Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. February 21, 2019 Devon Medical Products (Jiangsu) Ltd % Ruth Wu Consultant Devon MD LLC 700 American Ave Ste 100 King of Prussia, Pennsylvania 19406 Re: K182578 Trade/Device Name: Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: December 20, 2018 Received: January 7, 2019 Dear Ruth Wu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Fernando Aguel Fernando Aguel -S for Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K182578 Device Name Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device Indications for Use (Describe) The Devon 62 DVT Prevention Therapy Device is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510K Summary #### Submitter: Devon Medical Products (Jiangsu) Ltd. East Half Of 1-2F, Appt D2, - 1, Qingfeng Road Nantong, Jiangsu, CHINA 226017 Phone: 011-86-513-51080927 Fax: 011-86-513-51080928 Contact Person: Neil Cheng Date Prepared: August 29, 2018 ### Device: | Common Names: | Intermittent Pneumatic Compression Device | |----------------------|---------------------------------------------------------------| | Proprietary Name: | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | | Regulation Number: | 21 CFR 870.5800 | | Classification Name: | Compressive Limb Sleeve | | Regulatory Class: | II | | Product Code: | JOW | ### Predicate Devices: The Devon 62 DVT Prevention Therapy Device is equivalent to the following: | Predicate Device | Manufacturer | 510(k)# | |------------------|------------------------|---------| | Cirona 6200 | Devon Medical Products | K141578 | ### Device Description The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. {4}------------------------------------------------ The Devon 62 DVT Prevention Therapy Device, with a pair of extension tubing, is for use with Cirona DVT calf-thigh and foot garments (sleeves). The device alternatively inflates the two garments and mimic the natural walking pace to enhance circulation. The compression supplied by the device provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calfthigh and foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting. #### Indication for Use: The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments. #### Contraindications: The Devon 62 DVT Prevention Therapy Device should NOT be used in the following conditions: - · Severe atherosclerosis or other ischemic vascular diseases - · Suspected or known acute deep vein thrombosis - · Severe congestive cardiac failure - Existing pulmonary edema - Existing pulmonary embolisms - Extreme deformity of the limbs - Any local skin or tissue condition in which the garments would interfere: - Gangrene - Untreated or infected wounds - Recent skin graft - Dermatitis - · Known presence of malignancy in the legs - · Limb infections, including cellulitis, that have not received antibiotic coverage - Presence of lymphangiosarcoma #### Technological Characteristics: The manufacturer believes that the technological characteristics of the Devon 62 DVT Prevention Therapy Device are substantially equivalent to those of the predicate devices. {5}------------------------------------------------ The Devon 62 DVT Prevention Therapy Device has very similar components to its predicate devices and has very similar principles of operation. The device consists of an electrically generated source of compressed air; tubing to convey the pressurized air to the sleeve and, like the predicates, pressure is applied cyclically for 12 seconds inflated and 48 seconds deflated. A pressure of 40mmHq is used for the calf, calf-thigh and foot treatments. # Performance Tests To verify that the device design meet its function and performance requirements, samples of the device underwent function and mechanical testing. The following tests were conducted: | Function Performance Tests | | |----------------------------|--------------------------------------------------| | TR68.J001 | Devon 62 System Level Software Test Report | | TR68.J002 | Devon 62 Pressure Accuracy Test Report | | TR68.J003 | Devon 62 Cycle Time Test Report | | TR68.J004 | Devon 62 Alarm Function Test Report | | TR68.J005 | Devon 62 Pressure Sensor Calibration Test Report | | TR68.J006 | Devon 62 Battery Life Test Report | The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate. # Biocompatibility The Devon 62 DVT Prevention Therapy Device uses the same garments as its predicate and manufactured by the same manufacturer, so new biocompatibility testing was not run. # Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC tests were conducted according to the following standards: - IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC 60601-. 1:2012 reprint) Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance {6}------------------------------------------------ - IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests ## Statement of Substantial Equivalence The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is substantially equivalent in technology, function, operating parameters, and indication for use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness. ## Conclusions In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Products (Jiangsu) Ltd believes that the Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is substantially equivalent to the predicate device Cirona 6200 (K141578) as described herein.