CAIR DRIVE, NEUTRACLEAR

K133073 · Cair Lgl · FPA · Mar 20, 2014 · General Hospital

Device Facts

• Record ID: K133073
• Device Name: CAIR DRIVE, NEUTRACLEAR
• Applicant: Cair Lgl
• Product Code: FPA · General Hospital
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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 Story

Cair Drive and Neutraclear are bidirectional needleless injection valves; function as accessories to intravascular administration sets. Device features smooth swappable septum, microbial barrier, straight-through fluid pathway, zero dead space, and zero fluid displacement. Operation: male Luer tip insertion deforms internal elastomeric sleeve, opening fluid pathway; sleeve returns to original shape upon removal. Used in general hospital settings; operated by clinicians. Eliminates needle-stick injury risk; supports fluid administration/withdrawal and low-pressure power injection. Materials include polycarbonate and silicone.

Clinical Evidence

No clinical trials performed. Evidence based on literature review of scientific and bibliographic data, combined with extensive non-clinical bench testing (microbial ingress, biocompatibility, leak, vacuum, flow rate, tensile strength, and disconnection bolus) demonstrating performance equivalent to predicate.

Technological Characteristics

Materials: Polycarbonate (housing), silicone rubber (piston), fluorosilicone (lubricant), polyoxymethylene (retention ring). Design: Bidirectional needleless valve, luer lock connection. Sterilization: Ethylene oxide (ISO 11135:2007). Standards: ISO 8536-4, ISO 594-2, ISO 8536-10, ISO 14971, ISO 13485, ISO 10993. Non-invasive, single-use, latex-free, phthalate-free.

Indications for Use

Indicated for use as an accessory to intravascular administration sets for fluid administration or withdrawal via venous or arterial cannula. Suitable for use with low-pressure power injectors (up to 10 ml/s). Single-patient use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Arisure Neutral Valve (K120799)

Reference Devices

• MicroCLAVE B3300 Connector (K970855)
• CLAVE C 1000 Connector (K970855)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo and a date. The logo consists of a circle with a black dot at the top and a black triangle inside the circle. The text "CAIR L.G.L." is located below the logo. To the right of the logo is the date "MAR 2 0 2014".

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: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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)

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.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with a circle and a triangle inside, with a dot above the circle. To the right of the logo are the letters "CAIR L.G.L." Below the logo is the text "Section 5 - 510(k) Summary". The text is in a bold font.

| Device Trade<br>name | Regulation<br>Number | Regulatory<br>Class | Product<br>code | 510k<br>number | Classification<br>Name | Decision<br>date |
|--------------------------|----------------------|---------------------|-----------------|----------------|----------------------------------------|------------------|
| Arisure Neutral<br>Valve | 21 CFR<br>880.5440 | II | FPA | K120799 | Intravascular<br>administration<br>set | 03/30/2012 |
| Yukon medical | | | | | | |

## 5.4 - Identification of Equivalent Legally Marketed Device

Table 5.4.1: Identification of Equivalent Legally Marketed Device

| Legally<br>marketed<br>device | 510k<br>number | Intended use | Predicate Device |
|-------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Arisure Neutral<br>Valve<br>Yukon medical | K120799 | The Arisure Neutral Valve is a<br>single use, sterile, non-<br>pyrogenic device intended for<br>use as an accessory to<br>intravascular administration<br>sets for the administration or<br>withdrawal of fluids from a<br>patient through a cannula<br>placed in the vein or artery. | Predicate Device MicroCLAVE®<br>B3300 Connector and CLAVE®<br>C 1000 Connector<br>(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 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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with a circle and a black dot on top. Inside the circle, there is a black shape resembling a stylized letter. To the right of the logo, the text "CAIR L.G.L." is written. Below the logo, the text "Section 5 - 510(k) Summary" is written.

## 5.5.1 - Device Characteristics

| Software | The Cair bidirectional needleless injection valve does not include a<br>software. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biologics | The Cair bidirectional needleless injection valve does not include<br>biologics. |
| Drugs | The Cair bidirectional needleless injection valve does not include drugs. |
| Patient<br>Contacting<br>Materials | The Cair bidirectional needleless injection valve is non-invasive.<br>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<br>(plastifier).<br>Cair Drive (EL 500 variance) includes orange dyer.<br>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. |
| Sterilization<br>Method | The Cair bidirectional needleless injection valve are sterilized by<br>ethylene oxide in accordance with the ISO 11135:2007:<br>"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.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo with the text "CAIR L.G.L.". The logo features a circle with a black dot at the top and a black shape resembling a stylized arrow or flag pointing downwards and to the right. The text is positioned to the right of the circle and arrow shape.

## 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 needleless<br>injection valve<br>(Neutraclear and Cair Drive) | Arisure Neutral Valve<br>K120799 |
| Materials | Lower Housing (Internal Conduit) -<br>Polycarbonate<br>Pre-slit Silicone Piston: silicone rubber<br>Lubricant - Fluorosilicone<br>Upper Housing - Polycarbonate<br>Retention Ring- Polyoxymethylene | Lower Housing (Internal Conduit) -<br>Polycarbonate<br>Pre-slit Silicone Piston: silicone rubber<br>Lubricant - Fluorosilicone<br>Upper Housing - Polycarbonate<br>Retention Ring- Polycarbonate |
| Principles<br>of operation | The female Luer valve opens to permit<br>the introduction or withdrawal of fluids<br>when accessed by a male Luer tip. This<br>access deforms a compressible element<br>that returns to its original shape through<br>the mechanical properties of the<br>deformable element. | The female Luer valve opens to permit<br>the introduction or withdrawal of fluids<br>when accessed by a male Luer tip. This<br>access deforms a compressible element<br>that returns to its original shape through<br>the mechanical properties of the<br>deformable element. |
| Technology<br>and design | When activated by a male Luer, a pre slit<br>elastomeric sleeve advances over an<br>internal post, opening a fluid pathway<br>that connects the female and male ends<br>of the device. | When activated by a male Luer, a pre slit<br>elastomeric sleeve advances over an<br>internal post, opening a fluid pathway<br>that connects the female and male ends<br>of the device. |

## 5.7- Comparison summary

Table 5.7: Compurison summary

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the text "CAIR L.G.L." next to it. The logo consists of a circle with a black dot above a black triangle shape. Below the logo is the text "Section 5 – 510(k) Summary".

## 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.

{5}------------------------------------------------

## 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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo with the text "CAIR L.G.L." The logo consists of a circle with a black dot at the top and a stylized black shape inside. Below the logo is the text "Section 5 - 510(k) Summary".

## 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.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

{8}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{9}------------------------------------------------

#### 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)

Image /page/9/Picture/13 description: The image contains a block of text written in an unfamiliar language. The characters are small and densely packed together. Due to the unknown language and the image's low resolution, it is difficult to provide a more detailed description.

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