(15 days)
Intravascular catheter is a medical device intended to be used to introduce fluids or medicament through the peripheral veins and / or withdrawal of blood samples.
Intravascular catheter comprises of a short flexible plastic tube (the Catheter) which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded.
The intravascular catheter is used in aseptic environment.
Federal law (USA) restricts this device to sale by or on the order of a physician.
- Infusion of I.V. Solutions.
- Intermittent intravenous Drug administration.
As per ISO 10555-1, the generic definition of an intravascular catheter is - Intravascular catheter is a tubular device, single or multi lumen, designed to be partially or totally inserted into the cardiovascular system for diagnostic and/or therapeutic purpose
The device under this submission is an over-needle-peripheral catheter.
Over - the - needle peripheral intravascular catheters are intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. These catheters are designed for the introduction or withdrawal of liquids into or from the peripheral vascular system.
Please provide the acceptance criteria and details about the study that proves the device meets them.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medican Alpha Intravascular Catheter are based on established international and national standards for medical devices. The reported device performance indicates that the Medican Alpha successfully meets these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 10555-1: Sterile, Single-use intravascular catheter - General Requirements | Medican Alpha meets all general requirements. |
| ISO 10555-5: Sterile, Single-use intravascular catheter - Over Needle Peripheral Catheter | Medican Alpha meets all specific requirements. |
| USP-29: Non-volatile residue | Passes USP-29 test. |
| USP-29: Heavy metals | Passes USP-29 test. |
| USP-29: Residue on ignition | Passes USP-29 test. |
| USP-29: Buffering capacity | Passes USP-29 test. |
| USP-29: Bacterial Endotoxin tests | Passes USP-29 test. |
| USP-29: Sterility test | Passes USP-29 test. |
| ISO 10993-1:1997: Biological Evaluation of Medical Devices (Biocompatibility for External Communicating, Circulating Blood contact, and prolonged Exposure (>24 hrs to 30 days) device) | Biocompatibility is confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the test set in terms of number of devices or a patient cohort. The testing described is in-vitro performance testing and physicochemical testing of the device itself.
- Test Set Description: The test set appears to consist of Medican Alpha devices subjected to various laboratory tests.
- Data Provenance: The testing was conducted by EASTERN MEDIKIT LIMITED, located in Gurgaon, India. The results are presented as part of a 510(k) submission to the US FDA, implying that the data is intended to support market clearance in the USA. The nature of the tests (physical, chemical, biological compatibility) indicates this is retrospective data generated from product samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this 510(k) summary. The "ground truth" for the performance tests (e.g., whether a catheter meets specific tensile strength or sterility requirements) is established by the detailed specifications within the referenced ISO and USP standards, not by expert consensus on clinical cases. The tests are objective and quantitative.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving subjective interpretation of data (e.g., medical images). For the in-vitro performance, physicochemical, and biocompatibility testing described, no such adjudication method is mentioned or required. The results of these tests are direct measurements against pre-defined, objective standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI-assisted interpretation, where human readers interact with the device. The Medican Alpha is an intravascular catheter, and the studies performed are focused on its physical, chemical, and biological properties, not its interpretive performance in a clinical scenario with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The device itself (the catheter) is the subject of the performance evaluation, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Medican Alpha device's performance is based on established international and national standards and specifications.
- ISO 10555-1 & ISO 10555-5: These standards provide the detailed requirements and test methods for intravascular catheters. Meeting these specifications constitutes the ground truth for physical and functional performance.
- USP-29: This pharmacopeia provides methods and acceptance criteria for physicochemical tests, bacterial endotoxins, and sterility. Passing these tests against the USP-29 criteria represents the ground truth for these aspects.
- ISO 10993-1:1997: This standard dictates the requirements for biological evaluation of medical devices. Biocompatibility assessment against its guidelines forms the ground truth for biological safety.
8. The Sample Size for the Training Set
This document does not describe a "training set." The Medican Alpha is a physical medical device, not a machine learning model. Therefore, the concept of a training set is not applicable to the studies mentioned in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
§ 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).