K Number
K143150
Device Name
CO2 monitoring line with and without in-line filter
Date Cleared
2015-02-05

(94 days)

Product Code
Regulation Number
868.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CO2 Monitoring Lines are intended to connect from a CO2 sampling port to the expired gas monitor.
Device Description
The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas sampling equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.
More Information

Not Found

No
The device description and performance studies focus on the physical characteristics and flow resistance of tubing, with no mention of AI or ML.

No
The device is a monitoring line for gas sampling, designed to connect to an expired gas monitor. It does not provide any therapeutic intervention.

No

The device is described as tubing to connect a CO2 sampling port to an expired gas monitor. It facilitates the sampling of gas but does not itself analyze or diagnose. The diagnosis would be performed by the gas monitor ("expired gas monitor" or "gas sampling equipment") to which this device connects.

No

The device description clearly describes physical tubing, filters, and connectors, which are hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to connect a CO2 sampling port to an expired gas monitor. This is a component used in a system that monitors physiological parameters (CO2 levels in breath), not a device that performs tests on biological samples in vitro (outside the body).
  • Device Description: The description details tubing and connectors for gas sampling from a patient's breath. This is a physical connection for gas transport, not a diagnostic test performed on a sample.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing a diagnostic test in vitro.

The device is a component of a system used for physiological monitoring, which falls under a different regulatory category than IVDs.

N/A

Intended Use / Indications for Use

CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

Product codes

CCK

Device Description

The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.

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 from which gas monitoring is required

Intended User / Care Setting

Hospital and Sub-acute Institutions

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)

Non-Clinical Testing Summary:
Performed a number of tests including comparative resistance to flow.
Key results: results demonstrated equivalent performance.
The following tests were performed:

  • Flow resistance
  • Age and Environmental Testing
    • Pre and post- exposure
    • Luer fitting tests (ISO 594-2)

Clinical Testing:
No clinical testing was required or performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Resistance to flow without in-line filter:

  • 8.47 mbar at 100 mL/min flow
  • 24.35 mbar at 300 mL/min flow

Resistance to flow with in-line filter:

  • 11.96 mbar at 100 mL/min flow
  • 33.59 mbar at 300 mL/min flow

Leakage:

§ 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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2015

Besmed Health Business Corp c/o Paul Dryden Consultant No. 5. Lane 116. Wu-Kong 2nd Rd. New Taipei City, Wu-Ku District Taiwan

Re: K143150

Trade/Device Name: Besmed CO2 Monitoring Line With and Without In-Line Filter Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 6, 2015 Received: January 7, 2015

Dear Mr. 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. 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.

1

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143150

Device Name

Besmed CO2 monitoring line with and without in-line filter

Indications for Use (Describe)

CO2 Monitoring Lines are intended to connect from a CO2 sampling port 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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

3

510(k) Summary Page 1 of 3

Date Prepared:30-Oct-2014
Besmed Health Business Corp.
No. 5, Lane 116, Wu-Kong 2nd Rd,
Wu-Ku District, New Taipei City, TaiwanTel - 011-886-2-2290-3959
Fax - 011-886-2-2299-9076
Official Contact:Winnie Chung, Regulatory Affairs
Proprietary or Trade Name:Besmed CO₂ monitoring line with and without in-line filter
Common/Usual Name:CO₂ Monitoring Line
Classification Name:21CFR 868.1400
CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Class II
Predicate Devices:K122075 – Intersurgical – CO₂ Monitoring Line

Device Description:

The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.

Indications for Use:

CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

Patient Population:

There is no specific patient population associated with this device. The clinician makes a decision as to whether to sample expired gases. This is independent of patient population. The predicate, K122075, used the following language for its patient population: "Any patient from which gas monitoring is required."

Environments of use:

Hospital and Sub-acute Institutions

Substantial Equivalence Discussion:

Table 5.1 compares the key features of the proposed Besmed CO2 monitoring line with and without in-line filter with the identified predicate and demonstrates that the device can be found to be substantially equivalent. In summary one can conclude that substantial equivalence is met based upon the following:

4

510(k) Summary Page 2 of 3 30-Oct-2014

Table 5.1 – Predicate Comparison

AttributeK122075Proposed
Intersurgical- CO2 Monitoring Line withBesmed CO2 Monitoring Line with and
and without in-line filterwithout in-line filter
Intended use
Indications for UseCO2 monitoring lines are intended to connect
from a CO2 sampling port to the expired gas
monitor.CO2 monitoring lines are intended to
connect from a CO2 sampling port to the
expired gas monitor.
Target PopulationAny patient from which gas monitoring is
requiredAny patient from which gas monitoring is
required
Environment of useHospitals and sub-acute careHospitals and sub-acute care
Single useYesYes
Design and performance
Resistance to flow
without in-line filter13.54 mbar at 100 mL/min flow
37.61 mbar at 300 mL/min flow8.47 mbar at 100 mL/min flow
24.35 mbar at 300 mL/min flow
Resistance to flow
with in-line filter25.21 mbar at 100 mL/min flow
61.92 mbar at 300 mL/min flow11.96 mbar at 100 mL/min flow
33.59 mbar at 300 mL/min flow
Leakage