(171 days)
Not Found
No
The summary describes a mechanical valve for fluid administration and withdrawal, with no mention of AI, ML, or any computational processing of data.
No.
This device is an accessory for administering or withdrawing fluids; it does not directly treat a medical condition.
No
The device is described as a "Bidirectional needleless injection valve" intended for "administration or withdrawal of fluids from a patient," acting as an accessory to intravascular administration sets. Its function is to facilitate fluid transfer, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (polycarbonate, silicone) and mechanical functions (valve, septum, fluid pathway). The performance studies focus on physical properties and performance (leak testing, flow rate, tensile strength), not software validation.
Based on the provided information, 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 placed in the vein or artery. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The description focuses on the mechanical and material properties of the valve for fluid management within the patient's body.
- Performance Studies: The performance studies focus on the device's ability to prevent microbial ingress, maintain seals, handle pressure and flow, and its biocompatibility – all related to its function within the patient's circulatory system.
The device is an accessory for intravascular administration sets, which are used for direct patient care, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for 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.
Product codes
FPA
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.
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
Not Found
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 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)
- Liquid Leak (closed position)
- Vacuum Leak (open position)
- Vacuum Leak (closed position)
- Flow Rate
- 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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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: | +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)
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
name | Regulation
Number | Regulatory
Class | Product
code | 510k
number | Classification
Name | Decision
date |
|--------------------------|----------------------|---------------------|-----------------|----------------|----------------------------------------|------------------|
| Arisure Neutral
Valve | 21 CFR
880.5440 | II | FPA | K120799 | Intravascular
administration
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
marketed
device | 510k
number | Intended use | Predicate Device |
|-------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Arisure Neutral
Valve
Yukon medical | K120799 | The Arisure Neutral 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 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 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
software. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biologics | The Cair bidirectional needleless injection valve does not include
biologics. |
| Drugs | The Cair bidirectional needleless injection valve does not include drugs. |
| Patient
Contacting
Materials | 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. |
| Sterilization
Method | The Cair bidirectional needleless injection valve are sterilized by
ethylene 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.
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 | ||
| injection valve | ||
| (Neutraclear and Cair Drive) | Arisure Neutral Valve | |
| K120799 | ||
| Materials | Lower Housing (Internal Conduit) - | |
| Polycarbonate | ||
| Pre-slit Silicone Piston: silicone rubber | ||
| Lubricant - Fluorosilicone | ||
| Upper Housing - Polycarbonate | ||
| Retention Ring- Polyoxymethylene | Lower Housing (Internal Conduit) - | |
| Polycarbonate | ||
| Pre-slit Silicone Piston: silicone rubber | ||
| Lubricant - Fluorosilicone | ||
| Upper Housing - Polycarbonate | ||
| Retention Ring- Polycarbonate | ||
| 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 mechanical 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 mechanical properties of the | ||
| deformable element. | ||
| 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. |
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 (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
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