(58 days)
The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Baxter currently markets a line of intravascular administration sets containing 80 micron and 170 to 260 micron blood filters. These sets are used in blood transfusion procedures for the administration of blood, blood components and solutions. We plan to replace the current 80 micron and 170 to 260 micron filters in these blood sets with a modified filter design. The key differences between the current and proposed blood filters are in the material composition and design of the filter chamber. The current filters are polyester and nylon screen type filters housed in PVC chambers. The new filters will be polyester screen type filters but will be housed in chambers of a different material and design. The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4.
The provided text describes a 510(k) premarket notification for "Modified Blood Administration Sets" and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.
The document discusses "functional performance" but does not provide details on specific acceptance criteria, reported performance, sample sizes, expert involvement, or comparative effectiveness with human readers.
Therefore, I cannot populate the table or answer the questions based on the provided text. The only piece of information that hints at a standard is: "The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4." However, this is a design specification, not an acceptance criterion with a reported performance outcome.
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Nov 1 7 1999
K9931
510(k) Premarket Notification Modified Blood Administration Sets
510(k) SUMMARY
Modified Blood Administration Sets
Submitted by:
Judy Kannenberg Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: September 17, 1999
Proposed Device: Modified Blood Administration Sets
Predicate Devices: Blood /Solution Sets
Proposed Device Description:
Baxter currently markets a line of intravascular administration sets containing 80 micron and 170 to 260 micron blood filters. These sets are used in blood transfusion procedures for the administration of blood, blood components and solutions. We plan to replace the current 80 micron and 170 to 260 micron filters in these blood sets with a modified filter design. The key differences between the current and proposed blood filters are in the material composition and design of the filter chamber. The current filters are polyester and nylon screen type filters housed in PVC chambers. The new filters will be polyester screen type filters but will be housed in chambers of a different material and design. The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4.
Statement of Intended Use:
The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
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Summary of Technological Characteristics of New Device to Predicate Devices
The proposed Baxter sets are identical to currently marketed Baxter sets except for the design and material changes in the blood filters. All other technological characteristics in the blood administration sets remain unchanged.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
The biological and chemical reactivity of the new materials have 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 proposed blood filters have been generated. The data indicate that the proposed blood filters meet or exceed all functional requirements and support their suitability for use in blood administration sets.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its body and wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1999
Ms. Judy Kannenberg Manager, Regulatory Affairs Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490
K993120 Re : Modified Blood Administration Sets Trade Name: Regulatory Class: II Product Code: BRZ September 17, 1999 Dated: Received: September 20, 1999
Dear Ms. Kannenberg:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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
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Page 2 - Ms. Kannenberg
obligation you might have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as fleed in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinang or easibland device results in a classification for your markets predictions 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 yitro 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" (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.fdalgov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
y A. Ulatowski 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 Modified Blood Administration Sets
Not Available 510(k) Number:
Modified Blood Administration Set Device Name:
Indication for Use:
The modified Baxter blood sets have the same intended use as currently marketed Baxter The Intended use of these sets is the administration of blood, blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Patativa Assaré
(Division Sign-Off) Division of Dental, Info and General Hospita 5 10(k) Number
SEP 1 7 1999 like
§ 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.