The Altera Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line which is provided in 3 different lengths: 2, 2.5, and 3 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 a circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the sampling 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 in the host device, which pull the gas from the sampling port to the host device for gas monitoring.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically "Altera Gas Sampling Lines." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials as might be seen for novel technologies or higher-risk devices.

Based on the provided text, the device is a simple, single-use, disposable component (a gas sampling line) that connects a breathing circuit to an expired gas monitor. There is no evidence in this document of AI or machine learning components, nor any mention of a study involving human readers improving with AI assistance. Therefore, the questions related to AI performance, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this submission.

Here's an analysis of the provided information concerning the acceptance criteria and the study that proves the device meets them, primarily focusing on the device's physical and functional performance, as that is the scope of this 510(k).

Acceptance Criteria and Device Performance for Altera Gas Sampling Lines

Given the nature of this device (a gas sampling line), the "acceptance criteria" are primarily related to its physical and functional performance characteristics, ensuring it performs its intended function (transporting gas samples) safely and effectively, and equivalently to the predicate device. The "study" proving this involves various non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The table below summarizes the key performance attributes tested and the results presented in the document. The general acceptance criterion for these tests is that the proposed device (Altera GSL) performs comparably or better than the predicate device (Vyaire Vital Signs) and meets relevant industry standards.

Acceptance Criteria (Attribute)	Predicate (Vyaire Vital Signs) Performance (Reference/Value)	Proposed (Altera GSL) Performance (Reference/Value)	Comparison
Classification	CCK - Carbon Dioxide Gas Analyzer, 21 CFR 868.1400	CCK - Carbon Dioxide Gas Analyzer, 21 CFR 868.1400	Same
Indications for Use	Connects from a port in the breathing circuit to the expired gas monitor. Used with specific GE Healthcare monitors.	Connects from a port in the breathing circuit to the expired gas monitor.	Similar
Principle of Operation	Gas pulled from one end of the tube to the other by a pump in the gas sampling device.	Gas pulled from one end of the tube to the other by a pump in the gas sampling device.	Similar
Patient Population	Any patient population requiring gas monitoring.	Any patient population requiring gas monitoring.	Similar
Environments of Use	Hospitals.	Hospitals, sub-acute, pre-hospital.	Similar
Compatibility	Designed for specific GE Healthcare modules.	Designed for use with any gas monitoring device with luer connections.	Similar
Single patient use, disposable	Yes.	Yes.	Similar
Materials	ISO 10993 tested, Co-extruded PE/EVA/PVC.	ISO 10993 tested, Co-extruded PE/EVA/PVC.	Similar
Flow Resistance	~26 cmH2O @ 150 ml/min.	~12 - 17.5 cmH2O @ 150 ml/min.	Similar
Leakage (per ISO 80601-2-55)	< 10 ml/min.	< 10 ml/min.	Similar
Tubing ID / OD	ID - 1.2 mm, OD - 2.8 mm.	ID - 1.2 mm, OD - 2.8 mm.	Similar
Lengths Available	Up to 3 meters.	2, 2.5 and 3 meters.	Similar
Connectors	Standard ISO 80369 small bore luer fittings – male / female (referenced ISO 594-2).	Standard ISO 80369 small bore luer fittings – male / female (referenced ISO 80369-7).	Similar
Separation Force of Connectors	>35 Newtons.	>35 Newtons.	Similar
Leakage of Connectors	0.02-0.05 ml/min.	< 0.005 Pa*m3/s (units per ISO 80369-7).	Similar
ISO Luer Standard Compliance	ISO 594-2 (Unscrewing torque, Resistance to overriding, Stress cracking).	ISO 80369-7 (Unscrewing torque, Resistance to overriding, Stress cracking).	Similar
Performance post aging	N/A (for predicate, not explicitly stated).	After 3 years accelerated aging, performance testing still met pre-established acceptance criteria.	Improved/Additional

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes for each physical and functional test (e.g., how many gas sampling lines were tested for flow resistance, leakage, or mechanical properties). It broadly states "Performance Testing" was completed. For a 510(k) of this type, standard engineering and quality control practices would dictate appropriate sample sizes for manufacturing verification, but these details are not provided in the summary document.
Data Provenance: The tests would have been performed by the manufacturer, Meditera Tibbi Malzeme San. ve Tic. A.S., or their designated testing facilities. The country of origin for the manufacturing is Turkey (Izmir). The data provenance is retrospective in the context of the 510(k) submission, meaning the tests were completed and the data collected prior to the submission for regulatory review. There is no mention of prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. As previously stated, this device is a physical component without AI/ML. "Ground truth" in this context refers to engineering specifications and performance standards (e.g., ISO standards for luer fittings, flow resistance measurements). These are established through scientific principles and engineering testing, not by expert human interpretation of medical images or data.

4. Adjudication Method for the Test Set

Not Applicable. Since there are no human experts evaluating data (as in clinical trials or AI performance evaluations), there is no need for an adjudication method. Test results are based on objective measurements against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human performance (e.g., radiologists interpreting images). This device is a simple medical accessory, not an AI software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device does not involve an algorithm. The "standalone performance" refers to the physical and functional integrity of the gas sampling line itself, as detailed in the performance testing section.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, international performance standards (e.g., ISO 80601-2-55 for leakage, ISO 80369-7 for luer fittings), and comparative performance data against a legally marketed predicate device. The tests performed include:
- Flow resistance
- Accelerated aging (for 3-year shelf-life)
- Mechanical testing (luer fitting properties: fluid leakage, air leakage, stress cracking, separation force, unscrewing torque, resistance to overriding)
- Air leakage (general)

8. The Sample Size for the Training Set

Not Applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set exists for this type of device.

