(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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”