(127 days)
The MedSource ClearSafe Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource ClearSafe Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
The MedSource ClearSafe Safety IV Catheter is a medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The MedSource ClearSafe Safety IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber. The retraction mechanism is activated by the user using only one hand by means of a sliding motion.
The device is available in six gauges identified also by specific colors.
The provided text describes the MedSource ClearSafe Safety IV Catheter and its non-clinical testing to demonstrate substantial equivalence to a predicate device (MedSource IV Safety Catheter, K131555). It does not contain information about a study involving AI, human readers, or a training dataset. The studies described are primarily performance tests against international standards for medical devices.
Here's the information extracted from the document based on your request, structured to address as many points as possible, even if the answer is "not applicable" or "not provided" given the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (from standard or internal spec) | Reported Device Performance |
|---|---|---|
| Needle Point Geometry (Bevel) | Per ISO 10555-5:1996(E) and ISO 10555-1 requirements. | Complies with the requirements of ISO 10555-1. |
| Gravity Flow | Flow rate not less than 30 seconds. Specific limit (55 ml/min) mentioned for observed rate. | Flow rate observed is under the specified limit (55 ml/min). (Note: There seems to be a slight discrepancy in phrasing between "not less than 30s" and the 55 ml/min limit.) |
| Corrosion Resistance Test | Per ISO10555-1:1995. Visual inspection for signs of corrosion. | Cannula/needles checked visually for signs of corrosion and results comply with EN ISO 10555-1. |
| Method for Determining Force at Break (Hub-tube tensile test) | Force at break 5N OD 0.75-1.15 (Specified limit). | Average force at break - 22N (under the specified limit). |
| Catheter Collapse (Air leakage during aspiration) | No ingress of air bubbles to the syringe (visual inspection). | No air bubble formation observed from the hub assembly up to 30s. |
| Gauging Test | Complies with the requirement of EN 20594-1 as per steel gauge. | Catheter luer (body) complies with the requirement of EN 20594-1. |
| Liquid Leakage from Conical Fitting Assembly under Pressure | No liquid leakage observed from the assembly at 3 bar up to 15 min. | No liquid leakage observed from the assembly at 3 bar up to 15 min. |
| Air Leakage from Conical Fitting Assembly during Aspiration | No ingress of air bubbles. | No air bubble formation observed from the hub assembly up to 30s. |
| Liquid Leakage under Pressure | No liquid observed from the assembly at 3 bar up to 15 min. | No liquid observed from the assembly at 3 bar up to 15 min. |
| Separation Force of Conical Fitting Assembly | Under the specified limit (not explicitly stated, but 7.4N is reported). | Average force 7.4N observed for the separation of connection, which is under the specified limit. |
| Stress Cracking | No sign of any stress or cracking on the device material; no leakage from conical fitting up to 1 min. | No sign of any stress or cracking on the device material as well as no leakage was observed from the conical fitting up to 1 min. |
| Unscrewing Torque of Fitting Assembly | (Not explicitly stated, but 0.06 Nm is reported as acceptable) | Average force 0.06 Nm observed to unscrew the male luer assembly from the female luer assembly. |
| Ease of Assembly | Male reference fitting inserts without any jerk and fits securely. | Male reference fitting inserts without any jerk and fits securely. |
| Resistance to Overriding | No damage observed during the fitting of male reference fitting to the female luer. | No damage observed during the fitting of male reference fitting to the female luer. |
| Radiopacity of Catheter | Passed (implicitly refers to ASTM F640-07 standard). | Passed. X-Ray image is attached (not provided in text). |
| Catheter Elongation Testing | Strength at break should be 25 N for the tube with outer diameter > 1. | Passed. |
| Catheter Flexural Fatigue Strength Tolerance | Average kink length as observed (not explicitly stated); no kink mark observed while flow rate is Is no more difficult to use than other similar devices.Is easy to activate and does not require extensive training.Does not interfere with normal use of the product.Is required to be used when correctly operating the device.Eliminates the need for exposed needles in connections.Works well with a variety of hand sizes and under various, common uses.Operates reliably (0 units failed to activate the safety feature).Exposed sharp is covered after use and prior to disposal. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Tests (e.g., Corrosion, Flow Rate): The document does not explicitly state the sample size for each individual non-clinical test. It generally refers to "the test conditions contain herein" and "cannula/needles are checked."
- Activation Testing: 500 units of the MedSource ClearSafe Safety IV Catheter were tested (test set sample size = 500).
- Clinical Simulation Testing: The test was conducted using a "variety of Health Care Professionals." The exact number is not specified but the conclusion relates to the 500 units observed in the Activation Testing.
- Data Provenance: Not specified, but given the submission is to the US FDA, the tests were conducted for market clearance in the USA. It's a prospective testing process specifically for device clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: For the "Clinical Simulation Testing," unspecified "Health Care Professionals" were used as participants. Their qualifications (e.g., specific clinical roles, years of experience) are not provided. They were users of the device rather than traditional "experts" establishing a ground truth in a diagnostic sense.
- Ground Truth Establishment: For the technical performance tests, the "ground truth" is defined by the compliance with the referenced ISO/ASTM standards (e.g., a certain force at break, no leakage). For the safety feature activation and simulation testing, the "ground truth" is the observed functionality and user feedback on ease of use and reliability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or not specified. These are primarily performance and functionality tests against predefined criteria or direct observations (e.g., 0 failures in 500 activations). There's no indication of multiple reviewers adjudicating outcomes as one might see in a diagnostic study.
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: No, an MRMC comparative effectiveness study was not done. This document describes a medical device (an IV catheter) primarily undergoing non-clinical technical performance testing and a simulation test for its safety feature. It does not involve AI, image interpretation, or diagnostic decision-making by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this does not apply. The device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth:
- For the non-clinical performance tests (e.g., flow rate, tensile strength, corrosion, leakage), the ground truth is defined by the specific requirements and methodologies of the referenced international standards (ISO, ASTM, EN). The device's performance is compared against these engineering and material science specifications.
- For the "Activation Testing" and "Clinical Simulation Testing" of the safety feature, the ground truth is direct, observable functionality and user feedback related to the device's mechanism and ease of use. "0 failures to activate" is a direct observational ground truth.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document describes a medical device undergoing pre-market clearance testing, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable, as there is no training set for an AI algorithm.
§ 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).