(355 days)
No
The summary describes a disposable fluid administration set with a filter, focusing on material modifications and performance testing related to fluid flow, pressure, and biocompatibility. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as a "single use disposable device for administering fluids from container to a patient's vascular system" and "Used for the removal of particulate matter and elimination of air from infusion fluids while administering," indicating it's an accessory to fluid administration rather than a device intended to treat a disease or condition itself.
No
The device is described as a "Solution Set with 1.2 Micron Air Eliminating Filter" used for administering fluids and removing particulate matter/air. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines a physical medical device consisting of tubing, a filter, and connectors for administering fluids. The modifications described relate to the material of the tubing and packaging, 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 for administering fluids to a patient's vascular system and filtering those fluids. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of the fluid administration set and filter. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Keywords: There are no mentions of analyzing samples, detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device (K952074) is also described as a "Solution Set with 1.2 Micron Air Eliminating Filter," which aligns with a fluid administration device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to deliver fluids into the body, not to analyze samples from the body.
N/A
Intended Use / Indications for Use
For administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.
Product codes
FPA
Device Description
The Solution Set with 1.2 Micron Air Eliminating Filter product line consists of single use disposable device for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. The filter consists of a 1.2 micron filter consisting of polysulfone solution membrane and a Teflon air vent media enclosed in an acrylic housing and may be used with TPN solutions containing lipid emulsions. The 1.2 micron filter has a maximum pressure of 45 psi (2241 kPa). The Solution Set with 1.2 Micron Air Eliminating Filter was previously cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).
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
The following bench tests (Table 7) were conducted to evaluate the effect of using a proposed Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer. All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material.
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, Total Parenteral Nutrition (TPN) Resistance Test, Roller Clamp Flow Control Test, Administration Set Integrity Test After Maximum Fluid Delivery (Pump Compatibility Test), Flow Rate Accuracy Test (Pump Compatibility Test), ISO Luer Tests on Male Luer Lock Connectors.
Key results: All tests met the acceptance criteria. All pump testing performed with the Sigma Spectrum Pump.
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)]".
Biocompatibility Tests: In Vitro Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity Assay, Systemic Injection (Acute Toxicity), Sub-Chronic Toxicity (Repeat Dose), Material Mediated Pyrogen, Hemocompatibility (In Vitro Hemolysis), USP Physicochemical tests.
Key results: Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the Solution Sets with 1.2 Micron Air Eliminating Filter have been shown to be biocompatible and appropriate for their intended use.
The Solution Set with 1.2 Micron Air Eliminating Filter 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 using Method No. 1 as described in ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose."
Key results: These products are labeled “Sterile, Nonpyrogenic.” Package Verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak.
Baxter has provided aging testing to support a shelf-life claim of twenty-four (24) months.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2017
Baxter Healthcare Corporation Mr. John Lamela Regulatory Affairs Specialist 32650 North Wilson Road Round Lake, Illinois 60073
Re: K161808
Trade/Device Name: Solution Set with 1.2 Micron Air Eliminating Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 19, 2017 Received: May 22, 2017
Dear Mr. Lamela:
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.
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.
1
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,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161808
Device Name
Solution Set with 1.2 Micron Air Eliminating Filter
Indications for Use (Describe)
For administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
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| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K161808
June 19, 2017
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
John Lamela Regulatory Specialist, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270-2850 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Intravascular Administration Set Trade Name: Solution Set with 1.2 Micron Air Eliminating Filter Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA
Table 1. Product Codes for Solution Sets with 1.2 Micron Air Eliminating Filter
| Code Number | Name |
|---|---|
| 2C1103 | INTERLINK System Non-DEHP Extension Set with 1.2 Micron Downstream |
| Filter | |
| 2H8603 | CLEARLINK System Non-DEHP Extension Set |
| 2H8486 | CLEARLINK System Non-DEHP Solution Set |
| 2R8486 | CLEARLINK System Non-DEHP Solution Set |
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Image /page/4/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 the logo for the healthcare company Baxter International.
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Solution Set with 1.2 Micron | |||
| Air Eliminating Filter | Baxter Healthcare | ||
| Corporation | K952074 | July 27, 1995 |
Table 2. Predicate Device(s)
DESCRIPTION OF THE DEVICE:
The Solution Set with 1.2 Micron Air Eliminating Filter product line consists of single use disposable device for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. The filter consists of a 1.2 micron filter consisting of polysulfone solution membrane and a Teflon air vent media enclosed in an acrylic housing and may be used with TPN solutions containing lipid emulsions. The 1.2 micron filter has a maximum pressure of 45 psi (2241 kPa). The Solution Set with 1.2 Micron Air Eliminating Filter was previously cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).
