(350 days)
No
The device description and performance studies focus on material changes and mechanical performance of infusion sets, with no mention of AI or ML.
No.
This device is an administration set, which is used to deliver fluids and drugs to a patient, rather than providing therapy itself.
No
This device is for administering fluids into a patient's vascular system, primarily chemotherapeutic drugs, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as tubing, filters, clamps, and spikes, indicating it is a hardware device for fluid administration.
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 and drugs (specifically paclitaxel) to a patient's vascular system. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The device is a set of tubing, filters, and connectors designed for fluid administration. It does not perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide any information about a patient's health status or disease.
- Bench Tests: The performance studies focus on the physical and functional performance of the administration set (flow rate, drug compatibility, occlusion, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998).
The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented).
The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets.
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)
The following bench tests were conducted to evaluate the effect of the modifications on the functional performance of the Paclitaxel Sets: Clear Passage Test, Roller Clamp Force Test, Roller Clamp Shut-Off Test, Roller Clamp Tubing Leak Test, Solvent Bond Tensile Strength Test, Solvent Bond Air Pressure Test, Air Diffusion Test, Bubble Point Test, Gravity Flow Rate Test, Flow Rate Test Post Sterile Water Conditioning, Flow Rate Test Post Parenteral Nutrition Conditioning, Bacterial Retention Test, Upstream/Downstream Occlusion Test (with Baxter pumps: FLO-GARD and SIGMA Spectrum), Drug Compatibility Test (Paclitaxel Concentration), Drug Compatibility Test (pH), Drug Compatibility Test (Color), Drug Compatibility Test (Visual Inspection). All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use. For drug compatibility tests, the acceptance criteria was "Equivalence to predicate device."
Biocompatibility assessments were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," including Cytotoxicity (per ISO 10993-5), Systemic Toxicity (Acute and Sub-chronic) (per ISO 10993-11), Irritation/Intracutaneous Reactivity (per ISO 10993-10), Sensitization (per ISO 10993-10), Hemocompatibility (In Vitro Hemolysis) (per ISO 10993-4), Material Mediated Pyrogen (per ISO 10993-11), and USP Physicochemical (per USP ).
The Paclitaxel Sets are sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facilities to be within 14.2 – 25.0 kGy. Radiation sterilization validation and routine control at Baxter Healthcare Corporation is in compliance with ANSI/AAMI/ISO 11137-2. Package verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak.
Aging tests were conducted to support a shelf-life claim of eighteen (18) months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Baxter Healthcare Corporation Ms. Tiffany Lin Manager, Regulatory Affairs 32650 North Wilson Road Round Lake, Illinois 60073
Re: K160007
Trade/Device Name: Paclitaxel Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 15, 2016 Received: November 16, 2016
Dear Ms. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Tiffany Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160007
Device Name Paclitaxel Sets
Indications for Use (Describe)
To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 – 510(k) Summary
December 16, 2016
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Tiffany Lin Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-4343 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Intravascular Administration Sets Trade Name: Paclitaxel Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA
| Code Number | Name |
|---|---|
| 2C7557 | Interlink System Vented Paclitaxel Set |
| 2C7558 | Interlink System Paclitaxel Set |
| 2C8857 | Clearlink System Vented Paclitaxel Set |
| 2C8858 | Clearlink System Paclitaxel Set |
Table 1. Code Number for Paclitaxel Sets
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PREDICATE DEVICE:
Table 2. Predicate 510(k)
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Solution Administration Set | Baxter Healthcare | K981792 | August 17, 1998 |
REFERENCE DEVICES:
Table 3. Reference 510(k)s
| Device | Company | Reference 510(k) | Clearance Date |
|---|---|---|---|
| Nitroglycerin Sets with DUO- | |||
| VENT Spike | Baxter Healthcare | K150860 | April 16, 2015 |
| Solution Administration Sets | |||
| with 0.2 Micron Filter | Baxter Healthcare | K153158 | December 28, 2015 |
DESCRIPTION OF THE DEVICE:
The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998).
The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented).
The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets.
These changes do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as
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part of this update. The product labels are also being updated to revise statements regarding latex and pump device references, add the indications for use statement of the device, and implement other changes to comply with Baxter's labeling standards.
