(172 days)
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No
The summary describes a manual applicator device for delivering solutions and contains no mention of AI, ML, or related concepts like image processing or data analysis.
No.
The device is intended to deliver solutions to a medical or surgical site, but it is not described as directly treating or curing a medical condition.
No
Explanation: The device is intended to deliver two solutions simultaneously to a medical or surgical site. It does not perform any diagnostic functions like detecting, monitoring, or analyzing conditions.
No
The device description clearly outlines physical hardware components (applicators, applicator tips, cannulated tips, spray application device) used for delivering solutions. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver two solutions simultaneously to a medical or surgical site." This describes a device used on or in the body during a medical procedure, not a device used to test samples outside the body (in vitro).
- Device Description: The description details applicators and tips for delivering solutions, explicitly stating they are "specifically not intended for intravenous injection." This further reinforces its use in a surgical or medical setting for direct application, not for diagnostic testing of bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
Therefore, the ThermoGenesis Applicators and Applicator Tips are medical devices used for therapeutic or procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
medical or surgical site
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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TAB G SUMMARY OF SAFETY AND EFFECTIVENESS
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1
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.