(44 days)
The 40 Micron Transfusion Filter is indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.
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.
The provided text describes a 510(k) premarket notification for a modified 40 Micron Transfusion Filter. The submission focuses on a change in the fiber composition of the filter pad from the predicate device and a change in sterilization method from ETO to gamma.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets. Instead, the submission states that the modified device "meets or exceeds all functional requirements." The functional performance studies cover various aspects, and the reported outcome is that the device is suitable for its intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Biocompatibility | Biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. Materials found to be acceptable for their intended use. |
| Functional Performance | Filter Prime Time: Data generated and performance indicates suitability. Flow Rate: Data generated and performance indicates suitability. Filter Capacity: Data generated and performance indicates suitability. Filter Integrity (% change in hemolysis): Data generated and performance indicates suitability. Filtration Efficiency (% microaggregate removal): Data generated and performance indicates suitability. Residual Volume: Data generated and performance indicates suitability. % White Blood Cell (WBC) Removal: Data generated and performance indicates suitability. Residual WBC Count: Data generated and performance indicates suitability. % RBC Recovery (on packed red blood cells): Data generated and performance indicates suitability. Platelet Count (with platelets): Data generated and performance indicates suitability. Morphology (with platelets): Data generated and performance indicates suitability. pH (with platelets): Data generated and performance indicates suitability. % pH Change (with platelets): Data generated and performance indicates suitability. % LDH Change (with platelets): Data generated and performance indicates suitability. C3a/C5a Complement Activation (with platelets): Data generated and performance indicates suitability. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the functional performance tests. It also does not mention the provenance (country of origin, retrospective or prospective) of the data. The studies are described as "Data regarding the functional performance...have been generated," implying prospective testing conducted in a laboratory setting, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The testing for a blood transfusion filter involves objective measurements of physical and chemical properties (e.g., flow rate, filtration efficiency, hemolysis, cell counts, pH) rather than subjective expert interpretation or "ground truth" derived from expert consensus.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. The functional performance tests involve direct measurements and comparisons, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device. An MRMC study is typically used for diagnostic devices where human readers interpret medical images or data. This submission is for a physical filtration device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical filter, not an algorithm. The performance described is inherently standalone, as it's the filter's performance in laboratory tests.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on objective laboratory measurements and established scientific/biological methodologies. For example, filtration efficiency is determined by measuring microaggregate removal, hemolysis by quantifying red blood cell lysis, and WBC removal by counting cells. This is not "expert consensus," "pathology," or "outcomes data" in the conventional sense, but rather direct empirical evidence from controlled experiments.
8. Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI models. Therefore, the sample size for a training set is not applicable. The studies described are testing the performance of a physical product.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
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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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract depiction of an eagle, which is a common symbol of the United States.
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 (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 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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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
96
§ 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.