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K Number
K955282
Device Name
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
Manufacturer
THERMOGENESIS CORP.
Date Cleared
1996-05-06

(172 days)

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

ThermoGenesis Applicators and Applicator Tips are intended to deliver two solutions simultaneously to a medical or surgical site This products are supplied sterile and are intended for single patient use.

Device Description

The ThermoGenesis Applicator product line consists of two devices: (1) a drop applicator with various straight, angled and flexible dual cannulated applicator tips, and (2) a spray application device with tip. All configurations of these products allow the user to deliver two solutions using one hand. All configurations of the devices are only intended for simultaneous application of two solutions and are specifically not intended for intravenous injection.

AI/ML Overview

The provided text describes a medical device (ThermoGenesis Applicator) and its intended use, but it does not contain information about acceptance criteria, a study proving device performance, or any of the detailed study parameters requested in the prompt.

Therefore, I cannot fulfill your request for:

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

The document focuses on:

  • Device classification and naming.
  • Intended use (delivering two solutions simultaneously to a medical or surgical site).
  • Description of the product lines (drop applicator, spray applicator).
  • Statement of substantial equivalence to other liquid medication dispensers, asserting no new safety or effectiveness issues.

To answer your request, a document detailing actual performance testing, clinical studies, or engineering validation with specific acceptance criteria would be needed.

§ 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).