(30 days)
No
The device description and performance studies focus on the physical components and functionality of an IV administration set, with no mention of AI or ML technologies.
No
The device is an administration set for fluids, not a device that provides therapy. It is used to deliver substances to the patient, but does not itself provide a therapeutic effect.
No
The device description indicates that it is an administration set for fluids, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components such as tubing, drip chambers, clamps, and Luer locks, 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:
- IVDs are used to examine specimens derived from the human body. The device description clearly states that this device is for the "administration of fluids from a container into the patient's vascular system". This is a therapeutic or delivery function, not a diagnostic one involving the analysis of bodily samples.
- The intended use is for administering fluids. The primary purpose is to deliver solutions, particularly those with high lipid content, into the patient's bloodstream. This is a direct treatment or support function.
- There is no mention of analyzing or testing any biological samples. The description focuses on the physical components and their function in fluid delivery.
Therefore, this device falls under the category of a medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion).
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Non-DEHP IV Fat Emulsion Administration 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 needle or catheter inserted into a vein. The Non-DEHP IV Fat Emulsion Administration Sets are indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion). These sets are comprised of a drip chamber with a non-vented spike, non-DEHP polyvinyl chloride (PVC) tubing, and a two piece Luer lock. On all sets there is a fixture slide clamp and a regulating roller clamp. Configurations of these sets differ in drip chamber (60 drops/mL or 10 drops/mL). These devices are nonpyrogenic, sterile and can be used for gravity or pump infusion of I.V. fluids using Sigma Spectrum and other Baxter Infusion Pumps. The Non-DEHP IV Fat Emulsion Administration Sets were previously cleared on April 8, 1980 under 510(k) premarket notification "Low Plasticizer Solubility PVC Administration Sets" (K791496).
The basis for this premarket notification is modifications to the Non-DEHP IV Fat Emulsion Administration Sets product line. The modifications consist of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer, conversion to sterile packaging, and the addition of an expiration date. The proposed Non-DEHP PVC tubing material is currently used in Baxter's Solution Sets with 1.2 Micron Air Eliminating Filter and has been previously cleared under 510(k) premarket notification K161808 (cleared June 21, 2017).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 performed on subject device model code set configurations 2R1145 and 2R1146 in order to mitigate risks such as leaks, under/over infusion, failure to shut-off flow, interruption of therapy, air infused into patient, exposure to toxic materials, exposure to non-sterile product, exposure to endotoxins or pyrogens, set is not sterile and product not functioning during shelflife. This testing that was performed for the proposed Non-DEHP PVC tubing material mitigated these risks so the devices are substantially equivalent to the predicate and can meet their intended use.
All testing described in this section was performed on codes that are listed in this submission or a worst case/representative sample. Worst case/representative samples were chosen because of having characteristics that are the same as the proposed device (e.g. -same components, same materials, same dimensions, and clamp/tubing interface).
Tests performed: Solvent Bond Tensile Strength Test, Solvent Bond Air Pressure Test, Continuous Bubble Test (Pump Compatibility Test), Accumulated Bubble Test (Pump Compatibility Test), Slide Clamp Shut-Off Test, Slide Clamp Shut-Off Test-Post 24 Hour, Slide Clamp 7 Day Subsystem and Tubing Damage Test, Slide Clamp Flow Stability Test, Slide Clamp Tug Stability Test, Upstream Occlusion Test (Pump Compatibility Test), Downstream Occlusion Test (Pump Compatibility Test), Roller Clamp Force Test, Roller Clamp Shut-Off Test, Roller Clamp 7 Day Subsystem and Tubing Damage Test, Roller Clamp Flow Stability Test, Roller Clamp Tug Stability Test, Roller Clamp Flow Control Test, Administration Set Integrity Test After Maximum Fluid Delivery, Visual Inspection For Structural Damage After 24 hours Exposure to Lipids, Flow Rate Accuracy (Pump Compatibility Test), Non-DEHP Claim Verification.
All tests met the acceptance criteria.
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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Baxter Healthcare Corporation Jill Laack Regulatory Affairs Specialist 32650 N. Wilson Road Round Lake, Illinois 60073
Re: K172544
Trade/Device Name: Non-DEHP IV Fat Emulsion Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 21, 2017 Received: August 23, 2017
Dear Jill Laack:
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.
Image /page/0/Picture/10 description: The image is a seal for the U.S. Department of Health & Human Services. 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 three faces in profile, stacked on top of each other.
