Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
Device Facts
| Record ID | K171678 |
|---|---|
| Device Name | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable |
| Applicant | Vyaire Medical, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Apr 30, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
Indications for Use
The Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.
Device Story
Vital Signs Gas Sampling Lines are disposable, single-patient-use, narrow-diameter coextruded tubes; provided in 2m, 2.5m, 3m, and 6m lengths. Devices feature standardized male Luer connectors at both ends per ISO 594-2. Used in hospital environments to connect a breathing circuit port to an expired gas monitor (GE Healthcare Compact Airway, CARESCAPE Respiratory, or E-miniC modules). Operation involves a vacuum source and sensors within the host monitor pulling gas samples through the line in a one-directional flow from the patient circuit to the monitor. The device acts as a passive conduit for gas transport; it does not perform analysis itself. Healthcare providers use the resulting monitor data to assess respiratory gas levels (CO2, O2, N2O, anesthetic agents), facilitating clinical decision-making regarding patient ventilation and anesthesia management.
Clinical Evidence
Bench testing only. Performance testing included Luer connector gauge tests, separation force (>35N), unscrewing torque, ease of assembly, resistance to overriding, stress cracking, leakage testing (≤10 ml/min), and flow resistance. Biocompatibility testing (cytotoxicity, sensitization, irritation) conducted per ISO 10993-1, -5, and -10 for mucosal membrane contact.
Technological Characteristics
Coextruded narrow-diameter tubing; 1.2mm inner diameter, 2.8mm outer diameter. Standardized male Luer connectors (ISO 594-2:1998). Passive conduit; no energy source. Single-patient use. Compatible with GE Healthcare respiratory modules. Tested per ISO 80601-2-55.
Indications for Use
Indicated for any patient population requiring respiratory gas monitoring during the breathing cycle.
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Predicate Devices
- Disposable Gas Sampling Line (K946044)
Submission Summary (Full Text)
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April 30, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vyaire Medical, Inc. Colleen O'keefe Acting Director 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045
Re: K171678
Trade/Device Name: Vital Signs™ Gas Sampling Lines Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 22, 2018 Received: March 26, 2018
Dear Colleen O'keefe:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Michael J. Ryan -S
for Tina Kiang, Ph.D. 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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# Indications for Use
510(k) Number (if known)
K171678
Device Name Vital Signs Gas Sampling Lines
Indications for Use (Describe)
The Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K171678
26125 Riverwoods Blvd Mettawa II 60045 hone: (224) 706 -6818 arefusion.com
510K Summary
### 1. SUBMITTER
Vyaire Medical 26125 Riverwoods Blvd. Mettawa, IL 60045 Phone: 224-706-6818
Contact Person: Colleen Watson O'Keeffe Date Prepared: June 2, 2017
### 2. Device
| Product Name: | Vital Signs™ Gas Sampling Lines |
|----------------------------|-----------------------------------------------------------------|
| Trade or Proprietary Name: | Vital Signs™ |
| Device Name: | Gas Sampling Line |
| Common Name: | Gas Sampling Line |
| Classification Name: | Analyzer, gas, carbon dioxide, gaseous-phase<br>21 CFR 868.1400 |
| Regulatory Class: | II |
| Product Code: | CCK |
#### 3. Predicate Device
Disposable Gas Sampling Line cleared under K946044 on December 27, 1994. This predicate device has not been subject to a design-related recall.
#### 4. Device Description
Vital Signs Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line that is compatible with GE Healthcare Compact Airway, E-MiniC and CARESCAPE Respiratory Modules and are provided in four different lengths: 2 meters, 2.5 meters, 3 meters and 6 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends. The gas sampling line connects from a port in the breathing circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the
Image /page/3/Picture/13 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a stylized blue font, with a light blue swoosh above it. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font, also in blue.
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Image /page/4/Picture/2 description: The image shows the address and contact information for a business. The address is 26125 Riverwoods Blvd, Mettawa, IL 60045. The phone number is (224) 706 -6818. The website is carefusion.com.
breathing circuit port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are located in the host device, which pull the gas from the breathing circuit port to the host device for gas monitoring. The gas sampling lines are accessories to the gas monitoring devices.
