FENWAL 40 MICRON TRANSFUSION FILTER

K972159 · Baxter Healthcare Corp · CAK · Jul 23, 1997 · General Hospital

Device Facts

• Record ID: K972159
• Device Name: FENWAL 40 MICRON TRANSFUSION FILTER
• Applicant: Baxter Healthcare Corp
• Product Code: CAK · General Hospital
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed 40 micron transfusion filter has the same intended use as the currently marketed 40 micron transfusion filter. The filter is intended for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets.

Device Story

Device is a 40-micron transfusion filter used to remove microaggregates from whole blood and red blood cells and to facilitate platelet transfusion. It consists of a fiber pad supported by a single-layer screen within a housing. The subject device modifies the fiber composition of the filter pad by replacing approximately 50% of the fibers with a different material and size formulation. The device is intended for clinical use. Performance is verified through bench testing of filtration efficiency, flow rate, and blood component recovery.

Clinical Evidence

Bench testing only. Studies assessed filter prime time, flow rate, capacity, integrity (hemolysis), filtration efficiency (microaggregate removal), residual volume, and white blood cell removal. Platelet studies evaluated count, morphology, pH, LDH change, and C3a/C5a complement activation. Materials were assessed for biological and chemical reactivity per ISO 10993-1 and USP standards.

Technological Characteristics

Filter pad composed of fibers (modified material/size); supported by single-layer screen in a housing. Sterilization method changed from ETO to gamma radiation. Materials assessed per ISO 10993-1 and USP Physicochemical tests.

Indications for Use

Indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.

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

• 40 Micron Transfusion Filter

Submission Summary (Full Text)

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K972159

510(k) Premarket Notification Modified 40 Micron Tranfusion Filter

## 510(k) SUMMARY

JUL 2 3 1997

## Submitted by:

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

Date Prepared: June 6, 1997

Proposed Device: Modified 40 Micron Transfusion Filter

# Predicate Device:

40 Micron Transfusion Filter

# Proposed Device Description:

Baxter is currently marketing a 40 Micron Transfusion Filter indicated for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets. The filter consists of a fiber pad supported by a single layer screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. Fibers which comprise approximately 50% of the current filter pad are being discontinued by the supplier. These fibers are being replaced with fibers from another supplier which differ in size and material formulation.

# Statement of Intended Use:

The proposed 40 micron transfusion filter has the same intended use as the currently marketed 40 micron transfusion filter. The filter is intended for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets.

## Summary of Technological Characteristics of New Device to Predicate Devices

The design of the proposed 40 micron transfusion filter is identical to the current 40 micron transfusion filter except for a change in the size and material formulation of the fibers which currently comprise about 50% of the filter pad. There are no other changes in the design of the fiber pad or the filter. The materials and design of all other filter components, including the filter housing and filter screen, remain unchanged. The filter is currently ETO sterilized and will now be gamma sterilized.

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# Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

The biological and chemical reactivity of the new material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The materials were found to be acceptable for their intended use.

Data regarding the functional performance of the modified 40 Micron Transfusion Filter have been generated. Studies included filter prime time, flow rate, filter capacity, filter integrity (% change in hemolysis), filtration efficiency (% microaggregate removal), residual volume, % white blood cell (wbc) removal, residual wbc count, and % roc recovery on packed red blood cells. Studies were also performed with platelets and included platelet count, morphology, pH, % pH change % LDH change and C3a/C5a complement activation. Performance testing indicates that the modified device meets or exceeds all functional requirements and support its suitability for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Ellen Snyder Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

JUL 2 3 1997 --

Re : K972159 Fenwal 40 Micron Transfusion Filter Trade Name: Requlatory Class: II Product Code: CAK Dated: June 6, 1997 Received: June 9, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

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Page 2 - Ms. Synder

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

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.fda.gov/cdrh/dsmamain.html" a

Sincerely yours,

Timot v A 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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K972159

510(k) Premarket Notification 40 Micron Transfusion Filter

Not Available 510(k) Number:

40 Micron Transfusion Filter Device Name:

Indication for Use:

The 40 Micron Transfusion Filter is indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.

(Division Sign-Off) Patricia Crucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972159

**Prescription Use**
(Per 21 CFR 801.109)

JUN 06 1997

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