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 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 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.

AI/ML Overview

The provided text is a 510(k) summary for Vyaire Medical's Vital Signs™ Gas Sampling Lines. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does not describe a study involving a medical device that uses artificial intelligence (AI) or machine learning (ML) or a multi-reader multi-case (MRMC) study. The document focuses on the physical and performance characteristics of a gas sampling line, which is a passive medical device.

Therefore, I cannot extract the information required by your prompt, such as:

A table of acceptance criteria and reported device performance related to AI/ML.
Sample size used for the test set and data provenance for an AI/ML model.
Number of experts used to establish ground truth for an AI/ML model.
Adjudication method for an AI/ML model.
MRMC comparative effectiveness study or effect size.
Standalone performance of an AI/ML algorithm.
Type of ground truth for an AI/ML model.
Sample size for the training set of an AI/ML model.
How ground truth for the training set of an AI/ML model was established.

The document details engineering performance tests (e.g., gauge test, separation force, leakage test, flow resistance test, biocompatibility) to show that the gas sampling lines meet specific technical standards (e.g., ISO 594-2, ISO 80601-2-55, ISO 10993 series). The "Acceptance Criteria" in the document refer to these engineering specifications, not to the performance of an AI/ML algorithm.

Summary

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April 30, 2018

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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)

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-phase21 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

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 DeviceGas Sampling Line	Primary Predicate DeviceDisposable Gas SamplingLineK946044	Comparison Result	Does the differenceraise any questionsof safety andeffectiveness?
Indications for Use	The gas sampling lines areintended to connect from a portin the breathing circuit to theexpired gas monitor. These gassampling lines are used with GEHealthcare Compact Airwaymodules and CARESCAPERespiratory modules formonitoring CO2, 02, N2O andanesthetic agents and withE-miniC for monitoring CO2.	The gas sampling lines areintended to provide aconduit from the patientport in the breathing circuitto the gas monitor.	Different	While the intendeduse is the same, theindications differslightly in that thesubject devicespecifically stateswhich devices theyare intended to beused with. Thisdifference does notraise differentquestions of safety oreffectiveness.
Principle of Operation	Gas is pulled from one end of thetube to the other by a pump inthe gas sampling device.	Gas is pulled from one endof the tube to the other bya pump in the gas samplingdevice.	Same	N/A
Patient Population	Any patient population requiringgas monitoring	Any patient from which gasmonitoring is requiredduring the patientsbreathing cycle.	Same	N/A
Element of comparison	Proposed DeviceGas Sampling Line	Primary Predicate DeviceDisposable Gas SamplingLineK946044	Comparison Result	Does the differenceraise any questionsof safety andeffectiveness?
Environment of Use	Hospital Environment	Hospitals	Same	N/A
Compatibility withenvironment and otherdevices	Designed for the use with GEHealthcare Compact Airwaymodules and CARESCAPERespiratory modules formonitoring CO2, O2, N2O andanesthetic agents and with E-miniC for monitoring CO2.	Designed for use with gasmonitoring device (forexample a capnography)with luer connections forgas sampling.	Similar	No. The onlydifference is that theproposed gassampling lines arespecifically indicatedfor use with GEHealthcare CompactAirway modules andCARESCAPERespiratory modules
Characteristics
Inner diameter	1.2mm	1.34 mm	Similar	No. The difference ininner diameter isrequired forcompatibility withreferenced GEequipment.
Outer diameter	2.8mm	2.95 mm	Similar	No. The difference inouter diameter isrequired forcompatibility withreferenced GEequipment.
Separation force	>35 Newtons(PRO-CA-HL-17-005)	>35 Newtons(PRO-CA-HL-17-009)	Same	N/A
Flow resistance	26.22-27.76mbar at 150ml/minwith 3 meter gas sampling line(PRO-CA-HL-17-005)	16.61-19.17mbar at150ml/min with 3 metergas sampling line(PRO-CA-HL-17-009)	Similar	No. The difference inflow resistance is dueto the difference ininner diameter whichis required forcompatibility withreferenced GEequipment.
Leakage	0.02-0.05 ml/min	<1.0ml/min	Same	N/A
Connector	Luer connector according to ISO594-2(PRO-CA-HL-17-005)	Luer connector accordingto ISO 594-2(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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8.1 Performance Testing

Performance Characteristics	Standard
Conical fittings with 6 % (Luer) taper for syringes,needles and certain other medical equipment --Part 2: Lock fittings	ISO 594-2:1998
Medical electrical equipment - Part 2-55:Particular requirements for the basic safety andessential performance of respiratory gasmonitors	ISO 80601-2-55 First edition 2011-12-15

Test	Relevant Standard	StandardSection	Acceptance Criteria	Result
Gauge test	ISO 594-2 : 1998	4.1	The end of the conical Luer fittingshall lie between the minimum andmaximum limit planes of the gaugefor all tested samples.	Pass
Separation force	ISO 594-2 : 1998	4.3	For all tested samples Luerconnectors shall remain attached tothe reference fitting when pulledwith 35 N force for minimum of 10seconds.	Pass
Unscrewing torque	ISO 594-2 : 1998	4.4	For all tested samples Luerconnectors shall remain attached tothe reference fitting whenunscrewed with 0.02Nm forminimum of 10 seconds.	Pass
Ease of assembly	ISO 594-2 : 1998	4.5	For all tested samples a satisfactoryfit shall be achieved whenconnection is assembled applying anaxial force not exceeding 20N andwhile applying a torque notexceeding 0.08Nm.	Pass
Resistance tooverriding	ISO 594-2 : 1998	4.6	For all the tested samples thereference connector shall notoverride the threads of sample Luerconnector when applying a torquenot less than 0.15Nm for period of 5seconds.	Pass
Stress cracking	ISO 594-2 : 1998	4.7	For all the tested samples there shallbe no evidence of stress cracking inthe Luer connectors after keepingthe test sample connected to thereference 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	StandardSection	Acceptance Criteria	Result
Security ofattachment (Pulltest)	N/A	N/A	35 Newtons	Pass
Leakage test	ISO 80601-2-55:2011	201.102	≤ 10 ml/min	Pass
Flow resistance test	N/A	N/A	21-35 mbar for 3 meter gas samplingline42-70 mbar for 6 meter gas samplingline	Pass
"GAS SAMPLE"Marking test	ISO 80601-2-55:2011	201.7.2.101	Marking shall be clear and legible asdefined 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:Evaluation and Testing	AAMI/ANSI/ISO 10993-1:2009
Biological Evaluation of Medical Devices-Part 5: Testsfor In Vitro Cytotoxicity	AAMI/ANSI/ISO 10993-5:2009 (R2014)
Biological Evaluation of Medical Devices-Part 10: Testsfor Irritation and Skin Sensitization.	AAMI/ANSI/ISO 10993-10:2010(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.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
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.(b)
Classification. Class II (performance standards).