CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style

{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 seal with the words "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. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 13, 2015 DISPO-MED (MALAYSIA) SDN BHD c/o Mr. Paul Dryden Regulatory Consultant 21, Jalan Teknologi 3/5A Pusat Teknologi Sinar Damansara, Kota Damansara 47810 Petaling Jaya, Selangor Darul Ehsan, Malaysia Re: K143127 Trade/Device Name: Dispo-Med Oxygen Delivery / CO2 Sampling Cannula Style Dispo-Med Gas Sampling Only Style Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: January 13, 2015 Received: January 14, 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, Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The text is black and appears to be centered on a white background. The letters are slightly curved and have a classic, elegant look. 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) K143127 Device Name Dispo-Med Oxygen delivery / CO2 sampling cannula style Dispo-Med Gas sampling only style Indications for Use (Describe) The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor. Environment of use - hospital, sub-acute, and pre-hospital settings Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics. 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) {3}------------------------------------------------ ### 510(k) Summary Page 1 of 8 Date Prepared: 12-Feb-2015 DISPO-MED (MALAYSIA) SDN BHD 21, Jalan Teknologi 3/5A Pusat Teknologi Sinar Damansara, Kota Damansara 47810 Petaling Jaya, Selangor Darul Ehsan, Malaysia Tel – +603-6730 4966 Fax – +603-6143 6866 | Official Contact: | NC Leow - CEO | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------| | | Proprietary or Trade Name: Dispo-Med Oxygen delivery / CO2 sampling cannula style<br>Dispo-Med Gas sampling only style | | Common/Usual Name: | analyzer, gas, carbon-dioxide, gaseous phase (accessories) | | Classification Name: | analyzer, gas, carbon-dioxide, gaseous phase (accessories)<br>CCK - CFR 868.1400<br>Class II | | Predicate Devices: | O2/CO2 style devices<br>K010024 - Oridion<br>K011050 – Oridion<br>CO2 sampling style devices<br>K980325 – Oridion<br>K980325 – Oridion | #### Device Description: Dispo-Med has designed a series of exhaled gas sampling devices. They include: - Nasal cannula styles that can provide supplemental O2 and sample exhaled gases ● - . Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit All of the devices have the same indications for use and therefore can be combined into a single submission. We will present several different configurations which have been tested and compared to several predicates. Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling design connect to the monitor via a standard luer fitting, whether it is a female or male fitting. {4}------------------------------------------------ #### 510(k) Summary Page 2 of 8 12-Feb-15 #### Indications for Use: The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor. Environment of use - hospital, sub-acute, and pre-hospital settings Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics. ## O2 delivery / CO2 sampling Cannula style Table 1 - Comparison - O2 delivery / CO2 sampling Cannula style presents a comparison of the Dispo-Med Oxygen delivery / Gas Sampling cannula style products, which provide supplemental oxygen and samples expired gases like the predicates, K010024 and K011050 - Oridion Nasal cannula sampling products. The difference between the predicates is only that K011050 has a design which also allows for oral CO2 sampling, whereas K011024 only samples from the cannula nares. Otherwise the devices have the same indications for use. | Attribute | Predicates<br>Oridion<br>K010024 and K011050 | Proposed<br>DM-4000, DM-4441, DSM-6500, and<br>DM-4601 | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | K010024 - Oridion<br>To sample exhaled gas via a nasal cannula<br>and simultaneously provide supplemental<br>oxygen near the nose and mouth for<br>inhalation<br><br>K011050 - Oridion<br>Used whenever the physician needs to<br>measure the CO2 in a patient's breathing in<br>a non-intubated patient | The Dispo-Med nasal cannula styles are<br>intended to deliver supplemental oxygen to<br>patients and provide a means to sample<br>expired gases. | | Environments of use | Hospitals, sub-acute, pre-hospital settings | Hospitals, sub-acute, pre-hospital settings | | Prescriptive | Yes | Yes | | Patient population | Patient requiring supplemental oxygen and /<br>or sampling of expired gases | Patient requiring supplemental oxygen and /<br>or sampling of expired gases | | Multiple sizes | Adult to pediatric | Only one size | | Sampling tubing specs | Not provided | ID – 1.10 mm / OD – 2.20 to 3.00 mm<br>Length – 2 m | ### Table 1 - Comparison - O2 delivery / CO2 sampling Cannula style {5}------------------------------------------------ ### 510(k) Summary Page 3 of 8 12-Feb-15 | Attribute | Predicates<br>Oridion<br>K010024 and K011050 | Proposed<br>DM-4000, DM-4441, DSM-6500, and<br>DM-4601 | |-----------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Single patient use,<br>disposable | Yes | Yes | | Basic components | Channeled / split nasal cannula<br>Oxygen tubing<br>Gas sampling line<br>K011050<br>Mouth sampling part | Channeled / split nasal cannula<br>Oxygen tubing<br>Gas