Carefusion NeutraClear™ Needle-free connector is a bidirectional valve allowing injections and infusions to be given or sample taken via an intravenous line; or samples taken via arterial line. It seals and protects the line when it is not activated. The Carefusion NeutraClear™ needle-free connector may be used with low-pressure power injectors procedures to a maximum pressure of 325psi with a flow at 10mL per second.

Device Description

Carefusion NeutraClear™ Needle-free connector is a sterile, non-pyrogenic bidirectional needleless injection valve intended for single patient use as an accessory to intravascular administration sets allowing infusions to be given or samples taken via an intravenous line or via arterial line without using a needle, thus eliminating the potential for needle-stick injuries during use. It seals and protects the line when it is not activated. This bidirectional needleless injection valve may be used with low-pressure power injectors to a maximum pressure of 325psi with a flow at 10mL per second. The Carefusion NeutraClear™ can be used for up to 200 activations or 7 days.

AI/ML Overview

The provided document is a 510(k) premarket notification letter and summary for a medical device: the Carefusion NeutraClear™ Needle-free Connector (EL-NC1000). The document describes the device, its indications for use, technological characteristics, and performance data used to demonstrate substantial equivalence to a predicate device (NeutraClear™ EL200).

However, the document does not contain the kind of detailed information about acceptance criteria and study design that would be typical for clinical studies of AI/ML devices, such as:

A table of acceptance criteria and reported device performance for specific metrics like sensitivity, specificity, or accuracy.
Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for establishing ground truth in AI/ML performance evaluation.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Specifics about training set sample size or how ground truth was established for a training set (as this is not an AI/ML device).

Instead, this document describes the evaluation of a physical medical device (a needle-free connector) through non-clinical performance testing and adherence to recognized standards. The "acceptance criteria" here refer to the successful completion and meeting of requirements outlined in these standards and internal test methods.

Therefore, I will extract the information available in the document regarding the device's performance evaluation, framing it within the context of a physical medical device rather than an AI/ML system.

Acceptance Criteria and Study for Carefusion NeutraClear™ Needle-free Connector (EL-NC1000)

The Carefusion NeutraClear™ Needle-free Connector (EL-NC1000) is a physical medical device, not an AI/ML device. Therefore, the "acceptance criteria" and "study" described in the document refer to non-clinical performance testing against recognized international standards and internal test methods, rather than clinical trials or AI/ML specific performance metrics like sensitivity/specificity derived from ground truth established by experts.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The device 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 device." While specific numerical acceptance criteria (e.g., "leakage must be less than X mL/hr") are not explicitly listed in a table, the document refers to recognized standards and internal test methods that define these criteria.

Category of Performance Test	Relevant Standard/Test Method	Reported Device Performance
Mechanical/Functional	ISO 8536-4:2013 (Infusion sets)	Met acceptance criteria (implied by conclusion of substantial equivalence)
	ISO594-2:1998 (Conical fittings)	Met acceptance criteria
	ISO8536-10:2015 (Pressure infusion)	Met acceptance criteria
	Liquid leak - open/closed position (Internal Test Method)	Met acceptance criteria
	Vacuum leak - open/closed position (Internal Test Method)	Met acceptance criteria
	Pressure Resistance Testing (Internal Test Method)	Met acceptance criteria (specifically, tested for use up to 325psi)
	Flushing Volume (Internal Test Method)	Met acceptance criteria (specific flush volume of 2.5ml)
Biocompatibility	ISO 10993-1:2010 (Biological evaluation)	Met acceptance criteria
	ISO 10993-4 (Hemolysis testing)	Met acceptance criteria
	Compatibility with Chlorhexidine (Internal Test Method)	Met acceptance criteria (demonstrated compatibility)
Sterility	ISO 11135:2007 (Ethylene Oxide Sterilization)	Met acceptance criteria (validated sterilization process)
Microbial Ingress	Microbial Ingress testing (Internal Test Method)	Met acceptance criteria
Packaging Integrity	ISO 11607 (Packaging for sterilized devices)	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided in the document. For non-clinical performance testing of a physical device, sample sizes are typically determined by engineering principles, statistical power for specific tests (e.g., destructive testing, fatigue testing), and regulatory compliance testing requirements for the standards cited (e.g., number of units to test for sterility validation). The data provenance is internal laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth as typically understood in AI/ML (e.g., expert consensus on medical images) does not apply here. The "ground truth" for this device's performance is established by the objective physical and chemical properties of the device and its interaction with fluids and pressure, measured against established engineering and biological safety standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no "ground truth" derived from human interpretation. Performance is assessed through objective measurements and validated test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical medical device, not an AI/ML system requiring human-in-the-loop performance evaluation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is a physical medical device, not an AI/ML system. The "standalone" performance here refers to the device's ability to meet its functional and safety requirements independently, as demonstrated by the non-clinical tests.