INDICATIONS FOR USE:
To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices are equivalent to Baxter's currently legally marketed devices cleared under 510(k) premarket notification K981792 (cleared August 17, 1998). The modifications consist of a changes to the PE-lined trilayer tubing and 0.2 micron filter, which have been previously cleared under 510(k) premarket notifications K150860 (cleared April 16, 2015) and K153158 (cleared December 28, 2015), respectively. The intended use, basic design, and function for the proposed device are equivalent to the predicate device. Table 4 is a device comparison table outlining the differences between the current (predicate) device and the proposed device.
| Features | Current Device
(Cleared under K981792) | Proposed Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the administration of fluids from a
container into the patient's vascular
system through a vascular device. | Same |
| Indications for use | 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. | To administer fluids with Baxter
infusion pumps to a patient's
vascular system from a container
though a needle or catheter
inserted into a vein, primarily
used to administer solutions
containing the chemotherapeutic
drug paclitaxel, but can also be
used for general solution
administration.a |
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| Features | Current Device
(Cleared under K981792) | Proposed Device |
|-----------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Sterile | Yes | Same |
| Non-Pyrogenic | Yes | Same |
| Single Use | Yes | Same |
| Materials | | |
| Spike | Acrylonitrile Butadiene Styrene | Same |
| Drip Chamber | Polyvinyl Chloride | Same |
| Interlink Y-Site | Copolyester and Synthetic Polyisoprene | Same |
| Clearlink Y-Site | Polycarbonate and Silicone | Same |
| Minidrip Adapter | Synthetic Polyisoprene and Stainless
Steel | Same |
| Trilayer Tubing | Polyvinyl Chloride, Polyolefin and Low
Density Polyethylene | Polyvinyl Chloride, Polyolefin and
Linear Low Density Polyethyleneb |
| Tubing | Polyvinyl Chloride | Same |
| 0.2 Micron Filter | Copolyester, Polyethersulfone (Millipore)
and Polyvinylidiene Fluoride | Copolyester, Polyethersulfone
(Membrana) and Polyvinylidiene
Fluoridec |
| Male Luer Lock
Connector | Acrylonitrile Butadiene Styrene | Same |
Table 4. Device Comparison
a The indications for use are being clarified to remove brand names of infusion pumps to align with current market terminology. This does not alter the intended use of the device.
b Materials previously cleared under 510(k) premarket notification K150860 on April 16, 2015.
6 Materials previously cleared under 510(k) premarket notification K153158 on December 28, 2015.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use.
Performance Data:
The following bench tests were conducted to evaluate the effect of the modifications on the functional performance of the Paclitaxel Sets.
| Test | Acceptance Criteria |
|---|---|
| Clear Passage Test | Per Baxter test method. |
Table 5. Performance Testing Summary
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| Test | Acceptance Criteria |
|---|---|
| Roller Clamp Force Test | Per Baxter test method. |
| Roller Clamp Shut-Off Test | Per Baxter test method. |
| Roller Clamp Tubing Leak Test | Per Baxter test method. |
| Solvent Bond Tensile Strength Test | Per Baxter test method. |
| Solvent Bond Air Pressure Test | Per Baxter test method. |
| Air Diffusion Test | Per Baxter test method. |
| Bubble Point Test | Per Baxter test method. |
| Gravity Flow Rate Test | Per Baxter test method. |
| Flow Rate Test Post Sterile Water Conditioning | Per Baxter test method. |
| Flow Rate Test Post Parenteral Nutrition Conditioning | Per Baxter test method. |
| Bacterial Retention Test | Per Baxter test method. |
| Upstream/Downstream Occlusion Test | |
| (with Baxter pumps: FLO-GARD and SIGMA Spectrum) | Per Baxter test method. |
| Drug Compatibility Test (Paclitaxel Concentration) | Equivalence to predicate device. |
| Drug Compatibility Test (pH) | Equivalence to predicate device. |
| Drug Compatibility Test (Color) | Equivalence to predicate device. |
| Drug Compatibility Test (Visual Inspection) | Equivalence to predicate device. |
Table 5. Performance Testing Summary
Biocompatibility:
Biocompatibility assessments were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," to the category of prolonged duration, external communicating device, indirect blood path as recognized by FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993 and as recommended by the FDA Guidance Document issued July 11, 2008 "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]." The battery of testing included the following tests:
- Cytotoxicity (per ISO 10993-5)
- Systemic Toxicity (Acute and Sub-chronic) (per ISO 10993-11) ●
- Irritation/Intracutaneous Reactivity (per ISO 10993-10) ●
- Sensitization (per ISO 10993-10)
- Hemocompatibility (In Vitro Hemolysis) (per ISO 10993-4)
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- Material Mediated Pyrogen (per ISO 10993-11) ●
- USP Physiochemical (per USP )
Sterility:
The Paclitaxel Sets are sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10 € Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facilities to be within 14.2 – 25.0 kGy. Radiation sterilization validation and routine control at Baxter Healthcare Corporation is in compliance with ANSI/AAMI/ISO 11137-2.
These products are labeled "Sterile, nonpyrogenic." Package verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak.
Shelf-Life:
Baxter has provided aging tests to support a shelf-life claim of eighteen (18) months.
CONCLUSION:
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is currently marketed for the same intended use.