(328 days)
Not Found
No
The device is a simple disposable tube for transporting gas samples and does not involve any data processing or analysis that would require AI/ML.
No
The device is described as a gas sampling line accessory used to monitor expired gases, not to treat a condition. While it connects to the breathing circuit, its function is for diagnostic measurement, not therapeutic intervention.
No
The device is a gas sampling line that connects to an expired gas monitor. It is an accessory to gas monitoring devices, which are responsible for analyzing respiratory gases. The sampling line itself does not perform any diagnostic function.
No
The device description clearly states it is a physical, disposable gas sampling line made of coextruded tubing with luer connectors. It is a hardware accessory used to transport gas samples.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Vital Signs Gas Sampling Lines are described as a conduit for drawing gas samples from the breathing circuit to an expired gas monitor. The analysis of the gas is performed by the gas monitor, not the sampling line itself.
- Specimen Source: The gas being sampled is from the patient's breathing circuit, which is a direct measurement of respiratory gases, not a specimen derived from the human body in the typical sense of an IVD (like blood or tissue).
- Intended Use: The intended use is to connect to an expired gas monitor for monitoring CO2, O2, N2O, and anesthetic agents. This is a monitoring function related to respiration, not a diagnostic test performed on a biological specimen.
The device is an accessory to a gas monitoring system used in a hospital environment for monitoring respiratory gases. It facilitates the transport of the gas sample to the analyzing device, but it does not perform the diagnostic or analytical function itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCK
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.
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
Not Found
Intended User / Care Setting
Hospital Environment
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)
The Vital Signs Gas Sampling Lines were tested in accordance with the following standards: ISO 594-2:1998 for Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings, and ISO 80601-2-55 First edition 2011-12-15 for Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors.
Performance characteristics tested and their results:
- Gauge test (ISO 594-2:1998, 4.1): Pass. The end of the conical Luer fitting shall lie between the minimum and maximum limit planes of the gauge for all tested samples.
- Separation force (ISO 594-2:1998, 4.3): Pass. For all tested samples Luer connectors shall remain attached to the reference fitting when pulled with 35 N force for minimum of 10 seconds.
- Unscrewing torque (ISO 594-2:1998, 4.4): Pass. For all tested samples Luer connectors shall remain attached to the reference fitting when unscrewed with 0.02Nm for minimum of 10 seconds.
- Ease of assembly (ISO 594-2:1998, 4.5): Pass. For all tested samples a satisfactory fit shall be achieved when connection is assembled applying an axial force not exceeding 20N and while applying a torque not exceeding 0.08Nm.
- Resistance to overriding (ISO 594-2:1998, 4.6): Pass. For all the tested samples the reference connector shall not override the threads of sample Luer connector when applying a torque not less than 0.15Nm for period of 5 seconds.
- Stress cracking (ISO 594-2:1998, 4.7): Pass. For all the tested samples there shall be no evidence of stress cracking in the Luer connectors after keeping the test sample connected to the reference fitting for 48 ±1 hours.
- Security of attachment (Pull test) (N/A): Pass. Acceptance Criteria: 35 Newtons.
- Leakage test (ISO 80601-2-55:2011, 201.102): Pass. Acceptance Criteria: ≤ 10 ml/min.
- Flow resistance test (N/A): Pass. Acceptance Criteria: 21-35 mbar for 3 meter gas sampling line, 42-70 mbar for 6 meter gas sampling line.
- "GAS SAMPLE" Marking test (ISO 80601-2-55:2011, 201.7.2.101): Pass. Marking shall be clear and legible as defined by ISO 80601-2-55.
Biocompatibility testing was also performed for surface contact of mucosal membrane via airway with limited exposure (less than 24 hours) for Cytotoxicity, Sensitization, and Irritation in accordance with AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-5:2009 (R2014), and AAMI/ANSI/ISO 10993-10:2010 (R2014) respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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);
1
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
2
Indications for Use
510(k) Number (if known)
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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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 |
| 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
Gas Sampling Line | Primary Predicate Device
Disposable Gas Sampling
Line
K946044 | Comparison Result | Does the difference
raise any questions
of safety and
effectiveness? |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The 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. | The gas sampling lines are
intended to provide a
conduit from the patient
port in the breathing circuit
to the gas monitor. | Different | While the intended
use is the same, the
indications differ
slightly in that the
subject device
specifically states
which devices they
are intended to be
used with. This
difference does not
raise different
questions of safety or
effectiveness. |
| 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. | Same | N/A |
| Patient Population | Any patient population requiring
gas monitoring | Any patient from which gas
monitoring is required
during the patients
breathing cycle. | Same | N/A |
| Element of comparison | Proposed Device
Gas Sampling Line | Primary Predicate Device
Disposable Gas Sampling
Line
K946044 | Comparison Result | Does the difference
raise any questions
of safety and
effectiveness? |
| Environment of Use | Hospital Environment | Hospitals | Same | N/A |
| 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 E-
miniC for monitoring CO2. | Designed for use with gas
monitoring device (for
example a capnography)
with luer connections for
gas sampling. | Similar | No. The only
difference is that the
proposed gas
sampling lines are
specifically indicated
for use with GE
Healthcare Compact
Airway modules and
CARESCAPE
Respiratory modules |
| Characteristics | | | | |
| Inner diameter | 1.2mm | 1.34 mm | Similar | No. The difference in
inner diameter is
required for
compatibility with
referenced GE
equipment. |
| Outer diameter | 2.8mm | 2.95 mm | Similar | No. The difference in
outer diameter is
required for
compatibility with
referenced GE
equipment. |
| 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/min
with 3 meter gas sampling line
(PRO-CA-HL-17-005) | 16.61-19.17mbar at
150ml/min with 3 meter
gas sampling line
(PRO-CA-HL-17-009) | Similar | No. The difference in
flow resistance is due
to the difference in
inner diameter which
is required for
compatibility with
referenced GE
equipment. |
| Leakage | 0.02-0.05 ml/min |