AQ HYDROPHILIC DILATORS

K961904 · Cook Urological, Inc. · KOE · Oct 18, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961904
• Device Name: AQ HYDROPHILIC DILATORS
• Applicant: Cook Urological, Inc.
• Product Code: KOE · Gastroenterology, Urology
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nephrostomy fascial tract, urethra and ureters.

Device Story

AQ Hydrophilic Dilators; used for dilation of suprapubic/nephrostomy fascial tracts, urethra, and ureters. Device consists of polyurethane, polyethylene, and vinyl catheter body with hydrophilic coating. Coating becomes lubricious upon hydration to reduce friction during insertion. Used by clinicians in urological procedures. Output is physical dilation of anatomical tracts. Benefit: reduced friction during tract dilation.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and intended use similarity to predicate devices.

Technological Characteristics

Materials: polyurethane, polyethylene, vinyl. Features: hydrophilic coating for lubricity. Form factor: catheter-based dilator. Sterilization: standard procedures consistent with existing marketed devices.

Indications for Use

Indicated for dilation of the suprapubic tract, nephrostomy fascial tract, urethra, and ureters in patients requiring such procedures.

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

• Ureteral Dilators with Hydro Plus (Microvasive)
• Uncoated dilators (Cook Urological)

Submission Summary (Full Text)

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OCT 18 1996
K961904

510(k) Premarket Notification
AQ Hydrophilic Dilators
Cook Urological

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

**Submitted By:**

Tammy Bacon
Cook Urological
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
May 15, 1996

**Device**

**Trade Name:** AQ Hydrophilic Dilators

**Proposed Classification Name:** Dilator, Catheter, Ureteral Dilator, Urethral

**Predicate Devices:**

The AQ Hydrophilic Dilators are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Ureteral Dilators with Hydro Plus™ manufactured by Microvasive and uncoated dilators manufactured by Cook Urological.

**Device Description:**

The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nephrostomy fascial tract, urethra and ureters. The constructions of the materials are polyurethane, polyethylene and vinyl. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.

**Substantial Equivalence:**

These devices will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.