(231 days)
The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.
The Intermittent Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube.
Here's a breakdown of the acceptance criteria and study information for the Dynarex Intermittent Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | Predicate Device Performance (Self Cath, K100878) | Dynarex Intermittent Catheter Performance | Basis for Acceptance |
|---|---|---|---|
| Indications for Use | Bladder drainage | Substantially Equivalent | Comparison to Predicate (explicitly stated "Substantially Equivalent") |
| Target Population | Male, Female & Pediatric (Neonates, infants, children, adolescents, and transitional adolescents) | Male, Female & Pediatric (children, adolescents, and transitional adolescents) | Comparison to Predicate (slight difference in pediatric age range, but deemed substantially equivalent for adult and core pediatric use cases) |
| Materials | PVC | PVC | Material equivalence to predicate |
| Biocompatibility | ISO 10993 Part 5 & 10 (Cytotoxicity, Skin Irritation & Sensitization) | ISO 10993 Part 5 & 10 (Cytotoxicity, Skin Irritation & Sensitization) | Testing to recognized international standards (ISO 10993), matching predicate |
| Physical Testing | ASTM 10555 (Force to Break), ASTM F-623 (Flow Rate) | ASTM 10555 (Force to Break), ASTM F-623 (Flow Rate) | Testing to recognized ASTM standards, matching predicate |
| Anatomical sites | Urethral | Urethral | Urethral usage equivalence to predicate |
| Safety and Effectiveness | Deemed safe and effective (as per K100878 clearance) | Deemed safe and effective (as per Risk Analysis Report WL-E-19-12A) | Risk analysis (WL-E-19-12A, dated August 31, 2009) to demonstrate equivalence to the predicate's safety and effectiveness profile. |
Important Note: The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to the predicate device (Self Catheter, K100878). This is a common pathway for Class II devices where the FDA has not established specific performance standards or special controls. The "study that proves the device meets the acceptance criteria" is largely the comparison to the predicate device through the described technological characteristics, biocompatibility, and physical testing.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated as "test set" in the context of a clinical performance study with human subjects. The evaluation conducted involved material characterization (biocompatibility) and physical testing. For these types of tests, specific sample sizes are determined by the test standards (e.g., ISO 10993, ASTM 10555, ASTM F-623), but the exact number of units tested is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The data provenance for the physical and biocompatibility testing would be from the manufacturer's own testing laboratories or contracted labs. These are typically controlled laboratory environments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This 510(k) relies on demonstrating substantial equivalence through material properties, physical performance, and biocompatibility, not on a diagnostic accuracy study requiring expert consensus on a test set.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no diagnostic accuracy study with a "test set" of cases, no adjudication method is relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No. This submission is for an intermittent medical catheter, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is hardware (a catheter), not a software algorithm.
7. The Type of Ground Truth Used
- Established Standards and Predicate Device Performance: The "ground truth" for this submission comes from:
- Recognized International Standards: ISO 10993 (for biocompatibility) and ASTM (for physical testing like force to break and flow rate). Meeting these standards against defined criteria serves as the ground truth for these aspects.
- Predicate Device Characteristics: The performance and characteristics of the legally marketed predicate device (Self Catheter, K100878) serve as the benchmark or "ground truth" against which the new device is compared for substantial equivalence. For instance, if the predicate device is known to have a certain flow rate range, the new device must fall within that acceptable range.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not a machine learning or AI device.
§ 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.