Search Results

The LoFric® Primo™ and LoFric® Hydro-Kit™ are single-use catheters designed as intermittent pathways for drainage of the bladder. The catheters are available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available. Each catheter is packaged along with a water packet that is to be broken immediately before use in order to soak the tubing.

AI/ML Overview

The LoFric® Primo™ and LoFric® Hydro-Kit™ are urological catheters that were cleared based on substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics. Therefore, the information typically found in an AI/CAD device submission regarding detailed acceptance criteria and a study proving those criteria are met is not present. This submission relies on performance testing and biocompatibility testing as compared to existing, legally marketed predicate devices.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from Equivalence Claims)	Reported Device Performance (Summary)
Intended Use: Intermittent urinary catheterization	Met: Same intended use as predicate devices.
Operating Principle: Same as predicate devices	Met: Uses the same operating principle as predicate devices.
Basic Design: Same as predicate devices	Met: Incorporates the same basic design as predicate devices.
Materials: Same as predicate devices	Met: Incorporates the same materials as predicate devices.
Manufacturing Technology: Same as predicate devices	Met: Made using the same basic manufacturing technology.
Performance Characteristics: Similar to predicate devices	Met: Has similar performance characteristics. Performance testing according to ASTM F623 was conducted.
Biocompatibility: Demonstrated as safe	Met: Biocompatibility testing was submitted and addressed.
Sterilization: Same materials and processes	Met: Sterilized using the same materials and processes.
Packaging: Similar to predicate devices	Met: Has similar packaging.

Explanation: The "acceptance criteria" for this submission are fundamentally defined by the characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if they meet these characteristics and do not raise new issues of safety or efficacy.

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

This information is not provided in the submission. The submission describes non-clinical testing data including "dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623." However, specific sample sizes for these tests, or information on test sets derived from patient data (retrospective or prospective), are not included. Given that it's a medical device (catheter) rather than a diagnostic AI/CAD system, "data provenance" in the sense of patient data doesn't directly apply in this type of submission for substantial equivalence.

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

This information is not applicable/not provided. This is a submission for a physical medical device (catheter), not an AI/CAD system requiring expert-established ground truth on clinical images or data. The "ground truth" for demonstrating equivalence largely comes from engineering specifications, material science, and performance standards (like ASTM F623) in comparison to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, this is not an AI/CAD system requiring adjudication of interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable/not provided. MRMC studies are typically performed for diagnostic AI/CAD systems to evaluate the impact on human reader performance. This submission is for a physical medical device.

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

This information is not applicable/not provided. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is essentially derived from:

Predicate Device Characteristics: The established safety and effectiveness profiles of the legally marketed predicate devices.
Engineering Specifications and Standards: Compliance with relevant engineering and material standards, such as ASTM F623 for performance testing.
Biocompatibility Standards: Successful completion of biocompatibility testing to ensure safety in contact with biological tissues.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not an AI/ML device that requires a "training set" in the computational sense. The "learning" for the manufacturer comes from established manufacturing processes and prior device iterations (e.g., K113424, K043241, K050874, which are predicate devices).

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

This information is not applicable/not provided for the same reasons as point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1