sampling line<br>DM-4601<br>Mouth sampling part | | Materials | Cannula and tubing - PVC<br>Connectors - Polypropylene, ABS | Cannula and tubing - PVC<br>Connectors – Polypropylene, ABS | | Performance testing | Comparison End-tidal CO2 results and<br>waveform at various settings | Comparison End-tidal CO2 results and<br>waveform at various settings<br>Resistance to flow<br>Tensile strength of connections<br>Luer fitting testing<br>Age testing - Environmental<br>Mechanical testing | #### Substantial Equivalence Discussion - Tables 1 above compares the key features of the proposed Dispo-Med Oxygen delivery / CO2 sampling cannula style devices with the identified predicates, K010024 and K011050 - Oridion Nasal cannula sampling, and it demonstrates that the proposed devices can be found to be substantially equivalent. In summary, one can conclude that substantial equivalence is met based upon the following: #### Indications for Use - The indications for use are identical for the proposed device when compared to the predicate -K010024 and K011050 - Oridion Nasal cannula sampling. Discussion - Each device is indicated for use delivering supplemental oxygen and sampling expired gases. #### Technology and construction - The design, fabrication, shape, size, etc. are equivalent to the predicate - K010024 and K011050 - Oridion Nasal cannula sampling. Discussion – The design incorporates several styles of split / channeled nasal cannula where oxygen and expired gases are provided through the various ports within the cannula. For the oral / nasal style, there is an extra part which is placed near the mouth to sample expired gases which may be exhaled by the patient. {6}------------------------------------------------ #### 510(k) Summary Page 4 of 8 12-Feb-15 #### Environment of Use - The environments of use are identical to predicate - K010024 and K011050 - Oridion Nasal cannula sampling. Discussion - The environments of use are not specifically disclosed in the predicate 510(k) Summary, but literature would support the listed environments of use. There are no differences in the requirements of each environment of use which would raise any new safety concerns when compared to the predicate - K010024 and K011050 - Oridion Nasal cannula sampling. #### Patient Population - The patient population of pediatrics to adults is equivalent to the predicate - K010024 and K011050 - Oridion Nasal cannula sampling. Discussion - The patient populations are equivalent to the predicate - K010024 and K011050 -Oridion Nasal cannula sampling. #### Non-Clinical Testing Summary - We performed comparative testing which evaluated the ability to measure a breath, measure a gas, and breathe waveforms under several simulated breathing conditions. The tests included: - Comparative CO2 sampling and waveform performance at breathing rates (12 bpm and . 20 bpm), tidal volumes (300 ml and 500 ml), CO2 concentrations (1% and 5%), and oxygen flow rates (1 lpm and 5 lpm) if the device included supplemental oxygen delivery. - Environmental and Age testing - . Mechanical testing (Section 18) - Luer Fitting per ISO 594-2 O - O Flow - Strength of bonds o - o Tensile Strength The results presented show that the proposed Dispo-Med Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates. The area of differences occurred when there was a higher flow rate (5 lpm) of oxygen which is known to influence CO2 washout and can caused lower values, however the performance met the performance specifications. The differences in comparative performance are not considered clinically significant as the user is looking for breath rate and understands that higher oxygen flow rates may cause EtCOwashout, reduced values. In all testing demonstrated that the proposed devices are substantially equivalent to the predicates - K010024 and K011050 - Oridion Nasal cannula sampling. {7}------------------------------------------------ ### 510(k) Summary Page 5 of 8 12-Feb-15 #### Materials - We have performed ISO 10993 testing on the component materials of the proposed device which is considered as Indirect contact and direct (skin) contact with the patient which means the following tests are required if a material certification cannot be provided. - . Cytotoxicity - Sensitization ● - . Intracutaneous Irritation # Discussion of Differences – There are virtually no differences between the proposed devices and the predicate. The performance testing has demonstrated that any slight change is not significant to safety or performance. ### Gas Sampling only style Table 2 - Comparison - Gas Sampling only style presents a comparison of the Dispo-Med Gas Sampling only style products, which provide sample expired gases like the predicates, K980325 and K980327 - Oridion Nasal gas sampling only products. The difference between the predicates is only that K980325 is designed to sample for nonintubated patients while K980327 may be used with intubated patients. Otherwise the devices have the same intended for use, i.e., sampling expired gases. | Attribute | Predicates<br>Oridion<br>K980325 and K980327 | Proposed<br>DM-41000, DM-1000,<br>DM-7100, and DM-7700 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | K980325 – Oridion<br>Used whenever the physician needs to<br>measure the CO2 in a patient's breathing in<br>a non-intubated patient<br><br>K980325 – Oridion<br>Used