MiMo(TM) Negative Pressure Wound Therapy System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 27, 2019 Baymax Research, Inc. Richard Chen Executive Administrator 315 W36th St New York, New York 10018 Re: K181929 Trade/Device Name: MiMo™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 21, 2019 Received: February 22, 2019 ## Dear Richard Chen: 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. 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 {1}------------------------------------------------ 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.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-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, Kimberly Ferlin -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181929 Device Name MiMo(TM) Negative Pressure Wound Therapy System Indications for Use (Describe) The MiMo™ Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions MiMo™ Negative Pressure Wound Therapy System is a single patient use device. 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}------------------------------------------------ ## Traditional 510K Summary Negative Pressure Wound Therapy Baymax Research, Inc. 315 W 36th St, New York, NY 10018 E-mail: info@baymaxresearch.com Tel: 646.828.7848 Contact Person: Mr. Richard Chen Date Prepared: March 6, 2019 Name of Device MiMo™ Negative Pressure Wound Therapy System #### Common or Usual Name Powered Suction Pump #### Classification Name OMP, Negative Pressure Wound Therapy Powered Suction Pump 21 C.F.R. § 878.4780 #### Predicate Device Genadyne UNO Negative Pressure Wound Therapy System. K180840 ### Device Description The MiMo™ Negative Pressure Wound Therapy System is a portable, battery powered wound suction pump with the intention to deliver negative pressure to the wound. It consists of an electric diaphragm vacuum pump and the output pressure is regulated by a pressure sensor that reads the pressure from the wound site via connecting to the dressing. The system comes with 2 sets of silicone wound dressings. When the pump is turned on, the user will have a choice to either use 75mmHq suction or 125mmHq suction. The user will also have a choice to choose either a continuous therapy or an intermittent therapy. The MiMo™ Negative Pressure Wound Therapy System is intended for use in the professional healthcare environment. The device is powered by 4 x AAA batteries that would be able to last the user over 48 hours of usage depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with a new set of batteries. There will be no negative pressure at this point. The MiMo™ Negative Pressure Wound Therapy System does come with a carry bag as well as a leg strap for convenience use for the patient. {4}------------------------------------------------ ### Intended Use / Indications for Use The MiMo™ Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy, particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions The MiMo™ Negative Pressure Wound Therapy System is a single patient use device. ### Technological Characteristics Comparison between New and Predicate Device The indication for use statement of the MiMo™ Negative Pressure Wound Therapy System is similar to the Predicate device. The difference between the New device and the predicate device are as follow:- | <b>Comparative Information</b> | | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <b>Predicate Device</b> | <b>New Device</b> | | Company | Genadyne Biotechnolgies, Inc. | Baymax Research, Inc. | | Device Name | Genadyne UNO Negative Pressure<br>Wound Therapy System | MiMo™ Negative Pressure<br>Wound Therapy System | | 510(k) Number | K180840 | K181929 | | <b>Technical Data</b> | | | | Vacuum Choices | 125 mmHg and 80 mmHg | 125 mmHg and 75 mmHg | | Max Vacuum | 125 mmHg | 125 mmHg | | Battery Type | Alkaline Manganese<br>Dioxide AA<br>(QU1500) | AAA Batteries | | Power (Battery) | 3V DC | 6V DC | | Dimensions / Weight | 3" x 4.4" x 2.4" / 400g | 5.8" x 2.78" x 1.06" / 129g | | Operating Time | 7 days | 7 days | | Therapy Mode | Continuous and Intermittent | Continuous and Intermittent | | Accessories | | | | Canisters | Two 70 ml disposable canister with<br>a build-in hydrophobic shut off filter<br>for overflow protection | Two 60 ml disposable canister<br>with a build-in hydrophobic shut<br>off filter for overflow protection | | Reusable | No | No | | Sterile | Dressings provided are sterile | Dressings provided are sterile | | Accessories | | | | Dressings | 10cm x 20cm | 12.5 x 12.5 cm | | | 10cm x 30cm | 12.5 x 18.75 cm | | | 10cm x 40cm | 12.5 x 25 cm | | | 15cm x 15cm | 12.5 x 35 cm | | | 15cm x 20cm | 17.5 x 22.5 cm | | | 15cm x 30cm | 17.5 x 32.5 cm | | | 20cm x 20cm | 12.5 x 40 cm | | | 20cm x 25cm | | | | 25cm x 25cm | | | | 4 x Fixation Strips | 4 x Fixation Strips | | | Carrying Case | Carrying Case and Leg Strap | | Indications for Use | UNO is indicated for use in patients<br>who would benefit from negative<br>pressure wound therapy particularly<br>as the device may promote wound | The MiMo™ Negative Pressure<br>Wound Therapy System is<br>indicated for use in patients who<br>would benefit from negative<br>pressure wound therapy | | | moderate exudates and infectious<br>material. Appropriate wound types<br>include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and dehisced wounds<br>- Partial-thickness burns<br>- Ulcers (such as diabetic<br>or pressure)<br>- Flaps and grafts<br>- Closed surgical incisions<br>Genadyne UNO is a single patient<br>use device. | particularly as the device may<br>promote wound healing by the<br>removal of low to moderate<br>exudates and infectious material.<br>Appropriate wound types<br>include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and dehisced<br>wounds<br>- Partial-thickness burns<br>- Ulcers (such as diabetic or<br>pressure)<br>- Flaps and grafts<br>- Closed surgical incisions<br>The MiMo™ Negative Pressure<br>Wound Therapy System is a<br>single patient use device. | | Contraindications | | | | - | The UNO is contraindicated in the<br>presence of: | MiMo™ is contraindicated in the<br>presence of: | | - | Necrotic tissue with Eschar present | Necrotic tissue with Eschar<br>present | | - | Previously confirmed and untreated<br>osteomyelitis. | Untreated osteomyelitis | | - | malignancy in the wound bed or<br>margins of the wound (except in<br>palliative care to enhance quality of<br>life) | Malignancy (with exception to<br>enhance quality of life) | | - | Exposed arteries, veins, or organs | Exposed arteries, veins, or<br>organs | | - | Non-enteric and unexplored fistulas | Non-enteric and unexplored<br>fistulas | | - | Anastomotic sites | Anastomotic sites | | - | Emergency airway aspiration | Emergency airway aspiration | | - | Pleural, mediastinal or chest tube<br>drainage | Pleural, mediastinal or chest<br>tube drainage | | - | Surgical suction | Surgical suction | | | | | | Compliance | | | | | IEC 60601-1 | IEC 60601-1 | | | IEC 60601-1-2 | IEC 60601-1-2 | | | | IEC 60601-11 | | | | EN/ISO 62366 | | | | | | Storage / Transport | | | | | -18°C to +43°C (0°F to 110°F) | -25°C to +70°C (-13°F to 158°F) | | | Relative Humidity 10% to 95 % | Relative Humidity 20% to 85 % | | | 700 - 1060 mbar Atmospheric<br>pressure | 700 – 1060 mbar Atmospheric<br>pressure | | | | | | Operation | | | | | 18°C to 34°C (65°F to 94°F) | 5°C to 40°C (41°F to 104°F) | | | Relative Humidity 10% to 95 % | Relative Humidity 20% to 90 % | | | 700 - 1060 mbar Atmospheric<br>pressure | 700 - 1060 mbar Atmospheric<br>pressure | {5}------------------------------------------------ # K181929 {6}------------------------------------------------ {7}------------------------------------------------ ### Discussion of Non Clinical Tests Performed The biocompatibility of the MiMo™ Negative Pressure Wound Therapy System dressing has been demonstrated through assessment according to ISO 10993 standards. In-vitro and in-vivo tests were done on the complete dressing set that includes the fixation strips. Electrical safety testing was also completed in accordance to IEC 60601-1 and IEC 60601-1-2. Bench testing was completed to show evidence that the device meets the operational requirements, including pressure maintenance and fluid removal capacity. ### Conclusion & Determination of Substantial Equivalence Based on the information presented above, the MiMo™ Negative Pressure Wound Therapy System is technologically similar to the predicate device (Genadyne UNO Negative Pressure Wound Therapy System - K180840) in terms of pressure management and therapy mode provided. The MiMo™ Negative Pressure Wound Therapy System does not raise any new issues of safety and effectiveness. The MiMo™ Negative Pressure Wound Therapy System is substantially equivalent to the predicate device.