(122 days)
Not Found
No
The device description and performance testing focus solely on the physical properties and function of a gas sampling line, with no mention of data analysis, algorithms, or learning capabilities.
No.
The device is a gas sampling line that provides a conduit for drawing gas samples to an expired gas monitor. It does not exert any therapeutic effect on the patient.
No
Explanation: The device is a gas sampling line that provides a conduit for drawing gas samples to an external monitor, but it does not perform any diagnostic analysis itself. The diagnostic function would be performed by the 'expired gas monitor' or 'gas module host device'.
No
The device is a physical, disposable gas sampling line, not a software application. The description details its material, dimensions, and physical function in transmitting gas samples.
Based on the provided information, the Altera Gas Sampling Lines are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Altera Gas Sampling Lines Function: The Altera Gas Sampling Lines are used to transport a gas sample from the patient's breathing circuit to a gas monitor. The analysis is performed on the gas, not on a biological specimen from the patient's body.
- Intended Use: The intended use clearly states connecting to a breathing circuit to sample expired gas for monitoring. This is related to respiratory function, not the analysis of bodily fluids or tissues.
Therefore, the Altera Gas Sampling Lines are considered a medical device, but not an IVD. They are accessories used in conjunction with a gas monitor, which itself may or may not be considered an IVD depending on its specific function and the type of analysis it performs.
N/A
Intended Use / Indications for Use
The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.
Product codes (comma separated list FDA assigned to the subject device)
CCK
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.
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
Any patient population requiring gas monitoring
Intended User / Care Setting
Hospitals, sub-acute, pre-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)
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)
Key Results: "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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Flow resistance: ~ 12 - 17.5 cmH2O @ 150 ml/min
- Leakage per ISO 80601-2-55: 35 Newtons
- Leakage of connectors:
§ 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).
0
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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
1
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
2
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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FORM FDA 3881 (7/17)
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3
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 Kalkan
Quality Assurance Team Leader |
|----------------------------|-----------------------------------------------------------------|
| Proprietary or Trade Name: | Altera Gas sampling Lines |
| Common/Usual Name: | Carbon Dioxide Gas Analyzer |
| Classification: | 21CFR 868.1400
CCK - Carbon Dioxide Gas Analyzer
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.
4
| Attribute | Predicate
Vyaire Vital Signs | Proposed
Altera GSL | Comparison | Does the difference raise
new questions of safety
and effectiveness? |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------|
| K# | K171678 | N/A | N/A | N/A |
| Classification | CCK - Carbon Dioxide Gas Analyzer
21 CFR 868.1400 | CCK - Carbon Dioxide Gas
Analyzer
21 CFR 868.1400 | Same | No |
| 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. | The Altera Gas Sampling Lines
are intended to connect from a
port in the breathing circuit to
the expired gas monitor. | Similar | No.
The predicate is specific to
certain monitors, but they
have the same intended
use. |
| Principle of Operation | Gas is pulled from one end of the
tube to the other by a pump in
the gas sampling device. | Gas is pulled from one end of
the tube to the other by a pump
in the gas sampling device. | Similar | No |
| Patient Population | Any patient population requiring gas
monitoring | Any patient population
requiring gas monitoring | Similar | No |
| Environments of use | Hospitals | Hospitals, sub-acute, pre-hospital | Similar | No.
Expired gas monitoring is
utilized in other clinical
settings |
| Compatibility with
environment and other
devices | Designed for the use with GE Healthcare
Compact Airway modules and
CARESCAPE Respiratory modules for
monitoring CO2, O2, N2O and anesthetic
agents and with EminiC for monitoring
CO2. | Designed for use with gas
monitoring device (for example
a capnography) with luer
connections for gas sampling. | Similar | No.
While the predicate lists
specific monitors, all
expired gas sampling tend
to utilize a luer fitting |
| Single patient use,
disposable | Yes | Yes | Similar | No |
| Attribute | Predicate
Vyaire Vital Signs | Proposed
Altera GSL | Compa
rison | Does the difference raise
new questions of safety
and effectiveness? |
| Characteristics | | | | |
| Materials | ISO 10993 tested
Co-extruded PE/EVA/PVC | ISO 10993 tested
Co-extruded PE/EVA/PVC | Similar | No |
| Performance testing | Flow resistance –
~ 26 cmH2O @ 150 ml/min
Leakage per ISO 80601-2-55
35 Newtons | >35 Newtons | Similar | No |
| Leakage of connectors | 0.02-0.05 ml/min |