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K Number
K070814
Device Name
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
Manufacturer
CONFLUENT SURGICAL,INC
Date Cleared
2007-05-30

(65 days)

Product Code
FMF
Regulation Number
880.5860
Type
Special
Panel
HO
Reference & Predicate Devices
K050998
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Device Description

The Confluent Surgical MicroMyst Applicator will be configured using the following components: Applicator Air line with Filter Air Source

AI/ML Overview

The provided text describes a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance metrics, or details of a study that would prove the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Confluent Surgical MicroMyst Applicator and Air Pump K050998) based on similar technological characteristics, indications for use, operating principle, design, materials, and manufacturing processes. It states that "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." but provides no details about this testing.

Therefore, I cannot provide the requested information, which includes:

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

This document is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report with performance metrics against pre-defined acceptance criteria.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).