DYE STOP AND SAVE - QUICKFILL

K971624 · Shepherd Laboratories, Inc. · FPA · Sep 8, 1997 · General Hospital

Device Facts

• Record ID: K971624
• Device Name: DYE STOP AND SAVE - QUICKFILL
• Applicant: Shepherd Laboratories, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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.

Device Story

Contrast administration set for clinical use; connects contrast bottle to manifold/control syringe. Components: vented spike assembly, disconnect point with automatic shut-off valve, dual series one-way check valves, deformable burette chamber, chamber outlet float valve. Operation: spike penetrates bottle; one-way valves prevent retrograde flow of patient fluids; squeezing/releasing deformable chamber creates partial vacuum to draw contrast into burette (quick fill); float valve prevents air entry into patient tubing. Benefits: reduces contrast waste by allowing multi-patient bottle use; prevents bacteriological cross-contamination; ensures air-free delivery. Used by clinicians in settings requiring contrast administration.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Vented spike assembly; dual series one-way check valves; deformable burette chamber; high-pressure check valve; chamber outlet float valve; automatic shut-off valve at disconnect point. Mechanical operation; no energy source. Standalone administration set.

Indications for Use

Indicated for administration of contrast agents to patients; enables reuse of contrast agent supply bottles by isolating patient bodily fluids; facilitates rapid filling of burette chambers; prevents air entry into tubing connecting contrast chamber to control syringe.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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971624

Appendix A

Shepherd Laboratories, Inc.

SEP - 8 1997

402 Coast Boulevard South La Jolla, CA 92037

Mav 1, 1997

Document Mail Center (HFZ-401) Center of Devices and Radiological Health Food & Drug Administration 9200 Corporate Boulevard Rockville, MD 20850, USA

- Summary of Safety and Effectiveness Information for Shepherd RE: Laboratories®, Dye Stop and Save - Quick Fill®, Contrast Administration Set
Document Control Clerk Attention:

This summary of safety and effectiveness information for the Shepherd Laboratories. Inc., Dye Stop and Save-Quick Fill® Contrast Administration Set is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92.

## Intended Use

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.

## Summary of Characteristics

Contrast Agent Administration Sets are regularly used with anesthesia manifolds to administer contrast agents to patients. A number of manufacturers market sets for this purpose. They are much like standard IV administration sets that have volume measuring burettes installed. Most of these contrast administration sets are intended for use on only one patient to prevent bacteriological cross contamination. As a result, some contrast agent, which is a relatively expensive material, is potentially wasted in an effort to prevent such bacteriological cross contamination.

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Contrast agent administration sets have been marketed which use check valves in the contrast agent flow line to prevent backflow of the agent from a patient to the supply bottle. In addition, administration sets are marketed which include a "quick fill" feature that eliminates the need to wait a period of time to allow the burette to fill. The "quick fill" feature allows the user to create a higher pressure in the contrast agent bottle than in the burette chamber. This differential pressure causes the contrast agent to flow into the burette agent rapidly.

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 1. use of the remaining contrast agent in the bottle on subsequent patients.
- Provides a simple means of initiation of rapid fill flow. 2.
- Excludes air from entering the tubing connecting the contrast agent 3. 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.

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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.

Sincerely yours,

Paul Test

Paul S. Teirstein, M.D. President Shepherd Laboratories, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 1997

Paul S. Teirstein, M.D. President Shepherd Laboratories, Incorporated 402 Coaste Boulevard South LaJolla, California 92037

Re: K971624 Dye Stop and Save - Quickfill Administration Trade Name: Set Requlatory Class: II Product Code: FPA Dated: July 7, 1997 Received: July 9, 1997

Dear Dr. Teirstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Teirstein

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.ffa.gov/cdrh/dsmamain.html".

Sincerely yours

Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971624

Re: 510(k) K971624 Rev. September 3, 1997

## Shepherd Laboratories, Inc.

Dye Stop and Save - Quick Fill®, Contrast Agent Administration Set

Statement of Indication for Use

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.

Patrizia Casceniti

(Division Si Division of De and General Hospital I 510(k) Number