(172 days)
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.
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.
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size.
- 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.
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TAB G SUMMARY OF SAFETY AND EFFECTIVENESS
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Device Name:
| Classification Name: | Liquid Medication Dispensers: 21CFR 880.6430 Class I |
|---|---|
| Common/Usual Names: | Syringe, Applicator, Dispenser |
| Proprietary Names: | ThermoGenesis ApplicatorThermoGenesis Applicator KitsThermoGenesis Applicator TipsThermoGenesis Spray Applicator |
| Device Sponsor: | ThermoGenesis Corporation11431 Sunrise Gold Circle, Suite ARancho Cordova, CA 95742 |
| Regulatory Classification: | Class I |
Summary of Safety and Effectiveness:
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.
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.
ThermoGenesis Applicator products are substantially equivalent in design, function and materials to other liquid medication dispensers being distributed by companies like Hemaedics and Micromedics. These products utilize commonly available blunt syringes and hypodermic needles, and therefore, do not raise any new safety or effectiveness issues when compared to similar devices.
§ 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).