(69 days)
The L-Cath Modified Seldinger Technique Accessory Kit is designed for placement and/or exchange of the L-Cath Peripherally Inserted Catheter System in 16 ga. (5Fr.), 18 ga. (4Fr.), 20 ga. (3Fr.), 24 ga. (2.6 Fr.) and the L-Cath Dual Lumen 16 and 18 ga.
Utilization of a Modified Seldinger Technique for catheter placement has been demonstrated to be effective for the placement of peripherally inserted central catheters in patients, pediatric and adult, with difficult to access veins.
The L-Cath Modified Seldinger Technique Kit consists of over-the-needle insertion catheters, a scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, with a sheath dilator and guide wire, in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters, the "parent devices". Included in the kit are appropriate accessories to aid in this technique.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical device from 1997. It describes the L-Cath® Modified Seldinger Technique (MST) Kit. The primary purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the "study" described is focused on this comparison and functional testing, not a comprehensive efficacy or diagnostic accuracy study typical of AI/ML device submissions.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a kit of basic medical components, the "acceptance criteria" are implied to be functional compatibility with the L-Cath catheters and demonstration that the components are similar or identical to those in predicate devices. The "performance" is the successful physical fit and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Compatibility with L-Cath Catheters: | |
| Guide wire Outer Diameter (OD) must accommodate Inner Diameter (ID) of existing Luther Medical catheters (specifically for neonate/pediatric tubing). | "Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application." (This implies the guide wire successfully passed through the catheters without issue). The kit offers .010", .012", and .018" guide wire diameters to accommodate various catheter sizes. |
| Biocompatibility: | |
| Guide wire material must be biocompatible. | "Biocompatibility testing was completed on the guide wire of similar size in another 510(k) for Silicone catheters." (This references previous testing for a similar component, implying the guide wire material is safe for its intended use). |
| Substantial Equivalence: | |
| Device components must be similar or identical to legally marketed predicate devices. | The document provides a detailed comparison table (Section 2) listing components (scalpel, introducer, syringe, etc.) included in the Luther Medical kit and those found in kits from Arrow International, HDC, and Cook Critical Care. The summary states: "The contents of the kit are either similar or identical to those devices, with the same intended use, on the market." and "Based on the evidence presented the devices are either essentially similar/or identical materials. The intended use is the same and therefore the devices are considered substantially equivalent." |
| Kit must contain appropriate accessories to aid in the Modified Seldinger Technique. | The device description lists components such as over-the-needle insertion catheters, scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, sheath dilator, and guide wire, all "in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters." |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For the functional compatibility (guide wire OD through catheter ID): The document states "Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application." It does not specify the number of catheters or guide wires tested.
- For biocompatibility: No specific sample size is mentioned for this submission; it references "biocompatibility testing was completed on the guide wire of similar size in another 510(k)".
- Data Provenance: The document does not specify the country of origin. The testing would have been conducted by or on behalf of Luther Medical Products, Inc. (USA). The testing appears to be prospective in nature, as it describes a specific test performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a sterile kit of common medical components. "Ground truth" in the diagnostic sense is not a concept applied here. The assessment primarily relies on engineering specifications (e.g., guide wire OD, catheter ID) and material biocompatibility, confirmed through direct measurement and laboratory testing, not expert interpretation of diagnostic data.
4. Adjudication method for the test set
Not applicable. There was no "test set" requiring adjudication in the context of expert consensus. The assessment was based on physical measurements, material properties, and comparison to existing products.
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
Not applicable. This is a medical device kit, not a diagnostic AI/ML algorithm. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device kit, not an algorithm.
7. The type of ground truth used
- For functional compatibility: Engineering specifications (e.g., precise measurements of guide wire outer diameter and catheter inner diameter) and successful physical passage.
- For biocompatibility: Laboratory test results (implied from the reference to previous 510(k) submission).
- For substantial equivalence: Direct comparison of physical components, materials, and intended use to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).