Intermittent Pneumatic Compression system

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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, with flowing lines representing hair or clothing. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 03, 2016 DaeSung Maref Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025 Re: K160180 Trade/Device Name: DVT-4000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 28, 2016 Received: October 4, 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.G. Hillemann 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) K160180 Device Name DVT-4000 ### Indications for Use (Describe) DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 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-size:12pt;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12pt;">☐</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}------------------------------------------------ ### 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: July 18, 2016 ### I. SUBMITTER | Submitter's Name : | DAESUNG MAREF CO.,LTD. | |-------------------------|--------------------------------------------| | Submitter's Telephone: | 298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do, | | | Republic of Korea, 15809 | | Submitter's Telephone: | +82-31-459-7211 | | 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-4000 | |-------------------------|-------------------------------------------| | Common or Usual Name: | Intermittent Pneumatic Compression 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. | |-------------------------|-------------------------------------------| | 2) Device | : DVT-2600 | | 3) 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. ### IV. DEVICE DESCRIPTION DVT-4000 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 system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant. | NO | Items | Specification | |----|------------------------|------------------------------------------| | 1 | Model | DVT-4000 | | 2 | Rating Protection Type | Class II, BF-Type Device | | 3 | Usable Place | Indoor | | 4 | Rated Voltage | 100 - 240VAC, 50/60Hz | | 5 | Power Consumption | 60-80VA | | 6 | Safety circuit | Protection Circuit Module (PCM) equipped | Device Specification: A {5}------------------------------------------------ | 7 | Setting Pressure | Leg:20~60mmHg±10mmHg<br>Foot: 120~140mmHg±10mmHg | |----|------------------|--------------------------------------------------| | 8 | Setting Time | 1min~999hours (unit:1 Min.) | | 9 | Battery Voltage | 14.4V / 2600mAh | | 10 | Dimension | 181(W) * 214(D) * 186(H)mm | | 11 | weight | 2Kg(main system only) | ### ゃ Product Package ### 1. Controller Parts | Components | Qty. | Pictures | | |-------------|----------------|----------|-----------------------| | | Main Unit | 1ea | Image: Main Unit | | Main System | Power Cord | 1ea | Image: Power Cord | | | Extension hose | 2ea | Image: Extension hose | {6}------------------------------------------------ | Sleeve Parts & Specifications<br>i | て | | | | | |------------------------------------|---|--|--|--|--| |------------------------------------|---|--|--|--|--| | No | Name | Image | Type | Description | |----|--------------|---------------------|------------------|-----------------------------| | 1 | Thigh sleeve | Image: Thigh sleeve | Non-woven sleeve | DS011 / Small size sleeve | | | | | | DS012 / Medium size sleeve | | | | | | DS013 / Large size sleeve | | | | | | DS014 / X-Large size sleeve | | 2 | Calf sleeve | Image: Calf sleeve | Non-woven sleeve | DS021 / Small size sleeve | | | | | | DS022 / Medium size sleeve | | | | | | DS023 / Large size sleeve | | | | | | DS024 / X-Large size sleeve | | 3 | Foot sleeve | Image: Foot sleeve | Non-woven sleeve | DS031 / One size sleeve | ### Indications For Use: V. DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema-Acute, Edema-Chroni, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency. {7}------------------------------------------------ | A A A A A A A A A B A B A B A A A A A A A A A A A A A A A A A A A<br>A COLLECT COLLED A DICON TUTUR DE DE DE DE DE DELIT<br>1<br>I | | |------------------------------------------------------------------------------------------------------------------------------------|--| | A VALL 18 VARD V VAILAR FAMERIC VA 1 1 | | | T | | | 1 | | | Model Name | 510(k) Number | Classification | Picture | Indications for Use | Standard | Difference | (k) Submission: DVT-4000 | | -Identical- | Mode of<br>Compression | Mode description | Power Source | Therapy Time | Maximum and<br>Minimum<br>Pressure | Number of<br>Chamber | Compression<br>Interval