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K Number
K971487
Device Name
BKMI DISPOSABLE SYRINGE
Manufacturer
SUMI SALUD C.A.
Date Cleared
1997-09-04

(134 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

BKMI's Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.

Device Description

BKMI Disposable Piston Syringes With and Without Disposable Stainless Steel Single Lumen Hypodermic Needles

AI/ML Overview

The provided text describes a 510(k) clearance for a medical device, the BKMI Disposable Syringe. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a standard FDA clearance notification from 1997, confirming that the device is substantially equivalent to a predicate device and can be marketed. It focuses on regulatory compliance rather than performance study details.

Therefore, I cannot fulfill your request for information regarding:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sizes used for the test set and data provenance
  3. Number of experts used to establish ground truth and their qualifications
  4. Adjudication method
  5. MRMC comparative effectiveness study results
  6. Standalone performance study
  7. Type of ground truth used
  8. Sample size for the training set
  9. How the ground truth for the training set was established

This type of detailed performance data is typically found in the 510(k) submission summary or device's design control documentation, which is not provided in this regulatory 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).