VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER

{0}------------------------------------------------ K132709 VR Medical Heat and Moisture Exchanger and Filter Premarket Notification [510(k)] Application #### 510(k) SUMMARY SECTION 5 Date of Submission: August 16, 2013 Owner/Submitter: 90 Gao Xin Road, ZhouZhuang Kunshan 215325, China Phone: 86 512 5720 0500 Contact Person: Lee Pan, Ph.D. CEO, VR Medical Technology Co. 90 Gao Xin Road, ZhouZhuang Kunshan 215325, China T: 86 512 5720 0500 C: 137 8897 5958 I (US) 6262275727 lpan@vrmedical.net Proprietary Name: VR Medical Heat and Moisture Exchanger and Filter VR Medica! Technology Co. Common/ Usual Name: Breathing Circuit Bacterial Filter Classification Reference: 21 CFR 868.5260 Product Code: САН Datex - Ohmeda HMEF 750 (K031653) Predicate Devices: Datex- Ohmeda HMEF Mini (K023641) Drager Medical Breathing Circuit Bacterial Filter (K072002) Engineering Medical Systems HEPA Filter / HME (K013089) Indication for Use: The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours. Patient Population/ Environment of Use: The Heat and Moisture Exchanger and Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only. {1}------------------------------------------------ ### 9 of77 VR Medical Heat and Moisture Exchanger and Filter Premarket Notification [510(k)] Application # Device Description: The Heat and Moisture Exchanger and Filter (HMEF) consists of a plastic body which incorporates an electrostatic/ mechanical filter pad. 22 mm female / 15 mm male connectors in accordance with ISO 5356 (Anaesthetic and respiratory equipment-Conical connectors- Part 1: Cones and sockets) and a luer lock connector which is only used for gas monitoring. | Item | HMEF | HMEF | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | | VR003 | VR005 | | Filtration efficiency<br>(By Nelson Lab) | 99.999% (BFE*)<br>99.99% (VFE*) | 99.9999% (BFE*)<br>99.999% (VFE*) | | Filtration mechanism | electrostatic | mechanical | | Pressure Drop | 0.7 cm H2O at 30 L/min | 1.5 cm H2O at 30 L/min | | Internal Volume | 60mL | 85mL | | Recommended tidal<br>volume | 250 to 1500 mL | 250 to 1500 mL | | Conical connectors<br>ISO 5356 | 15 mm Inner Diameter (ID) X22<br>mm Outer Diameter (OD) fitting to<br>connect to the endotracheal tube or<br>face mask 15 mm OD X22 mm ID<br>fitting to connect to the breathing<br>circuit Y-piece | 15 mm iD X22 mm OD<br>fitting to connect to the<br>endotracheal tube or face<br>mask 15 mm OD.fitting to<br>connect to the breathing<br>circuitY-piece | | Moisture loss ISO 9360* | 10.5 mg/L at VT=500 mL | 7.8 mg/L at VT=500 mL | | Gas sampling port | Yes | Yes | | Material | | | | Housing: | K-Resin (Styrene-Butadiene<br>Copolymer Plastic) | K-Resin (Styrene-Butadiene<br>Copolymer Plastic) | | Filter medium | Synthetic fibers (Polyolefin) | Paper glass fiber | | Foam | Polyurethane (PU) impregnated<br>with calcium chloride (CaCl2) | Polyurethane (PU)<br>impregnated with calcium<br>chloride (CaCl2) | # * Notes BFE: Bacterial filtration efficiency VFE: Virus filtration efficiency ISO 9360: Anaesthetic and respiratory equipment-Heat and moisture exchangers (HMEs) for humidifying respired gases in humans-Part 1:HMEs for use with minimum tidal volumes of 250 ml Design verification tests (as well as an evaluation under ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) were conducted on the HMEF as a result of the resulting risk analysis and product requirements. It must be noted that the HMEF is provided non-sterile. Therefore, all corresponding sterilization tests are not necessary and were not performed. {2}------------------------------------------------ # Substantial Equivalence: The intended use and indications for use for the proposed device are the same as the predicate devices. The comparison of the data demonstrates similar values for the key performance data. The VRM HMEF devices demonstrate similar values in filtration efficiency, internal volume, pressure drop and recommended tidal volumes when compared to the legally marketed devices. It must be pointed out that there is an interdependency regarding filtration efficiency. moisture loss, internal volume and pressure drop. A higher amount of media will result in a higher efficiency in filtration or humidification but with the consequence of having more internal volume and higher pressure drop. The main differences that may influence