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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Cure Catheter Insertion Kit" and related products. It outlines the regulatory classification, intended use, and a comparison to a predicate device.

However, it does not contain information about specific acceptance criteria or a study that objectively proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or screening device.

The "Performance Data" section lists various validation tests for general device characteristics, such as:

• Sterilization validation: Conforms to AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019.
• Biocompatibility testing: Conforms to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1".
• Sterile packaging: Conforms to ISO 11607-1:2019 and ISO 11607-2:2019.
• Real-time aged shelf-life testing: Conforms to ISO 11607-1:2006 with justification to version 2019.
• Packaging integrity testing: Conforms to ASTM F2096-11 (2019).
• Urinary catheter testing: Conforms to ISO 20696:2018.

These are standard engineering and safety tests for medical devices, ensuring they are safe, sterile, and perform their basic mechanical function. They are not clinical performance studies to assess diagnostic accuracy or the direct clinical efficacy of a software-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity), study design details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), is not available in this 510(k) clearance letter.

This document is for a urological catheter and accessories, which are physical medical devices, not an AI or software-based diagnostic tool. The performance data listed refers to the manufacturing, material, and sterility aspects, which are crucial for this type of device, but do not involve the types of criteria and studies you've asked about for AI/diagnostic devices.

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The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device. It is a 510(k) premarket notification for a urological catheter, a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these concepts apply to the evaluation of AI/ML algorithms.

The document discusses:

• Device Name: Cure Dextra® and Cure Catheter® Closed System
• Device Type: Intermittent urinary catheter
• Regulation Number: 21 CFR 876.5130 (Urological Catheter and Accessories)
• Predicate Device: Cure Catheter® Closed System (K080881)
• Non-Clinical Performance Testing: A summary of tests performed to demonstrate substantial equivalence, including sterilization validation, biocompatibility, sterile packaging, shelf-life, packaging integrity, diameter/shaft length, flow rate, tensile strength, and kink stability testing. These are standard tests for physical medical devices and not related to AI/ML performance.

The submission concludes that the subject devices are substantially equivalent to the predicate device based on these non-clinical performance tests.

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The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag and intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cure Catheter™ Closed System:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria and Performance:

• The document primarily focuses on biocompatibility and substantial equivalence to a predicate device as the key acceptance criteria.
• The "Reported Device Performance" column largely reiterates that the device met the stated criteria or aligns with the design specifications, indicating compliance.
• The document doesn't provide specific numerical thresholds or detailed pass/fail rates for these criteria beyond stating that they were "met."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a sample size for the test set used in the nonclinical testing for biocompatibility. It only states that "Standard biocompatibility tests were performed."
• Data Provenance: The biocompatibility tests were performed by North America Science Associates, Inc. (NAmSA). The country of origin of the data is not explicitly stated but can be inferred to be within North America given the name of the testing organization. The tests were nonclinical, meaning they were not performed on human subjects but rather in a laboratory setting (e.g., in-vitro or in-vivo animal studies as per ISO 10993). Therefore, the data is retrospective in the sense that it's a report on tests already completed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. For nonclinical biocompatibility testing, ground truth is established by adherence to recognized standards (like ISO 10993-1) and the successful outcome of the tests as interpreted by relevant scientific personnel, but not typically by "experts" in the sense of clinical reviewers establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

• This is not applicable and not provided as the evaluation involved nonclinical biocompatibility testing and substantial equivalence, not a diagnostic or clinical performance study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or data, often comparing AI assistance to unassisted human performance. The Cure Catheter™ is a urological catheter, and its evaluation focuses on material safety, functional design, and substantial equivalence, not diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The Cure Catheter™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is inherent in its physical properties and design.

7. The Type of Ground Truth Used

• The "ground truth" for the biocompatibility testing was established by adherence to internationally recognized standards (US FDA General Program Memorandum #G95-1 and ISO 10993-1) and the measured outcomes of the performed tests (e.g., absence of cytotoxicity, irritation, sensitization).
• For the substantial equivalence claim, the ground truth was the characteristics of the predicate device (Rusch MMG/O'Neil Catheter) and the comparison of the Cure Catheter's features, function, and intended use against those characteristics.

8. The Sample Size for the Training Set

• This is not applicable as the Cure Catheter™ is a physical medical device and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as the device does not involve a training set.

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