(66 days)
The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.
The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.
The provided text describes the MEDRAD Twist & Go High Pressure Connector Tubing and its clearance through the FDA 510(k) process. This document is a summary for a medical device (tubing for contrast media delivery) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a comprehensive clinical study to prove performance against specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic algorithm.
Therefore, many of the requested elements (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, type of ground truth for learning algorithms) are not applicable to this type of device submission as it is not an AI/ML-based algorithm or a diagnostic tool requiring such rigorous evaluation against clinical endpoints.
Instead, the "acceptance criteria" here are largely defined by equivalence to the predicate device and adherence to bench and laboratory testing standards relevant for a fluid delivery tube.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a direct "acceptance criteria" table with numerical targets in the same way an AI/ML study would. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device (MEDRAD High Pressure Connecting Tube K810924) and passing various bench and laboratory tests.
The comparison of features table (page 2) serves as the primary evidence for demonstrating functional equivalence.
| Item | Acceptance Criteria (Implied by Predicate Equivalence & Testing) | Reported Device Performance (MEDRAD Twist & Go High Pressure Connector Tube) |
|---|---|---|
| Intended Use | Delivery of contrast media during angiographic procedures. Compatibility with MEDRAD injectors. | Delivery of contrast media and common flushing solutions with Twist & Go Syringes. Single use only with MEDRAD injectors. (Broader than predicate by including flushing solutions, but within acceptable scope) |
| Material/Construction | Appropriate materials for medical use, luer connections. | Polycarbonate hub UV bonded to a flexible polyurethane nylon tube. Clear Polycarbonate Twist & Go Fasturn Nut for syringe. Clear Polycarbonate rotating male luer for administration. |
| Tubing Volumes | Within acceptable range for contrast delivery (1.00 - 4.78 ml equivalent). | 1.22 – 4.33 ml (Within predicate's range) |
| Tubing Lengths | Within acceptable range for angiographic procedures (25-122 cm equivalent). | 50-150 cm (Within predicate's range, with some extension) |
| Outer Diameter | Equivalent to predicate (.478 cm (.188")). | .368 cm (.145") (Smaller than predicate, implying potential for different flow dynamics or material strength, addressed by testing) |
| Inner Diameter | Equivalent to predicate (.224 cm (.088")). | .183 cm (.072") (Smaller than predicate, implying potential for different flow dynamics or material strength, addressed by testing) |
| Adhesive | Secure connections without leakage. | UV adhesive (Predicate did not use adhesive, implying this was evaluated for safety/performance) |
| Packaging | Sterile pouch, Tyvek and clear polymer film. | Pouch, Tyvek and clear polymer film (Equivalent) |
| Shelf Life | 3 years. | 3 years (Equivalent) |
| Biocompatibility | Compliant to ISO/AAMI 10993-1:2009. | Compliant to applicable sections of ISO/AAMI 10993-1:2009 (Equivalent) |
| Pyrogenicity | Non-pyrogenic. | Non-pyrogenic fluid path (Equivalent) |
| Latex Content | Not made with natural rubber latex. | Not made with natural rubber latex (Equivalent) |
| Sterilization Type | Ethylene Oxide. | Ethylene Oxide (Equivalent) |
| Sterilization Assurance Level (SAL) | 10-6. | 10-6 (Equivalent) |
| Pressure Rating | 1000 psi. | 1200 psi (Exceeds predicate, indicating improved performance in this aspect) |
| Overall Performance | Safe and effective for intended use, equivalent to predicate. | Bench and laboratory testing performed to support substantial equivalence, including Performance, Package Integrity, and System level testing with a MEDRAD automated injector. Results provide assurance that the device conforms to requirements for its intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of a "test set" for a diagnostic algorithm. The testing described is bench and laboratory testing on device prototypes or production samples. The number of samples for each specific test (e.g., pressure rating, leak testing, material property verification) is not provided in this summary.
- Data Provenance: The data is generated from bench and laboratory testing conducted by MEDRAD, Inc. (Bayer Medical Care, Inc.) in Indianola, PA, USA. There is no mention of country of origin of clinical data, as this is a device component, not a clinical diagnostic. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (connector tubing) and does not involve AI/ML or a diagnostic test where expert-established ground truth would be required. The "ground truth" for a connector tube's performance relies on engineering specifications and physical test results (e.g., pressure resistance, flow rates, biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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 or a diagnostic requiring a reader study.
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. The "standalone performance" refers to the physical and functional performance of the tubing itself when subjected to specified conditions (e.g., pressure, flow). The summary states "System level testing with a MEDRAD automated injector" which implies testing the device in its intended use environment, but this is not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device type is primarily based on engineering specifications, material science standards, and performance test results. For example, pressure rating is verified against a specified mechanical test standard, and biocompatibility is confirmed against ISO standards. There is no pathology or outcomes data mentioned for this type of device component in a 510(k) summary.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. Device design and development would involve various iterations and testing, but not in the sense of training a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. See 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.