IV Fat Emulsion Administration Sets
Device Facts
| Record ID | K172544 |
|---|---|
| Device Name | IV Fat Emulsion Administration Sets |
| Applicant | Baxter Healthcare Corporation |
| Product Code | FPA · General Hospital |
| Decision Date | Sep 22, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Indicated for use when low plasticizer solubility is desired (e.g., for administration of high lipid content solutions such as parenteral fat emulsion).
Device Story
Single-use disposable IV administration sets; deliver fluids from container to patient vascular system via needle/catheter. Components: drip chamber (10 or 60 drops/mL), non-vented spike, non-DEHP PVC tubing, Luer lock, slide clamp, roller clamp. Used in clinical settings for gravity or pump infusion (e.g., Sigma Spectrum pumps). Operation: clinician inserts spike into fluid container, connects to patient access site, adjusts flow via clamps. Modifications include non-DEHP PVC tubing (using TOTM or DEHT plasticizers), sterile packaging, and 2-year shelf life. Benefits: reduced plasticizer leaching during lipid administration; maintains fluid delivery integrity.
Clinical Evidence
Bench testing only. Performance testing included solvent bond strength, air pressure, bubble tests, clamp shut-off/stability, occlusion tests, flow rate accuracy, and visual inspection after lipid exposure. Biocompatibility assessed per ISO 10993-1 and FDA guidance. Sterility validated per ANSI/AAMI/ISO 11137-2. Shelf life supported by aging testing.
Technological Characteristics
Materials: Non-DEHP PVC tubing (plasticizers: TOTM or DEHT), ABS (spike, Luer body), Stainless Steel 304 (cannula). Energy: Gravity or pump-driven. Connectivity: Compatible with Sigma Spectrum and other Baxter infusion pumps. Sterilization: Radiation (SAL 10^-6). Standards: ISO 10993-1, ANSI/AAMI/ISO 11137-2, ASTM F88, ASTM F2096.
Indications for Use
Indicated for patients requiring administration of high lipid content solutions (e.g., parenteral fat emulsion) where low plasticizer solubility is desired.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Low Plasticizer Solubility PVC Administration Set (K791496)
Reference Devices
Related Devices
- K042129 — F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK · Cedic S.R.L. · Jan 27, 2005
- K093773 — AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS · Amsino International, Inc. · Mar 10, 2010
- K121803 — INTRAVASCULAR ADMINISTRATION SET · Acta Medical, LLC · Dec 19, 2012
- K202437 — Infusion Sets for Single Use · Jiangsu Suyun Medical Materials Co., Ltd. · Mar 25, 2022
- K090012 — DISPOSABLE INFUSION SET · Shan Dong Wei Gao Group Medical Polymer Products · Jun 11, 2009
Submission Summary (Full Text)
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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.
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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
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#### 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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#### 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<br>86" (2.2 m) Approximately 10 drops/mL |
| 2C1146 | Non-DEHP IV Fat Emulsion Administration Set<br>86" (2.2 m) Approximately 60 drops/mL |
| 2R1145 | Non-DEHP IV Fat Emulsion Administration Set<br>86" (2.2 m) Approximately 10 drops/mL |
| 2R1146 | Non-DEHP IV Fat Emulsion Administration Set<br>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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#### PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---------------------------------------------------------|---------------------------------|------------------|----------------|
| Low Plasticizer<br>Solubility PVC<br>Administration Set | Travenol Laboratories,<br>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<br>Micron Air Eliminating<br>Filter | Baxter Healthcare<br>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<br>Administration Set 86" (2.2 m) Approximately 10<br>drops/mL | 1. Label Changes<br>2. Conversion to sterile packaging<br>3. Addition of Expiration Date |
| 2C1146 - Non-DEHP IV Fat Emulsion<br>Administration Set 86" (2.2 m) Approximately 60<br>drops/mL | 1. Label Changes<br>2. Conversion to sterile packaging<br>3. Addition of Expiration Date |
| 2R1145 - Non-DEHP IV Fat Emulsion<br>Administration Set 86" (2.2 m) Approximately 10<br>drops/mL | 1. Label Changes<br>2. Conversion to sterile packaging<br>3. Addition of Expiration Date<br>4. Use of Non-DEHP PVC Tubing<br>Material that uses Di (2-<br>Ethylhexyl) terephthalate as a<br>plasticizer |
