(361 days)
Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.
The Safety Straight IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needle stick injury. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, needle hub, vent fitting, safety clip, lid, valve tube, actuator, anti-reflux valve.
Straight IV Catheter System is the same as The Safety Straight IV Catheter System except for the safety device designed to minimize blood exposure.
Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, heparin plug, needleless connector, Luer adapter with dual port.
Closed IV Catheter System is the same as Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
Needleless Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, needleless connector, Luer adapter with dual port.
Needleless Closed IV Catheter System is the same as Needleless Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
The provided text is a 510(k) summary for a Disposable IV catheter. It outlines the device's features, intended use, and a comparison to a predicate device (K183399, Nexiva IV Catheter System) to establish substantial equivalence.
However, the document does not describe a study in the context typically expected for acceptance criteria for an AI/ML powered medical device, such as a multi-reader, multi-case study, or standalone algorithm performance. This document is for a traditional medical device (IV catheter) and focuses on engineering and biocompatibility testing against recognized standards.
Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance for an algorithm, and ground truth types) are not applicable to the information contained in this 510(k) summary for an IV catheter.
I will attempt to extract the relevant "acceptance criteria" and "device performance" based on the provided engineering and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with the referenced ISO and ASTM standards. The reported device performance is that it met these standards.
| Acceptance Criteria (Defined by Standard Compliance) | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance: | |
| Compliance with ISO 594-1:1986 (Conical fittings for syringes, needles, etc. - General requirements) | Bench test results meet requirements of the recognized standards. |
| Compliance with ISO 594-2:1998 (Conical fittings for syringes, needles, etc. - Lock fittings) | Bench test results meet requirements of the recognized standards, specifically for ease of assembly performance testing for the plunger. |
| Compliance with ISO 9626:2016 (Stainless steel needle tubing - Requirements and test methods) | Bench test results meet requirements of the recognized standards. |
| Compliance with ISO 10555-1: 2013 (Intravascular catheters - General requirements) | Bench test results meet requirements of the recognized standards for different gauge sizes. Catheter burst pressure exceeds peak pressure at maximum flow, and flow rate meets allowable limits. Test results meet standard requirements for extension tubing. |
| Compliance with ISO 10555-5: 2013 (Intravascular catheters - Over-needle peripheral catheters) | Bench test results meet requirements of the recognized standards, specifically for vent fitting test for the needle hub. |
| Compliance with ISO 23908: 2011 (Sharps injury protection - Requirements and test methods) | Bench test results meet requirements of the recognized standards for needlestick injury prevention feature. |
| Compliance with ISO 80369-7: 2016 (Small-bore connectors for liquids and gases - Intravascular/hypodermic applications) | Bench test results meet requirements of the recognized standards. |
| Biocompatibility: | |
| Compliance with ISO 10993-1:2009 and FDA guidance (Biological evaluation of medical devices - General) | Biological evaluation and testing with the final device, including all materials, showed no biological risk. This implicitly covers specific tests for genotoxicity, carcinogenicity, reproductive toxicity, blood interactions, cytotoxicity, local effects, irritation, skin sensitization, and systemic toxicity as per ISO 10993-3, -4, -5, -6, -10, -11. |
| Compliance with ISO 10993-7:2009 (Biological Evaluation of Medical Device - Ethylene Oxide Sterilization residuals) | Bench test results meet requirements of the recognized standards. |
| Sterility/Packaging: | |
| Compliance with ASTM F1980-07 (Accelerated aging of sterile barrier systems) | Bench test results meet requirements of the recognized standards. |
| Sterilization by Ethylene oxide (consistency with predicate) | Yes, sterilized by Ethylene oxide. |
| Packaging (consistency with predicate) | Blister packaging. |
| Single Sterile Wrapped (consistency with predicate) | Yes. |
| Power Injector Compatibility: | |
| 22-18 GA devices suitable for use with power injectors set to max pressure of 300 psi (when access ports not suitable for power injectors are removed) | Catheter burst pressure exceeds peak pressure at maximum flow conditions when tested according to ISO 10555-1:2013. Identified as capable with 18G, 20G, 22G. |
| Injection Port Functionality (for models with this feature): | Bench tests (ISO 10555-1, Leakage Test) conducted; results meet requirements. |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test mentioned (e.g., how many catheters were burst tested, how many were put through flow rate tests, etc.). The phrase "bench testing" is used, implying laboratory tests on manufactured samples.
- Data provenance is not provided geographically, but it is implied to be from the manufacturer's (Shinva Ande Healthcare Apparatus Co., Ltd.) testing facilities, which are based in China.
- The tests are "non-clinical," meaning they are not conducted on human subjects. They are prospective in the sense that they are performed on device samples to verify compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML-powered device or a study involving expert consensus on images/data. The "ground truth" here is compliance with engineering and biological standards, determined through validated test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments, primarily in clinical or image-based studies. These are objective engineering and biological tests against established standards.
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 as this is not an AI/ML-powered device. No human reader studies (with or without AI assistance) were performed or are relevant for this type of medical device's 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML-powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this traditional medical device, the "ground truth" is defined by compliance with internationally recognized engineering performance standards (ISO, ASTM) and biocompatibility standards (ISO 10993 series), and that test results meet the specified requirements of these standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML-powered device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML-powered 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).