Search Results
Found 1 results
510(k) Data Aggregation
(143 days)
The Bard RiteCath Intermittent Urinary Catheter is intended for use by male and female patients for draining urine from the bladder.
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 (8 – 18 Fr.), lengths (6" 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 ond routine control of a sterilized process for medical devices). The catheter is for single use.
The provided text describes a 510(k) submission for the Bard RiteCath Intermittent Urinary Catheter and focuses on demonstrating substantial equivalence to a predicate device, not on a full clinical study with acceptance criteria and AI performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details, AI performance) are not applicable or cannot be extracted from this document.
However, I can extract information related to the performance data presented within the scope of this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Functional Performance | BS EN 1616: 1997 + A1:1999 (Sterile urethral catheters for single use) | Adherence to standard's requirements for sterile urethral catheters. | "Nonclinical functional performance testing was performed per BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use." (Implies compliance) |
| Biocompatibility | ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Adherence to standard's requirements for biological evaluation. | "Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009..." (Implies compliance) |
| Biocompatibility | FDA Bluebook Memorandum G95-1 (Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.") | Adherence to FDA guidance for biological evaluation. | "...and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.'" (Implies compliance) |
| Sterilization | ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – ethylene oxide – Part 1: Requirements for development, validation ond routine control of a sterilized process for medical devices) | Sterilization according to standard. | "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 ond routine control of a sterilized process for medical devices)." (Implies compliance) |
2. Sample size used for the test set and the data provenance:
- This document does not describe a clinical test set in the traditional sense. The "performance data" refers to nonclinical functional and biocompatibility testing against recognized standards. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluation is based on engineering and biological performance standards, not expert clinical assessment of images or outcomes.
4. Adjudication method for the test set:
- This information is not applicable for the type of testing described (functional and biocompatibility).
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. The device is an intermittent urinary catheter and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is an intermittent urinary catheter and does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by adherence to recognized international and national standards for medical device safety, functional performance, and biocompatibility (e.g., BS EN 1616, ISO 10993-1, ANSI/AAMI/ISO 11135-1).
8. The sample size for the training set:
- This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning device. The performance data relates to physical device testing.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no mention of a "training set." The device performance is assessed against established engineering and biological standards.
Ask a specific question about this device
Page 1 of 1