| 2R1146 - Non-DEHP IV Fat Emulsion<br>Administration Set 86" (2.2 m) Approximately 60<br>drops/mL | 1. Label Changes<br>2. Conversion to sterile packaging<br>3. Addition of Expiration Date<br>4. Use of Non-DEHP PVC<br>Tubing Material that uses Di (2-<br>Ethylhexyl) terephthalate as a<br>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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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<br>(Cleared under<br>K791496) | Proposed Devices<br>(2C1145, 2C1146, 2R1145,<br>2R1146) | Assessment of Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The IV Fat Emulsion<br>Administration Sets are<br>indicated for use when<br>low plasticizer solubility<br>is desired (e.g., for<br>administration of high<br>lipid content solutions<br>such as parenteral fat<br>emulsion). | The IV Fat Emulsion<br>Administration Sets are<br>indicated for use when low<br>plasticizer solubility is<br>desired (e.g., for<br>administration of high lipid<br>content solutions such as<br>parenteral fat emulsion). | Same |
| Sterile | Yes | Yes | Same |
| Non-<br>Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Pump<br>Compatibility | Not identified in<br>submission | Yes, compatible with<br>SIGMA Spectrum and other<br>Baxter infusion pumps. | Pump compatibility was not<br>identified in the original<br>submission for the Predicate<br>Device. Proposed codes have<br>been tested for pump<br>compatibility. |
| Materials | | | |
| Non-vented<br>Spike | Not identified in<br>submission | Acrylonitrile Butadiene<br>Styrene | Materials were not identified<br>in the original submission for<br>the Predicate Device. The<br>material has been previously<br>cleared for the same intended<br>use. All materials that are<br>currently used have gone<br>through design control<br>activities which confirmed<br>there was no impact to the<br>safety or effectiveness of the<br>device due to any changes of<br>material. |
| Features | Predicate Device<br>(Cleared under<br>K791496) | Proposed Devices<br>(2C1145, 2C1146, 2R1145,<br>2R1146) | Assessment of Differences |
| Drip<br>Chamber | Not identified in<br>submission | Polyvinyl Chloride | Materials were not identified<br>in the original submission for<br>the Predicate Device. The<br>material has been previously<br>cleared for the same intended<br>use. All materials that are<br>currently used have gone<br>through design control<br>activities which confirmed<br>there was no impact to the<br>safety or effectiveness of the<br>device due to any changes of<br>material. |
| Non-DEHP<br>Tubing | Not identified in<br>submission | Material: Polyvinyl Chloride<br>Plasticizer: Tris (2-<br>Ethylhexyl) Trimellitate<br>(TOTM) (For codes 2C1145,<br>2C1146)<br>Plasticizer: Di (2-Ethylhexl)<br>Terephthalate (DEHT) (For<br>codes 2R1145, 2R1146) | Materials were not identified<br>in the original submission for<br>the Predicate Device. The<br>material has been previously<br>cleared for the same intended<br>use. All materials that are<br>currently used have gone<br>through design control<br>activities which confirmed<br>there was no impact to the<br>safety or effectiveness of the<br>device due to any changes of<br>material. |
| Cannula | Not identified in<br>submission | Stainless Steel 304 | Materials were not identified<br>in the original submission for<br>the Predicate Device. The<br>material has been previously<br>cleared for the same intended<br>use. Materials that are<br>currently used have gone<br>through design control<br>activities which confirmed<br>there was no impact to the<br>safety or effectiveness of the<br>device due to any changes of<br>material. |
| Features | Predicate Device<br>(Cleared under<br>K791496) | Proposed Devices<br>(2C1145, 2C1146, 2R1145,<br>2R1146) | Assessment of Differences |
| Two Piece<br>Luer Body | Not identified in<br>submission | Acrylonitrile Butadiene<br>Styrene | Materials were not identified<br>in the original submission for<br>the Predicate Device. The<br>material has been previously<br>cleared for the same intended<br>use. All materials that are<br>currently used have gone<br>through design control<br>activities which confirmed<br>there was no impact to the<br>safety or effectiveness of the<br>device due to any changes of<br>material. |
# Table 7. Device Comparison
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### 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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#### 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<br>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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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.
