(252 days)
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.
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.
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.
§ 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.