CO2 monitoring line with and without in-line filter

{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.<br>No. 5, Lane 116, Wu-Kong 2nd Rd,<br>Wu-Ku District, New Taipei City, Taiwan | Tel - 011-886-2-2290-3959<br>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<br>CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase<br>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 | 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 connect<br>from a CO2 sampling port to the expired gas<br>monitor. | CO2 monitoring lines are intended to<br>connect from a CO2 sampling port to the<br>expired gas monitor. | | Target Population | Any patient from which gas monitoring is<br>required | Any patient from which gas monitoring is<br>required | | Environment of use | Hospitals and sub-acute care | Hospitals and sub-acute care | | Single use | Yes | Yes | | Design and performance | | | | Resistance to flow<br>without in-line filter | 13.54 mbar at 100 mL/min flow<br>37.61 mbar at 300 mL/min flow | 8.47 mbar at 100 mL/min flow<br>24.35 mbar at 300 mL/min flow | | Resistance to flow<br>with in-line filter | 25.21 mbar at 100 mL/min flow<br>61.92 mbar at 300 mL/min flow | 11.96 mbar at 100 mL/min flow<br>33.59 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 | | Performance<br>Testing | | Age Testing<br>Pre and post- exposure<br>Environmental Testing<br>Luer fitting<br>Resistance to flow<br>ISO 594-2 luer fittings | | Principle of operation | Gas is pulled from one end of the tube to the<br>other by a pump in the gas sampling device | Gas is pulled from one end of the tube to the<br>other by a pump in the gas sampling device | | Compatibility | Designed for use with gas monitoring device<br>(for example a Capnograph) with luer<br>connections to gas sampling tubing | Designed for use with gas monitoring device<br>(for example a Capnograph) with luer<br>connections to gas sampling tubing | | Materials | PVC (sample tubing)<br>PC (luer connectors)<br>Hydrophobic filter | PVC (sample tubing)<br>PC (luer connectors)<br>Hydrophobic filter | | Biocompatibility | ISO 10993 | ISO 10993<br>No 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.