(83 days)
The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.
The SUPERCATH 5 (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 (PROPOSED) is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub. The SUPERCATH 5 (PROPOSED) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein. blood flows up and through the side-notch and returns down along the inside of the catheter tube. The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.
This document, K140419, is a 510(k) premarket notification for a medical device, specifically an "Intravascular Catheter" named SUPERCATH 5. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices (K093546 and K112290) rather than proving performance against specific acceptance criteria for a novel AI/ML device. Therefore, the requested information related to AI/ML device performance (acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set details) is not applicable to this 510(k) submission.
This submission is for a conventional medical device, an intravascular catheter, and the evidence provided is primarily through bench testing, biocompatibility testing, and a comparison to predicate devices, not an AI/ML effectiveness study.
Here's an analysis of the provided text, focusing on the information that is present regarding device evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several bench tests and their general acceptance criteria rather than presenting them in a formal table with specific quantitative pass/fail values. The "reported device performance" is a general statement that the device "meets" or "is impervious to" the criteria.
| Test Title | Acceptance Criteria (General Description) | Reported Device Performance (General Description) |
|---|---|---|
| Tensile Strength for the Catheter | Meets acceptable minimum force until breakage (according to ISO 10555-1) | "The tensile strength of the catheter meets acceptable minimum force until breakage when tested according to ISO 10555-1." |
| Air and Liquid Leakage for the Hub Attachment | Impervious to air/liquid infiltration when subjected to positive pressure and aspiration (according to ISO 10555-1) | "The catheter hub is impervious to air/liquid infiltration when subjected to positive pressure and aspiration when tested according to ISO 10555-1." |
| Flow Rate | Meets allowable limits (according to ISO 10555-5) | "The flow rate through catheter meets allowable limits when tested according to ISO 10555-5." |
| Leakage at the Check Valve under Pressure | Impervious to liquid infiltration when subjected to positive pressure (according to in-house standard) | "The built-in check valve is impervious to liquid infiltration when subjected to positive pressure according to in-house standard." |
| Tensile Strength for the Wing | Meets acceptable minimum force until breakage (according to in-house standard) | "The tensile strength of the wing meets acceptable minimum force until breakage when tested according to in-house standard." |
Biocompatibility Testing:
The acceptance criterion for biocompatibility tests is the absence of concerns. The reported performance is a general statement that "no biocompatibility concern was raised."
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (General Description) |
|---|---|---|
| Cytotoxicity | No biocompatibility concern | "No biocompatibility concern was raised." |
| Intracutaneous reactivity | No biocompatibility concern | "No biocompatibility concern was raised." |
| Delayed hypersensitivity | No biocompatibility concern | "No biocompatibility concern was raised." |
| Acute Systemic Toxicity | No biocompatibility concern | "No biocompatibility concern was raised." |
| Hemocompatibility | No biocompatibility concern | "No biocompatibility concern was raised." |
| Genotoxicity | No biocompatibility concern | "No biocompatibility concern was raised." |
| Pyrogen test | No biocompatibility concern | "No biocompatibility concern was raised." |
| LAL test | No biocompatibility concern | "No biocompatibility concern was raised." |
| Leachable test | No biocompatibility concern | "No biocompatibility concern was raised." |
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: For the bench testing, specific sample sizes are not explicitly stated in the provided text for each test. For biocompatibility, the 14G SUPERCATH 5 (PROPOSED) was used as a sample, noted as being the "largest size."
- Data Provenance: The document implies that the testing was conducted by TOGO MEDIKIT CO., LTD. in Japan, as they are the listed owner/company. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This is a conventional medical device undergoing physical and chemical property testing and biocompatibility assessments, not a diagnostic AI/ML device requiring expert-established ground truth on a test set.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the tests are objective measurements of physical and chemical properties and biological reactions, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This type of study is relevant for AI/ML diagnostic tools that assist human readers. The SUPERCATH 5 is an intravascular catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used:
For the bench tests, the "ground truth" is defined by the objective measurement standards (e.g., ISO 10555-1, ISO 10555-5, or in-house standards) and the physical properties of the device. For biocompatibility, it's about the absence of adverse biological reactions, confirmed by standard biological testing protocols.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning; therefore, there is no training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set exists for this type of 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).