1
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 (QS) 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 (DICE) 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 (DICE) 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,
Tina
Kiang-S
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)
K172544
Device Name Non-DEHP IV Fat Emulsion Administration Sets
Indications for Use (Describe)
Indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion).
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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Image /page/3/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right.
K172544
Section 5. 510(k) Summary
September 22, 2017
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Jill M. Laack Regulatory Specialist, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270-2686 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Intravascular Administration Sets Trade Name: Non-DEHP IV Fat Emulsion Administration Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA
| Code Number | Name |
|---|---|
| 2C1145 | Non-DEHP IV Fat Emulsion Administration Set |
| 86" (2.2 m) Approximately 10 drops/mL | |
| 2C1146 | Non-DEHP IV Fat Emulsion Administration Set |
| 86" (2.2 m) Approximately 60 drops/mL | |
| 2R1145 | Non-DEHP IV Fat Emulsion Administration Set |
| 86" (2.2 m) Approximately 10 drops/mL | |
| 2R1146 | Non-DEHP IV Fat Emulsion Administration Set |
| 86" (2.2 m) Approximately 60 drops/mL |
Table 1.Device Model Code(s) Non-DEHP IV Fat Emulsion Administration Sets
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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly italicized, giving the word a sense of movement. The word is likely a logo or brand name, given its prominent display.
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Low Plasticizer | |||
| Solubility PVC | |||
| Administration Set | Travenol Laboratories, | ||
| S.A.1 | K791496 | April 8, 1980 |
Table 2. Predicate Device
1 Travenol Laboratories, S.A. became Baxter Healthcare Corporation in 1988
Table 3. Reference 510(k)
| Device | Company | Reference 510(k) | Clearance Date |
|---|---|---|---|
| Solution Set With 1.2 | |||
| Micron Air Eliminating | |||
| Filter | Baxter Healthcare | ||
| Corporation | K161808 | June 21, 2017 |
DESCRIPTION OF THE DEVICE:
The Non-DEHP IV Fat Emulsion Administration 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 needle or catheter inserted into a vein. The Non-DEHP IV Fat Emulsion Administration Sets are indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion). These sets are comprised of a drip chamber with a non-vented spike, non-DEHP polyvinyl chloride (PVC) tubing, and a two piece Luer lock. On all sets there is a fixture slide clamp and a regulating roller clamp. Configurations of these sets differ in drip chamber (60 drops/mL or 10 drops/mL). These devices are nonpyrogenic, sterile and can be used for gravity or pump infusion of I.V. fluids using Sigma Spectrum and other Baxter Infusion Pumps. The Non-DEHP IV Fat Emulsion Administration Sets were previously cleared on April 8, 1980 under 510(k) premarket notification "Low Plasticizer Solubility PVC Administration Sets" (K791496).
The basis for this premarket notification is modifications to the Non-DEHP IV Fat Emulsion Administration Sets product line. The modifications consist of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer, conversion to sterile packaging, and the addition of an expiration date. The proposed Non-DEHP PVC tubing material is currently used in Baxter's Solution Sets with 1.2 Micron Air Eliminating Filter and has been previously cleared under 510(k) premarket notification K161808 (cleared June 21, 2017).
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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The overall impression is of a clean and professional logo.
The product labels are being updated to include compatible infusion pump device references, the addition of the indications for use statement, the addition of a latex statement, the addition of an expiration date, a change to the sterility claim, and to implement other clarifying information and modifications to comply with Baxter's labeling standards and other labeling enhancements.
See Table 4 for a summary of the proposed changes to the codes that are part of this premarket notification.
| Code and Description | Change Summary |
|---|---|
| 2C1145 - Non-DEHP IV Fat Emulsion | |
| Administration Set 86" (2.2 m) Approximately 10 | |
| drops/mL | 1. Label Changes |
- Conversion to sterile packaging
- Addition of Expiration Date |
| 2C1146 - Non-DEHP IV Fat Emulsion
Administration Set 86" (2.2 m) Approximately 60
drops/mL | 1. Label Changes - Conversion to sterile packaging
- Addition of Expiration Date |
| 2R1145 - Non-DEHP IV Fat Emulsion
Administration Set 86" (2.2 m) Approximately 10
drops/mL | 1. Label Changes - Conversion to sterile packaging
- Addition of Expiration Date
- Use of Non-DEHP PVC Tubing
Material that uses Di (2-
Ethylhexyl) terephthalate as a
plasticizer |
| 2R1146 - Non-DEHP IV Fat Emulsion
Administration Set 86" (2.2 m) Approximately 60
drops/mL | 1. Label Changes - Conversion to sterile packaging
- Addition of Expiration Date
- Use of Non-DEHP PVC
Tubing Material that uses Di (2-
Ethylhexyl) terephthalate as a
plasticizer |
Table 4. Summary of Proposed Changes per Device Model Code
These modifications do not impact the intended use or the fundamental technology of the devices.