The basis for this premarket notification is modifications to the Solution Set with 1.2 Micron Air Eliminating Filter product line. The modifications consists of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer to provide an alternate to the current Non-DEHP PVC tubing material, conversion to sterile packaging, addition of an expiration date, and updates to the labeling.
| Code and Description | Change Summary |
|---|---|
| 2C1103 – INTERLINK System Non-DEHP Extension Set | |
| with 1.2 Micron Downstream Filter | 1. Label Changes |
- Packaging Change
- Addition of Exp. Date |
| 2H8603 - CLEARLINK System Non-DEHP Extension Set | 1. Label Changes - Packaging Change
- Addition of Exp. Date |
| 2H8486 - CLEARLINK System Non-DEHP Solution Set | 1. Label Changes - Packaging Change
- Addition of Exp. Date |
| 2R8486 - CLEARLINK System Non-DEHP Solution Set | 1. Label Changes - Packaging Change
- Addition of Exp. Date |
Table 3. Summary of Proposed Changes per Product Code
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Image /page/5/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 centered and takes up most of the image.
| Code and Description | Change Summary |
|---|---|
| 4. Use of Non-DEHP PVC Tubing Material | |
| that uses Di (2-Ethylhexyl) terephthalate as a | |
| plasticizer |
Table 3. Summary of Proposed Changes per Product Code
These modifications do not impact the intended use or the fundamental technology of the devices. The product labels are being updated to revise statements regarding latex and pump device references, add the indications for use statement that was previously cleared for this device (K952074 - cleared July 27, 1995), include expiration dating, change from "fluid path is sterile" to "sterile" (sterile packaging), and implement other modifications to comply with Baxter's labeling standards. Note: The indications for use statement from the previously cleared 510(k) was modified, per the FDAs recommendation, to include the description in 21 CFR 880.5440.
Table 4. Set Configuration Using Proposed Non-DEHP PVC Tubing Material
| Device Description | Code Number |
|---|---|
| CLEARLINK System Non-DEHP Solution Set | |
| Image: CLEARLINK System Non-DEHP Solution Set | 2R8486 |
Table 5. Set Configuration of Current Codes
| Device Description | Code Number |
|---|---|
| INTERLINK System Non-DEHP Extension Set with 1.2 Micron Downstream Filter | 2C1103 |
| CLEARLINK System Non-DEHP Extension Set | 2H8603 |
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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 blurred, giving it a sense of depth. The background is white.
Image /page/6/Figure/1 description: This image shows a table with two columns, "Device Description" and "Code Number". The device description is "CLEARLINK System Non-DEHP Solution Set", and there is a diagram of the device below the text. The code number for this device is "2H8486".
Table 5. Set Configuration of Current Codes
INDICATIONS FOR USE:
For administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.
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 K952074 (cleared July 27, 1995).
DEVICE COMPARISON TABLE:
The comparison table below identifies similarities and differences of the proposed devices to the current legally marketed devices to which substantial equivalency is claimed.
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| | Features | Predicate Device
(K952074) | Proposed Devices | Assessment of
Differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for use | The Baxter solution
administration sets with
1.2 micron Supor IV-3
filter will be used for the
removal of particulate
matter and elimination of
air from infusion fluids.
The 1.2 micron filter sets
may be used with TPN
solutions containing lipid
emulsions. | For administering fluids
from a container to a
patient's vascular system
through a vascular access
device. Used for the
removal of particulate
matter and elimination of
air from infusion fluids
while administering. May
be used with TPN
solutions containing lipid
emulsions. | Alignment of language
provided in 21 CFR
880.5440.
In addition, reference to
trade name (Supor IV-3)
filter was removed since
this name is no longer
used (filter remains the
same).
