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 10 ml/s, in state of connection.

Device Description

The CAIR LGL valves features include a smooth swappable septum surface, septum seal integrity with no gaps or openings, a microbial physical barrier, straight through fluid pathway, zero dead space, zero fluid displacement low priming volume, saline-only flush option and no clamping sequence or positive pressure syringe technique required.
The Cair bidirectional needleless injection valve may be used with low pressure power injectors having a pressure of 7 bars with a luer lock connection.
The subject device is composed of materials (polycarbonate, silicone) that have been successfully and safely used in medical devices including the predicate device. The materials used in the subject device have been subjected to and passed biocompatibility testing.

AI/ML Overview

This document describes the 510(k) summary for the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear). It does not contain information about a study proving that the device meets acceptance criteria via performance metrics as would typically be found for AI/ML-enabled devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and conformity to various standards.

Therefore, many of the requested sections related to AI/ML device studies, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or inferred from the provided text, primarily regarding non-clinical testing for substantial equivalence:

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

The document states: "Testing conducted, that reference the design verification and validation testing of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear), meets predetermined acceptance criteria for the device." However, the specific acceptance criteria and the quantitative performance results are not detailed in this summary section beyond general statements of meeting criteria. The types of tests performed are listed, implying that the device "meets predetermined acceptance criteria" for each of these:

Acceptance Criterion (Type of Test)	Reported Device Performance
Microbial Ingress Testing	Meets predetermined criteria
Biocompatibility Testing	Meets predetermined criteria
Liquid Leak (open position)	Meets predetermined criteria
Liquid Leak (closed position)	Meets predetermined criteria
Vacuum Leak (open position)	Meets predetermined criteria
Vacuum Leak (closed position)	Meets predetermined criteria
Flow Rate	Meets predetermined criteria
Tensile Strength	Meets predetermined criteria
Disconnection Bolus	Meets predetermined criteria

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

Not applicable, as this is a traditional medical device (not AI/ML) and the document describes non-clinical engineering and biological tests rather than studies with patient data. No sample sizes are specified for the non-clinical tests conducted. The submitter is CAIR L.G.L. from France.

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)

Not applicable. The "ground truth" here would be established by validated test methods and standards for the non-clinical tests (e.g., ISO standards for sterility, biocompatibility, leak rates), not by expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for expert review of clinical cases. For non-clinical tests, conformance to specified test protocols and standards dictates success or failure.

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

Not applicable. This device is not an AI/ML diagnostic or assistive tool, so MRMC studies are irrelevant.

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

Not applicable. This device is a passive mechanical component, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by established international standards (e.g., ISO, 21 CFR) and their specific pass/fail criteria for each test (e.g., sterility, leak rates, biocompatibility).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable.

Summary

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Section 5 - 510(k) Summary

K133073 Section 5 - 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

5.1 - Submitter's Identification

Company name:	CAIR L.G.L.
Address:	ZI le Pontet - 69380 Civrieux - France
Telephone:	+33 (0) 478 437 744
Fax:	+33 (0) 478 437 707
E-mail:	dmolinari@cairlgl.fr
Contact Person:	Delphine MOLINARI
Prepared:	09/06/2013
Revised:	Not applicable

5.2 - Identification of the device

Trade name 1:	Cair Drive (EL 500 orange variance)
Trade name 2:	Neutraclear (EL 200 transparent variance)
Common Name:	Bidirectional needleless injection valve
Regulation Name:	Intravascular administration set
Regulation Number:	21 CFR 880.5440
Product Code:	FPA
Regulatory Class:	II

5.3 - Indications for Use (Cair Drive and Neutraclear)

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Device Tradename	RegulationNumber	RegulatoryClass	Productcode	510knumber	ClassificationName	Decisiondate
Arisure NeutralValve	21 CFR880.5440	II	FPA	K120799	Intravascularadministrationset	03/30/2012
Yukon medical

5.4 - Identification of Equivalent Legally Marketed Device

Table 5.4.1: Identification of Equivalent Legally Marketed Device

Legallymarketeddevice	510knumber	Intended use	Predicate Device
Arisure NeutralValveYukon medical	K120799	The Arisure Neutral Valve is asingle use, sterile, non-pyrogenic device intended foruse as an accessory tointravascular administrationsets for the administration orwithdrawal of fluids from apatient through a cannulaplaced in the vein or artery.	Predicate Device MicroCLAVE®B3300 Connector and CLAVE®C 1000 Connector(510(k):K970855)

Table 5.4.2: Intended use and predicate device

The indication for use of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) is equivalent to the legally marketed device chosen as a predicate device. The Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) is substantially equivalent, with respect to questions of safety and effectiveness, to the predicate Arisure Neutral Valve Yukon medical.

Cair bidirectional needleless injection valve 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.

5.5 - Description of the device and Technological Characteristics

The Cair bidirectional needleless injection valve may be used with low pressure power injectors having a pressure of 7 bars with a luer lock connection.

