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.

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.

AI/ML Overview

This document describes the regulatory submission (510k) for the Carefusion NeutraClear™ Needle-free connector. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive independent clinical effectiveness studies typical for novel devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing performed to demonstrate that the modified device (with minor changes compared to the predicate) performs as intended and is as safe and effective as the predicate. The document doesn't detail a traditional clinical study but rather a series of performance and safety tests.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" alongside "reported device performance" in a quantitative table for each test. Instead, it states that various tests were performed and that the device met the acceptance criteria for all of them. The "reported device performance" is summarized as having met these criteria.

Acceptance Criterion Category	Reported Device Performance
Functional Performance	Met all functional performance criteria.
Microbial Ingress	Met microbial ingress criteria.
Hemolysis	Met hemolysis criteria.
Priming Volume/Flow Rate	Met priming volume/flow rate criteria.
Sterility	Met sterility criteria (Ethylene oxide sterilization in accordance with ISO 11135-1:2007 and ISO 10993-7:2008).
Biocompatibility	Met biocompatibility criteria (in accordance with ISO 10993-1:2009).
Other Performance Criteria	Met other performance criteria.

(Note: The specific quantitative results or acceptance thresholds for each test are not detailed in this summary.)

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the individual performance tests (microbial ingress, hemolysis, priming volume/flow rate, etc.). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) summary for minor device modifications, these details are often kept in the full submission, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This type of information (experts, ground truth for test sets) is typically relevant for studies evaluating diagnostic or AI-driven devices, where human expertise is used to define a "correct" answer against which the device is measured. For a medical device like a needle-free connector, which undergoes performance and safety testing, "ground truth" is established by adherence to recognized standards and objective measurements performed in a laboratory setting, not by human expert interpretation. Therefore, this information is not applicable and not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Similar to point 3, adjudication methods are relevant for subjective assessments or when discrepancies arise in human interpretation (e.g., in reading medical images). Performance testing of a physical medical device against predefined standards does not involve an adjudication method by human experts. Therefore, this information is not applicable and not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC studies and the concept of "human readers improving with AI assistance" are specific to AI/CAD devices. The Carefusion NeutraClear™ Needle-free connector is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed, and this information is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is also specific to AI/algorithm performance. The device in question is a physical needle-free connector. Therefore, a standalone algorithm performance study was not performed, and this information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for evaluating the performance of this device is based on objective measurements and adherence to recognized performance standards and guidance, such as ISO 8536-4:2010, ISO 594-2:1998, ISO 8536-10:2004, ISO 10993-1:2009, ISO 11135-1:2007, and ISO 10993-7:2008. These standards define the acceptable physical, mechanical, and biological properties and performance characteristics of such devices. For example, for microbial ingress, the ground truth is whether microorganisms can penetrate the device under specific test conditions, as defined and measured by the test method.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, not an AI system. Therefore, there is no training set, and this information is not applicable.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

Summary

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Public Health Service

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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

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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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K171132

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

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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

1. New commercial name
1. New reference number
1. Add a protective cap

IV. Device Description

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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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 ConnectorEL-NC1000A	(K133073)	Equivalence
Product Name	Carefusion NeutraClear™ Needle-free connector	NeutraClear TM	DifferenceNew productname, newreferencenumber given
Product referencenumber	EL-NC1000A	EL200	to differentiatethe device withthe protectivecap
ProductDescription	Bidirectional needleless injectionvalve with a protective cap	Bidirectional needlelessinjection valve	DifferenceNewcomponentadded -Protective capis added
TechnologicalCharacteristics	Subject DeviceCarefusion NeutraClear ™Needle-free ConnectorEL-NC1000A	Predicate DeviceNeutraClear™ EL200(K133073)	SubstantialEquivalence
Intended use	Intended for single patient use inintravenous and bloodadministration sets without needfor needles, thus eliminating thepotential for needle-stick injuriesduring use. The subject device isnot intended to treat existinginfections. The device is notintended to have any effect oncontaminated infusion solutions	Intended for single patient usein intravenous and bloodadministration sets withoutneed for needles, thuseliminating the potential forneedle-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 deviceintended for use as an accessory tointravascular administration sets forthe administration or withdrawal offluids from a patient through acannula placed in the vein or forwithdraw of fluids through theartery. Carefusion NeutraClear™Needle-free connector may be usedwith low-pressure power injectorswith a flow at 10ml/s, in state ofconnection.	Bidirectional needleless injectionvalve is a single use, sterile, non-pyrogenic device intended for useas an accessory to intravascularadministration sets for theadministration or withdrawal offluids from a patient through acannula placed in the vein or forwithdraw of fluids through theartery. Bidirectional needlelessinjection valve may be used withlow-pressure power injectors witha flow at 10ml/s, in state ofconnection.	Equivalent
Maximuminjection pressure	100 psi	100 psi	Equivalent
Material	Housing: PolycarbonateSeal: SiliconeRing: PolyoxymethyleneLubricant: Silicone	Housing: PolycarbonateSeal: SiliconeRing: PolyoxymethyleneLubricant: Silicone	Equivalent
Material of cap	Polyethylene	N/A	DifferenceNew capadded tosubject device
ContactingMaterials	Blood path indirect , with an IVsolution or blood	Local , with an IV solution orblood	Equivalent
Single-use	Yes	Yes	Equivalent
TechnologicalCharacteristics	Carefusion NeutraClear TMNeedle-free ConnectorEL-NC1000A	NeutraClear™ EL200(K133073)	SubstantialEquivalence
Provide Sterile	Yes	Yes	Equivalent
Sterilizationmethod	Ethylene oxide	Ethylene oxide	Equivalent
Shelf life	3 years	3 years	Equivalent
Environmental ofUse	General Hospital	General Hospital	Equivalent
Intended users	Adult and pediatrics	Adult and pediatrics	Equivalent
Principles ofoperation	The female Luer valve opens topermit the introduction orwithdrawal of fluids when accessedby a male Luer tip. This accessdeforms a compressible element thatreturns to its original shape throughthe mechnical properties of thedeformable element.	The female Luer valve opens topermit the introduction orwithdrawal of fluids whenaccessed by a male Luer tip. Thisaccess deforms a compressibleelement that returns to its originalshape through the mechnicalproperties of the deformableelement.	Equivalent
Technology anddesign	When activated by a male Luer, apre slit elastomeric sleeve advancesover an internal post, opening afluid pathway that connects thefemale and male ends of the device.	When activated by a male Luer, apre slit elastomeric sleeveadvances over an internal post,opening a fluid pathway thatconnects the female and male endsof the device.	Equivalent
Duration of use	7 days	7 days	Equivalent

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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

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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.

Regulation Number and Section

§ 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.