(88 days)
K83284A
K83284A
No
The document describes a standard solution administration set and does not mention any AI or ML components.
No.
The device is used to administer fluids and drugs, not to treat a disease directly.
No
Explanation: The device is an administration set used to deliver fluids and medication (paclitaxel) to a patient's vascular system. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly describes a physical solution administration set with tubing, a filter, and specific material properties (polyethylene-lined tubing, no DEHP plasticized PVC). This 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 administer fluids (specifically solutions containing paclitaxel and general solutions) to a patient's vascular system. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical components and materials designed for safe and effective administration of solutions, particularly addressing concerns with drug compatibility (paclitaxel and DEHP). This aligns with a delivery device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are designed to perform tests in vitro (outside the body).
- Anatomical Site: The device interacts with the patient's vascular system in vivo (inside the body) for administration. IVDs typically work with samples collected from the body.
The device is clearly intended for the administration of substances into the body, which falls under the category of medical devices used for treatment or delivery, not diagnosis.
N/A
Intended Use / Indications for Use
The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.
Product codes
FPA
Device Description
The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Data regarding the functional performance of the proposed solution administration set including its compatibility with paclitaxel have been generated. A description of the functional testing along with test results has been provided. All data indicate that the proposed paclitaxel device meets or exceeds all functional requirements and thus support its suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nitroglycerin Set, K83284A
Reference Device(s)
Not Found
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.
0
510(k) Premarket Notification Solution Administration Set
AUG 1 4 1998
510(k) Summary
Solution Adminstration Set
Submitted by:
Mary Ellen Snyder Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rt. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
May 20, 1998
Proposed Device:
Solution Administration Set
Predicate Device:
Nitroglycerin Set Solution Administration Sets with 0.22 Micron Filter
Proposed Device Description:
The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.
Statement of Intended Use
The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.
1
Summary of Technological Characteristics of New Device to Predicate Devices
The product is similar to the currently marketed Baxter nitroglycerin set, cleared under K83284A on December 29, 1983. The principal differences between the proposed solution set and the predicate nitroglycerin set include a modified spike design, addition of a 0.22 µm filter, and use of TEHTM to plasticize the PVC components. There are no new materials involved in the proposed device. All solution contact materials to be used in the proposed set are identical to materials used in legally marketed devices under comparable conditions of use.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
Data regarding the functional performance of the proposed solution administration set including its compatibility with paclitaxel have been generated. A description of the functional testing along with test results has been provided. All data indicate that the proposed paclitaxel device meets or exceeds all functional requirements and thus support its suitability for use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 1998
Ms. Mary Ellen Synder Requlatory Affairs Manager Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
Re: K981792 Solution Administration Set Trade Name: Requlatory Class: II Product Code: FPA Dated: May 20, 1998 Received: May 21, 1998
Dear Ms. Synder:
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. ਸਾ 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 requlatory 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. Snyder
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) 594-4692. 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,
S. Dutman for
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 Solution Administration Set
Indication for Use
510(k) Number: Not Available
Device Name: Solution Administration Set
Indication for Use: The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.
(Division Sign-Off)/3.
Division of Dental, Infection Control,
and General Hospital Devices 14981792 510(k) Number _