#### Principle of Operation 5.
The gas sampling line provides a conduit for drawing gas samples from the breathing circuit port to the gas monitor. Gas is pulled from one end of the tube to the other by a pump in the gas sampling device. Gas sampling line is connected to gas monitor and suitable breathing circuit component with standardized Luer connector.
# 6. Indication for use
The Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, 02, N2O and anesthetic agents and with E-miniC for monitoring CO2.
| Element of comparison | Proposed Device<br>Gas Sampling Line | Primary Predicate Device<br>Disposable Gas Sampling<br>Line<br>K946044 | Comparison Result | Does the difference<br>raise any questions<br>of safety and<br>effectiveness? |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The gas sampling lines are<br>intended to connect from a port<br>in the breathing circuit to the<br>expired gas monitor. These gas<br>sampling lines are used with GE<br>Healthcare Compact Airway<br>modules and CARESCAPE<br>Respiratory modules for<br>monitoring CO2, 02, N2O and<br>anesthetic agents and with<br>E-miniC for monitoring CO2. | The gas sampling lines are<br>intended to provide a<br>conduit from the patient<br>port in the breathing circuit<br>to the gas monitor. | Different | While the intended<br>use is the same, the<br>indications differ<br>slightly in that the<br>subject device<br>specifically states<br>which devices they<br>are intended to be<br>used with. This<br>difference does not<br>raise different<br>questions of safety or<br>effectiveness. |
| Principle of Operation | Gas is pulled from one end of the<br>tube to the other by a pump in<br>the gas sampling device. | Gas is pulled from one end<br>of the tube to the other by<br>a pump in the gas sampling<br>device. | Same | N/A |
| Patient Population | Any patient population requiring<br>gas monitoring | Any patient from which gas<br>monitoring is required<br>during the patients<br>breathing cycle. | Same | N/A |
| Element of comparison | Proposed Device<br>Gas Sampling Line | Primary Predicate Device<br>Disposable Gas Sampling<br>Line<br>K946044 | Comparison Result | Does the difference<br>raise any questions<br>of safety and<br>effectiveness? |
| Environment of Use | Hospital Environment | Hospitals | Same | N/A |
| Compatibility with<br>environment and other<br>devices | Designed for the use with GE<br>Healthcare Compact Airway<br>modules and CARESCAPE<br>Respiratory modules for<br>monitoring CO2, O2, N2O and<br>anesthetic agents and with E-<br>miniC for monitoring CO2. | Designed for use with gas<br>monitoring device (for<br>example a capnography)<br>with luer connections for<br>gas sampling. | Similar | No. The only<br>difference is that the<br>proposed gas<br>sampling lines are<br>specifically indicated<br>for use with GE<br>Healthcare Compact<br>Airway modules and<br>CARESCAPE<br>Respiratory modules |
| Characteristics | | | | |
| Inner diameter | 1.2mm | 1.34 mm | Similar | No. The difference in<br>inner diameter is<br>required for<br>compatibility with<br>referenced GE<br>equipment. |
| Outer diameter | 2.8mm | 2.95 mm | Similar | No. The difference in<br>outer diameter is<br>required for<br>compatibility with<br>referenced GE<br>equipment. |
| Separation force | >35 Newtons<br>(PRO-CA-HL-17-005) | >35 Newtons<br>(PRO-CA-HL-17-009) | Same | N/A |
| Flow resistance | 26.22-27.76mbar at 150ml/min<br>with 3 meter gas sampling line<br>(PRO-CA-HL-17-005) | 16.61-19.17mbar at<br>150ml/min with 3 meter<br>gas sampling line<br>(PRO-CA-HL-17-009) | Similar | No. The difference in<br>flow resistance is due<br>to the difference in<br>inner diameter which<br>is required for<br>compatibility with<br>referenced GE<br>equipment. |
| Leakage | 0.02-0.05 ml/min | <1.0ml/min | Same | N/A |
| Connector | Luer connector according to ISO<br>594-2<br>(PRO-CA-HL-17-005) | Luer connector according<br>to ISO 594-2<br>(PRO-CA-HL-17-009) | Same | N/A |
# 7. Comparison of technological characteristics with the predicate device
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Image /page/5/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is blue and features the word "Vyaire" in a stylized font. Below the word "Vyaire" is the word "MEDICAL" in a smaller font. Above the word "Vyaire" is a light blue swoosh design.
