Venous Assist System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 12, 2016 DaeSung Maref Co., Ltd. % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025 Re: K150980 Trade/Device Name: DVT-Pro Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 31. 2016 Received: April 5, 2016 Dear Dave Kim: 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. 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 {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. 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 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 vours. M.A. Hilleman 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) K150980 Device Name DVT-Pro #### Indications for Use (Describe) DVT-Pro is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-Pro is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | ### 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}------------------------------------------------ # 510(k) Summary This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date 510k summary prepared: May 4, 2016 #### I. SUBMITTER | Submitter's Name : | DaeSung Maref Co., Ltd. | |-------------------------|-------------------------------------------------------------------------| | Submitter's Telephone: | 298-24, Gongdan-Ro, Gunpo-shi, Gyeonggi-Do, Republic of Korea, 435-862 | | Submitter's Telephone: | +82-31-459-7200 | | Contact person: | Jae-Wha Lee / President | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | (U.S. Designated agent) | | | Address: | 8310 Buffalo Speedway, Houston, TX 77025 | | Telephone: | +713-467-2607 | | Fax: | +713-583-8988 | #### II. DEVICE | Trade/proprietary name: | DVT-Pro | |-------------------------|-------------------------------------| | Common or Usual Name: | The Venous Assist System | | Regulation Name : | Compressible Limb Sleeve | | Classification: | 21 CFR 870.5800 (Product Code: JOW) | | Regulatory Class: | II | {4}------------------------------------------------ #### III. PREDICATE DEVICE | 1) Primary Manufacturer | : DaeSung Maref Co., Ltd. | |-------------------------|-------------------------------------------| | Device | : DVT-2600 | | 510(k) Number | : K112677 (Decision Date – Jan. 13, 2012) | This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### DEVICE DESCRIPTION IV. DVT-Pro device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot. - > Device Identification: - (1) Adaptor Specification - (1) Input Voltage and Frequency: 100-240V~, 47~63Hz - (2) Input Current: 0.5A max. (at 90Vac input) - Output Voltage : 9Vdc/2A, 15W (3) #### (2) Battery Specification - (1) Battery Cell type and quantity : Li-ion 18650(ICR18650 B4 2600mAh), 4-cell(2s x 2p) - Battery Voltage : 7.4V(5200mAh) (2) - Safety circuit : PCM equipped (overcharge, over discharge, overcurrent prevention) (3) - (3) Specification - (1) Time range : unlimited (using time can be set : ~999hour 50min, unit : 10min) - Interval time range : 28s, 48s (2) - (3) Pressure range : Leg : 20 ~ 65mmHg(unit 5mmHg), Foot : 120~140mmHg(unit 10mmHg), AUX : 20~50mmHg(unit:5mmHg) - Mode : DVT mode (4) {5}------------------------------------------------ - Photos (4) ### 1) Main Body Image /page/5/Figure/3 description: The image shows three different views of a black handheld device. The views are labeled as "Front", "Right", and "Left". The front view shows a screen and several buttons, while the right and left views show the side profiles of the device. The device appears to be some sort of electronic instrument. Top Back Image /page/5/Picture/6 description: The image shows two views of a black, square-shaped electronic device. The left view displays the front of the device, which features a screen, several buttons, and the text "OS MAREF" printed on the side. The right view shows the back of the device, revealing a smooth surface with four screws located at each corner. Image /page/5/Picture/7 description: The image shows two different types of hoses. The first hose is labeled "2) Air Hose" and appears to be a black air hose with metal connectors on each end. The second hose is labeled "3) AUX" and appears to be a black AUX cable connected to a black device. - 4) Garments(cuffs) Image /page/5/Figure/9 description: The image shows two different medical devices, a calf cuff and a foot device, used for DVT (Deep Vein Thrombosis) mode. The calf cuff has 3 chambers and provides a pressure of 20-65mmHg with a unit of 5mmHg. The foot device has 1 chamber and provides a pressure of 120-140mmHg with a unit of 10mmHg. {6}------------------------------------------------ Image /page/6/Picture/12 description: The image shows three different products with descriptions. The first product is non-woven and has dimensions of 620mm and 360mm. The second product is also non-woven and has dimensions of 420mm and 230mm. The third product is 2M PVC. - > Device Characteristics (address all that apply) ### (1) Components The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot. ### (2) Characteristics of the device - 1) Operation The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid). PCB consists of user input switch, LED or LCD display and button for pressure control and controls the air pump and solenoid via micro controller. Air pump is connected to the hose and supplies air to the distributor. Air distributor supplies the air to each air chamber in order and thus, repeats the inflation of Chamber 1 → inflation of Chamber 2 → inflation of Chamber 3 → in this order until the end of the set time. {7}------------------------------------------------ - (2) Electric Characteristics(Adaptor) - a. Rated Voltage: 100-240V~ - b. Rated Frequency: 47~63Hz - c. Power Consumption: 0.5A max (at 90Vac Input) - (3) Protection against electric shock Class II , Type BF - 4 Software - a. File Name: DVT-PRO.c - b. Version: V 1.0 - c. Main features: switch, display, pump, solenoid, pressure