(291 days)
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.
The High Pressure Sets are a group of luer compatible connection devices that aid in the prevention of needlesticks and offer ease of use in the environment for the healthcare professional. The use of the CLAVE®; MicroCLAVE™; Y-CLAVE™; and CLC2000™ is a natural fit with the high pressure sets. Testing included with this submission, validates the 400 psi claim with these unique connectors. The functional technology of the high pressure set has not changed but is augmented by the addition of the ICU connectors. The devices are sterilized to ensure a 10⁻⁶ SAL and they have been tested under the ISO 10993-1:2003 ~ Biological evaluation of medical devices ~ Part 1: Evaluation and resting and the results from these tests were found to be acceptable and are enclosed in this submission.
The provided document describes the ICU Medical High Pressure Sets - 400 psi, which are luer compatible connection devices intended for use in cardiovascular procedures where contrast media is injected using control syringes or power injectors. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance that are then directly compared to "reported device performance" in a typical table format. Instead, it relies on demonstrating that the device has undergone "non-clinical testing (simulated use) ... according to the product specification and that testing demonstrates that the device is safe and effective by meeting predefined criteria." The key performance claim is its ability to safely handle up to 400 psi.
Based on the information provided, we can infer the following:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Maximum Pressure Rating | 400 psi | Validated to 400 psi |
| Sterilization | Sterile (10⁻⁶ SAL) | Sterilized to 10⁻⁶ SAL |
| Biocompatibility | Acceptable | Found acceptable per ISO 10993-1:2003 |
Note: The document emphasizes substantial equivalence to predicate devices for characteristics like materials, functional use (high-pressure infusion), sterilization method (Gamma), and packaging (Peel pouch). While not explicit acceptance criteria, demonstrating equivalence implies meeting the safety and performance standards of these legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "non-clinical testing (simulated use)." It only states that "Test data is part of this submission as evidence."
The data provenance is retrospective as the testing was conducted on the device to demonstrate compliance with specifications for the purpose of the 510(k) submission. There is no mention of country of origin for the data, but it is implied to be from testing conducted by ICU Medical Inc., a US-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is non-clinical, simulated use testing against product specifications. This typically does not involve human experts establishing "ground truth" in the way a clinical study might for diagnostic accuracy. The "ground truth" for the performance characteristics (e.g., pressure resistance, sterility) would be the physical measurements and results of the laboratory tests.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. As the testing is non-clinical, simulated use, and involves objective measurements (e.g., pressure, sterility), an adjudication method as typically defined for human-expert validation is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or prognostic devices that involve human interpretation of images or data. The ICU Medical High Pressure Sets are infusion sets, and their effectiveness is determined by their physical performance (e.g., pressure resistance, biocompatibility), not by human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study (or rather, standalone testing in this context) was done. The "non-clinical testing (simulated use)" evaluates the device's inherent performance characteristics, such as its ability to withstand 400 psi pressure and its sterility, without human intervention or interaction as part of the performance evaluation. The device itself is evaluated in isolation against its predefined criteria.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective physical and chemical measurements and engineering standards. This includes:
- Pressure Resistance: Verification that the device can safely handle up to 400 psi.
- Sterility: Confirmation that the device meets a Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility: Results from tests conducted according to ISO 10993-1:2003, ensuring materials are safe for biological contact.
- Luer Compatibility: Adherence to industry standards like ISO 594-1 and ISO 594-2 for luer connections.
8. The Sample Size for the Training Set
This question is not applicable as the ICU Medical High Pressure Sets are medical devices with mechanical and material properties, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.