26125 Riverwoods Blvd
Mettawa, IL 60045
Phone: (224) 706 -6818
carefusion.com
#### 8. Performance Data
The Vital Signs Gas Sampling Lines tested in accordance with the following standards
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Image /page/6/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a bold, blue font, with the word "MEDICAL" in a smaller, lighter blue font underneath. There is a light blue, wave-like design above the word "Vyaire."
# 8.1 Performance Testing
| Performance Characteristics | Standard |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Conical fittings with 6 % (Luer) taper for syringes,<br>needles and certain other medical equipment --<br>Part 2: Lock fittings | ISO 594-2:1998 |
| Medical electrical equipment - Part 2-55:<br>Particular requirements for the basic safety and<br>essential performance of respiratory gas<br>monitors | ISO 80601-2-55 First edition 2011-<br>12-15 |
| Test | Relevant Standard | Standard<br>Section | Acceptance Criteria | Result |
|-----------------------------|-------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Gauge test | ISO 594-2 : 1998 | 4.1 | The end of the conical Luer fitting<br>shall lie between the minimum and<br>maximum limit planes of the gauge<br>for all tested samples. | Pass |
| Separation force | ISO 594-2 : 1998 | 4.3 | For all tested samples Luer<br>connectors shall remain attached to<br>the reference fitting when pulled<br>with 35 N force for minimum of 10<br>seconds. | Pass |
| Unscrewing torque | ISO 594-2 : 1998 | 4.4 | For all tested samples Luer<br>connectors shall remain attached to<br>the reference fitting when<br>unscrewed with 0.02Nm for<br>minimum of 10 seconds. | Pass |
| Ease of assembly | ISO 594-2 : 1998 | 4.5 | For all tested samples a satisfactory<br>fit shall be achieved when<br>connection is assembled applying an<br>axial force not exceeding 20N and<br>while applying a torque not<br>exceeding 0.08Nm. | Pass |
| Resistance to<br>overriding | ISO 594-2 : 1998 | 4.6 | For all the tested samples the<br>reference connector shall not<br>override the threads of sample Luer<br>connector when applying a torque<br>not less than 0.15Nm for period of 5<br>seconds. | Pass |
| Stress cracking | ISO 594-2 : 1998 | 4.7 | For all the tested samples there shall<br>be no evidence of stress cracking in<br>the Luer connectors after keeping<br>the test sample connected to the<br>reference fitting for 48 ±1 hours. | Pass |
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Image /page/7/Picture/2 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the logo is a light blue graphic that resembles a wave or a breath.
| Test | Relevant Standard | Standard<br>Section | Acceptance Criteria | Result |
|------------------------------------------|-------------------------|---------------------|--------------------------------------------------------------------------------------------|--------|
| Security of<br>attachment (Pull<br>test) | N/A | N/A | 35 Newtons | Pass |
| Leakage test | ISO 80601-2-<br>55:2011 | 201.102 | ≤ 10 ml/min | Pass |
| Flow resistance test | N/A | N/A | 21-35 mbar for 3 meter gas sampling<br>line<br>42-70 mbar for 6 meter gas sampling<br>line | Pass |
| "GAS SAMPLE"<br>Marking test | ISO 80601-2-<br>55:2011 | 201.7.2.101 | Marking shall be clear and legible as<br>defined by ISO 80601-2-55 | Pass |
# 8.2 Biocompatibility
Test for surface contact of mucosal membrane via airway with limited exposure (less than 24 hours): Cytotoxicity, Sensitization, Irritation
| Performance Characteristic | Standard |
|---------------------------------------------------------------------------------------------------|----------------------------------------|
| Biological Evaluation of Medical Devices—Part 1:<br>Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices-Part 5: Tests<br>for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 10: Tests<br>for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010<br>(R2014) |
# 9. Conclusion
The non-clinical data support the substantial equivalence of the proposed device. Also, test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device.
