CONTINU-FLO SOLUTION SET

K971701 · Baxter Healthcare Corp · FPA · Jun 6, 1997 · General Hospital

Device Facts

• Record ID: K971701
• Device Name: CONTINU-FLO SOLUTION SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Continu-Flo® solution sets with the proposed check valve the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

Device Story

Continu-Flo® solution sets facilitate fluid administration to patient vascular systems. Device incorporates check valve to prevent backflow from secondary medication containers into primary containers. Proposed design replaces disc valve with duck bill valve, relocated from tubing to Y-injection site housing. Valve material updated to polyisoprene. Used in clinical settings for IV therapy; operated by healthcare professionals. Output is controlled fluid delivery; prevents medication cross-contamination between primary and secondary lines.

Clinical Evidence

No clinical data. Bench testing only. Biological and chemical reactivity of new polyisoprene material assessed per ISO 10993-1 and USP Physicochemical tests. Functional performance testing confirmed the check valve meets or exceeds all functional requirements.

Technological Characteristics

Solution administration set with integrated duck bill check valve. Valve material: polyisoprene. Housing/cap materials consistent with predicate. Connectivity: standalone fluid delivery. Sterilization: not specified. No software or electronic components.

Indications for Use

Indicated for administration of fluids from a container to the patient's vascular system, including secondary medication administration with backflow prevention.

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.

Predicate Devices

• Continu-Flo® Solution Sets with Check Valve (K881052)

Submission Summary (Full Text)

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K 971701

JUN - 6 1997

## 510(k) SUMMARY

Continu-Flo® Solution Sets with Modified Check Valve

## Submitted by:

Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

## Date Prepared:

May 7, 1997

# Proposed Device:

Continu-Flo® Solution Sets with Modified Check Valve

#### Predicate Devices:

Continu-Flo® Solution Sets with Check Valve

#### Proposed Device Description:

The proposed Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during administration of secondary medication. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The new check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set.

There is one material in the proposed check valve design which is new to Baxter devices. The valve itself will be formulated from a new polyisoprene material. The materials used on the proposed check valve cap and housing, are the same as those in use on the current check valve body and Y-injection site housing on Continu-Flo® solution sets. All other materials in the solution sets remain unchanged.

## Statement of Intended Use:

Continu-Flo® solution sets with the proposed check valve the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

MAY 0 7 1997

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# Summary of Technological Characteristics of New Device to Predicate Devices

The proposed solution sets are identical to currently marketed Continu-Flo® Solution Sets with Check Valve, previously cleared under K881052, except for the design and location change of the check valve component. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The proposed check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set. All other components of the solution administration sets remain unchanged.

# Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.

Data regarding the functional performance of the proposed check valve have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Ms. Mary Ellen Snyder ·Manager, Regulatory Affairs Baxter Healthcare Corporation Route 120 And Wilson Road Round Lake, Illinois 60073

Re : K971701 Continu-Flo® Solution Sets with Modified Trade Name: Check Valve Requlatory Class: II Product Code: FPA Dated: May 07, 1997 Received: May 08, 1997

Dear Ms. Snyder:

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, qood 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. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation

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Fage 2 - Ms. Snyder

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (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 Smapl Manufacturers Assistance at its toll-free number (800) 638/2041 or at [phone].

Sincerely yours

Claturd

Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number: Not Available

Continu-Flo® Solution Sets with Modified Check Valve Device Name:

Indication for Use:

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Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a
container to the for a contrise vascular system. Continu-Floor sets contain a prevents backflow of solution from the secondary medication container into the primary ontainer during the administration of secondary medication.

(Division Sign-Off) Fabricia Encontr
Division of Dental, Infection Control,

Division of Dental, ENT,
and General Hospital Devices
§10(k) Number K971701

Prescription Use
(Per 21 CFR 801.109)

MAY 0 7 1997

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