Who is the manufacturer of BARD EAGLE INFLATION DEVICE?

Ryder Intl. Corp. filed the 510(k) submission for BARD EAGLE INFLATION DEVICE (K962611).

What is the FDA product code for BARD EAGLE INFLATION DEVICE?

KOE. It is classified under 21 CFR 876.5520 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for BARD EAGLE INFLATION DEVICE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BARD EAGLE INFLATION DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BARD EAGLE INFLATION DEVICE

K962611 · Ryder Intl. Corp. · KOE · Oct 21, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K962611
Device Name	BARD EAGLE INFLATION DEVICE
Applicant	Ryder Intl. Corp.
Product Code	KOE · Gastroenterology, Urology
Decision Date	Oct 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5520
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for patients undergoing urological balloon dilation procedures requiring balloon inflation, pressure monitoring, and deflation.

Regulatory Classification

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)

Related Devices

K953522 — USCI IDEAL PTCA KIT · Ryder Intl. Corp. · Apr 17, 1996
K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE · Atrion Medical Products, Inc. · Oct 10, 1997
K130566 — BASIXTOUCH · Merit Medical Systems, Inc. · Jun 19, 2013
K955869 — SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE · Scimed Life Systems, Inc. · Mar 22, 1996
K040138 — VICEROY INFLATION DEVICE · Merit Medical Systems, Inc. · Feb 13, 2004

Submission Summary (Full Text)

{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