(59 days)
The indications or intended use for the Inrad IV Decanter - Flexible as well as the predicate device, Medtronic/DLP "IV Decanter" (K812852) are the same. Both have the same indications, which is for dispensing fluids from flexible containers.
Aseptic Decanting of fluids from flexible containers
The design of the Inrad IV Decanter Flexible is similar to the predicate device referenced in the Comparison Information Section. It features a flexible tube with a spike attached at one end for attaching to the flexible bag. A clamp is furnished as a means of stopping the fluid flow from the bag which is the same as the Medtronic/DLP "IV Decanter". The device is manufactured from plastic which has no patient contact.
The provided K980587 document is a 510(k) summary for the Inrad IV Decanter - Flexible. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies against specific acceptance criteria.
Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert ground truth, MRMC study, training set details) are not applicable or not present in this document as they are typically associated with performance studies for novel devices or those requiring clinical data.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The submission does not provide a table of acceptance criteria or performance metrics for the device. Instead, it asserts substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No specific test set or clinical study data is presented in this 510(k) summary. The comparison is based on the design, materials, and intended use of the new device relative to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. There was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not Applicable. There was no test set or expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not Applicable. This device is a fluid dispensing product, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance improvement are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not Applicable. No ground truth was established as there were no performance studies presented. The "ground truth" for substantial equivalence is primarily the regulatory status, design, materials, and intended use of the predicate device.
8. The Sample Size for the Training Set
Not Applicable. This device does not involve a training set as it's a physical product, not an algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
Summary of Device Acceptance and Study (based on 510(k) process):
The device, Inrad IV Decanter - Flexible, was accepted for marketing based on the FDA's determination of substantial equivalence to a predicate device, the Medtronic/DLP "IV Decanter" (K812852).
The "study" that proves the device meets acceptance criteria in this context is the 510(k) submission itself, which details a comparison of the new device to the predicate. The key points of this comparison are:
- Indications for Use: Identical to the predicate ("for dispensing fluids from flexible containers").
- Design: "Similar" to the predicate, featuring a flexible tube with a spike and a clamp for fluid flow control, mirroring the predicate.
- Materials: Manufactured from plastic with no patient contact. Biocompatibility testing was performed and found acceptable for these conditions.
- Safety and Effectiveness: "No differences in safety and effectiveness" asserted, based on similar intended use, design characteristics, and acceptable biocompatibility.
- Differences: The primary difference noted is the "color of the tubing," used to distinguish the two products. This difference was deemed not to raise new questions of safety or effectiveness.
The FDA's letter (APR 17 1998) confirms that "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976" and allows the marketing of the device. This substantial equivalence determination serves as the "acceptance" for the device, based on the comparative information provided in the 510(k) submission.
§ 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.