← Product Code [KOE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOE) · K962611 # BARD EAGLE INFLATION DEVICE (K962611) _Ryder Intl. Corp. · KOE · Oct 21, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOE/K962611 ## Device Facts - **Applicant:** Ryder Intl. Corp. - **Product Code:** [KOE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOE.md) - **Decision Date:** Oct 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5520 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## 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. ## Device Story Manual syringe-based inflation device; features screw-type plunger, locking lever, rotating palm grip, manometer, and high-pressure connecting tube. Used in clinical settings by physicians during urological balloon dilation. Device inflates/deflates balloon and monitors pressure via manometer. Fluid capacity 20 cc; operating pressure range vacuum to 20 atm. Single-use design. ## Clinical Evidence Bench testing only. Materials contacting contrast solution tested per USP guidelines; results confirm safety for intended use. ## Technological Characteristics Plastic syringe with screw-type plunger, locking lever, rotating palm grip, manometer, and high-pressure tubing. Fluid capacity 20 cc. Operating pressure range: vacuum to 20 atm. Single-use. Materials tested per USP guidelines. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Ryder International Balloon Catheter (USCI® Ideal™) Inflation Device ([K953522](/device/K953522.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} RJRJDER OCT 21 1996 K962611 # 12. SUMMARY OF SAFETY AND EFFECTIVENESS 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 Subsidiary of Alu Tewa Research Inc. 000042 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOE/K962611](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOE/K962611) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com