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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Besmed CO2 Monitoring Line With and Without In-Line Filter." This document does not pertain to an Artificial Intelligence (AI) device, but rather a passive medical accessory. As such, many of the requested categories related to AI device evaluation (such as sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable or a study as described would not have been performed.

However, I can extract the acceptance criteria and performance data provided for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the proposed device's performance to that of a legally marketed predicate device (K122075 – Intersurgical – CO2 Monitoring Line). The goal is to demonstrate "equivalent performance."

Attribute	Predicate Device (K122075) Performance (Acceptance Criteria)	Proposed Device (Besmed CO2 Monitoring Line) Performance
Resistance to flow (without in-line filter)
at 100 mL/min flow	13.54 mbar	8.47 mbar
at 300 mL/min flow	37.61 mbar	24.35 mbar
Resistance to flow (with in-line filter)
at 100 mL/min flow	25.21 mbar	11.96 mbar
at 300 mL/min flow	61.92 mbar	33.59 mbar
Leakage	<1.0 mL/min	<1.0 mL/min
Connectors	2 x luer lock connectors	2 x luer lock connectors
Outer diameter	3.05 mm	3.0 mm
Inner diameter	1.47 mm	1.5 mm
Materials	PVC (sample tubing), PC (luer connectors), Hydrophobic filter	PVC (sample tubing), PC (luer connectors), Hydrophobic filter
Biocompatibility	ISO 10993	ISO 10993 (No direct or indirect patient contact)
Packaged	Non sterile	Non sterile

The reported performance for the Besmed CO2 Monitoring Line demonstrates lower resistance to flow compared to the predicate device, which is considered favorable. Leakage performance is equivalent. Other attributes are either identical or functionally equivalent.

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

The document mentions "a number of tests" were performed for "comparative resistance to flow" and "pre and post-exposure" for age and environmental testing. However, specific sample sizes for these tests are not provided in the summary. The provenance of this data is from the manufacturer's internal testing as part of their 510(k) submission, likely performed in Taiwan where the manufacturer is located, but this is not explicitly stated as "country of origin for data." All testing appears to be retrospective bench testing on manufactured units.

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

Not applicable. This device is a fluidic component, not an AI or diagnostic device that requires expert interpretation for a ground truth. The "ground truth" for its performance is derived from direct physical measurements (e.g., flow resistance, leakage).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described or required for this type of bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret cases. The device in question is a CO2 monitoring line, an accessory to a gas monitoring system, and its performance is evaluated through bench tests, not human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to a non-AI medical device. The device's performance is inherently "standalone" in the sense that it's the physical tubing and filter, and its function is measured directly, not through an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on direct physical measurements and engineering standards, such as ISO 594-2 for luer fittings and internal manufacturer specifications for resistance to flow and leakage. The comparison is against the performance of a legally marketed predicate device, with the implication that the predicate's performance serves as an acceptable benchmark.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI device, there is no training set or ground truth in the context of machine learning.

Summary

{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, Taiwan	Tel - 011-886-2-2290-3959Fax - 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 868.1400CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 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

Attribute	K122075	Proposed
	Intersurgical- CO2 Monitoring Line with	Besmed CO2 Monitoring Line with and
	and without in-line filter	without in-line filter
Intended use
Indications for Use	CO2 monitoring lines are intended to connectfrom a CO2 sampling port to the expired gasmonitor.	CO2 monitoring lines are intended toconnect from a CO2 sampling port to theexpired gas monitor.
Target Population	Any patient from which gas monitoring isrequired	Any patient from which gas monitoring isrequired
Environment of use	Hospitals and sub-acute care	Hospitals and sub-acute care
Single use	Yes	Yes
Design and performance
Resistance to flowwithout in-line filter	13.54 mbar at 100 mL/min flow37.61 mbar at 300 mL/min flow	8.47 mbar at 100 mL/min flow24.35 mbar at 300 mL/min flow
Resistance to flowwith in-line filter	25.21 mbar at 100 mL/min flow61.92 mbar at 300 mL/min flow	11.96 mbar at 100 mL/min flow33.59 mbar at 300 mL/min flow
Leakage	<1.0mL/min	<1.0mL/min
Connectors	2 x luer lock connectors	2 x luer lock connectors
Outer diameter	3.05mm	3.0mm
Inner diameter	1.47mm	1.5mm
PerformanceTesting		Age TestingPre and post- exposureEnvironmental TestingLuer fittingResistance to flowISO 594-2 luer fittings
Principle of operation	Gas is pulled from one end of the tube to theother by a pump in the gas sampling device	Gas is pulled from one end of the tube to theother by a pump in the gas sampling device
Compatibility	Designed for use with gas monitoring device(for example a Capnograph) with luerconnections to gas sampling tubing	Designed for use with gas monitoring device(for example a Capnograph) with luerconnections to gas sampling tubing
Materials	PVC (sample tubing)PC (luer connectors)Hydrophobic filter	PVC (sample tubing)PC (luer connectors)Hydrophobic filter
Biocompatibility	ISO 10993	ISO 10993No direct or indirect patient contact
Packaged	Non sterile	Non sterile

{5}------------------------------------------------

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

Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate -K122075 - Intersurgical - CO2 Monitoring Line.

Discussion - Each device is intended to connect from a CO2 sampling port to the expired gas monitor.

Technology and construction -

The design, components, shape, size, etc. are equivalent to the predicate - K122075 -Intersurgical CO2 Monitoring Line.

Discussion - Both the proposed device and the predicate are similar in design, construction, and materials.

Environment of Use -

The environments of use are identical to predicate - K122075 - Intersurgical - CO2 Monitoring Line.

Discussion - The environments of use are identical to the predicate - K122075 - Intersurgical -CO2 Monitoring Line.

Patient Population -

There is no specific patient population associated with this device. The predicate, K122075, used the following language for its patient population: "Any patient from which gas monitoring is required."

Discussion - The patient populations are equivalent to the predicate - K122075 - Intersurgical -CO2 Monitoring Line.

Non-Clinical Testing Summary -

We performed a number of tests including comparative resistance to flow and the results demonstrated equivalent performance, which is discussed in details in Section 18 - Performance - Bench demonstrating the proposed device is equivalent to the - K 122075 - Intersurgical CO2 Monitoring Line.

The following tests were performed:

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

Clinical Testing -

No clinical testing was required or performed.

Substantial Equivalence Conclusion:

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