(265 days)
Not Mentioned
Not Found
No
The summary describes a purely mechanical device for inflating and monitoring balloon catheters, with no mention of AI or ML components or functions.
No.
The device is used to inflate and deflate balloon catheters during angioplasty procedures and monitor pressure, which are procedural tools rather than directly therapeutic actions.
No
The device is described as an inflation device for balloon catheters used during angioplasty procedures, monitoring pressure, and deflating the balloon. Its primary function is therapeutic/interventional (inflating/deflating balloons during a procedure), not diagnostic (identifying a disease or condition). The manometer measures pressure, which is a control parameter for the therapeutic action rather than a diagnostic output.
No
The device description clearly outlines physical components such as a plastic syringe, plunger, locking lever, rotating pairn grip, manometer, and connecting tube, indicating it is a hardware device with mechanical functions.
Based on the provided information, the Ryder device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a mechanical device (syringe, manometer, connecting tube) used for pressure control and fluid delivery, consistent with a device used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Ryder device is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.
Product codes
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Device Description
The Ryder Balloon Catheter Inflation Device consists of a plastic syringe with a screen-type plunger and a locking lever and rotating pairn grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.
The Ryder Device has a fluid capacity of 20 cc. and an operating pressure range of vacuum to 30 bars.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Merit Medical Systems Monarch™ Balloon Catheter inflation Syringe
Reference Device(s)
Not Found
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.
0
353522
SUMMARY OF SAFETY AND EFFECTIVENESS XIL
| Date of Preparation: | July xx, 1995 |
|---|---|
| Device Name: | Ryder Balloon Catheter Inflation Syringe |
| Classification Name: | Balloon Catheter Inflation Syringe |
| Manufacturer: | Ryder International Corporation, 100 Curt Francis Road, |
| Arab, AL 35016 | |
| Contact: | Mr. D. Clark, Ryder International Corporation, 100 Curt Francis |
| Road, Arab. AL 35016 | |
| Predicate: | Merit Medical Systems Monarch™ Balloon Catheter inflation |
| Syringe |
Device Description/ Intended Use:
The Ryder Balloon Catheter Inflation Device consists of a plastic syringe with a screen-type plunger and a locking lever and rotating pairn grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.
The Ryder Device has a fluid capacity of 20 cc. and an operating pressure range of vacuum to 30 bars.
The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.
Summary of Safety Testing:
The materials of the device which contrast solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.
0000068