(105 days)
Not Found
No
The description focuses on the mechanical function and performance of a needle-free connector, with no mention of AI or ML capabilities.
No.
The device is described as an accessory for administering or withdrawing fluids. It does not treat or cure any medical condition.
No
This device is described as an accessory for administering or withdrawing fluids, not for diagnosing conditions. Its intended use is to facilitate fluid management through connection to intravascular administration sets.
No
The device description clearly describes a physical, mechanical device (needle-free connector) used for fluid administration, not a software application. The performance studies also focus on physical properties like microbial ingress and hemolysis.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the administration or withdrawal of fluids from a patient through a cannula. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes (like drawing blood for testing, but the device itself isn't performing the test).
- Device Description: The description reinforces its use as an accessory to administration sets for fluid management and preventing needle-stick injuries.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or other components used to test biological samples like blood, urine, or tissue.
The device is a medical device used for patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector maybe used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Carefusion NeutraClear™ Needle-free connector is a bidirectional needleless injection valve. The Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Carefusion NeutraClear™ Needle-free connector is intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.
The subject device has a permeable protective cap added to the predicate device. The cap is made of Polyethylene and will not contact the fluid path of the device.
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
Adult and pediatrics
Intended User / Care Setting
General Hospital
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 NeutraClear EL-NC1000A:
- ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed
- ISO 594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment - part 2 Locking fittings
- ISO8536-10:2004 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to maximum of 200kPa (2 bar)
- ISO 10993-1:2009, Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process
The following functional performance testing has been carried out to demonstrate that the device performs as intended:
- Microbial ingress testing
- Hemolysis testing
- Priming volume/ flow rate testing
The results of the non-clinical testing and risk analysis assessment exhibited that the device met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria. The conclusions drawn from the non-clinical tests demonstrate that Carefusion NeutraClear ™ Needle-free connector (EL-NC1000A) is as safe and as effective and performs as well as the legally marketed 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple-line design representing the faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cair L.G.L. % Irving Wiesen Manager Wiesen Law Offices 420 Lexington Avenue - Suite 2400 New York, New York 10170
Re: K171132
Trade/Device Name: Carefusion NeutraClear™ Needle-free connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: June 28, 2017 Received: July 17, 2017
Dear Irving Wiesen:
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
2
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 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, 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
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Image /page/3/Picture/0 description: The image shows a logo with a purple color scheme. The logo features a circle with a dot above a triangle shape. To the right of the shape and circle are the letters "CAIR L.G.L." in a simple font.
Special 510(k) Premarket Notification Carefusion NeutraClear™ Needle-free Connector
510k Summary
I. Submitter's Identification
Submitter Name: Cair L.G.L Address: 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@groupe-cair.com Date of Preparation: June 27, 2017
II. Identification of the device
Subject Device
Trade Name: Carefusion NeutraClear™ Needle-free connector (EL-NC1000A) Common Name: Bidirectional needleless injection valve Classification Name: Intravascular administration set Product Code: FPA Regulation: 21 CFR 880.5440 Device Class: II
Predicate Device
Trade Name: NeutraClear™ (EL 200 transparent variances) Common Name: Bidirectional needleless injection valve Classification Name: Intravascular administration set Product Code: FPA Regulation: 21 CFR 880.5440 Device Class: II 510k Number: K133073
4
Image /page/4/Picture/0 description: The image shows a logo for CAIR L.G.L. The logo consists of a circle with a dot above it, and a purple triangle pointing downwards inside the circle. The text "CAIR L.G.L." is written in a stylized font to the right of the circle. The logo appears to be for an organization or company with the initials CAIR L.G.L.
III. Reason of submission
-
- New commercial name
-
- New reference number
-
- Add a protective cap
IV. Device Description
Carefusion NeutraClear™ Needle-free connector is a bidirectional needleless injection valve. The Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Carefusion NeutraClear™ Needle-free connector is intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.
V. Indication for Use
Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector maybe used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
VI. Technological Characteristics
The subject device, Carefusion NeutraClear™ Needle free connector, has the same indication for use as predicate device. NeutraClear™ EL200. They are bidirectional needleless injection valves for administration or withdrawals of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. The subject device and predicate devices may be used with lowpressure injectors with a flow rate of 10ml per second. The subject device is identical or similar in
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Image /page/5/Picture/0 description: The image shows a logo with a circular design. A purple circle is at the top, and a purple triangle is below it. The text "CAIR L.G.L." is to the right of the triangle. The logo appears to be for an organization or company with the initials CAIR L.G.L.
principles of operation, technology and design, configuration, materials, sterilization method, performance specifications as the predicate device.
The subject device has a permeable protective cap added to the predicate device. The cap is made of Polyethylene and will not contact the fluid path of the device. The additional feature is verified and validated by testing to support the subject device is sufficient for its intended use and therefore substantially equivalent to the predicate device.
