(234 days)
Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.
Stopcocks and Manifolds are generally used for administration of fluids into the human. body. There is a wide use of Stopcocks as flow controls and sampling sites in I.V sets, critical care applications and monitoring kits. Stopcocks are used individually or in the form of Manifolds, units comprised of several Stopcocks joined together ("gang"). High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures. The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products: i. High Pressure (HP) Stopcocks ii. Medium Pressure (MP) Stopcocks High Pressure (HP) Manifolds iii. Premium High Pressure (PHP) Manifolds iv.
The provided document is a 510(k) summary for medical devices (stopcocks and manifolds), not an AI/ML device study. Therefore, most of the requested information (sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable or present in this type of regulatory submission.
However, I can extract the acceptance criteria and the stated performance relative to those criteria from the document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the proposed devices to legally marketed predicate devices, and by performing specific tests to demonstrate that the new devices, particularly in handling higher pressures, meet relevant safety and performance standards. The acceptance criteria are largely defined by adherence to specific ISO standards and the ability to withstand stated pressure ratings.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Pressure Rating | - HP Stopcocks: 1200 psi (82 Bar) | Proposed device designed to meet these pressure ratings. |
| - MP Stopcocks: 500 psi (35 Bar) | ||
| - HP Manifold: 600 psi (41.3 bar) | ||
| - PHP Manifolds: 800 psi (54.6 bar) | ||
| High Pressure Performance | Conformity to ISO 8536-10 standard (Infusion equipment for medical use - Part 10: accessories for pressure infusion apparatus) | "High pressure performance tests for conformity to ISO 8536-10 standard" were performed. |
| Biocompatibility | Tests performed according to ISO 10993 | "Tests performed according to ISO 10993" |
| Material/Functionality Integrity after EtO Sterilization | Materials and product functionality are not affected by EtO sterilization process or aging over rated lifetime. | "The materials and the product functionality are not affected by EtO sterilization process or as a result of aging over rated life time specification." |
| Sterilization and Sterile Package Integrity | Conformity to ISO 11135-1 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process) and ISO 11607-1/2 (Packaging for terminally sterilized medical devices) | "Tests performed according to: ISO 11135-1, ISO 11607-1 and ISO 11607-2." |
| General Performance Standards | Conformity to ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements) and ISO 594-2 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 2: Lock fittings) | "Tests performed according to: ISO 594-1, ISO 594-2." |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a review of a 510(k) submission for physical medical devices, not a study involving a test set with patient data for an AI/ML algorithm. The "tests" mentioned are engineering and performance validation tests on the devices themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here. The "truth" is established by physical measurements and compliance with international standards.
4. Adjudication method for the test set:
Not applicable.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The "ground truth" for the device's performance is established through physical testing and adherence to recognized international standards (e.g., ISO 8536-10, ISO 10993, ISO 11135-1, ISO 11607-1/2, ISO 594-1, ISO 594-2). These standards define the expected performance and safety characteristics.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.