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5.5.1 - Device Characteristics

Software	The Cair bidirectional needleless injection valve does not include asoftware.
Biologics	The Cair bidirectional needleless injection valve does not includebiologics.
Drugs	The Cair bidirectional needleless injection valve does not include drugs.
PatientContactingMaterials	The Cair bidirectional needleless injection valve is non-invasive.The type of contact is a local contact with IV solution and blood.
Coatings	The Cair bidirectional needleless injection valve does not include coatings.
Additives	The Cair bidirectional needleless injection valve does include bisphenol(plastifier).Cair Drive (EL 500 variance) includes orange dyer.Cair Drive and Neutraclear do not include phtalates and are latex free.
Single-use	The Cair bidirectional needleless injection valve is single use.
Sterile	The Cair bidirectional needleless injection valve is sterile.
SterilizationMethod	The Cair bidirectional needleless injection valve are sterilized byethylene oxide in accordance with the ISO 11135:2007:"Sterilization of Healthcare Products - Ethylene Oxide" standard.
Environment	General Hospital

Of Use

5.5.2 - Materials of Use

The subject device is composed of materials (polycarbonate, silicone) that have been successfully and safely used in medical devices including the predicate device. The materials used in the subject device have been subjected to and passed biocompatibility testing.

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Section 5 - 510(k) Summary

5.6- Safety and Effectiveness, comparison to the predicate device

This subject device, Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) and predicate device are substantially equivalent: they have the same intended use and indication for use. Technological and performance differences (refer to close 5.7 of this section) do not raise any new questions of safety or effectiveness. Comparison analysis, including comparison tables, of the subject device versus the predicate device are provided in the section below.

	Table 5.7: Comparison summary
	Subject Device	Predicate device
	Cair bidirectional needlelessinjection valve(Neutraclear and Cair Drive)	Arisure Neutral ValveK120799
Materials	Lower Housing (Internal Conduit) -PolycarbonatePre-slit Silicone Piston: silicone rubberLubricant - FluorosiliconeUpper Housing - PolycarbonateRetention Ring- Polyoxymethylene	Lower Housing (Internal Conduit) -PolycarbonatePre-slit Silicone Piston: silicone rubberLubricant - FluorosiliconeUpper Housing - PolycarbonateRetention Ring- Polycarbonate
Principlesof operation	The female Luer valve opens to permitthe introduction or withdrawal of fluidswhen accessed by a male Luer tip. Thisaccess deforms a compressible elementthat returns to its original shape throughthe mechanical properties of thedeformable element.	The female Luer valve opens to permitthe introduction or withdrawal of fluidswhen accessed by a male Luer tip. Thisaccess deforms a compressible elementthat returns to its original shape throughthe mechanical properties of thedeformable element.
Technologyand design	When activated by a male Luer, a pre slitelastomeric sleeve advances over aninternal post, opening a fluid pathwaythat connects the female and male endsof the device.	When activated by a male Luer, a pre slitelastomeric sleeve advances over aninternal post, opening a fluid pathwaythat connects the female and male endsof the device.

5.7- Comparison summary

Table 5.7: Compurison summary

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5.8-Statement of substantial equivalence

Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) is substantially equivalent with the predicate device identified in the table 5.7: Comparison summary.

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Section 5 - 510(k) Summary

5.9-Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence

The following non-clinical tests have been done to support the substantial equivalence of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) to the predicate Arisure Neutral Valve device:

Microbial Ingress Testing ■
Biocompatibility Testing ■
Liquid Leak (open position) 트
Liquid Leak (closed position) 트
Vacuum Leak (open position) ■
Vacuum Leak (closed position) 트
트 Flow Rate
를 Tensile Strength
. Disconnection Bolus

Results from non-clinical testing indicate that the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) is as safe and effective as the predicate device. Testing conducted, that reference the design verification and validation testing of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear), meets predetermined acceptance criteria for the device. Testing conducted as a direct comparison of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) and predicate device demonstrate the substantial equivalence of the devices.

In addition the following standards have been used for the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear):

ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use Part 4: I Infusion sets for single use, gravity feed - Recognized Consensus Standards (FPA)
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles, and I certain other medical equipment - part 2 Lock fittings
ISO 8536-10:2004 applies to sterilized infusion sets for single use for use with . pressure infusion equipment up to a maximum of 200 kPa (2 bar).
트 ISO 14971 : 2007 Medical devices -- Application of risk management to medical devices
체 ISO 13485 : 2003 Medical devices -- Quality management systems --Requirements for regulatory purposes
ISO 10993 : Biological Evaluation of Medical Devices 트

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5.10- Discussion of Clinical Tests Performed

A literature review (scientific and bibliographic data) was conducted for the clinical assessment of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear). This review demonstrates clinical evidence of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear).

5.11- Conclusions

Based on the information provided in this submission we conclude that the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear) is substantially equivalent to the predicate and is safe and effective for its intended use and indication for use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Cibilis Silver Spring, MI) 20993-0002

March 20, 2014

Wiesen Law Offices Mr. Irving Wiesen C/O CAIR L.G.L. 420 Lexington Avenue, Suite 2400 New York. NY 10170

Re: K133073

Trade/Device Name: Cair Drive (EL 500 orange variance) Neutraclear (EL. 200 transparent variance) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 18, 2014 Received: February 18, 2014

Dear Mr. 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

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Page 2 - Mr. Wiesen

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin | Keith -S

Erin I. Keith, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) Not assigned yet

Device Name

Cair Drive (EL 500 orange variance) / Neutraclear (EL 200 transparent variance)

Indications for Use (Describe)

Bidrectional needleless injection valve is a single use, sterile, non-pyrogenic device intended for use a vither win a sea with as a samith to a Diblication sets for the administration or withdrawal of fluids from a patient through a cannula placed in the ven of for within a administration sees for the administration valve may be used with low-pressure power injectors with a flow at 10 mi/s, in state of connection.

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

Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (6/13)

Page 1 of 2

Digitally signed by Richard C. Chapman
Date: 2014.03.20 11:19:22 -04Y00'

Price Public Justice Sugar 2011 3 161 467

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.