Substantial equivalence table
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Technological | Carefusion NeutraClear TM | NeutraClear™ EL200 | Substantial |
| Characteristics | Needle-free Connector | ||
| EL-NC1000A | (K133073) | Equivalence | |
| Product Name | Carefusion NeutraClear™ Needle- | ||
| free connector | NeutraClear TM | Difference | |
| New product | |||
| name, new | |||
| reference | |||
| number given | |||
| Product reference | |||
| number | EL-NC1000A | EL200 | to differentiate |
| the device with | |||
| the protective | |||
| cap | |||
| Product | |||
| Description | Bidirectional needleless injection | ||
| valve with a protective cap | Bidirectional needleless | ||
| injection valve | Difference | ||
| New | |||
| component | |||
| added - | |||
| Protective cap | |||
| is added | |||
| Technological | |||
| Characteristics | Subject Device | ||
| Carefusion NeutraClear ™ | |||
| Needle-free Connector | |||
| EL-NC1000A | Predicate Device | ||
| NeutraClear™ EL200 | |||
| (K133073) | Substantial | ||
| Equivalence | |||
| Intended use | Intended for single patient use in | ||
| intravenous and blood | |||
| administration sets without need | |||
| for needles, thus eliminating the | |||
| potential for needle-stick injuries | |||
| during use. The subject device is | |||
| not intended to treat existing | |||
| infections. The device is not | |||
| intended to have any effect on | |||
| contaminated infusion solutions | Intended for single patient use | ||
| in intravenous and blood | |||
| administration sets without | |||
| need for needles, thus | |||
| eliminating the potential for | |||
| needle-stick injuries during use. | |||
| The subject device is not |
| Equivalent |
| Indications for use | Carefusion NeutraClear™ Needle-
free connector is a single use,
sterile, non-pyrogenic device
intended for use as an accessory to
intravascular administration sets for
the administration or withdrawal of
fluids from a patient through a
cannula placed in the vein or for
withdraw of fluids through the
artery. Carefusion NeutraClear™
Needle-free connector may be used
with low-pressure power injectors
with a flow at 10ml/s, in state of
connection. | Bidirectional needleless injection
valve is a single use, sterile, non-
pyrogenic device intended for use
as an accessory to intravascular
administration sets for the
administration or withdrawal of
fluids from a patient through a
cannula placed in the vein or for
withdraw of fluids through the
artery. Bidirectional needleless
injection valve may be used with
low-pressure power injectors with
a flow at 10ml/s, in state of
connection. | Equivalent |
| Maximum
injection pressure | 100 psi | 100 psi | Equivalent |
| Material | Housing: Polycarbonate
Seal: Silicone
Ring: Polyoxymethylene
Lubricant: Silicone | Housing: Polycarbonate
Seal: Silicone
Ring: Polyoxymethylene
Lubricant: Silicone | Equivalent |
| Material of cap | Polyethylene | N/A | Difference
New cap
added to
subject device |
| Contacting
Materials | Blood path indirect , with an IV
solution or blood | Local , with an IV solution or
blood | Equivalent |
| Single-use | Yes | Yes | Equivalent |
| Technological
Characteristics | Carefusion NeutraClear TM
Needle-free Connector
EL-NC1000A | NeutraClear™ EL200
(K133073) | Substantial
Equivalence |
| Provide Sterile | Yes | Yes | Equivalent |
| Sterilization
method | Ethylene oxide | Ethylene oxide | Equivalent |
| Shelf life | 3 years | 3 years | Equivalent |
| Environmental of
Use | General Hospital | General Hospital | Equivalent |
| Intended users | Adult and pediatrics | Adult and pediatrics | Equivalent |
| Principles of
operation | The female Luer valve opens to
permit the introduction or
withdrawal of fluids when accessed
by a male Luer tip. This access
deforms a compressible element that
returns to its original shape through
the mechnical properties of the
deformable element. | The female Luer valve opens to
permit the introduction or
withdrawal of fluids when
accessed by a male Luer tip. This
access deforms a compressible
element that returns to its original
shape through the mechnical
properties of the deformable
element. | Equivalent |
| Technology and
design | When activated by a male Luer, a
pre slit elastomeric sleeve advances
over an internal post, opening a
fluid pathway that connects the
female and male ends of the device. | When activated by a male Luer, a
pre slit elastomeric sleeve
advances over an internal post,
opening a fluid pathway that
connects the female and male ends
of the device. | Equivalent |
| Duration of use | 7 days | 7 days | Equivalent |
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Image /page/6/Picture/0 description: The image shows a logo with a purple color scheme. The logo features a stylized letter 'T' or a simplified airplane wing shape, also in purple. This shape is positioned within a partial circle, with a purple dot completing the circle at the top. To the right of the emblem, the text "CAIR L.G.L." is written in a simple, sans-serif font, also in purple.
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Image /page/7/Picture/0 description: The image shows a logo for CAIR L.G.L. The logo consists of a circle with a smaller circle above it, and a purple triangle pointing downwards inside the circle. The text "CAIR L.G.L." is written in a stylized font to the right of the circle. The logo appears to be for an organization or company with the initials CAIR L.G.L.
Special 510(k) Premarket Notification Carefusion NeutraClear™ Needle-free Connector
Performance Data VII.
The following FDA recognized performance standards and guidance were performed in evaluating the functionality of NeutraClear EL-NC1000A:
- . ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed
- . ISO 594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment - part 2 Locking fittings
- . ISO8536-10:2004 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to maximum of 200kPa (2 bar)
- . ISO 10993-1:2009, Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process
8
Image /page/8/Picture/0 description: The image shows a logo for CAIR L.G.L. The logo consists of a circle with a purple dot above it. Inside the circle is a purple shape that resembles a stylized letter 'I' or a stylized sail. The text "CAIR L.G.L." is located to the right of the circle and the purple shape.
The following functional performance testing has been carried out to demonstrate that the device performs as intended.
- . Microbial ingress testing
- Hemolysis testing
- Priming volume/ flow rate testing
VIII. 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.
IX. Shelf life
The subject device has 3 years of shelf life.
X. Risk Management
The assessment of risk analysis for modifications made to the subject device was conducted in accordance with ISO 14971:2013 did not raise new issues of safety or effectiveness.
XI. Conclusions
The results of the non-clinical testing and risk analysis assessment exhibited that the device met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria. The conclusions drawn from the non-clinical tests demonstrate that Carefusion NeutraClear ™ Needle-free connector (EL-NC1000A) is as safe and as effective and performs as well as the legally marketed predicate devices.