(110 days)
No
The device description and intended use focus on mechanical components for inflation and pressure monitoring, with no mention of AI/ML terms or functionalities.
No
The device is used to inflate, monitor pressure within, and deflate a urological balloon, which is part of a procedure but the device itself does not provide a therapeutic effect. It is an accessory for a therapeutic procedure.
No.
The device inflates, monitors, and deflates a balloon during urological procedures. Its function is interventional (therapeutic/procedural), not diagnostic.
No
The device description explicitly details physical components like a plastic syringe, screw-type plunger, locking lever, rotating palm grip, manometer, and connecting tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used while performing urological balloon dilation procedures to inflate, monitor pressure, and deflate a balloon. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical device for manipulating pressure and volume, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The document 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 based on sample analysis.
Therefore, this device is a medical device used in a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
Product codes
Not Found
Device Description
The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.
The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.
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 materials of the device which contact the 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5520 Urethral dilator.
(a)
Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.(b)
Classification. (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the word "RYDER" in large, bold, black letters. Below the word "RYDER" is the word "INTERNATIONAL" in smaller, thinner, black letters. The text appears to be a logo or branding for a company called Ryder International. The image is in black and white.
OCT 21 1996
SUMMARY OF SAFETY AND EFFECTIVENES 12.
| Date of Preparation: | June 28, 1996 |
|---|---|
| Device Name: | Ryder Urological Balloon Catheter Inflation Device |
| Classification Name: | Balloon Inflation/Deflation Device |
| Manufacturer: | Ryder International Corporation, PO Box 564, 1426 Curt |
| Francis Road, Arab, AL 35016 | |
| Contact: | Mr. Dan Clark, Ryder International Corporation, PO Box 564, |
| 1426 Curt Francis Road, Arab, AL 35016 | |
| Telephone: (205) 586-1580 | |
| Fax: (205) 586-5553 | |
| Predicate: | Ryder International Balloon Catheter (USCI® Ideal™) Inflation |
| Device cleared for market under K953522. |
Device Description/ Intended Use:
The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.
The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.
The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
Technological Characteristics:
The Ryder Urological Balloon Catheter Inflation Device has an operating pressure range of vacuum to 20 atm while the predicate device has a range of vacuum to 30 bars. There are no other significant technological characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.
Summary of Safety Testing:
The materials of the device which contact the 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.
Ryder International Corporation 100 Curt Francis Road Arab, Alabama 35016 205-586-1580 of Alo Time Resen.
Image /page/0/Picture/14 description: The image shows the number 000042 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.