(24 days)
The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.
The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.
The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, Y-site, tubing, clamp, needless injection site, 'twist-off' and Luer connection.
The purpose of this Special 510(k) is to add the following two new designs of IV Administration Sets to the one already cleared for sale in the US under K121269:
- TEVADAPTOR Connecting Set with ULTRASITE Injection Site
- TEVADAPTOR Spike Port Adaptor with ULTRASITE Injection Site
All components used in the two new Administration Sets were used in the predicate device cleared under K121269, except for two, which are identical to components cleared under K071741.
This document is a 510(k) summary for a "Special" submission regarding Teva Medical I.V. Administration Sets, dated May 16, 2014. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K121269) rather than presenting a study with specific acceptance criteria and performance data for a novel device.
Therefore, the requested information, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training data details, are not explicitly provided or applicable in the context of this 510(k) Special submission.
Here's an explanation based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- This document does not present a table of quantitative acceptance criteria and reported device performance in the way that would typically be seen for a new device's efficacy or accuracy study.
- Instead, the submission aims to demonstrate "substantial equivalence" of modified I.V. Administration Set designs to a predicate device. The "performance" assessment is qualitative, focusing on whether changes have a significant effect on safety and effectiveness.
2. Sample sized used for the test set and the data provenance:
- Not applicable / Not explicitly stated. This submission is not based on a new clinical or laboratory study with a defined "test set" in the traditional sense. It's a "Special 510(k)" which usually relies on a comparison to an already cleared predicate device, and verification/validation activities performed under the manufacturer's quality system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by external experts described for a test set in this kind of regulatory submission. The evaluation is conducted internally by the manufacturer against regulatory standards and comparison to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As there is no external "test set" in the context of a clinical study, there is no adjudication method described.
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 document pertains to an I.V. Administration Set, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the safety and effectiveness profile of the predicate device (K121269), which has already been cleared by the FDA. The submission's "truth" is that the new designs are equally safe and effective.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Device and Acceptance Criteria (as implied by a Special 510(k)):
The core "acceptance criteria" for a Special 510(k) is the demonstration of Substantial Equivalence (SE) to a predicate device. This means showing that the modified device is as safe and effective as the legally marketed predicate. For a Special 510(k), this typically involves:
- No new Indications for Use: The current device maintains the same intended use as the predicate. (Stated as identical).
- Fundamental Technology: The core operational principle remains the same. (Stated as identical).
- Performance (Safety and Effectiveness): Any changes in design, materials, or features do not adversely affect safety or effectiveness. This is assessed through internal verification and validation activities under the manufacturer's quality system (21 CFR 820). The document states: "none of the changes from the predicate device have been identified as having any significant effect on safety and effectiveness compared with the original FDA-cleared device. Where verification/validation of applicable changes was required, these have been carried out under the control of Teva Medical's quality system."
- Biocompatibility, Sterilization, Single-use only, Interconnecting features, Interaction with patient and other devices, Safety features: These aspects are stated as identical to the predicate.
Differences Noted:
- Shorter lengths of devices.
- No drip chamber, flow control, or air venting in new devices.
- Addition of a twist-off component in one device.
- Changed labeling.
- Changed packaging materials and process.
The document implicitly states that these differences were evaluated under the quality management system and found to not raise any additional safety and effectiveness issues, leading to the conclusion of substantial equivalence.
§ 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.