the technological characteristics between the proposed device and the predicate devices are the different shape and size of the housing. The shape of the proposed device is cuboid-shaped, but the predicate devices are cylindershaped. These differences can influence the performance of internal volume and related performances, but as the designed volume of the housing is substantial equivalent to predicate devices, the proposed device have the similar internal volume and related performances as the predicated devices. Thus the differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness. . The Heat and Moisture Exchanger and Filter is manufactured from K-Resin (Styrene-Butadiene Copolymer Plastic), Polyurethane (PU), Synthetic fibers (Polyolefin), Paper glass fibers. All materials have been evaluated in accordance with ISO 10993-1 Biological Evaluation of Medical Device -Part 1: Evaluation and testing within a risk management process and FDA General Program Memorandum #G95-1. Thus, VR Medical conducted two confirmatory in-vitro tests (utilize both polar and non-polar solvents) and five confirmatory tests (cytotoxicity, sensitization, irritation, genotoxicity, and implantation) which confirmed the acceptable biocompatible status of these materials, #### Summary of Non-Clinical Tests: The following in-vitro tests were conducted: - Bacterial Filtration Efficiency (BFE) . - . Viral Filtration Efficiency (VFE) - . Salt Test (ISO 23328-1) - . Pressure Drop - . Internal Volume - . Moisture Loss - Conical Connectors Related Performance (ISO 5356) (Including the General Requirements and Special Requirement) {3}------------------------------------------------ - . Package Integrity - . Accelerated Aging Package Transport Test** - Constant Temperature and Humidity . - . Compression Testing - . Fixed Displacement Vibration Testing - . Free Fall Drop Testing - Package Transport Test Standards Utilized - 1STA 2A ISTA Packaged Products 150 1b (68 kg) or less; ISTA 2 Series Partial Simulation Performance Test Procedure - ASTM D4169-08 Standard Practices for Performing Testing of Shipping Containers and Systems Biocompatibility - · According to evaluation using ISO 10993-1 and FDA 095-1; - · The materials are either identical to, or substantially equivalent to predicate devices; - . Furthermore, two confirmatory in-vitro tests (utilize both polar and non-polar solvents) and five confirmatory tests (cytotoxicity, sensitization, irritation, genotoxicity, and implantation) demonstrated the materials acceptable biocompatible status - Cytotoxicity (ISO 10993-5:2009) o - Sensitization (ISO 10993-10:2010) 0 - Irritation (ISO 10993-10:2010) 0 - Genotoxity (ISO 10993-3:2003) 0 - 0 Implantation (ISO 10993-6:2007) # Summary of Clinical Tests: The subject of this premarket submission, VR Medical Heat and Moisture Exchanger and Filter did not require clinical studies to support substantial equivalence. ## Conclusion VR Medical has demonstrated that the proposed device is as safe, as effective and the performance testing results are substantially equivalent to the described predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002 July 30, 2014 VR Medical Technology Co. Lee Pan, Ph.D. CEO 90 Gao Xin Road, ZhouZhuang Kun Shan, Jiangsu 215325 CHINA Re: K132709 Trade/Device Name: VR Medical Heat and Moisture Exchanger and Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Class: Il Product Code: CAH Dated: May 21, 2014 Received: June 30, 2014 # Dear Dr. Pan: 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. {5}------------------------------------------------ # Page 2 - Dr. Pan 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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/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 {6}------------------------------------------------ 7 of 77 VR Medical Heat and Moisture Exchanger and Filter Premarket Notification [510(k)] Application . INDICATION FOR USE STATEMENT SECTION 4 Page 1 of 1 510(k) Number (if known): _K132709 Device Name: VR Medical I-leat and Moisture Exchanger and Filter Indication for Use: The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours. Patient Population/ Environment of Use: The Heat and Moisture Exchanger and Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only. X Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) K132709 Anya C. Harry -S 2014.07.29 13:58:36 -04'00'