control #### V. Indications For Use: DVT-PRO is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-PRO is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema-Acute, Edema-Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency. {8}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE | Device Name | DVT-PRO | DVT-2600 | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K150980 | K112677 | | Classification | Class II Device / JOW<br>(21 CFR 870.5800) | Class II Device / JOW<br>(21 CFR 870.5800) | | Intended Use | DVT-PRO is a system to prevent<br>DVT (Deep Vein Thrombosis) by<br>improving the blood velocity of<br>patients. DVT-PRO is Circulation<br>Enhancement, Deep Vein<br>Thrombosis Prophylaxis Edema –<br>Acute, Edema – Chronic, Extremity<br>Pain Incident to Trauma or Surgery<br>Leg Ulcers, Venous Stasis / Venous<br>Insufficiency | DVT-2600 is a system to prevent<br>DVT (Deep Vein Thrombosis) by<br>improving the blood velocity of<br>patients. DVT-2600 is Circulation<br>Enhancement, Deep Vein<br>Thrombosis Prophylaxis Edema –<br>Acute, Edema – Chronic, Extremity<br>Pain Incident to Trauma or Surgery<br>Leg Ulcers, Venous Stasis / Venous<br>Insufficiency | | Contraindications | - Pre-existing deep vein<br>thrombosis, phlebothrombosis<br>or pulmonary embolism<br>- Presumptive evidence of<br>Congestive Heart Failure<br>- Inflammatory Phlebitis Process<br>- Severe arteriosclerosis or other<br>ischemic vascular disease<br>- Decompensated cardiac<br>insufficiency<br>- Carcinoma metastasis in the<br>affected Extremity<br>- Lymphatic return is undesirable<br>- Severe arteriosclerosis or active<br>infection<br>- Acute pulmonary edema<br>- Acute thrombophlebitis<br>- Acute congestive cardia failure<br>- Acute infections<br>- Episodes of Pulmonary<br>embolism<br>- Wounds lesions or tumors at or<br>in the vicinity of application | - Pre-existing deep vein<br>thrombosis, phlebothrombosis<br>or pulmonary embolism<br>- Presumptive evidence of<br>Congestive Heart Failure<br>- Inflammatory Phlebitis Process<br>- Severe arteriosclerosis or other<br>ischemic vascular disease<br>- Decompensated cardiac<br>insufficiency<br>- Carcinoma metastasis in the<br>affected Extremity<br>- Lymphatic return is undesirable<br>- Severe arteriosclerosis or active<br>infection | | | | | | | Bone fractures or dislocations<br>-<br>at or in the vicinity of<br>application | | | | | | | | EN ISO 14971 | EN ISO 14971 | | Standard | EN 60601-1<br>EN 60601-1-2 | EN 60601-1<br>EN 60601-1-2 | | | | EN 60601-1-4 | | Mode of | | | | Compression | Sequential | Sequential | | | | | | No of Modes | DVT mode 1 | Lymph mode 1<br>Foot mode 1 | | | | | | Therapy Time | Continuous | Continuous | | Maximum and | 20 ~ 65mmHg(Leg), | | | minimum pressure | 120~140mmHg(Foot) | 20 ~ 60 mmHg (Leg), | | | 20~50mmHg(AUX) | 120~140 mmHg (Foot) | | Number of | Calf cuff : 3chamber | | | chambers | Foot cuff : 1chamber | Leg sleeves / Foot cuffs | | Compression cycle | | | | time | 40s,60s/1cycle | 12 sec 1 cycle | | Compression<br>applicator garments | | | | sleeve material | | | | | Non-woven | Nylon / Fabric | | Operating | | | | Temperature | 10~40 °C | -20C ~40° C | | | | | | Operating Humidity | 30 ~ 75% | 90% | | Atmospheric | | | | Pressure | 700 - 1060 hPa | | | Size | 140 (W) x 143 (D) x 45 (H) mm | 200 (W) x 170(D) x 190 (H) mm | | Weight | 0.8 kg | 2 kg | | Input Voltage<br>100 ~240VAC / 47 ~ 63 Hz | | 100 ~240V AC / 50~ 60 Hz | | Input Current<br>0.5 A max at 90VAC Input | | | | Output Voltage | 9Vdc / 2A, 15W | | | | Li-ion 18650(ICR18650 B4 | | | Battery Spec | 2600mAh), 4-cell(2s x 2p) | | | Battery Voltage | 7.4V (5200mAh) | | | | DVT-PRO | DVT-<br>2600(3000) | | Pump | 200g | 285g | | Solenoid Valve | 140g | 250g | | Internal frame | 0g | 325g | | SMPS | 0g | 130g | | Case | 175g | 469 | | Total | 515g | 1459g | {9}------------------------------------------------ {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains two medical devices. The device on the left is black and has a screen and several buttons. The device on the right is white and also has a screen and buttons. The contraindications is revised to include additional medical conditions which predate or concurrent to the treatment of DVT-Pro. Contraindications listed here should be considered for using a pneumatic device with cuffs. There is no direct cause and effect relationship between disease associated with the contraindication and the treatment of DVT equipment. DVT-Pro was developed as a dedicated DVT treatment device and deleted the Lymph Mode of the predicate device to reduce the size and weight of the product. DVT-Pro was developed as a portable device with a built-in battery adapter and replaced SMPS (power supply circuits) with an external power supply for the user's convenience. DVT-Pro used the critical parts with less weight than the predicate device. Weight of the critical components Weight difference of the critical components is approximately 944g (1459 - 515). The risk management report contains the analysis of overall hazard situations generated from the parts with less weight and adapting an external power adapter during the development of a portable device. The technical report of the device validated the outcome. {11}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination. Biocompatibility testing (ISO10993-5, ISO10993-10) Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. ### Software Verification and Validation Testing Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for his device was considered as a "minor" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator. All test results were satisfactory. # VIII. CONCLUSIONS In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification DaeSung Maref Co. Ltd. concludes that DVT-Pro is substantially equivalent in comparison with DVT-2600. the predicate device as described herein.