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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MiMo™ Negative Pressure Wound Therapy System. This type of submission is for demonstrating substantial equivalence to an already legally marketed device (predicate device), not for proving novel performance against specific acceptance criteria through a clinical study. Therefore, some of the requested information, such as the effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable to this type of regulatory submission as it does not involve an AI/ML powered device or a comparative effectiveness study in the typical sense.

However, the document does mention "Discussion of Non Clinical Tests Performed" which includes bench testing. This section can be interpreted as the study proving the device meets operational requirements.

Here's the information that can be extracted and inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format with corresponding "reported device performance." Instead, it highlights the technical characteristics of the new device (MiMo™) and compares them to the predicate device (Genadyne UNO). The implication is that the new device's performance is acceptable if it is comparable or within acceptable ranges of the predicate device for features like vacuum choices, max vacuum, operating time, and therapy modes, along with meeting safety and biocompatibility standards.

Feature	New Device (MiMo™) Reported Performance	Predicate Device (Genadyne UNO) Corresponding Value	Implicit Acceptance Criteria (Inferred)
Vacuum Choices	125 mmHg and 75 mmHg	125 mmHg and 80 mmHg	Comparable negative pressure options.
Max Vacuum	125 mmHg	125 mmHg	Equivalent maximum negative pressure.
Operating Time	7 days	7 days	Equivalent operational duration.
Therapy Mode	Continuous and Intermittent	Continuous and Intermittent	Equivalent therapy modes.
Fluid Removal Capacity	Tested (bench testing)	NA (implied to be acceptable for predicate)	Meets operational requirements for fluid removal.
Pressure Maintenance	Tested (bench testing)	NA (implied to be acceptable for predicate)	Meets operational requirements for pressure maintenance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document refers to "bench testing" for operational requirements. For biocompatibility, "in-vitro and in-vivo tests" were performed, but no sample sizes or specifics are given.
Data Provenance: Not specified. The studies are described as "non-clinical tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-clinical device and does not involve image interpretation or expert ground truth establishment in the context of clinical expert consensus. The "ground truth" for non-clinical tests would be the measured physical parameters according to standardized test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical device; adjudication methods are typically used for clinical study endpoints, often involving expert review of medical images or patient outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool. No MRMC study or AI-assistance evaluation was performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (pump) and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned:

Biocompatibility: The ground truth would be established through standardized chemical and biological assays as per ISO 10993, measuring cellular responses, cytotoxicity, irritation, etc.
Electrical Safety: The ground truth would be established by conformance to the electrical safety standards (IEC 60601-1 and IEC 60601-1-2), measuring electrical leakage, insulation, etc.
Bench Testing (Pressure Maintenance & Fluid Removal): The ground truth would be measured physical parameters (e.g., pressure readings, fluid volume collected) compared against design specifications and predicate device performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181929

Device Name

MiMo(TM) Negative Pressure Wound Therapy System

Indications for Use (Describe)

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)

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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

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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:-

Comparative Information
	Predicate Device	New Device
Company	Genadyne Biotechnolgies, Inc.	Baymax Research, Inc.
Device Name	Genadyne UNO Negative PressureWound Therapy System	MiMo™ Negative PressureWound Therapy System
510(k) Number	K180840	K181929
Technical Data
Vacuum Choices	125 mmHg and 80 mmHg	125 mmHg and 75 mmHg
Max Vacuum	125 mmHg	125 mmHg
Battery Type	Alkaline ManganeseDioxide AA(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 witha build-in hydrophobic shut off filterfor overflow protection	Two 60 ml disposable canisterwith a build-in hydrophobic shutoff 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 patientswho would benefit from negativepressure wound therapy particularlyas the device may promote wound	The MiMo™ Negative PressureWound Therapy System isindicated for use in patients whowould benefit from negativepressure wound therapy
	moderate exudates and infectiousmaterial. Appropriate wound typesinclude:- Chronic- Acute- Traumatic- Subacute and dehisced wounds- Partial-thickness burns- Ulcers (such as diabeticor pressure)- Flaps and grafts- Closed surgical incisionsGenadyne UNO is a single patientuse device.	particularly as the device maypromote wound healing by theremoval of low to moderateexudates and infectious material.Appropriate wound typesinclude:- Chronic- Acute- Traumatic- Subacute and dehiscedwounds- Partial-thickness burns- Ulcers (such as diabetic orpressure)- Flaps and grafts- Closed surgical incisionsThe MiMo™ Negative PressureWound Therapy System is asingle patient use device.
Contraindications
-	The UNO is contraindicated in thepresence of:	MiMo™ is contraindicated in thepresence of:
-	Necrotic tissue with Eschar present	Necrotic tissue with Escharpresent
-	Previously confirmed and untreatedosteomyelitis.	Untreated osteomyelitis
-	malignancy in the wound bed ormargins of the wound (except inpalliative care to enhance quality oflife)	Malignancy (with exception toenhance quality of life)
-	Exposed arteries, veins, or organs	Exposed arteries, veins, ororgans
-	Non-enteric and unexplored fistulas	Non-enteric and unexploredfistulas
-	Anastomotic sites	Anastomotic sites
-	Emergency airway aspiration	Emergency airway aspiration
-	Pleural, mediastinal or chest tubedrainage	Pleural, mediastinal or chesttube 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 Atmosphericpressure	700 – 1060 mbar Atmosphericpressure

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 Atmosphericpressure	700 - 1060 mbar Atmosphericpressure

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K181929

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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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.