Altera gas Sampling Lines

K192563 · Meditera Tibbi Malzeme San VE Tic AS · CCK · Jan 17, 2020 · Anesthesiology

Device Facts

• Record ID: K192563
• Device Name: Altera gas Sampling Lines
• Applicant: Meditera Tibbi Malzeme San VE Tic AS
• Product Code: CCK · Anesthesiology
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

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

Device Story

Altera Gas Sampling Lines are disposable, single-patient-use, coextruded (PE/EVA/PVC) narrow-diameter tubes; lengths of 2, 2.5, and 3 meters; standardized male luer connectors at both ends. Device functions as a conduit for one-directional gas flow from a patient breathing circuit port to a host gas monitor. Host device utilizes an internal vacuum pump to pull gas samples through the line for analysis. Used in hospitals, sub-acute, and pre-hospital settings. Healthcare providers connect the line to the circuit and monitor to facilitate respiratory gas analysis (e.g., capnography). Output allows clinicians to monitor patient respiratory status, aiding in clinical decision-making regarding ventilation and gas exchange.

Clinical Evidence

Bench testing only. Testing included flow resistance, mechanical testing (separation force, unscrewing torque, resistance to overriding), fluid/air leakage per ISO 80601-2-55, stress cracking, and luer fitting compliance per ISO 80369-7:2018. Accelerated aging studies confirmed 3-year shelf-life performance.

Technological Characteristics

Coextruded PE/EVA/PVC tubing; 1.2 mm ID / 2.8 mm OD; standardized male luer connectors per ISO 80369-7. Passive conduit; no internal energy source. Sterilization not specified. Bench testing per ISO 80601-2-55 and ISO 10993.

Indications for Use

Indicated for any patient population requiring gas monitoring via connection from a breathing circuit port to an expired gas monitor.

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

• Vyaire - Vital Signs Gas sampling Lines (K171678)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [phone]

| Official Contact: | Cenk Kılıç Kalkan<br>Quality Assurance Team Leader |
|----------------------------|-----------------------------------------------------------------|
| Proprietary or Trade Name: | Altera Gas sampling Lines |
| Common/Usual Name: | Carbon Dioxide Gas Analyzer |
| Classification: | 21CFR 868.1400<br>CCK - Carbon Dioxide Gas Analyzer<br>Class II |
| Predicate Device: | K171678 - Vyaire - Vital Signs Gas sampling Lines |

#### Device Description:

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.

### 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 | Predicate<br>Vyaire Vital Signs | Proposed<br>Altera GSL | Comparison | Does the difference raise<br>new questions of safety<br>and effectiveness? |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------|
| K# | K171678 | N/A | N/A | N/A |
| Classification | CCK - Carbon Dioxide Gas Analyzer<br>21 CFR 868.1400 | CCK - Carbon Dioxide Gas<br>Analyzer<br>21 CFR 868.1400 | Same | No |
| Indications for Use | The Vital Signs Gas Sampling Lines are<br>intended to connect from a port in the<br>breathing circuit to the expired gas monitor.<br>These gas sampling lines are used with GE<br>Healthcare Compact Airway modules and<br>CARESCAPE Respiratory modules for<br>monitoring CO2, O2, N2O and anesthetic<br>agents and with E-miniC for monitoring<br>CO2. | The Altera Gas Sampling Lines<br>are intended to connect from a<br>port in the breathing circuit to<br>the expired gas monitor. | Similar | No.<br>The predicate is specific to<br>certain monitors, but they<br>have the same intended<br>use. |
| 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 of<br>the tube to the other by a pump<br>in the gas sampling device. | Similar | No |
| Patient Population | Any patient population requiring gas<br>monitoring | Any patient population<br>requiring gas monitoring | Similar | No |
| Environments of use | Hospitals | Hospitals, sub-acute, pre-hospital | Similar | No.<br>Expired gas monitoring is<br>utilized in other clinical<br>settings |
| Compatibility with<br>environment and other<br>devices | Designed for the use with GE Healthcare<br>Compact Airway modules and<br>CARESCAPE Respiratory modules for<br>monitoring CO2, O2, N2O and anesthetic<br>agents and with EminiC for monitoring<br>CO2. | Designed for use with gas<br>monitoring device (for example<br>a capnography) with luer<br>connections for gas sampling. | Similar | No.<br>While the predicate lists<br>specific monitors, all<br>expired gas sampling tend<br>to utilize a luer fitting |
| Single patient use,<br>disposable | Yes | Yes | Similar | No |
| Attribute | Predicate<br>Vyaire Vital Signs | Proposed<br>Altera GSL | Compa<br>rison | Does the difference raise<br>new questions of safety<br>and effectiveness? |
| Characteristics | | | | |
| Materials | ISO 10993 tested<br>Co-extruded PE/EVA/PVC | ISO 10993 tested<br>Co-extruded PE/EVA/PVC | Similar | No |
| Performance testing | Flow resistance –<br>~ 26 cmH2O @ 150 ml/min<br>Leakage per ISO 80601-2-55<br>< 10 ml/min | Flow resistance –<br>~ 12 - 17.5 cmH2O @ 150<br>ml/min<br>Leakage per ISO 80601-2-55<br>< 10 ml/min | Similar | No<br>Flow resistance is just a<br>reported value |
| Tubing<br>ID / OD | ID - 1.2 mm<br>OD - 2.8 mm | ID - 1.2 mm<br>OD - 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 –<br>male / female | Standard ISO 80369 small bore<br>luer fittings - male / female | Similar | No<br>Predicate referenced ISO<br>594-2 vs. ISO 80369-7 |
| Separation force of<br>connectors | >35 Newtons | >35 Newtons | Similar | No |
| Leakage of connectors | 0.02-0.05 ml/min | < $0.005Pa*m3/s$<br>Units per ISO 80369-7 | Similar | No |
| ISO 594-2 or<br>ISO 80369-7 | ISO 594-2<br>Unscrewing torque<br>Resistance to overriding<br>Stress cracking | ISO 80369-7<br>Unscrewing torque<br>Resistance to overriding<br>Stress cracking | Similar | No<br>Both devices passed the<br>requirements for luer<br>fittings even though they<br>used a different standard |
| Performance post<br>aging | N/A | After 3 years accelerated aging<br>performance testing still met the<br>pre-established acceptance<br>criteria | | 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.