whenever the physician needs to<br>measure the CO2 in a patient's breathing in<br>an intubated patient | The Dispo-Med gas sampling lines are<br>intended to interface with the patient via<br>nasal cannula, nares connector, or standard<br>sampling port connectors to the expired gas<br>monitor. | | Environments of use | Hospitals and / or sub-acute | Hospitals and / or sub-acute | | Prescriptive | Yes | Yes | | Patient population | Patient requiring sampling of expired gases<br>Non-intubated (K980325) and Intubated<br>(K980327) | Patient requiring sampling of expired gases | | Multiple sizes | Adult to pediatric | One size | | Table 2 - Comparison - Gas Sampling only style | | | |------------------------------------------------|---|--| | | C | | {8}------------------------------------------------ ### 510(k) Summary Page 6 of 8 12-Feb-15 | Attribute | Predicates<br>Oridion<br>K980325 and K980327 | Proposed<br>DM-41000, DM-1000,<br>DM-7100, and DM-7700 | |-----------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sampling tubing specs | Not provided | ID – 1.10 mm / OD – 2.20 to 3.00 mm<br>Length – 2 m | | Single patient use,<br>disposable | Yes | Yes | | Basic components | Connector to sample from the patient<br>Small bore tubing<br>Connects to expired gas monitor | Connector to sample from the patient<br>Nasal cannula, nares connector or sampling<br>port<br>Small bore tubing<br>Connects to expired gas monitor | | Materials | Cannula and tubing - PVC<br>Connectors - Polypropylene, ABS | Cannula and tubing - PVC<br>Connectors - Polypropylene, ABS | | Performance testing | Comparison End-tidal CO2 results and<br>waveform at various settings | Comparison End-tidal CO2 results and<br>waveform at various settings<br>Resistance to flow<br>Tensile strength of connections<br>Luer fitting testing<br>Age testing - Environmental<br>Mechanical testing | #### Substantial Equivalence Discussion - Tables 2 above compares the key features of the proposed Dispo-Med CO2 sampling only style devices with the identified predicates, K980325 and K980327 - Oridion Nasal gas sampling only products, and it demonstrates that the proposed devices can be found to be substantially equivalent. In summary, one can conclude that substantial equivalence is met based upon the following: #### Indications for Use - The indications for use are identical for the proposed device when compared to the predicate -K980325 and K980327 - Oridion Nasal gas sampling only products. Discussion - Each device is indicated for use sampling expired gases. #### Technology and construction - The design, fabrication, shape, size, etc. are equivalent to the predicates - K980325 and K980327 - Oridion Nasal gas sampling only products. Discussion – The design incorporates simple means to interface with the patient or the breathing / ventilator circuit. #### Environment of Use - The environments of use are identical to predicate - K980325 and K980327 - Oridion Nasal gas sampling only products. {9}------------------------------------------------ # 510(k) Summary Page 7 of 8 12-Feb-15 Discussion - The environments of use are not specifically disclosed in the predicate 510(k) Summary, but literature would support the listed environments of use. There are no differences in the requirements of each environment of use which would raise any new safety concerns when compared to the predicate - K980325 and K980327 - Oridion Nasal gas sampling only products. ### Patient Population - The patient population of pediatrics to adults is equivalent to the predicate - K980325 and K980327 - Oridion Nasal gas sampling only products. Discussion - The patient populations are equivalent to the predicate - K980325 and K980327 -Oridion Nasal gas sampling only products. ### Non-Clinical Testing Summary - We performed comparative testing which evaluated the ability to measure a breath, measure a gas, and breathe waveforms under several simulated breathing conditions. The tests included: - . Comparative CO2 sampling and waveform performance at breathing rates (12 bpm and 20 bpm), tidal volumes (300 ml and 500 ml), CO2 concentrations (1% and 5%). - . Environmental and Age testing - Mechanical testing ● - o Luer Fitting per ISO 594-2 - o Flow - o Strength of bonds - o Tensile Strength The results show that the proposed Dispo-Med CO2 sampling only style devices performed equivalent to the predicates. The differences in comparative performance related to better performance of the proposed device vs. the predicates. In all testing demonstrated that the proposed devices are substantially equivalent to the predicates - K980325 and K980327 - Oridion Nasal gas sampling only products. #### Materials - We have performed ISO 10993 testing on the component materials of the proposed device which is considered as Indirect contact and direct (skin) contact with the patient which means the following tests are required if a material certification cannot be provided. - Cytotoxicity . - Sensitization ● - Intracutaneous Irritation {10}------------------------------------------------ #### 510(k) Summary Page 8 of 8 12-Feb-15 # Discussion of Differences – There are virtually no differences between the proposed devices and the predicate. The performance testing has demonstrated that any slight change is not significant to safety or performance. ### 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.