GUARDIANCATHETER-URINARY DRAINAGE CATHETER

• K Number: K063795
• Device Name: GUARDIANCATHETER-URINARY DRAINAGE CATHETER
• Manufacturer: MARIAN MEDICAL, INC.
• Date Cleared: 2007-03-05 ( 73 days)
• Product Code: GBM
• Regulation Number: 876.5130
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

Device Description

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "GuardianCatheter"-Infant Urinary Drainage Catheter. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

The letter mentions:

• Device Name: GuardianCatheter"-Infant Urinary Drainage Catheter
• Regulation Number: 21 CFR §876.5130
• Regulation Name: Urological catheter and accessories
• Regulatory Class: II
• Product Code: GBM
• Indications for Use: "The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter."

However, it does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in the 510(k) submission summary or device-specific testing reports, not in the FDA's clearance letter itself.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.