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510(k) Data Aggregation
(49 days)
The Bard RiteCath Intermittent Urinary Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder. Pediatric patients include neonates, infants, children and adolescents.
The Bard RiteCath Intermittent Urinary Catheter is a biocompatible, polyvinyl chloride (PVC) catheter used to drain urine from the bladder. The catheter consists of a funnel, shaft with two staggered eyelets and a tip. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel. The catheter will be offered in multiple French sizes (6 – 18 Fr.), lengths (6", 10" and two tip designs (straight and coude). The product is ethylene oxide sterilized (per ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products – ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is for single use.
The provided document describes the Bard RiteCath Intermittent Urinary Catheter and its substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria for a specific performance metric directly related to the device's efficacy, nor does it present a study that measures the device's performance against such criteria in a quantitative manner with reported performance values.
Instead, the document focuses on:
- Biocompatibility testing: Ensuring the materials used are safe for bodily contact.
- Nonclinical functional performance testing: Confirming the device meets general standards for urethral catheters (e.g., flow rates, strength, ease of insertion, etc., as per BS EN 1616: 1997 + A1:1999).
- Comparison to predicate devices: Demonstrating that its technological characteristics and intended use are similar to already approved catheter devices.
Therefore, many of the requested details about acceptance criteria and a study proving performance against them cannot be extracted from this document. The information available is presented below, and where specific requested details are not present, it is noted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1:2009 for Biological Evaluation of Medical Devices. The battery of testing included: Cytotoxicity, Sensitization, Vaginal Mucosal Irritation. A toxicological risk assessment for diisononyl phthalate (DINP) was performed per ISO 10993-17:2002. | All tests passed; subject device is considered mucosal contacting with limited exposure, and is safe for its intended use. (Implied acceptability based on "nonclinical test data demonstrates that the subject device is safe and effective.") |
| Functional Performance | "Nonclinical functional performance testing of the subject device was performed in accordance with BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use." This standard specifies requirements for sterile urethral catheters, including physical, chemical, and biological tests for product design, materials, and performance (e.g., flow rates, integrity, strength, sterility, lubrication characteristics, etc.). | The subject device was found to be "substantially equivalent to the legally, marketed predicate devices and nonclinical test data demonstrates that the subject device is safe and effective." (Implied compliance with the standard). |
| Sterilization | Ethylene Oxide sterilization (per ANSI/AAMI/ISO 11135-1:2007) | Compliant with the standard for sterility. |
Missing Information: The document does not provide specific numerical targets (e.g., "flow rate must be > X mL/min") or quantitative results (e.g., "average flow rate was Y mL/min") for functional performance. The assessment relies on compliance with an international standard for sterile urethral catheters and substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any of the performance tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests are described as "nonclinical functional performance testing" and "biocompatibility evaluation," implying laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. The testing described is primarily laboratory-based physical and biological evaluation against established standards, not interpretation by human experts to establish "ground truth" in terms of diagnosis or clinical outcome.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. The testing described does not involve expert adjudication.
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
- This information is not applicable and not provided. The device is a urinary catheter, not an AI-assisted diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. The device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Compliant with ISO standards for materials, as determined by laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
- For Functional Performance: Compliant with BS EN 1616: 1997 + A1:1999 (Sterile urethral catheters for single use), evaluated through specific physical and chemical tests defined by the standard. This represents an engineering standard as the "ground truth."
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The device is a physical product, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided, as there is no training set for this type of device.
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