See Table 5 for the subject device model code set configuration that will utilize the proposed Non-DEHP PVC tubing material. Table 6 contains the remaining subject device model code set configurations that are part of this premarket notification.
Table 5. Set Configuration Using Proposed Non-DEHP PVC Tubing Material
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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of forward motion.
Image /page/6/Figure/1 description: The image shows a medical device called a Non-DEHP IV Fat Emulsion Administration Set. The set is 86 inches (2.2 m) long and delivers approximately 60 drops/mL. The image also contains the code 2R1146.
Table 6. Set Configuration of Current Codes
Image /page/6/Figure/3 description: The image shows a table with two rows describing medical devices. The first row describes a Non-DEHP IV Fat Emulsion Administration Set 86" (2.2 m) that dispenses approximately 10 drops/mL, with a code number of 2C1145. The second row describes a similar device, also a Non-DEHP IV Fat Emulsion Administration Set 86" (2.2 m), but this one dispenses approximately 60 drops/mL and has a code number of 2C1146.
INDICATIONS FOR USE:
Indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion).
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices have equivalent technological characteristics as Baxter's current legally marketed device cleared under 510(k) premarket notification K791496 (cleared April 8, 1980).
DEVICE COMPARISON TABLE:
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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly slanted to the right. The word is likely a logo or brand name.
Table 7 provides a comparison of the (predicate) device and the proposed devices. This comparison identifies similarities and differences of the proposed devices to the current legally marketed devices to which substantial equivalency is claimed.
| Features | Predicate Device
(Cleared under
K791496) | Proposed Devices
(2C1145, 2C1146, 2R1145,
2R1146) | Assessment of Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The IV Fat Emulsion
Administration Sets are
indicated for use when
low plasticizer solubility
is desired (e.g., for
administration of high
lipid content solutions
such as parenteral fat
emulsion). | The IV Fat Emulsion
Administration Sets are
indicated for use when low
plasticizer solubility is
desired (e.g., for
administration of high lipid
content solutions such as
parenteral fat emulsion). | Same |
| Sterile | Yes | Yes | Same |
| Non-
Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Pump
Compatibility | Not identified in
submission | Yes, compatible with
SIGMA Spectrum and other
Baxter infusion pumps. | Pump compatibility was not
identified in the original
submission for the Predicate
Device. Proposed codes have
been tested for pump
compatibility. |
| Materials | | | |
| Non-vented
Spike | Not identified in
submission | Acrylonitrile Butadiene
Styrene | Materials were not identified
in the original submission for
the Predicate Device. The
material has been previously
cleared for the same intended
use. All materials that are
currently used have gone
through design control
activities which confirmed
there was no impact to the
safety or effectiveness of the
device due to any changes of
material. |
| Features | Predicate Device
(Cleared under
K791496) | Proposed Devices
(2C1145, 2C1146, 2R1145,
2R1146) | Assessment of Differences |
| Drip
Chamber | Not identified in
submission | Polyvinyl Chloride | Materials were not identified
in the original submission for
the Predicate Device. The
material has been previously
cleared for the same intended
use. All materials that are
currently used have gone
through design control
activities which confirmed
there was no impact to the
safety or effectiveness of the
device due to any changes of
material. |
| Non-DEHP
Tubing | Not identified in
submission | Material: Polyvinyl Chloride
Plasticizer: Tris (2-
Ethylhexyl) Trimellitate
(TOTM) (For codes 2C1145,
2C1146)
Plasticizer: Di (2-Ethylhexl)
Terephthalate (DEHT) (For
codes 2R1145, 2R1146) | Materials were not identified
in the original submission for
the Predicate Device. The
material has been previously
cleared for the same intended
use. All materials that are
currently used have gone
through design control
activities which confirmed
there was no impact to the
safety or effectiveness of the
device due to any changes of
material. |
| Cannula | Not identified in
submission | Stainless Steel 304 | Materials were not identified
in the original submission for
the Predicate Device. The
material has been previously
cleared for the same intended
use. Materials that are
currently used have gone
through design control
activities which confirmed
there was no impact to the
safety or effectiveness of the
device due to any changes of
material. |
| Features | Predicate Device
(Cleared under
K791496) | Proposed Devices
(2C1145, 2C1146, 2R1145,
2R1146) | Assessment of Differences |
| Two Piece
Luer Body | Not identified in
submission | Acrylonitrile Butadiene
Styrene | Materials were not identified
in the original submission for
the Predicate Device. The
material has been previously
cleared for the same intended
use. All materials that are
currently used have gone
through design control
activities which confirmed
there was no impact to the
safety or effectiveness of the
device due to any changes of
material. |
Table 7. Device Comparison
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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The overall impression is of a clean and professional logo.
