(184 days)
The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Note: The miraDry System is not indicated for use in the treatment of hyperhidrosis related to other body areas or generalized hyperhidrosis.
The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands reside using a surface contact applicator. The miraDry System consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover. As described in K103014, the miraDry System also includes Class I components/accessories. The MD4000-TS template system is a reguired component for the miraDry treatment as well as the MD4000-PK priming kit. The MD4000-PK priming kit is required when the system is initially set up at a user facility. Optional accessories include an Armrest and disposable ice packs. The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface. The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient. The technological characteristics and the principles of operation for the MD4000 miraDry System are the same as the predicate miraDry System.
This 510(k) summary describes a modified version of the miraDry System, which is a microwave device for treating primary axillary hyperhidrosis. The submission (K131162) concerns the substantial equivalence of the modified device to a predicate device (K103014).
Based on the provided text, the submission focuses on demonstrating that the modified miraDry System is substantially equivalent to its predicate, rather than presenting a study that establishes new acceptance criteria or proves the device meets entirely new performance metrics. The core argument for substantial equivalence is that the modifications do not raise new questions of safety or effectiveness.
Therefore, the structure of the acceptance criteria and study proving it are presented as conformance to existing standards and equivalence to the predicate.
Here's a breakdown of the information as requested, though some categories may not be directly applicable due to the nature of a substantial equivalence submission for device modification:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Conformance)
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance (Modified miraDry System, K131162) |
|---|---|---|
| Indications for Use | Identical to predicate device (K103014) | "The miraDry System bears the following Indications for Use statement that is identical to the FDA authorized indications for use for the predicate." (Intended Use section) |
| Technological Characteristics | Equivalent to predicate device (K103014) | "The technological characteristics and the principles of operation for the MD4000 miraDry System are the same as the predicate miraDry System." (Device Description Section) |
| Safety Standards Conformance | Conformance to relevant IEC 60601 series standards | IEC 60601-1:2005 + A1:2012 (Medical Electrical Equipment - General Requirements for Safety) |
| IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic Compatibility) | ||
| IEC 60601-1-6:2010 (Medical Electrical Equipment - Usability) | ||
| IEC 60601-2-6:2012 (Medical Electrical Equipment - Particular Requirements for the Safety of Microwave Therapy Equipment) (All found in "Testing" section) | ||
| Material Safety/Biocompatibility | Meet strict design requirements for durability and biocompatibility | "All materials used in the manufacture of the modified miraDry System have been demonstrated to meet strict design requirements, including requirements for durability and biocompatibility, and are therefore suitable for use..." (Materials section) |
| No New Questions of Safety or Effectiveness | Modifications do not introduce new safety or effectiveness concerns compared to predicate | "Based on the risk assessment of the modifications, bench testing and pre-clinical testing were performed to ensure continued conformance to all product specifications, and equivalence to the predicate device." (Testing section) |
| "There are no changes in materials that raise questions of safety or effectiveness." (Materials section) |
Study Details Demonstrating Substantial Equivalence
The provided text describes the rationale and testing performed to demonstrate substantial equivalence for a modification to an already cleared device, rather than a de novo clinical study proving the primary efficacy of the miraDry system itself.
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Sample size used for the test set and the data provenance:
- The document mentions "bench testing and pre-clinical testing" for the modifications. However, specific sample sizes for these tests are not provided within this 510(k) summary.
- Data provenance: Not explicitly stated, but the testing would typically be conducted by the manufacturer, Miramar Labs, Inc. The nature of the testing (bench and pre-clinical) suggests laboratory/engineering data rather than human clinical trial data for direct performance comparison in patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. "Ground truth" in the clinical sense (e.g., disease diagnosis) is not established by a panel of experts for this substantial equivalence submission. The "truth" here is the conformance to engineering standards and equivalence to the predicate, which is evaluated by the submitter and FDA.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes. The testing described here is focused on engineering and functional performance.
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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:
- No, an MRMC study was not done. This device is an electrosurgical cutting and coagulation device (microwave therapy for hyperhidrosis), not an AI-based diagnostic imaging tool that would typically undergo MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical system that requires human operation. The concept of "standalone algorithm" does not apply to this type of medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench testing and pre-clinical testing" conducted for the modifications, the 'ground truth' would be defined by engineering specifications, design requirements, and established performance parameters of the predicate device. These would be used to verify that the modified device performs as expected and similarly to the original. For the safety standards, the 'ground truth' is compliance with the requirements outlined in the cited IEC standards.
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The sample size for the training set:
- Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
Summary of the Study for this 510(k):
The core "study" for K131162 is a technical and risk assessment to demonstrate substantial equivalence of a modified miraDry System to its predicate (K103014). This involved:
- Comparison of Indications for Use: Showing identity to the predicate.
- Comparison of Technological Characteristics: Demonstrating they are the same as the predicate.
- Bench Testing and Pre-clinical Testing: Performed to ensure the modified aspects (e.g., new materials for durability, functional changes) continue to conform to product specifications and maintain equivalence to the predicate. This testing addressed potential risks associated with the modifications.
- Conformance to International Electrotechnical Commission (IEC) Standards: The device was tested and found to conform to multiple IEC 60601 series standards related to general safety, electromagnetic compatibility, usability, and specific requirements for microwave therapy equipment.
The conclusion drawn from these activities is that the device "is substantially equivalent to the predicate device... The indications for use and technological characteristics are equivalent; therefore, the miraDry System is substantially equivalent to the predicate device."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.