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.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for a modified Fenwal® 20 Micron Pediatric Transfusion Filter (K982822). The submission focuses on a change in the fiber composition of the filter pad, rather than a new AI-powered diagnostic device. Therefore, the specific questions regarding acceptance criteria and studies for AI performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable to this document.

However, I can extract the relevant information regarding the performance of this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance testing indicates that the modified device meets or exceeds all functional requirements and supports its suitability for use." While specific numerical acceptance criteria are not detailed in the provided summary, the key performance aspects evaluated were:

Acceptance Criteria Category	Reported Device Performance
Filter Efficiency (% microaggregate removal)	The modified device's performance in filter efficiency `meets or exceeds` the current device. Specific quantitative details (e.g., percentage removal threshold) are not provided in this summary.
Filtration Integrity (% hemolysis)	The modified device's performance in filtration integrity (specifically, % hemolysis) `meets or exceeds` the current device. Specific quantitative details are not provided.
Filtration Integrity (red blood count)	The modified device's performance in filtration integrity (specifically, red blood count) `meets or exceeds` the current device. Specific quantitative details are not provided.
Filter Capacity	The modified device's performance in filter capacity `meets or exceeds` the current device. Specific quantitative details (e.g., volume processed before occlusion) are not provided.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a nonclinical performance comparison of the proposed modified filter with the current Fenwal® 20 Micron Pediatric Transfusion Filter.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The document only mentions "Test data has been generated comparing the performance... using packed red blood cells."
Data Provenance: The tests were nonclinical (laboratory-based) and used "packed red blood cells." The country of origin for the data is not specified, but given Baxter Healthcare Corporation's location in Round Lake, IL, USA, it is highly likely the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the new filter design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. This is a medical device performance study, not an AI diagnostic study requiring expert consensus for ground truth. The "ground truth" here refers to the measured physical performance characteristics of the filter (e.g., actual microaggregate removal percentage, actual hemolysis percentage) in a controlled laboratory setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are relevant for human interpretation or AI output reviews, not for direct physical performance measurements of a medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This device is a passive filtration device, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth used was empirical measurement of physical performance characteristics (e.g., filter efficiency, hemolysis, red blood count, filter capacity) of the filter, likely against established industry standards or internal specifications for the existing predicate device.

8. The sample size for the training set:

This question is not applicable. There is no AI model or "training set" for this physical device.

9. How the ground truth for the training set was established:

This question is not applicable.

Summary

{0}------------------------------------------------

SEP 3 0 1998

510(k) Premarket Notification Fenwal® 20 Micron Pediatric Transfusion Filter

K982822

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:

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

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

BAXTER 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.