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 the acceptance criteria, and support that the proposed devices are appropriately designed for their intended use. All testing was performed on the configuration of the devices presented in this premarket notification.
Performance Data:
The following bench tests (Table 8) were performed on subject device model code set configurations 2R1145 and 2R1146 (Table 5) in order to mitigate risks such as leaks, under/over infusion, failure to shut-off flow, interruption of therapy, air infused into patient, exposure to toxic materials, exposure to non-sterile product, exposure to endotoxins or pyrogens, set is not sterile and product not functioning during shelflife. This testing that was performed for the proposed Non-DEHP PVC tubing material mitigated these risks so the devices are substantially equivalent to the predicate and can meet their intended use.
All testing described in this section was performed on codes that are listed in this submission or a worst case/representative sample. Worst case/representative samples were chosen because of having characteristics that are the same as the proposed device (e.g. -same components, same materials, same dimensions, and clamp/tubing interface).
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Image /page/10/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, with the letters slanting slightly to the right. The word is presented in a simple, clean design, with no additional graphics or elements surrounding it.
Table 8. Performance Testing Summary
| Test | Acceptance Criteria |
|---|---|
| Solvent Bond Tensile Strength Test | Per Baxter Test Method. |
| Solvent Bond Air Pressure Test | Per Baxter Test Method. |
| Continuous Bubble Test (Pump Compatibility Test) | Per Baxter Test Method. |
| Accumulated Bubble Test (Pump Compatibility Test) | Per Baxter Test Method. |
| Slide Clamp Shut-Off Test | Per Baxter Test Method. |
| Slide Clamp Shut-Off Test-Post 24 Hour | Per Baxter Test Method. |
| Slide Clamp 7 Day Subsystem and Tubing Damage Test | Per Baxter Test Method. |
| Slide Clamp Flow Stability Test | Per Baxter Test Method. |
| Slide Clamp Tug Stability Test | Per Baxter Test Method. |
| Upstream Occlusion Test (Pump Compatibility Test) | Per Baxter Test Method. |
| Downstream Occlusion Test (Pump Compatibility Test) | Per Baxter Test Method. |
| Roller Clamp Force Test | Per Baxter Test Method. |
| Roller Clamp Shut-Off Test | Per Baxter Test Method. |
| Roller Clamp 7 Day Subsystem and Tubing Damage Test | Per Baxter Test Method. |
| Roller Clamp Flow Stability Test | Per Baxter Test Method. |
| Roller Clamp Tug Stability Test | Per Baxter Test Method. |
| Roller Clamp Flow Control Test | Per Baxter Test Method. |
| Administration Set Integrity Test After Maximum Fluid Delivery | Per Baxter Test Method |
| Visual Inspection For Structural Damage After 24 hours Exposure | |
| to Lipids | Per Baxter Test Method |
| Flow Rate Accuracy (Pump Compatibility Test) | Per Baxter Test Method |
| Non-DEHP Claim Verification | Per Baxter Test Method |
Note: All pump compatibility testing was performed with the Sigma Spectrum Pump All tests met the acceptance criteria.
Biocompatibility:
The following cleared 510k submissions: K161808, K153158, and K130245 have identical materials and similar intended uses compared to this Non-DEHP I.V. Fat Emulsion Administration Sets premarket notification. All the devices in these submissions have similar risks that were adequately mitigated through testing to show the devices are substantially equivalent to the predicate and meet their intended use.
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Image /page/11/Picture/0 description: The image shows the word "Baxter" in a stylized, bold, blue font. The font appears to be italicized, with the letters slanted to the right. The color of the text is a vibrant blue, which stands out against the white background. The word is easily readable and takes up a significant portion of the image.
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path, and Blue Book Memorandum G95-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as recommended in the IV Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]''.
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.
Sterility
The Intravenous (IV) Fat Emulsion Administration Set product line is sterilized with 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 facility as described in ANSI/AAMI/ISO ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose."
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 performed aging testing to support a shelf-life claim of 2 (two) years.
CONCLUSION:
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed.