B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System

{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 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. July 10, 2020 B & J Manufacturing Ltd % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Black A, Time Square, Xili Town Shenzhen, Guangdong 518055 China Re: K200568 Trade/Device Name: B&J MHP800 Deep Vein Thrombosis Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 5, 2020 Received: June 8, 2020 Dear Fu Ailing: 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. 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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) K200568 Device Name B&J MHP800 Deep Vein Thrombosis Prevention System #### Indications for Use (Describe) The B&I MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The device can be used in the home or clinical settings to: - Aid in the prevention of DVT; - Enhance blood circulation; - Diminish post-operative pain and swelling; - Reduce wound healing time; - Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs; - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time Type of Use (Select one or both, as applicable) | <span style="vertical-align:middle"><b></b></span> <span style="vertical-align:middle">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="vertical-align:middle"><b></b></span> <span style="vertical-align:middle">Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| |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) Submission # 510(k) Summary [As required by 21 CFR 807.92] # 1. Date Prepared [21 CFR807.92 (a) (1)] February 10, 2020 ## 2. Submitter's Information [21 CFR807.92 (a) (1)] Name of Sponsor: B&J Manufacturing Ltd. Address: Room 701 & 101, Building 24, Block B, Yuanshan Industrial Zone, Shangcun Community, Gongming Street, Guangming District, Shenzhen, 518106 China Contact Name: Billy Yu Telephone No.: +86-0755-88210239 Fax No.: +86-0755-88210289 Email Address: yl_billy@126.com # 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)] | Trade Name/Model: | B&J MHP800 Deep Vein Thrombosis Prevention System | |-----------------------|---------------------------------------------------| | Common Name: | MHP800 DVT Compression Device | | Classification Name: | Sleeve, Limb, Compressible | | Regulation Number: | 21 CFR 870.5800 | | Product code: | JOW | | Classification Panel: | Cardiovascular | | Device Class: | II | # 4. Identification of Predicate and Reference Devices [21 CFR 807.92(a) (3)] The identified predicate within this submission is as follows: Devon Medical Products, Cirona 6300 Disposable Deep Vein Thrombosis (DVT) {4}------------------------------------------------ Prevention System has been cleared by FDA through 510(k) No. K151189 (Decision Date - September 18, 2015). The identified reference devices within this submission are as follows: Eezcare Medical Corp, Ezvena IPC, Ezvena SQS has been cleared by FDA through 510(k) No. K191937 (Decision Date - January 29, 2020). Devon Medical Inc., Cirona 6200 Deep Vein Thrombosis Prevention System has been cleared by FDA through 510(k) No. K141578 (Decision Date - June 27, 2014). # 5. Description of the Device [21 CFR 807.92(a) (4)] The B&J MHP800 Deep Vein Thrombosis Prevention System is an intermittent pneumatic compression system that aids in the prevention of deep vein thrombosis a potentially life-threatening condition which can lead to pulmonary embolism. The DVT compression device is a non-invasive mechanical prophylactic system that helps decrease the incidence of deep vein thrombosis. The system consists of a pair of pump and sleeve assemblies. The DVT pump will inflate each leq cuff to a preset pressure of 45mmhg for 12 seconds, and followed by 48 seconds of deflation period once the pressure is reached. This happens once every minute. The cycles are repeated on each unit until the power is turned off. Internal rechargeable batteries allow the MHP800 to be completely portable to prevent interruptions in treatment. ## 6. Intended Use [21 CFR 807.92(a)(5)] The B&J MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The device can be used in the home or clinical settings to: - Aid in the prevention of DVT; - Enhance blood circulation; - Diminish post-operative pain and swelling; - Reduce wound healing time; - Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs; {5}------------------------------------------------ - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time # 7. Technological Characteristics [21 CFR 807.92(a)(6)] | General Specification: | | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------|---------------| | Model No. | MHP800 | | | Size | 145mm (L)*61mm(W)*36mm(H) | | | Weight | 0.2 kg | | | AC/DC Adapter | AC Input: 100V-240V 50/60Hz; DC Output: 5V, 2A (2 plugs) | | | Mode of Operation/ Operating Time | Continuous / 8 hours | | | Battery Type | Lithium Battery 7.4V 650mAh (rechargeable) | | | Charging Time | 2.5 Hours | | | Pressure Range | 45 ±10% mmHg (default) | | | Reset Time | 60s | | | Humidity | Operation: 15% to 93 % (without condensation)<br>Storage & Transportation: 10% to 95% (without condensation) | | | Air pressure | Operation: 525mmHg to 795mmHg<br>Storage & Transportation: 165mmHg-805mmHg | | | Temperature | Operation: +5° C (41° F) to +40° C (104° F)<br>Storage & Transportation: -20° C (-4° F) to +55° C (131° F) | | | Sleeve component: | | | | Model Name | Description | Circumference | | MHP801M | Medium<br>Latex Free Calf Garment (Pair) | Up to 18" | ### MHP800 DVT Pump # 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] #### 8.1 Intended use: {6}------------------------------------------------ | ID | Comparison Item | Proposed Device<br>B&J DVT Prevention System<br>(MHP800) | Predicate Device<br>Devon DVT Prevention System<br>(Cirona 6300) | | |-----|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | 1 | 510(K) No. | To be assigned | K151189 | | | 2 | Intended Use | The B&J MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).<br>The device can be used in the home or clinical settings to:<br>- Aid in the prevention of DVT;<br>- Enhance blood circulation;<br>- Diminish post-operative pain and swelling;<br>- Reduce wound healing time;<br>- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;<br>- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time | The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).<br>The device can be used in the home or clinical settings to:<br>· Aid in the prevention of DVT;<br>· Enhance blood circulation;<br>· Diminish post-operative pain and swelling;<br>· Reduce wound healing time;<br>· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;<br>· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time | | | 3 | Type of use | Prescription Use | Prescription Use | | | ID | Comparison Item | Proposed Device<br>B&J DVT<br>Prevention<br>System<br>(MHP800) | Predicate Device<br>Devon DVT<br>Prevention<br>System<br>(Cirona 6300) | Explanation of Difference | | 4 | General Specification | | | | | 4.1 | Size | 145 *61*36(mm) | 65 *130*30(mm) | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | | 4.2 | Weight | 0.2 kg | 0.3 kg | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | | 4.3 | AC/DC Adapter | AC Input:<br>100V-240V<br>50/60Hz; DC Output:<br>5V, 2A (2 plugs) | AC Input:<br>100V-240V<br>50/60Hz; DC Output:<br>5V, 2A (2 plugs) | | | 4.4 | Mode of<br>Operation/<br>Operating Time | Continuous / 8<br>hours | Continuous / 8<br>hours | | | 4.5 | Battery Type | Lithium Battery<br>7.4V 650mAh<br>(rechargeable) | Lithium Battery<br>3.7V 1350mAh<br>(rechargeable) | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence;<br>Refer to<br>K151189 and<br>K170814. | | 4.6 | Charging Time | 2.5 Hours | 3 Hours | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence;<br>Refer to<br>K151189 and<br>K170814. | | | | | | | | 4.7 | Pressure Range | $45\pm10\%$ mmHg<br>(default) | $50\pm5$ mmHg<br>(default) | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence;<br>Refer to<br>K191937. | | 4.8 | Reset Time | 60s | 50s | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence;<br>Refer to<br>K141578. | | 4.9 | Applied Mode of<br>Pressure | Intermittent | Intermittent | - | #### Table 1 Intended Use Comparison ### 8.2 Comparison table {7}------------------------------------------------ #### Table 2 General Comparison between MHP800 and Cirona 6300 {8}------------------------------------------------ It is clear that MHP800 is as safe and effective as the predicate by comparing above technological characteristics. #### 8.3 Non-clinical Testing The following safety and performance tests were conducted to assess MHP800 DVT compression device. - 0 Biocompatibility - 0 Software validation - O Electromagnetic compatibility and electrical safety - 0 Reliability - 0 Performance - System level software - Pressure accuracy - Cycle time - Bladder burst - Leak All the test results demonstrate MHP800 DVD compression device meet the requirements of its predefined acceptance criteria and intended use. {9}------------------------------------------------ # 9. Conclusion [21 CFR 807.92(b) (3)] In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, B&J Manufacturing Ltd. concludes that: - The intended use of MHP800 is totally same as that of the predicate device. - The technological characteristics differences between MHP800 and Cirona 6300 do not affect the safety and effectiveness, no new risk is raised. - Demonstrated by the safety and performance tests, the characteristics of MHP800 is equivalent to those of the predicate device.