Time | Compression<br>Garments Sleeve<br>Material | |------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----------------------------------------------------|-------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------| | DVT-4000 | K160180 | Class II Device /JOW<br>(21 CFR 870.5800) | Image: DVT-4000 device | DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema – Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery<br>Leg Ulcers, Venous Stasis / Venous Insufficiency | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 | Identical- | Contraindications | | | Sequential | DVT mode 1 | Battery Specifications<br>Battery Model/Type reference : HY-BP08 / 4ICR19 / 66-0<br>Battery Ratings : 14.4Vdc(2600mAh)<br>Safety circuit : PCM equipped (overcharge, overdischarge, overcurrent prevention) | Continuous | 20~60mmHg(Calf, Thigh, Boot),<br>120~140mmHg(Foot) | Calf, Thigh, Boots cuff : 3chamber<br>Foot cuff : 1 chamber | 28sec, 48sec, 60sec | Non-woven<br>consist of Polyethylene Terephthalate ≥<br>99.25% and Titanium Dioxide ≤0.35% | | DVT-2600 | K112677 | Class II Device /JOW (21 CFR 870.5800) | Image: DVT-2600 device | DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema – Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery<br>Leg Ulcers, Venous Stasis / Venous Insufficiency | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 | Identical- | - 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 infection | DVT-2600 device is a specialized<br>intermittent pneumatic compression (IPC)<br>system to prevent DVT (Deep Vein<br>Thrombosis) and PE (Pulmonary<br>Embolism) by improving the venous blood<br>flow in at risk patients.<br><br>The system consists of the controller, the<br>tubing sets and garments.<br><br>The system offers Sequential inflation<br>promoting venous blood movement and<br>metabolism and then has sufficient<br>interval time to refill with blood<br>sufficiently after deflation.<br><br>The operation of the inflation and<br>deflation is repeated until the stop button<br>is activated.<br><br>We recommend using the device<br>separately or with anti-coagulant<br>materials or compression stocking to help<br>prevent DVT and PE under a doctor's<br>consultant. | -Identical- | Sequential | DVT mode 1<br>Lymph mode 1 | ①Electricity Supply: AC 100-240V~,<br>50/60Hz<br>②Power consumption: 35VA | Continuous | 20~60mmHg(Calf, Thigh, Boot),<br>120~140mmHg(Foot) | Calf, Thigh, Boots cuff : 3chamber<br>Foot cuff : 1chamber | 28sec, 48sec, 60sec | Non-woven<br>consist of Polyethylene Terephthalate ≥<br>99.25% and Titanium Dioxide ≤0.35% | | | DVT-4000 device is a specialized<br>intermittent pneumatic compression (IPC)<br>system to prevent DVT (Deep Vein<br>Thrombosis) and PE (Pulmonary<br>Embolism) by improving the venous blood<br>flow in at risk patients.<br><br>The system consists of the controller, the<br>tubing sets and garments.<br><br>The system offers Sequential inflation<br>promoting venous blood movement and<br>metabolism and then has sufficient<br>interval time to refill with blood<br>sufficiently after deflation.<br><br>The operation of the inflation and<br>deflation is repeated until the stop button<br>is activated.<br><br>We recommend using the device<br>separately or with anti-coagulant<br>materials or compression stocking to help<br>prevent DVT and PE under a doctor's<br>consultant. | | Identical- | DVT-4000 is designed for the<br>DVT mode only<br>Note 1 | DVT-4000 was developed with a built-in-battery adapter and replaced SMPS<br>(power supply circuits) with an external<br>power supply for the user convenience.<br>The battery performance is verified in<br>accordance with IEC62133<br>Note 2 | Identical- | Identical-(Note 3) | Identical-(Note 3) | Identical- | Identical (Note 3) | | | | | | | | | | Description | | | | | | | | | | | | | | | | | {8}------------------------------------------------ 510(k) Submission : DVT-4000 {9}------------------------------------------------ 510(k) Submission : DVT-4000 {10}------------------------------------------------ 510(k) Submission : DVT-400 ## Note 1. Description on Mode difference | Description | Verification Data | Performance Testing and<br>Risk Assessment | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Thigh Sleeve, Calf Sleeve, Boot Sleeve<br>Image: [Three leg diagrams showing the inflation sequence of the sleeve] | | | 1 | Most frequently used DVT mode:<br>Air pressure is applied in each chamber in sequence from the bottom to the top as shown in the Figure.