Conclusion from the document:

The manufacturer concluded, and the FDA agreed in the 510(k) clearance, that the "Altera Gas Sampling Lines" are substantially equivalent to the predicate device (Vyaire Vital Signs Gas sampling Lines) based on a comparison of intended use, principle of operation, technological characteristics, and non-clinical performance testing. The performance testing ensured the device met applicable standard requirements and did not raise new questions of safety or effectiveness compared to the predicate.

Summary

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Meditera Tibbi Malzeme San. ve Tic. A.S. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K192563

Trade/Device Name: Altera Gas Sampling Lines Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: December 18, 2019 Received: December 19, 2019

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192563

Device Name

Altera Gas Sampling Lines

Indications for Use (Describe)

The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:

16-Dec-2019

ALTERA TIBBI MALZEME SAN VE TIC AS Ibni Melek Mah Organize Sanayi Bolgesi Tire Izmir, TURKEY 35900 +90 232 513 51 10

Official Contact:	Cenk Kılıç KalkanQuality Assurance Team Leader
Proprietary or Trade Name:	Altera Gas sampling Lines
Common/Usual Name:	Carbon Dioxide Gas Analyzer
Classification:	21CFR 868.1400CCK - Carbon Dioxide Gas AnalyzerClass II
Predicate Device:	K171678 - Vyaire - Vital Signs Gas sampling Lines

Device Description:

Principle of Operation:

The principle of operation is that gas is pulled from a luer port on a circuit on the patient end of the tubing to the other end which is connected to a gas sampling monitor which has an internal vacuum pump pulling the gas to be sampled.

Indications for Use:

The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.

The following table presents a comparison of the subject device to the predicate.

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Attribute	PredicateVyaire Vital Signs	ProposedAltera GSL	Comparison	Does the difference raisenew questions of safetyand effectiveness?
K#	K171678	N/A	N/A	N/A
Classification	CCK - Carbon Dioxide Gas Analyzer21 CFR 868.1400	CCK - Carbon Dioxide GasAnalyzer21 CFR 868.1400	Same	No
Indications for Use	The Vital Signs Gas Sampling Lines areintended to connect from a port in thebreathing circuit to the expired gas monitor.These gas sampling lines are used with GEHealthcare Compact Airway modules andCARESCAPE Respiratory modules formonitoring CO2, O2, N2O and anestheticagents and with E-miniC for monitoringCO2.	The Altera Gas Sampling Linesare intended to connect from aport in the breathing circuit tothe expired gas monitor.	Similar	No.The predicate is specific tocertain monitors, but theyhave the same intendeduse.
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 end ofthe tube to the other by a pumpin the gas sampling device.	Similar	No
Patient Population	Any patient population requiring gasmonitoring	Any patient populationrequiring gas monitoring	Similar	No
Environments of use	Hospitals	Hospitals, sub-acute, pre-hospital	Similar	No.Expired gas monitoring isutilized in other clinicalsettings
Compatibility withenvironment and otherdevices	Designed for the use with GE HealthcareCompact Airway modules andCARESCAPE Respiratory modules formonitoring CO2, O2, N2O and anestheticagents and with EminiC for monitoringCO2.	Designed for use with gasmonitoring device (for examplea capnography) with luerconnections for gas sampling.	Similar	No.While the predicate listsspecific monitors, allexpired gas sampling tendto utilize a luer fitting
Single patient use,disposable	Yes	Yes	Similar	No
Attribute	PredicateVyaire Vital Signs	ProposedAltera GSL	Comparison	Does the difference raisenew questions of safetyand effectiveness?
Characteristics
Materials	ISO 10993 testedCo-extruded PE/EVA/PVC	ISO 10993 testedCo-extruded PE/EVA/PVC	Similar	No
Performance testing	Flow resistance –~ 26 cmH2O @ 150 ml/minLeakage per ISO 80601-2-55< 10 ml/min	Flow resistance –~ 12 - 17.5 cmH2O @ 150ml/minLeakage per ISO 80601-2-55< 10 ml/min	Similar	NoFlow resistance is just areported value
TubingID / OD	ID - 1.2 mmOD - 2.8 mm	ID - 1.2 mmOD - 2.8 mm	Similar	No
Lengths	Up to 3 meters	2, 2.5 and 3 meters	Similar	No
Connectors	Standard ISO 80369 small bore luer fittings –male / female	Standard ISO 80369 small boreluer fittings - male / female	Similar	NoPredicate referenced ISO594-2 vs. ISO 80369-7
Separation force ofconnectors	>35 Newtons	>35 Newtons	Similar	No
Leakage of connectors	0.02-0.05 ml/min	< $0.005Pa*m3/s$Units per ISO 80369-7	Similar	No
ISO 594-2 orISO 80369-7	ISO 594-2Unscrewing torqueResistance to overridingStress cracking	ISO 80369-7Unscrewing torqueResistance to overridingStress cracking	Similar	NoBoth devices passed therequirements for luerfittings even though theyused a different standard
Performance postaging	N/A	After 3 years accelerated agingperformance testing still met thepre-established acceptancecriteria		No

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Performance Testing

We completed the following performance testing:

. Flow resistance
Accelerated ageing including environmental ●
3 years shelf-life
. Mechanical testing
Luer fitting per ISO 80369-7:2018
Fluid leakage
Air leakage
Stress cracking
Separation force
. Unscrewing torque
Resistance to overriding .
Air leakage (ISO 80601-2-55) ●

Diseussion of Differences and Substantial Equivalence Conclusion

There are no differences between the proposed device and the predicate. The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. There were no differences which raise different risks vs. the predicate.

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

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).