(123 days)
No
The device description and performance studies focus on the physical and functional characteristics of an extension set and needle-free connector, with no mention of AI or ML.
No.
The device (Extension Set with needle-free connector) is used for the administration of drugs, blood, or fluids, which means it facilitates a therapeutic process but is not a therapeutic device itself.
No
Explanation: The device, described as an "Extension Set with needle-free connector(s)", is intended for direct injection, intermittent infusion, continuous infusion, or aspiration of drugs, blood, or fluids. Its function is to administer or aspirate substances, not to diagnose medical conditions or provide diagnostic information.
No
The device description and performance studies clearly indicate this is a physical medical device (extension set with needle-free connectors) and not a software-only device. The testing performed relates to physical properties, sterility, and material compatibility.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the direct, intermittent, or continuous infusion or aspiration of drugs, blood, or fluids. This describes a device used in vivo (within the body) for delivering or removing substances.
- Device Description: The description reinforces the intended use by mentioning infusion and aspiration of drugs, blood, or fluids. It also describes features related to connecting to patients and preventing needle stick injuries, all consistent with in vivo use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
The device described is an infusion/extension set, which is a medical device used for administering fluids or medications directly to a patient. This is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direction, intermittent infusion, continuous infusion, or aspiration.
Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are Extension Sets that are intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood or fluids. All Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) has a Neutraclear connector that is removable or bonded to the extension set tubing. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) allows thorough and easy disinfection due to a solid flat smooth surface and eliminates the risk of needle stick injuries. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are sterile single patient devices that can be used for 200 activations and for 7 days. All extension set included are not made from natural rubber latex or DEHP.
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
pediatrics
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 FDA recognized performance standards and guidance were performed in evaluating the functionality of Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s):
- ISO 8536-4:2013 Infusion equipment for medical use- Part 4: Infusion set for single use, gravity feed
- ISO8536-8:2015 Infusion equipment for medical use - part 8 : Infusion sets for single use with pressure infusion apparatus
- ISO 8536-9:2015 Infusion equipment for medical use – part 9: Fluid lines for single use with pressure infusion equipment
- ISO8536-10:2015 applies to sterilized infusion set for use with pressure infusion equipment up to maximum of 200kPa (2 bar)
- Particulate contamination
- Tensile strength
- Filter for fluid
- Infusion liquid flow rate
- Absence of air bubble
- Leakage test
- Test of 200 connections and disconnections
- Alcohol: alcohol-resistant
- Lipids : Lipid-resistant 7 days
- Disinfection with isopropyl alcohol 70% (disinfection of valve)
- Resist to 325psi for the pressure rated extension sets
- ISO594-1:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment - Part 1 General requirements
- ISO594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other
- medical equipment part 2 Locking fittings
- Dimensions of male and female connectors in accordance with the table and diagrams in standard ISO594-1
- Liquid leaks
- Air leaks
- Force of separation
- Unscrewing torque
- Resistance to thread stripping
- Cracks due to pressure
- medical equipment part 2 Locking fittings
- ISO14971:2013 Medical devices- Quality management systems- Requirements for regulatory purposes
- ISO 10993-1:2009, Biological evaluation of medical devices – part 1: Evaluation and testing within a risk management process
- Cytotoxicity
- Intracutaneous injection
- Systemic injection
- Sensitization (Kligman Maximization Test)
- Hemolysis
- Hemocompatibility
- Pyrogenicity test
- Particulate contamination
- Limulus Amebocyte Lysate test (endotoxin)
- Extractable and leachable agent extraction test
- ISO 11135:2007 Standard: "Sterilization of Healthcare Products - Ethylene Oxide" : validation of the sterilization process with ethylene oxide according to the half-cycle method
- Bioberdum test
- Sterility Test
- EOR and ECH residual tests
- ISO 11607 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Part2: Validation requirements for forming, sealing and assembly processes
- Sterility barrier after aging
The following functional performance testing has been carried out to demonstrate that the device performs as intended:
- Microbial ingress and barrier testing (FDA Guidance for Industry and FDA Staff : Intravascular Administration Sets Premarket Notification Submission [510(k)])
- Hemolysis testing (ISO 10993-4)
- Shelf life performance testing (ISO 8536-4, ISO 8536-10, ISO 11607-1, ISO 11607-2)
- Harsh Infusates testing (ISO 8536-4, ISO 8536-10)
- Priming volume (dead volume)/ flow rate testing (ISO 8536)
- Sterilization validation testing (ISO 11135)
- Pressure resistance testing (internal testing method)
A sterilization validation has been performed and a shelf life testing has been conducted.
Key results: The results of the non-clinical testing exhibited that Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices.
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple and monochromatic.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2017
Cair L.G.L. Delphine Molinari Official Correspondent 1, Allée des Chevreuils Parc Tertiaire de Bois Dieu 69380 Lissieu FRANCE
Re: K171118
Trade/Device Name: Carefusion Neutraclear™ multi-fuse Extension Set with Needle-free Connector(s) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: June 21, 2017 Received: July 10, 2017
Dear Delphine Molinari:
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. Isting 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
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 device-related 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 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" (21CFR 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,
Tara A. Ryan -S
for Lori Wiggin, CPT 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
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171118
Device Name
Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s)
Indications for Use (Describe)
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direction, intermittent infusion, continuous infusion, or aspiration.
Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
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Image /page/4/Picture/0 description: The image shows a logo with a purple color scheme. The logo features a circle with a purple dot above it, and a stylized purple shape that resembles a wing or a stylized letter. To the right of the logo is the text "CAIR L.G.L.", also in purple.
l. Submitter's Identification
Submitter Name: Cair L.G.L Adressa: 1, allée des chevreuils, Parc tertiaire de Bois Dieu- 69380 Lissieu, France Contact Person: Delphine Molinari Telephone number: +33-0-478-437-744 Fax Number: +33-0-478-437-707 E-mail: dmolinari@cairlgl.fr Date of Preparation: August 3rd 2017
II. Identification of the device
Subject Device
Trade Name: Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) Common Name: IV Extension Set Classification Name: Intravascular administration set Product Code: FPA Regulation: 21 CFR 880.5440 Device Class: II 510k Number : K171118
Predicate Device
Trade Name: MaxZero Extension Set with Needleless connector Common Name: IV Extension Set Classification Name: Intravascular administration set Product Code: FPA Regulation: 21 CFR 880.5440 Device Class: II 510k Number: K140831
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Image /page/5/Picture/0 description: The image shows a logo for CAIR L.G.L. The logo is purple and features a circle with a dot above it and a triangle inside. The text "CAIR L.G.L." is to the right of the circle.
III. Device Description
Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are Extension Sets that are intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood or fluids. All Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) has a Neutraclear connector that is removable or bonded to the extension set tubing. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) allows thorough and easy disinfection due to a solid flat smooth surface and eliminates the risk of needle stick injuries. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are sterile single patient devices that can be used for 200 activations and for 7 days. All extension set included are not made from natural rubber latex or DEHP.
IV. Indication for Use
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.
V. Technological Characteristics
Similarities between the predicate device and the subject device:
The subject device will have the same indication for use, principles of operation, same duration of use and the same resistance to pressure injectors (325psi with a flow rate of 10ml per second) as the predicate device.
Difference between the predicate device and the subject device:
The subject device will have a different sterilization method as the predicate device (but the sterilization method has been verified and validated by testing to demonstrate the subject device is sufficient for its intended use and therefore substantially equivalent to the predicate device).
For more details, please see below for a comparison table of the Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) and the predicate device.
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Image /page/6/Picture/0 description: The image shows a logo with the text "CAIR L.G.L.". To the left of the text is a purple graphic. The graphic consists of a circle with a filled-in circle at the top, and a triangle shape that intersects the circle.
Substantial Equivalence Table
| | Carefusion NeutraClear™
multi-fuse Extension Set
with needle-free
connector(s), (Subject
Device) | MaxZero Extension Set
with Needleless
Connector | Substantial
Equivalence |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| FDA Reg.
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Equivalent |
| FDA
Requlation
Name | Intravascular Administration
Set | Intravascular Administration
Set | Equivalent |
| FDA Class | Class II | Class II | Equivalent |
| FDA Product
Code | FPA | FPA | Equivalent |
| Product
Description | Carefusion NeutraClear™
multi-fuse Extension Set with
needle-free connector are
sterile, single patient use,
including pediatrics and
immunocompromised
patients for direct inject,
intermittent infusion,
continuous infusion or
aspiration of drugs, blood
and fluids | MaxZero Extension Set with
Needleless Connector and
the predicate devices are
sterile, single patient use,
including pediatrics and
immunocompromised
patients for direct inject,
intermittent infusion,
continuous infusion or
aspiration of drugs, blood
and fluids | Equivalent |
| Intended
Use | Carefusion NeutraClear™
multi-fuse Extension Set with
needle-free connector is a
sterile single patient use
device intended to be used
for the delivery and/or
aspiration of fluids to/from
an IV catheter. | The MaxZero Extension Set
With Needleless Connector is
a sterile single patient use
device intended to be used
for the delivery and/or
aspiration of fluids to/from
an IV catheter. | Equivalent |
| Indications
for Use | Non Pressure Rated: The
Carefusion NeutraClear™
multi-fuse Extension Set with
needle-free connector is for
single use only. The
extension set may be used
for direct injection,
intermittent infusion,
continuous infusion or
aspiration.
Pressure Rated: The
Carefusion NeutraClear™
multi-fuse Extension Set with | Non Pressure Rated: The
MaxZero multi fuse extension
set with needleless
connector(s) is for single use
only. The extension set may
be used for direct injection,
intermittent infusion,
continuous infusion or
aspiration.
