(129 days)
The Shepherd Laboratories, Inc., Dye Stop and Save-Quick Fill® Contrast Administration Set is intended to administer contrast agent to a patient while isolating the patient's bodily fluids from the contrast bottle to allow reuse of the contrast bottle on subsequent patients, and to exclude air from entering the tubing connecting the contrast bottle to the control syringe.
The Dye Stop and Save-Quick Fill® device is indicated as a means to administer contrast agents to a patient and to isolate a patient's bodily fluids from the contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients. It is also indicated to provide a simple means of initiation of rapid fill flow, and to exclude air from entering the tubing connecting the contrast agent chamber with a control syringe.
The Dye Stop and Save-Quick Fill®, Contrast Agent Administration Set consists of two major components which perform the task of administering the contrast agent. The first is a Spike Assembly that is used to communicate the contrast agent out of the contrast agent bottle. The second is a Deformable Chamber and Tubing Set which blocks the contrast agent from retrograde flow, provides flow initiation means via the deformable chamber, displays volume flow indications in the chamber, and provides a chamber outlet float valve which prevents air from entering the tubing line to the patient.
The Dye Stop and Save-Quick Fill® device, therefore, is designed to administer contrast agents to a patient like other such devices but also:
- Isolates a patient's bodily fluids from a contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients.
- Provides a simple means of initiation of rapid fill flow.
- Excludes air from entering the tubing connecting the contrast agent chamber with the control syringe.
The Dye Stop and Save-Quick Fill® device incorporates a vented spike that is used to penetrate the stopper of the contrast agent bottle. A disconnect point is included just downstream of the spike. This disconnect point is provided with an automatic shut off valve which prevents contrast from leaking out of the disconnect when it is separated. A sterility protection cap is provided to close the end of the disconnect to prevent contamination.
Downstream of the disconnect point are two one-way valves. These two valves are mounted in series and provide added security. These valves prevent a patients' bodily fluids from traveling backwards and entering the contrast agent bottle.
Downstream of the two one-way valves is a deformable burette chamber. At the top of the burette chamber is a high-pressure check valve. When the burette chamber is squeezed, the high-pressure check valve will open allowing air within the burette chamber to vent to the atmosphere. When the squeezed burette chamber is released a partial vacuum is created within the burette chamber. This partial vacuum causes the aforementioned differential pressure to occur, drawing contrast agent from the bottle into the burette chamber in a quick fill mode.
Contained in the bottom of the burette chamber is a floating check valve that acts to prevent air from escaping from the bottom of the burette chamber when fluid flow ceases and the burette empties. A section of tubing then connects the burette chamber to a manifold/control syringe assembly.
This looks like a 510(k) premarket notification for a medical device submitted to the FDA in 1997. The document describes the device, its intended use, and states that it has been determined to be substantially equivalent to devices marketed prior to 1976. However, it does not contain a detailed study report with acceptance criteria, performance metrics, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a modern clinical study section.
Therefore,Based on the provided text, the document focuses on the regulatory submission and approval of the "Dye Stop and Save - Quick Fill® Contrast Administration Set" rather than a detailed study proving its performance against specific acceptance criteria.
The document does not contain the following information typically found in a study proving device performance:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone (algorithm only) performance study.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
What the document does provide in relation to criteria/performance:
The document describes the device's design and its intended functions, implicitly outlining the performance claims. These claims are the basis for the FDA's "substantial equivalence" determination, meaning it performs similarly to predicate devices already on the market.
Implicit "Acceptance Criteria" based on the Intended Use and Summary of Characteristics:
While not explicitly called "acceptance criteria" with numerical targets, the document outlines the device's functional goals, which could be considered implicit performance benchmarks:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Characteristics) |
|---|---|
| Isolate patient's bodily fluids from the contrast bottle to allow reuse on subsequent patients. | "Isolates a patient's bodily fluids from a contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients." Achieved via: |
- Disconnect point with automatic shut-off valve.
- Sterility protection cap.
- Two one-way valves mounted in series to prevent backflow of patient's bodily fluids. |
| Provide a simple means of initiation of rapid fill flow. | "Provides a simple means of initiation of rapid fill flow." Achieved via: - Deformable burette chamber.
- High-pressure check valve (opens when squeezed, vents air).
- Creation of partial vacuum when released, causing differential pressure to draw contrast rapidly from the bottle into the burette. (This is the "quick fill" feature). |
| Exclude air from entering the tubing connecting the contrast agent chamber with the control syringe (to the patient). | "Excludes air from entering the tubing connecting the contrast agent chamber with the control syringe." Achieved via: - Floating check valve in the bottom of the burette chamber that acts to prevent air from escaping from the bottom of the burette chamber when fluid flow ceases and the burette empties. |
| Administer contrast agent effectively. | Functions "to administer contrast agent to a patient like other such devices." - Spike assembly to communicate contrast out of the bottle.
- Deformable chamber and tubing set for flow initiation, volume display, and air exclusion. |
| Prevent bacteriological cross-contamination (when reusing contrast bottle). | Implicitly addressed by the isolation mechanism mentioned above. The reason for isolating fluids is to "prevent bacteriological cross contamination," especially when "some contrast agent... is potentially wasted in an effort to prevent such bacteriological cross contamination." The device aims to solve this problem by allowing reuse while preventing contamination. |
§ 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.