<br>A(Inflated)B(Deflated)C(Deflated)<br>→A(Inflated)B(Inflated)C(Deflated)<br>→A(Inflated)B(Inflated)C(Inflated)<br>→A(Deflated)B(Deflated)C(Deflated)<br>Foot Sleeve<br>Image: [Foot sleeve diagram] | Through the performance testing, the air pressure in each chamber is properly inflated sequentially.<br><br>There is no new risk associated with the DVT mode compared to the predicate device. | | DVT-4000 is designed to have one mode, the DVT mode.<br><br>Some devices, including DVT-2600, the predicate device, are designed to have dual modes: DVT and Lymph mode.<br><br>Through customer feedback, the DVT-4000 is designed and manufactured to function with the DVT mode exclusively instead of dual modes. Its technology, features, materials and principle of operations are identical to DVT-2600, except DVT-4000 is with a single mode only, DVT mode. | | | | Description | Verification Data | Performance Testing and Risk<br>Assessment | | DVT-4000 was developed with a built-in-<br>battery adapter and replaced SMPS (power<br>supply circuits) with an external power<br>supply for the user convenience. | The battery performance is verified in accordance with IEC62133. | Potential problems of having a<br>battery were examined in the risk<br>management report. Efficiency<br>and risk of the battery was proved<br>through the battery test report and<br>the product test report conforming<br>to the Medical Appliances Act | | The battery power is not intended to be<br>used as the main power supply but as<br>auxiliary power when the main power fails<br>or when the patient is moving. | | Risk assessment and mitigating<br>measures related to the application<br>of a battery are described in the<br>risk management report. | {11}------------------------------------------------ # Note 2. Description on Power source difference ### Note 3. Description of Sleev | Garments | Image | Chamber | Sleeve port | Pressure | Mode | | Sleeve<br>Material | Size | | Location<br>on the body | Biocompatibility test | Hose Image | Hose Length | |--------------|---------------------|-----------|---------------------------------------------------------------------------------------------------------------------|--------------------|----------|------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------| | Foot Sleeve | Image: Foot Sleeve | 1 chamber | 1 port<br>(Foot sleeves use different connecting<br>ports separately and;<br>incompatible with other sleeve types.) | $120~140\pm10mmHg$ | DVT mode | 510(k) Submission : DVT-4000 | Non-woven sleeves<br>consist of Polyethylene Terephthalate ≥99.25% and Titanium Dioxide ≤0.35% | 420mmX230mm (One size) | | Foot | ISO10993-10 : Intracutaneous Reactivity (test report no.: GB16001)<br>ISO10993-10 : Skin sensitization (test report no.: GB16002)<br>ISO10993-5 : Cytotoxicity (test report no.: GB16050) | Image: Hose Image. The sleeve is provided in a state that the hose has been connected. | 2 meters | | Calf Sleeve | Image: Calf Sleeve | 3 chamber | 3 port | $20~60\pm10mmHg$ | | | | 500mmX310mm (Small)<br>620mmX360mm (Medium)<br>770mmX380mm (Large)<br>970mmX380mm(X-Large) | | Calf | | Image: Hose | | | Thigh Sleeve | Image: Thigh Sleeve | 3 chamber | 3 port | $20~60\pm10mmHg$ | | | | 600mmX545mm (Small)<br>750mmX640mm (Medium)<br>930mmX670mm (Large)<br>1130mmX670mm (X-Large) | | Thigh | | | | | Boots Sleeve | Image: Boots Sleeve | 3 chamber | 3 port | $20~60\pm10mmHg$ | | | | 635mmX710mm (One size) | | Both foot and calf | | Image: Hose | | {12}------------------------------------------------ Polyvinyl chlorid (PVC) Hose Material {13}------------------------------------------------ ### VII. PERFORMANCE DATA The following performance testing was performed in substantial equivalence determination. ### Electrical safety and EMC performance testing Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 and EMC testing was conducted in accordance with standard IEC 60601-1-2:2007. ### Biocompatibility testing (ISO10993-5, ISO10993-10) Biocompatibility for the sleeve material is testing reports are available as follows: ISO10993-10 : Intracutaneous Reactivity (test report no. : GB16001) ISO10993-10 : Skin sensitization (test report no. : GB16002) ISO10993-5 : Cytoxicity (test report no. : GB16050) ### Software Verification and Validation Testing Software verification and validation testing were conducted 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 "moderate" 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. The intended use of the subject device has not changed as a result of the modifications. ### 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-4000 is substantially equivalent in comparison with DVT-2600, the predicate device as described herein.