7. Type of Ground Truth Used

The "ground truth" for the performance of this physical device is defined by:

Established engineering principles: Performance under pressure, flow rates, leak resistance, etc.
Biological safety standards: Biocompatibility, sterility, absence of hemolysis.
Regulatory standards: Conformity to ISO standards and FDA requirements for medical devices.
Internal specifications: Defined by the manufacturer for functional parameters.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2017

Cair L.G.L Delphine Molinari Official Correspondent 1, Allée des Chevreuils Parc Tertiaire de Bois Dieu 69380 Lissieu FRANCE

Re: K171117

Trade/Device Name: Carefusion NeutraClear™ Needle-free connector (EL-NC1000) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 7, 2017 Received: August 21, 2017

Dear Ms. 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. 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

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the quality systems (OS) 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,

Tara A. Ryan -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171117

Device Name

Carefusion NeutraClear™ Needle-free Connector

Indications for Use (Describe)

Carefusion NeutraClear™ Needle-free Connector is a bidirectional valve allowing injections and infusions to be given or sample taken via an intravenous line; or samples taken via arterial line. It seals and protects the line when it is not activated. The NeutraClear™ needle-free connector may be used with low-pressure power injectors procedures to a maximum pressure of 325psi with a flow at 10mL per second

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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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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@cairlgl.fr Date of Preparation: August 29, 2017

II. Identification of the device

Subject Device

Trade Name: Carefusion NeutraClear™ needle-free connector (EL-NC1000) Common Name: Bidirectional needleless injection valve Regulation Name: Intravascular administration set Product Code: FPA Regulation: 21 CFR 880.5440 Device Class: II 510k Number: K171117

Predicate Device

Trade name: NeutraClear TM (EL200 transparent variance) 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

Page 1 of 6 510k Summary

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III. Device Description

IV. Indication for Use

V. Technological Characteristics

The subject device, Carefusion NeutraClear™ Needle free connector and predicate device, NeutraClear EL200 are both bidirectional needleless injection valves for administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of blood through the artery. The subject device may be used with low-pressure injectors with a maximum pressure of 325 psi and a flow rate of 10ml per second.

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Please see below for a comparison table of the Carefusion NeutraClear™ Needle free connector to the predicate device.

	Subject Device	Predicate Device
TechnologicalCharacteristics	Carefusion NeutraClearTM Needle-free connectorEL-NC1000	NeutraClear EL200	SubstantialEquivalence
ProductDescription	Bidirectional needlelessvalve with a permeableprotective cap inPolyethylene	Bidirectional needlelessvalve without a protectivecap	Different
Indications forUse	Carefusion NeutraClear™Needle-free connector is abidirectional valve allowinginjections and infusions tobe given or sample takenvia an intravenous line; orsamples taken via arterialline. It seals and protectsthe line when it is notactivated. The CarefusionNeutraClear™ needle-freeconnector may be used withlow-pressure powerinjectors procedures to amaximum pressure of325psi with a flow at 10mLper second.	NeutraClear™bidirectional needlelessinjection valve is a singleuse, sterile, non-pyrogenicdevice intended for use asan accessory tointravascularadministration sets for theadministration orwithdrawal of fluids froma patient through acannula placed in the veinor for withdraw of fluidsthrough the artery.Bidirectional needlelessinjection valve may beused with low-pressurepower injectors with aflow at 10ml/s, in state ofconnection.	Different
Material	Housing: PolycarbonateSeal: SiliconeRing: PolyoxymethyleneLubricant: Silicone	Housing: PolycarbonateSeal: SiliconeRing: PolyoxymethyleneLubricant: Silicone	Equivalent
Material ofprotective cap	Polyethylene	N/A	Different
Single-use	Yes	Yes	Equivalent
Sterilizationmethod	Ethylene oxide	Ethylene oxide	Equivalent
Shelf life	3 years	3 years	Equivalent
Environmentalof Use	General Hospital	General Hospital	Equivalent