Pressure Rated: The
MaxZero multi fuse extension
set with needleless
connector(s) is for single use | Equivalent |
| | needle-free connector is for
single use only. The | only. The extension set may
be used for direct injection, | |
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Image /page/7/Picture/0 description: The image shows a logo for CAIR L.G.L. The logo is purple and features a circle with a dot on top and a triangle pointing down. The text "CAIR L.G.L." is written in a stylized font to the right of the circle and triangle.
| CareFusion NeutraClear™ multi-fuse Extension Sets with needle-free connector(s) | |
|---|---|
| | extension set can be used for
direct injection, intermittent
infusion, continuous infusion
or aspiration. This set may
be used with power injector
procedures to a maximum
pressure of 325 psi at a flow
rate of 10mL per second. | intermittent infusion,
continuous infusion or
aspiration. This set may be
used with power injector
procedures to a maximum
pressure of 325 psi at a flow
rate of 10mL per second. | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Needless
Connector | Carefusion NeutraClear™
Needle-free connector EL-
NC1000 | CareFusion MZ1000,
(K132413) | Different |
| Maximum
injection
pressure | 325psi | 325psi | Equivalent |
| Components | Tubing, Luer, Needle-free
connector, male spin lock,
bifurcated connector,
stopcock | Tubing, Luer, Needleless
connectors, Male Spin Lock,
bifurcated connector | Equivalent |
| Sterilization
Method | Ethylene Oxide | E-beam (Radiation) | Different |
| Single
patient use | Yes | Yes | Equivalent |
| Duration of
use | 7 days
200 activations | 7 days
200 activations | Equivalent |
| Provided
Sterile | Yes | Yes | Equivalent |
VI. Performance Data
The following FDA recognized performance standards and guidance were performed in evaluating the functionality of Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s):
- . ISO 8536-4:2013 Infusion equipment for medical use- Part 4: Infusion set for single use, gravity feed
ISO8536-8:2015 Infusion equipment for medical use - part 8 : Infusion sets for single use with pressure infusion apparatus
ISO 8536-9:2015 Infusion equipment for medical use – part 9: Fluid lines for single use with pressure infusion equipment
ISO8536-10:2015 applies to sterilized infusion set for use with pressure infusion equipment up to maximum of 200kPa (2 bar)
- o Particulate contamination
- Tensile strength о
- O Filter for fluid
- O Infusion liquid flow rate
- O Absence of air bubble
8
Traditional 510(k) premarket Notification
Image /page/8/Picture/34 description: The image shows a logo for CAIR L.G.L. The logo consists of a purple circle with a purple triangle pointing to the right. The circle is connected to the triangle, and the text "CAIR L.G.L." is to the right of the logo.
CareFusion NeutraClear™ multi-fuse Extension Sets with needle-free connector(s)
- Leakage test O
- Test of 200 connections and disconnections O
- Alcohol: alcohol-resistant O
- O Lipids : Lipid-resistant 7 days
- Disinfection with isopropyl alcohol 70% (disinfection of valve) O
- O Resist to 325psi for the pressure rated extension sets
- . ISO594-1:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment - Part 1 General requirements ISO594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other
- medical equipment part 2 Locking fittings
- o Dimensions of male and female connectors in accordance with the table and diagrams in standard ISO594-1
- Liquid leaks O
- Air leaks O
- Force of separation O
- O Unscrewing torque
- O Resistance to thread stripping
- Cracks due to pressure O
- medical equipment part 2 Locking fittings
- . ISO14971:2013 Medical devices- Quality management systems- Requirements for regulatory purposes
- ISO 10993-1:2009, Biological evaluation of medical devices – part 1: Evaluation and testing within a risk management process
- o Cytotoxicity
- Intracutaneous injection O
- O Systemic injection
- O Sensitization (Kligman Maximization Test)
- o Hemolysis
- Hemocompatibility O
- Pyrogenicity test O
- Particulate contamination O
- Limulus Amebocyte Lysate test (endotoxin) O
- Extractable and leachable agent extraction test O
- . ISO 11135:2007 Standard: "Sterilization of Healthcare Products - Ethylene Oxide" : validation of the sterilization process with ethylene oxide according to the half-cycle method
- o Bioberdum test
- o Sterility Test
9
CareFusion NeutraClear™ multi-fuse Extension Sets with needle-free connector(s)
- EOR and ECH residual tests O
- . ISO 11607 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Part2: Validation requirements for forming, sealing and assembly processes
- o Sterility barrier after aging
The following functional performance testing has been carried out to demonstrate that the device performs as intended:
- . Microbial ingress and barrier testing (FDA Guidance for Industry and FDA Staff : Intravascular Administration Sets Premarket Notification Submission [510(k)])
- . Hemolysis testing (ISO 10993-4)
- . Shelf life performance testing (ISO 8536-4, ISO 8536-10, ISO 11607-1, ISO 11607-2)
- Harsh Infusates testing (ISO 8536-4, ISO 8536-10)
- . Priming volume (dead volume)/ flow rate testing (ISO 8536)
- . Sterilization validation testing (ISO 11135)
- . Pressure resistance testing (internal testing method)
A sterilization validation has been performed and a shelf life testing has been conducted.
VII. Sterilization
The subject device is Ethylene oxide sterilized. Sterilization is performed according to the requirements of the ISO 11135-1"2007 and ISO 10993-7:2008.
VIII. Shelf life
The subject device has a shelf life of 3 years.
IX. Conclusions
The results of the non-clinical testing exhibited that Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices.