Zeroveno

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 22, 2020 Dimedi Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, 08507 Kr Re: K192337 Trade/Device Name: Zeroveno Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 18, 2020 Received: May 28, 2020 Dear Sanglok Lee: 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 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192337 Device Name ZEROVENO Indications for Use (Describe) The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following: - Management of the symptoms of post thrombotic syndrome (PTS) - Prevention of deep vein thrombosis, (DVT) - Treatment of lymphedema - Treatment of leg swelling due to vascular insufficiency - Treatment of varicose veins - Treatment of chronic venous insufficiency Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | 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 ## The assigned 510(k) Number: K192337 ## 01. Date of Submission: August 23, 2019 #### 02. Applicant Company name: DIMEDI Co., Ltd. Address: 209ho, Wonju Venture Plaza, 130-2, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea TEL: +82-33-744-0174 FAX: +82-33-744-0175 Email: sales@dimedi.co.kr ## 03. Submission Correspondent Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 7088123619 / +82 28313615 FAX: +82 50 4031 3619 Email: info@wisecompany.org ## 04. Proposed Device Identification Proprietary Name: ZEROVENO Classification Name: Compressible limb sleeve Device Class: Class II Regulation Number:21 C.F.R.870.5800 Product Code: JOW #### 05. Indication for use The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following: - Management of the symptoms of post thrombotic syndrome (PTS) - Prevention of deep vein thrombosis, (DVT) - Treatment of lymphedema - Treatment of leg swelling due to vascular insufficiency - Treatment of varicose veins - Treatment of chronic venous insufficiency #### 06. Predicate devices - Predicate Device 510(k) Number: K073028 Device Name: Venowave VW5-10 Manufacturer: SARINGER LIFE SCIENCE TECHNOLOGIES INC. #### 07. Device Description ZEROVENO is a product designed to distribute the pressure applied to the leg by changing the position of the contact part which supports the load of the leg alternately with the pressing pressure periodically. The swept volume or volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (8cm) and the depth of the wave (1cm) or approximately 0.1 L/cycle. {4}------------------------------------------------ ZEROVENO has a maximum continuous operation time of 20 hours on a low-speed basis when the built-in lithium-ion battery is fully charged. Detailed specification of ZEROVENO is as below. | Product Name/Model Name | Sequential Compression Device/ ZEROVENO | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Rated Voltage(Main Part) | DC 5 V, 1.0 A | | Rated Voltage(Adapter) | Input: AC 100 - 240 V, 50 - 60 Hz, 0.3 A<br>Output: DC 5 V, 2.0 A) | | Inner Power(Battery) | DC 3.63 V, 3350 mAh | | Power Consumption | 5 VA | | Dimension | Main body: 186.5mm(D)×111.9mm(W)×52.7mm(H)<br>Band: 580mm(D)×200mm(W)×8mm(H)<br>Charging adapter: 84mm(D)×47mm(W)×31mm(H) | | Weight | Main body: 400g<br>Dedicated Band: 70g<br>Charging adapter: 130g | | Pressing pressure | ≥ 80 N, < 100N | | Alternating cycle | L step : 12sec ±20%<br>H step : 6sec ±20% | | Operating environment | Temperature: 10 to 40 °C<br>Humidity: 30 to 75%<br>Atmospheric pressure: 700 to 1,060 hPa | | Transportation and storage environment | Temperature: -20 to 60 °C<br>Humidity: 10 to 90%<br>Atmospheric pressure: 700 to 1,060 hPa | | Life cycle | 2.5 years | ## 08. Performance Standards No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, ZEROVENO voluntarily complies with the standards below. - IEC 60601-1 - IEC 60601-1-6 - IEC 60601-1-2 - IEC 62304 ## 09. Performance Data & Substantial Equivalence: The following table compares the ZEROVENO to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc. Table. Comparison of Technology Characteristics | | Subject device | Predicate device | |-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | MANUFACTURER | DIMEDI, Korea | SARINGER LIFE SCIENCE<br>TECHNOLOGIES INC., Canada | | Property name | ZEROVENO | VW5-10 | | 510(k) Number | Not assigned | K073028 | | Product Code | JOW | JOW | | Picture | Image: ZEROVENO | Image: SARINGER LIFE SCIENCE TECHNOLOGIES INC., Canada | | Principle of<br>operation | ZEROVENO deploys a peristaltic<br>pumping action using a mechanical plate<br>to compress the muscles of the calf<br>thereby increasing upward venous and<br>lymphatic flow. | Same | | Indication for use | The ZEROVENO device induces improved<br>vascular and lymphatic flow of the lower<br>limbs. The device is intended to treat<br>the following:<br>- Management of the symptoms of post<br>thrombotic syndrome (PTS)<br>- Prevention of deep vein thrombosis,<br>(DVT)<br>- Treatment of lymphedema<br>- Treatment of leg swelling due to<br>vascular insufficiency<br>- Treatment of varicose veins<br>- Treatment of chronic venous<br>insufficiency | Same | | Patient<br>population | 1) Age: all ages except infant, Children,<br>pregnant woman<br>2) Gender: Male and Female | Same | | Patient contact | Main body does not contact the patient<br>but its dedicated bend does contact<br>intact skin of patient's calf | Same | | Size<br>(main body) | 186.5mm(D)×111.9mm(W)×52.7mm(H) | 190mm(D)×100mm(W)×48mm(H) | | Weight<br>(main body) | 400 g (include battery) | 270g (without battery) | | Pressing pressure | 80 N ~ 100N | 50 N ~ 100N | | Power(Battery) | DC 3.63V, 3350 mA | 1.5V AA×2 (2000 mAh or higher). | | Speed | Operating at two speeds | Same | | Maximum<br>number of times<br>the wave plate<br>cycles each<br>minute | ZEROVENO: maximum 10 cycles/minute<br>The device capable of operating at two<br>speeds. (H step : 10 cycles/minute, L<br>step : 5 cycles/minute) | VW5-10: maximum 10 cycles/minute<br>The device capable of operating at<br>two speeds. | | Material of<br>Compression<br>Applicator<br>(Dedicated band) | Rubber, Velcro | Rubber, Velcro | {5}------------------------------------------------ {6}------------------------------------------------ ## Software verification and validation testing Software verification and validation testing were conducted and documentation was provided 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 this device was considered as a "minor" level of concern, since failures or latent design flaws are unlikely to cause any injury to the patient or operator. #### Mechanical testing - Pressing pressure - Maximum pressing height - Pressing cycle duration - Pressing range ## 10. CONCLUSIONS The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate the ZEROVENO should perform as intended in the specified use conditions. Therefore, the ZEROVENO is substantially equivalent to the predicate device.