(155 days)
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters.
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.
This document is a 510(k) summary for a medical device called "AQ Hydrophilic Dilators." It is a premarket notification to the FDA. The document focuses on establishing substantial equivalence to predicate devices based on indications for use, design, and materials, rather than providing a performance study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
The document primarily describes:
- Device Name: AQ Hydrophilic Dilators
- Intended Use: To dilate the suprapubic and/or nephrostomy fascial tract, urethra, and ureters.
- Materials: Polyethylene and vinyl with a hydrophilic coating for lubricity.
- Predicate Devices: Ureteral Dilators with Hydro Plus™ (Microvasive) and uncoated dilators (Cook Urological).
- Substantial Equivalence Argument: Based on similar indications, design, materials, manufacturing processes, packaging, and sterilization to predicate devices.
There is no mention of a clinical study or performance data against specific acceptance criteria in this 510(k) summary.
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510(k) Premarket Notification AQ Lydrophilic Dilators Couk Urulogical
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 15, 1996
Device
Trade Name:
AQ Hydrophilic Dilators
Proposed Classification Name:
Dilator, Catheter, Urcleral Dilator, Urchra!
Predicate Devices:
The AQ Hydrophilic Dilators are substantially equivalent to prodicate 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 nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.
Substantial Equivalence:
These devices will be manufactured according to specificd 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.
§ 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.