These administrative
changes have no impact
to safety or effectiveness
of the device. |
| | Sterile | Yes | Same | No difference |
| | Non-Pyrogenic | Yes | Same | No difference |
| | Single Use | Yes | Same | No difference |
| | Materials | | | |
| | Solution
Membrane | Polysulfone | Same | No difference |
| 1.2
Micron
Filter | Air Vent
Membrane | Teflon | Same | No difference |
| | Housing | Acrylic
(Polymethyl
Methacrylate) | Same | No difference |
| | Spike | | Acrylonitrile Butadiene
Styrene | Same |
| | Non-DEHP Drip
Chamber | Polyvinyl Chloride | Same | No difference |
| Features | Predicate Device
(K952074) | Proposed Devices | Assessment of
Differences | |
| Female Luer Lock
Connector | N/A | Blend of Copolyester and
Hytrel | The predicate device does
not have a female luer
lock connector. Design
control activities
confirmed there was no
impact to the safety or
effectiveness of the
device due to this change. | |
| Non-DEHP Tubing1
(used on codes
2H8486, 2C1103,
and 2H8603) | Material: Polyvinyl
Chloride
Plasticizer: Tris (2-
Ethylhexyl) Trimellitate | Same | No difference | |
| Non-DEHP Tubing2
(used on code
2R8486) | N/A | Material: Polyvinyl
Chloride
Plasticizer: Di (2-
Ethylhexyl) terephthalate | This is the basis of this
submission: modification
consisting of the use of a
Non-DEHP PVC tubing
material that uses Di (2-
Ethylhexyl) terephthalate
as a plasticizer.
Design control activities
have confirmed there is
no impact to the safety or
effectiveness for the new
material. | |
| Interlink Y-Site | N/A | Copolyester (Housing)
Synthetic polyisoprene
(Septum) | The predicate device does
not have an Interlink Y-
Site. Design control
activities confirmed there
was no impact to the
safety or effectiveness of
the device due to this
change. | |
| Clearlink Y-Site | N/A | Silicone Rubber (Gland)
Polycarbonate (Housing,
Housing Inlet, and Center
Post) | The predicate device does
not have a Clearlink Y-
Site. Design control
activities confirmed there
was no impact to the
safety or effectiveness of
the device due to this
change. | |
| Features | Predicate Device
(K952074) | Proposed Devices | Assessment of
Differences | |
| Two-Piece Male
Luer Lock
Connector | N/A | Acrylonitrile Butadiene
Styrene | The predicate device does
not have a Two-Piece
Male Luer Lock
Connector. Design control
activities confirm the
device meets the
functional test
requirements when used
in accordance with the
instructions for use. | |
| One-Piece Male
Luer Lock
Connector | Acrylonitrile Butadiene
Styrene | Same | No difference | |
Table 6. Device Comparison
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and the letters are closely spaced together.
Table 6. Device Comparison
1 Non-DEHP tubing material for current codes (2H8486, 2C1103, and 2H8603).
2 Non-DEHP tubing material for proposed code (2R8486).
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Table 6. Device Comparison
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 (Table 7) were conducted to evaluate the effect of using a proposed Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer. All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material.
| 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. |
Table 7. Performance Testing Summary
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| Test | Acceptance Criteria |
|---|---|
| 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. |
| Total Parenteral Nutrition (TPN) Resistance Test | Per Baxter Test Method. |
| Roller Clamp Flow Control Test | Per Baxter Test Method. |
| Administration Set Integrity Test After Maximum Fluid Delivery | |
| (Pump Compatibility Test) | Per Baxter Test Method. |
| Flow Rate Accuracy Test (Pump Compatibility Test) | Per Baxter Test Method. |
| ISO Luer Tests on Male Luer Lock Connectors | Per ISO Standard 594 |
Table 7. Performance Testing Summary
Note: All pump testing performed with the Sigma Spectrum Pump.
All tests met the acceptance criteria.
Biocompatibility:
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 Biocompatibility Tests and the applicable standards are listed in Table 8.
Table 8. Biocompatibility Tests and Applicable Standards
| Biocompatibility Test | Applicable Standard |
|---|---|
| In Vitro Cytotoxicity | ISO10993-5 |
| Sensitization | ISO10993-10 |
| Intracutaneous (Irritation) Reactivity Assay | ISO10993-10 |
| Systemic Injection (AcuteToxicity) | ISO10993-11 |
| Sub-Chronic Toxicity (Repeat Dose) | ISO10993-11 |
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Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif, and the letters are closely spaced together.
| Biocompatibility Test | Applicable Standard |
|---|---|
| Material Mediated Pyrogen | ISO10993-11 |
| Hemocompatibility (In Vitro Hemolysis) | ISO10993-4 |
| USP Physiochemical tests | USP |
Table 8. Biocompatibility Tests and Applicable Standards
Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the Solution Sets with 1.2 Micron Air Eliminating Filter have been shown to be biocompatible and appropriate for their intended use.
Sterilitv
The Solution Set with 1.2 Micron Air Eliminating Filter 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 using Method No. 1 as described in 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 provided aging testing to support a shelf-life claim of twenty-four (24) months.
CONCLUSION:
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed.