Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.

AI/ML Overview

This document is a 510(k) summary for Fenwal's Blood Component Recipient and Infusion Sets. It does not contain a study evaluating the performance of the device against specific acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K881321 and K811078).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is not part of this 510(k) submission. The submission states: "Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed." This implies that the design and performance characteristics are identical to the predicate devices, and a separate study for this 510(k) was not deemed necessary for safety and effectiveness, as long as it is proven to be substantially equivalent.

Summary

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5. 510(K) SUMMARY

Date Prepared:

November 2, 2007

Owner and Contact Person:

Name: Sharyn Orton, PhD
Title: Director, Regulatory Affairs
Fenwal, Inc.
Address (street): Three Corporate Drive
Address (City, State, Zip Code): Lake Zurich, IL 60047
Telephone: (847) 550-7908
Fax: (847) 550-2960
E-mail: sharyn.orton@fenwalinc.com
Owner/Operator Number 9098803

Device Name(s):

(4C2160) Blood Component Recipient Set with Standard Size Filter
(4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter
(4C2223) Blood Component Infusion Set with Side Arm Luer Connector

Common Name:

Set, Blood Transfusion

Classification Name:

Intravascular Administration Set (21 CFR 880.5440)

Legally Marketed Device:

Blood/Solution Set with Pressure Pump (K881321)

Radiation Sterilized Administration Sets (K811078)

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Device Description

Transfusion sets have been classified by the General Hospital and Personal Use Section of the General Medical Device Panel as Class II in 21 CFR 880.5440 under the classification name intravascular administration set.

Statement of Intended Use

Administration of blood and blood by-products.

Technological Characteristics

Fenwal Blood Transfusion Sets are designed to transfuse blood components such as platelets, plasma products, cryoprecipitate and leukocytes. The Y-type set has a small surface area filter and the set offers the user the flexibility of starting the infusion with saline and rinsing the container and tubing of blood components before completing the transfusion. The transfusion set with the luer connector has a filter screen in the distal needle/catheter adapter to minimize platelet loss. The side arm Luer connector facilitates syringe-push technique, suitable for infusion.

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Page 3 of 3 Section 5: 510(k) Summary or 510(k) Statement

Conclusion

The devices listed in this summary have been cleared for Baxter Healthcare Corporation under 510(k) numbers K881321 and K811078, which showed the product to be safe and effective. Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sharyn Orton Ph. D. Director, Regulatory Affairs Fenwal, Incorporated Three Corporate Drive, 2nd Floor Lake Zurich, Illinois 60047

MAR - 3 2008

Re: K073339 Trade/Device Name: (4C2160) Blood Component Recipient Set with Standard Size Filter (4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter (4C2223) Blood Component Infusion Set with Side Arm Luer Regulation Number: 21 CFR 880.5440 Regulation Name: Blood Transfusion Set Regulatory Class: II Product Code: BRZ Dated: February 7, 2008 Received: February 11, 2008

Dear Dr. Orton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Orton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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

Enclosure

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4. INDICATION FOR USE STATEMENT

510(k) Number (If Known):

Not yet assigned

Device Names:

(4C2160) Blood Component Recipient Set with Standard Size Filter

(4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter

(4C2223) Blood Component Infusion Set with Side Arm Luer

Indication(s) for Use:

Administration of blood and blood by-products.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta D.n

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Fenwal Confidential

Regulation Number and Section

§ 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.