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	Subject Device	Predicate Device
TechnologicalCharacteristics	Carefusion NeutraClearTM Needle-free connectorEL-NC1000	NeutraClear EL200	SubstantialEquivalence
Technology anddesign	When activated by a maleLuer, a pre slit elastomericsleeve advances over aninternal post, opening afluid pathway that connectsthe female and male ends ofthe device.	When activated by a maleLuer, a pre slitelastomeric sleeveadvances over an internalpost, opening a fluidpathway that connects thefemale and male ends ofthe device.	Equivalent
CompatibilitywithChlorhexidine	Yes	No	Different
Flush Volume	2.5 ml	10 ml	Different
Maximuminjectionpressure	325psi	7 bars	Different
Priming Volume(Dead Volume)	0.049ml	0.05ml	Equivalent
Duration of use	7 days200 activations	7 days400 activations	Different

Explanation of Similarities and Differences Technological Characteristics compared to Predicate Device

The Subject device, Carefusion NeutraClear™ Needle-free connector have the following similarities to the predicate device:

Principle of operation
Same technology and design ●
Same configuration
Same materials used
Same sterilization method
Same performance specifications

The following are technical characteristics differences between the subject and predicate devices.

These additional characteristics are verified and validated by testing to demonstrate the subject device is sufficient for its intended use and therefore substantially equivalent to the

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predicate device. The additional characteristics do not raise different questions of safety or effectiveness.

. A permeable protective cap is added to the predicate device. The cap is made of Polyethylene and will not contact the fluid path of the device.
Compatibility with Chlorhexidine
Increase maximum injection pressure rate to 325 psi for use with power injector ●
Flush Volume: clears fluid path with 2.5ml of saline ●
Duration for Use up to 7 days or 200 activations ●
New Indication for Use introduced to the subject device for using with a low-● pressure power injectors procedures to a maximum pressure of 325 psi with a flow at 10 ml per second.

VI. Performance Data

The following FDA recognized performance standards and guidance were performed in evaluating the functionality of Carefusion NeutraClear™ needle-free connector EL-NC1000:

ISO 8536-4:2013 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed
. ISO594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment - part 2 Locking fittings
. ISO8536-10:2015 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to maximum of 200kPa (2 bar)
ISO14971:2013 Medical devices- Quality management systems- Requirements for regulatory purposes
. ISO 10993-1:2010, Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process
ISO 11135:2007 : "Sterilization of Healthcare Products - Ethylene Oxide" : validation of the sterilization process with ethylene oxide according to the half-cycle method
. 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
ISO 10993-4 Hemolysis Testing: Biological Evaluation of Medical Devices-Part 4 Selection of tests for interactions with blood

The following additional functional performance testing has been carried out to demonstrate that the device performs as intended based on internal specification and test methods.

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Liquid leak-open/closed position (Internal Test Method) ●
Vacuum leak- open/closed position (Internal Test Method)
. Microbial Ingress testing
Pressure Resistance Testing (Internal Test Method)
Flushing Volume (Internal Test Method)
Compatibility with Chlorhexidine (Internal Test Method)

VII. Conclusions

The results of the non-clinical testing and risk analysis assessment exhibited that no new questions of safety and efficacy are raised with the proposed introduction of Carefusion NeutraClear™ EL-NC1000. The device 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 device.

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.