(50 days)
No
The device description and performance studies focus on the physical filtration mechanism and material composition, with no mention of AI or ML technologies.
No
The device is a filter used to remove microaggregate particles from blood, which is a supportive function during blood transfusion, not a direct therapeutic intervention on a patient's condition.
No
This device is a filter designed to remove particles from blood, not to diagnose a condition or disease.
No
The device description clearly describes a physical filter with a fiber pad and housing, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove microaggregate particles from whole blood and red blood cells during transfusion. This is a physical process applied to the blood product itself, not a test performed on a sample of blood or other bodily fluid to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The device is a filter, designed to physically separate particles from the blood. This aligns with a medical device used in a procedure (transfusion), not a diagnostic test.
- Lack of Diagnostic Language: The description and performance metrics focus on the filter's ability to remove particles and maintain blood integrity (hemolysis, red blood count), not on measuring or detecting specific substances or markers in the blood for diagnostic purposes.
IVD devices are typically used to perform tests on samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device is used to process a blood product before it is administered to a patient.
N/A
Intended Use / Indications for Use
The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.
Product codes
CAK
Device Description
Baxter's Fenwal® 20 Micron Pediatric Transfusion Filter is a depth-type filter which traps microaggregates composed of degenerating platelets, leukocytes, fibrin strands and other particles which form in blood after storage. The filter consists of a fiber pad supported by a screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. The filter pad is currently comprised of five types of fiber strands. The supplier of one of the fibers has discontinued production. We are proposing to eliminate two of the five fibers used in construction of the filter pad and increase the percentage composition of the remaining three sizes. This change will make the composition of the 20 micron pediatric filter pad identical to the composition of the pad in the Fenwal® 20 Micron High Capacity Transfusion Filter covered by K830057.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Test data has been generated comparing the performance of the proposed and current 20 micron pediatric transfusion filters using packed red blood cells. Data regarding filter efficiency (% microaggregate removal), filtration integrity (% hemolysis and red blood count) and filter capacity were collected. Performance testing indicates that the modified device meets or exceeds all functional requirements and supports its suitability for use.
Key Metrics
% microaggregate removal, % hemolysis, red blood count, filter capacity
Predicate Device(s)
Fenwal® 20 Micron Pediatric Transfusion Filter, Fenwal® 20 Micron High Capactiy Transfusion Filter
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SEP 3 0 1998
510(k) Premarket Notification Fenwal® 20 Micron Pediatric Transfusion Filter
510(k) SUMMARY
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
August 10, 1998
Proposed Device:
Modified Fenwal® 20 Micron Pediatric Transfusion Filter
Predicate Device:
Fenwal® 20 Micron Pediatric Transfusion Filter Fenwal® 20 Micron High Capactiy Transfusion Filter
Proposed Device Description:
Baxter's Fenwal® 20 Micron Pediatric Transfusion Filter is a depth-type filter which traps microaggregates composed of degenerating platelets, leukocytes, fibrin strands and other particles which form in blood after storage. The filter consists of a fiber pad supported by a screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. The filter pad is currently comprised of five types of fiber strands. The supplier of one of the fibers has discontinued production. We are proposing to eliminate two of the five fibers used in construction of the filter pad and increase the percentage composition of the remaining three sizes. This change will make the composition of the 20 micron pediatric filter pad identical to the composition of the pad in the Fenwal® 20 Micron High Capacity Transfusion Filter covered by K830057.
s:\510k\20filsum.doc
AUG 1 0 1998
1
Statement of Intended Use:
The proposed Fenwal® 20 Micron Pediatric Transfusion Filter has the same intended use as the current Fenwal® 20 Micron Pediatric Transfusion Filter. The filter is intended for the removal of microaggregates from whole blood and red blood cells.
Summary of Technological Characteristics of New Device Compared to Predicate Devices
The proposed Fenwal® 20 Micron Pediatric Transfusion Filter is identical to the current Fenwal 20 Micron Pediatric Transfusion Filter except for a change in the composition of the filter pad. The materials and design of all other filter components, including the filter housing and filter screen, remain unchanged. The modified 20 micron pediatric filter pad is also identical in composition to the Fenwal® 20 Micron High Capacity Filter but is physically smaller to fit into the pediatric-sized housing.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Test data has been generated comparing the performance of the proposed and current 20 micron pediatric transfusion filters using packed red blood cells. Data regarding filter efficiency (% microaggregate removal), filtration integrity (% hemolysis and red blood count) and filter capacity were collected. Performance testing indicates that the modified device meets or exceeds all functional requirements and supports its suitability for use.
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Image /page/2/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 words "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
SEP 3 0 1998
Ms. Mary Ellen Synder Senior Manager, Requlatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
Re : K982822 Trade Name: Fenwal® 20 Micron Pediatric Transfusion Filter Model 4C7701 Regulatory Class: II Product Code: CAK Dated: August 10, 1998 Received: August 11, 1998
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 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). 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 Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours, warr
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Fenwal® 20 Micron Pediatric Transfusion Filter
510(k) Number: Not Available
Device Name: Fenwal® 20 Micron Pediatric Transfusion Filter
Indication for Use:
The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.
Patricia Cucenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ्द
510(k) Number K98280
AUG 1 0 1998
1
BAXTER CONFIDENTIAL
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