
880.5430
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 J-Tip Needleless Injector system is used for the subcutaneous administration of medications which are appropriate to deliver by jet injection.

Device Description

J-Tip Needles Injector

AI/ML Overview

Apologies, but the provided text from the FDA 510(k) letter for the "J-Tip Needleless Injector" does not contain the information requested regarding acceptance criteria and details of a study proving device performance.

The document is a substantial equivalence determination letter, which means the FDA has determined that the J-Tip Needleless Injector is as safe and effective as a legally marketed predicate device. This letter typically does not include the detailed study methodology, acceptance criteria, or performance data that would be found in a 510(k) summary or the actual submission itself.

Therefore, I cannot provide the specific details you've asked for based on the input document, such as:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Training set details.
  9. Ground truth establishment for the training set.

The letter focuses on the regulatory decision and the device's classification, not the technical study details.

§ 880.5430 Nonelectrically powered fluid injector.

(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).