THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

K955282 · Thermogenesis Corp. · FMF · May 6, 1996 · General Hospital

Device Facts

• Record ID: K955282
• Device Name: THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
• Applicant: Thermogenesis Corp.
• Product Code: FMF · General Hospital
• Decision Date: May 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

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 Story

Device line includes drop applicators with dual cannulated tips and spray application devices; enables one-handed simultaneous delivery of two solutions to surgical/medical sites. Used by clinicians in medical/surgical settings. Operates via manual dispensing of two solutions; utilizes blunt syringes and hypodermic needles. Benefits include simplified, simultaneous application of dual-component solutions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual liquid medication dispenser; dual-cannulated tips; drop and spray configurations; sterile; single-patient use; non-intravenous design.

Indications for Use

Indicated for simultaneous delivery of two solutions to a medical or surgical site. Not intended for intravenous injection.

Regulatory Classification

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.

Predicate Devices

• Hemaedics liquid medication dispensers
• Micromedics liquid medication dispensers

Submission Summary (Full Text)

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K955282

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## SUMMARY OF SAFETY AND EFFECTIVENESS

106

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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 Applicator
ThermoGenesis Applicator Kits
ThermoGenesis Applicator Tips
ThermoGenesis Spray Applicator

## Device Sponsor:

ThermoGenesis Corporation
11431 Sunrise Gold Circle, Suite A
Rancho 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.