(235 days)
No
The device description focuses on mechanical and digital pressure measurement and display, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device inflates/deflates balloons and measures pressure within them during angioplasty, making it an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
The device is used to inflate/deflate balloons and to measure pressure within the balloon during angioplasty procedures. This is an interventional/therapeutic use, not a diagnostic one. While it measures pressure, this measurement is for procedural control rather than for diagnosing a condition or disease.
No
The device description clearly outlines physical components like a syringe barrel, pressure gauge, threaded plunger, and latching mechanism, indicating it is a hardware device with a digital display for pressure.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a mechanical device (syringe, pressure gauge, timer) used to manipulate pressure within a balloon catheter. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for use in a clinical setting during an interventional procedure, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.
Product codes
Not Found
Device Description
The Breeze Digital Inflation Device, like its predicates, the Morse Balloon Inflation Device and the Merit Monarch Inflation Syringe is a Balloon Inflation Syringe. A Balloon angioplasty catheter provides a fluid column which communicates pressure inside the balloon to the digital pressure gage. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The analog signal from the sensor is then displayed on the liquid crystal display of the gage. The manual timer operates independently of the above mentioned pressure gage. The timer is started and stopped by depressing the Start/Stop button and can be reset to 00m00s by depressing the Reset Button.
The Breeze Digital Inflation Device shares a common design with the Morse Balloon Inflation Device in that they both are comprised of a clear syringe barrel with an attached pressure gauge, a threaded plunger and a latching mechanism that operate in tandem to generate and control balloon inflation pressure. The Breeze Digital Inflation Device has in common with the Merit Monarch Inflation Syringe, a digital pressure gauge.
The Breeze Digital Inflation Device differs from the Morse Balloon Inflation Device with regard to design in the following ways: 1) the latching mechanism is actuated differently; 2) a digital pressure gauge replaces an analog Bourdon tube pressure gauge; 3) the elastomeric closure for the new device is an O-ring vs. a stopper; 4) the gauge pressure rating has been increased from 22 ATM to 30 ATM; and 5) the total syringe volume is increased from 12 to 25 cc's.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Breeze Digital Inflation Device has been subjected to non-clinical performance testing to provide data supporting the gauge pressure rating and accuracy claimed on the label. (ie: 0-30 ATM +/- 2% of full scale). The results of the tests do support the claimed pressure and accuracy.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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VII: 510(K) SUMMARY
| K953676 | |
|---|---|
| -- | --------- |
| Manufacturer: | NAMIC U.S.A. Corporation
Glens Falls, New York 12801 |
|-----------------|--------------------------------------------------------------------|
| Contact Person: | Mary Meagher Rubin
Regulatory Affairs Specialist |
| | Telephone Number (518) 798-0067
Facsimile Number (518) 798-5475 |
| Date Prepared: | August 4, 1995 |
| Trade Name: | Breeze™ Digital Balloon Inflation Device |
|---|---|
| Common Name: | Balloon Inflation Syringe |
| Classification Name: | Syringe, Balloon Inflation |
| MAR 29 1996 |
|---|
| ------------- |
The Breeze Digital Inflation Device, like its predicates, the Morse Balloon Inflation Device and the Merit Monarch Inflation Syringe is a Balloon Inflation Syringe. These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.
A Balloon angioplasty catheter provides a fluid column which communicates pressure inside the balloon to the digital pressure gage. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The analog signal from the sensor is then displayed on the liquid crystal display of the gage. The manual timer operates independently of the above mentioned pressure gage. The timer is started and stopped by depressing the Start/Stop button and can be reset to 00m00s by depressing the Reset Button.
The Breeze Digital Inflation Device shares a common design with the Morse Balloon Inflation Device in that they both are comprised of a clear syringe barrel with an attached pressure gauge, a threaded plunger and a latching mechanism that operate in tandem to generate and control balloon inflation pressure. The Breeze Digital Inflation Device has in common with the Merit Monarch Inflation Syringe, a digital pressure gauge.
1
VII. 510(K) Summary (Continued).
Biocompatibility testing has been performed on the Morse Balloon Inflation Device (K904275), the Transducer Manifold (K902472), the Contrast Controller (K903493), and the Hemostatic Introducer Sheath (K915078). These devices have all been previously cleared through Premarket Notification.
The material composition of the fluid path of the Breeze Digital Balloon Inflation Device is identical to the currently marketed NAMIC products, named above.
The Breeze Digital Inflation Device differs from the Morse Balloon Inflation Device with regard to design in the following ways: 1) the latching mechanism is actuated differently; 2) a digital pressure gauge replaces an analog Bourdon tube pressure gauge; 3) the elastomeric closure for the new device is an O-ring vs. a stopper; 4) the gauge pressure rating has been increased from 22 ATM to 30 ATM; and 5) the total syringe volume is increased from 12 to 25 cc's.
The digital gauge used for the Breeze Digital Inflation Device differs from the one used in the Merit Monarch Inflation Syringe in that the latter contains a software driven microprocessor whereas the proposed NAMIC gauge utilizes non software driven solid-state circuitry.
The Breeze Digital Inflation Device has been subjected to non-clinical performance testing to provide data supporting the gauge pressure rating and accuracy claimed on the label. (ie: 0-30 ATM ± 2% of full scale). The results of the tests do support the claimed pressure and accuracy.