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510(k) Data Aggregation
(112 days)
The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.
An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.
This 510(k) summary describes a traditional medical device (catheter introducer) and not an AI/ML powered device, therefore, many of the requested fields are not applicable.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Activation force within specified limits. | "The activation force was within specified limits." (Specific limits are not provided in the summary.) |
| Puncture force with shielded needle meets requirement. | "The puncture force with the shielded needle exceeded that with the unshielded needle in all cases." (Specific requirements for puncture force are not provided, but the statement indicates the shielded needle performed better, implying it met or surpassed safety expectations in preventing accidental punctures.) |
| Force to override needle shielding exceeds minimum. | "The force to override the needle shielding feature exceeds the minimum requirements." (Specific minimum requirements for the override force are not detailed, but the performance confirms the feature requires adequate force to disengage, thus preventing accidental shielding removal.) |
| Substantially equivalent in safety and effectiveness. | "Substantially equivalent to the T-Peel introducer with the addition of a needlestick protection feature that is comparable in safety and effectiveness to a similar feature in the Punctur-Guard® Blood Collection Needle." (This is a general statement of equivalence based on the successful performance in the specific tests outlined.) The original T-Peel Introducer (K924562) had already been on the market for several years and had undergone previous testing and qualification, indicating its established safety and effectiveness for catheter introduction features. No design, dimensional, or material changes were made to these features in the Blunt T-Peel Plastic Sheath Introducer. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. The tests described are bench tests for mechanical properties, not clinical studies on patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical properties is established by engineering specifications and physical measurements, not expert consensus in a medical context.
- Adjudication method for the test set: Not applicable. The tests involved quantitative measurements (activation force, puncture force, override force) against predefined limits, not subjective adjudication.
- 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 not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: For the mechanical tests, the ground truth was based on established engineering specifications and measurement standards for forces and performance characteristics of medical devices, particularly those with needlestick protection features.
- The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML device, and therefore does not have a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
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(74 days)
The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein.
The ONECATH Catheter System consists of a SafeSide DEVICE DESCRIPTION: II® introducer and a radiopaque single lumen polyurethane catheter with a clear tip. The SafeSideII introducer consists of a stainless steel needle and a two-part locking needle protection device with a flashback chamber and introducer protector. The 60, 50 and 20 cm catheters are marked in 5cm increments, in a linear tear protective sleeve. For the 60, 50 and 20 cm catheters a stylet is pre-inserted through the Y-site injection port that is connected to the catheter. A vent plug is inserted in the side port of the Y-site. The SafeSide II introducer is pre-inserted in the catheter through an aperture approximately 2cm from the tip. The ONECATH catheter system is available in various lengths of 60. 50 and 20 cm and is packaged in a two-part tray in a pouch. The ONECATH 5cm catheter is packaged in a pouch with a hemostasis valve. The product contains no DEHP or latex. The female luer is lipid resistant. Non serrated forceps are included.
This document is a 510(k) Pre-Market Notification for a medical device (ONECATH® Catheter System), indicating that the manufacturer believes their modified device is "substantially equivalent" to a previously marketed device. In such a submission, the acceptance criteria and a detailed study proving the device meets those criteria, as typically requested in your prompt for AI/algorithm performance, are generally not provided in the same way.
Instead, the submission focuses on demonstrating that the modified device is equivalent to a predicate device and that the modification poses no additional risks or potential questions of efficacy. The "study" isn't a comprehensive clinical trial with ground truth and expert adjudication, but rather a comparison of specifications and an affirmation that existing literature addresses potential complications.
Therefore, many of your requested fields will be filled with "Not Applicable" or explanations based on the context of a 510(k) submission for a physical medical device modification.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission for a physical device modification, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, and by showing that the modification does not introduce new risks.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Efficacy Equivalence to Predicate Device | The modification (minor tip configuration change) poses "no additional risks or potential questions of efficacy." (Statement from summary) |
| Material Equivalence to Predicate Device | "Manufactured using essentially the same materials" (Conclusion) - Radiopaque Polyurethane. |
| Design Equivalence to Predicate Device | The basic device is "essentially the same as the original ONECATH with a minor change in tip configuration." (Summary) Design elements like introducer, catheter markings, proximal end configuration are the same. Catheter gauge size and length have minor differences from the predicate, but are accepted. |
| Intended Use Equivalence to Predicate Device | "There is no change in intended use." (Summary) - I.V. Administration, Blood Therapy, Blood Sampling. |
| Operational Equivalence to Predicate Device | Mode of operation described as "Catheter Insertion Over the Needle Introducer with protected needle" and recommended sites are identical to the predicate device. |
| Historical Safety Record of Predicate Device | The ONECATH (predicate device) has been marketed since 1994 "with no reported adverse effects." (Substantial Equivalence section) |
| Known Complications are Documented and Understood | "Extensive studies are available in the scientific literature to address the known complications from the insertion of Catheters." (Potential Complications section) |
| No DEHP or Latex (for Modified and Predicate) | "The product contains no DEHP or latex." (Device Description) |
| Lipid Resistance of Female Luer (for Modified and Predicate) | "The female luer is lipid resistant." (Device Description) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. This is not a study involving a "test set" of data in the AI/algorithm sense. The evaluation is based on a comparison of device specifications and the historical performance of its predicate.
- Data Provenance: Not applicable in the context of an AI test set. The submission relies on the existing market history of the predicate device (ONECATH, marketed since 1994) and general scientific literature on catheter complications. This would be considered retrospective in the sense of reviewing past performance and existing knowledge. The country of origin of this historical data is not specified but would be global, primarily originating from clinical use of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. No "ground truth" was established based on expert review of a test set in this context. The "ground truth" for a medical device such as this is defined by its mechanical and material properties, and its safe and effective performance in a clinical setting over time, usually through post-market surveillance.
- Qualifications of Experts: Not applicable for establishing ground truth of a test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication was used.
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
- MRMC Study Done: No. This is a submission for a physical medical catheter, not an AI or imaging device with "human readers."
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a physical medical device like a catheter, "ground truth" refers to its physical specifications, material composition, functional performance (e.g., flow rates, tensile strength, sterility), and clinical safety and efficacy.
- In this submission, the ground truth is implicitly established by:
- Material specifications (Radiopaque Polyurethane, no DEHP or latex, lipid-resistant luer).
- Design specifications (tip configuration, introducer type, markings, lengths, gauges).
- Intended use and anatomical locations.
- The historical safety record of the predicate device ("no reported adverse effects" since 1994).
- General scientific literature on known complications of similar devices.
- In this submission, the ground truth is implicitly established by:
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/algorithm development. Device design and manufacturing processes are iteratively refined (which could be considered a form of "training" in a very broad sense), but there isn't a quantifiable "training set" of data as understood in AI.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. There is no training set in the AI sense. The design and manufacturing processes of medical devices are established through engineering principles, material science, regulatory standards (e.g., ISO, FDA guidance), bench testing, and potentially pre-clinical studies, rather than a "ground truth" for a training set.
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(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.
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