The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.

Device Description

The miraDry MD4000 System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat and odor glands and hair bulbs reside using a surface contact applicator. The miraDry MD4000 System consists of:

MD4000-MC Console: O
MD4000-HP miraDry Handpiece; and O
MD4000-BT miraDry bioTip that snaps onto the Handpiece O

The miraDry MD4000 System also includes the following Class I components/accessories:

MD4000-TS template system, a required component for the miraDry treatment O
MD4000-PK priming kit; and O
MD4000-BT-DE demonstration bioTip. O

The MD4000-PK priming kit and the non-sterile "demo" bioTip are 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 of the Handpiece has a single patient use disposable, the miraDry bioTip, which contacts the underarm skin of the patient.

AI/ML Overview

This document is a 510(k) summary for the miraDry System MD4000, specifically addressing a modification to the packaging of its bioTip component. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study showcasing clinical performance or an AI-based device.

Therefore, most of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, expert involvement, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this document as it relates to a change in the packaging of a disposable component, not a clinical efficacy or AI performance study.

The document explicitly states: "The purpose of this Special 510(k) submission is to modify how the treatment bioTip component of the miraDry System is provided to the User. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification." and "Therefore, the miraDry System MD4000 remains substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act except for one characteristic: the condition of use of the bioTips."

Here's the relevant information that can be extracted:

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

Acceptance Criteria for this Submission: The primary "acceptance criteria" for this Special 510(k) is demonstrating substantial equivalence to the predicate device (miraDry MD 4000 System K160141) despite the change in bioTip packaging. This is not about clinical performance metrics, but rather about safety and effectiveness remaining reasonably assured.
Reported Device Performance (in context of this submission): The document claims that "The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance." This is the "performance" relevant to the specific change (packaging of the bioTip).
Performance (General Indication for Use):
- Indication: Treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV.
- Definition of Permanent Hair Reduction: Long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- Additional Benefit: May reduce underarm odor when used for hyperhidrosis.

(As this is not a clinical study report, specific numerical performance metrics for hyperhidrosis or hair reduction are not provided in this regulatory submission for the packaging change.)

2. Sample sizes used for the test set and the data provenance:

Not applicable. This document describes a regulatory submission for a device modification (packaging change), not a clinical trial or AI model testing. There is no "test set" in the context of clinical performance data described.
Data Provenance (for the underlying device performance, not this submission): The original predicate device (K160141) likely involved clinical studies to establish its efficacy for hyperhidrosis and hair reduction, but details of those studies are not provided in this specific document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment for a medical device's clinical efficacy is typically done through clinical trials with defined endpoints, often involving expert assessments (e.g., dermatologists for hyperhidrosis/hair reduction). However, this document pertains to a packaging change and does not detail such studies.

4. Adjudication method for the test set:

Not applicable. See point 3.

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 an electrosurgical system, not an AI-assisted diagnostic device.

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

Not applicable. This device is an electrosurgical system, not an AI or algorithm.

7. The type of ground truth used:

Not applicable to this specific submission. For the original device's indications, ground truth would likely be clinical outcomes (e.g., sweat reduction measured objectively, hair count, patient satisfaction). For this 510(k), the "ground truth" is the predicate device's existing clearance and safety/performance profile, against which the modified device is compared for equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" for an AI model mentioned in this document.

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

Not applicable. See point 8.

Summary of what is relevant from the document regarding the modification:

Nature of Modification: The disposable bioTips, previously provided sterile, will now be provided as clean and non-sterile for single patient use only.
Rationale for Substantial Equivalence: The intended use, technological characteristics (device class, energy type, mode of action, product code, function, overall system structure, key components, console control mechanism, coolant usage, bioTip materials), and condition of use (single patient use, disposable) remain the same as the predicate device. The only difference is the "Treatment Condition" of the bioTip (sterile vs. clean, non-sterile).
Risk Mitigation for the Change: Miramar Labs, Inc. utilized its established quality system and design control requirements, performing risk-based assessments including:
- Risk assessment (including Hazard Analysis)
- Complaints incidence and review
- Manufacturing environment and process evaluation, including bioburden testing and monitoring trends
- Instructions for Use
- User interface and clinician user feedback
Conclusion regarding safety/effectiveness of the modification: "No new risks were identified as a result of this change." and "The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance."

Summary

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March 15, 2018

Miramar Labs, Inc. Cynthia Kada Sr. Director, QA 2790 Walsh Avenue Santa Clara, California 95051

Re: K180396

Trade/Device Name: miraDry System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY, OUB, MWY Dated: February 12, 2018 Received: February 13, 2018

Dear Cynthia Kada:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Cynthia Kada

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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.

Jennifer R. Stevenson -S3

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) K180396

Device Name miraDry System MD4000

Indications for Use (Describe)

When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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2. 510(k) SUMMARY

Classification:	Class II (special controls)
Classification No.:	21 CFR 878.4400
Classification Name:	Electrosurgical cutting and coagulation device andaccessories.
Product Code(s):	OUB, NEY, MWY
Common Name:	Instrument for Treatment of HyperhidrosisSystem, Ablation, Microwave And AccessoriesSystem, Microwave, Hair Removal
Trade Name	miraDry MD4000 System
Predicate Device	miraDry MD 4000 System K160141
Submitter:	Miramar Labs, Inc.2790 Walsh AvenueSanta Clara, CA 95051, USATel: 408-940-8700Fax: 408-940-8795
FDA Registration No.	3008082710
Contact:	Cynthia Kada
Date:	February 12, 2018

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PURPOSE OF SUBMISSION

The purpose of this Special 510(k) submission is to modify how the treatment bioTip component of the miraDry System is provided to the User. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification.

DEVICE DESCRIPTION

MD4000-MC Console: O
MD4000-HP miraDry Handpiece; and O
MD4000-BT miraDry bioTip that snaps onto the Handpiece O

The miraDry MD4000 System also includes the following Class I components/accessories:

MD4000-TS template system, a required component for the miraDry treatment O
MD4000-PK priming kit; and O
MD4000-BT-DE demonstration bioTip. O

The MD4000-PK priming kit and the non-sterile "demo" bioTip are 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.

DEVICE MODIFICATION

As described in K160141, the bioTip is disposable and for single patient use, and is provided sterile. The only change to the miraDry MD4000 system cleared under K160141 that is the subject of this Special 510(k) involves supplying the disposable bioTips to the user as clean and non-sterile for single patient use only. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification.

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INDICATIONS FOR USE

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.

SUMMARY OF SUBSTANTIAL EQUIVALENCE

The miraDry MD4000 System described and cleared in 510(k) number K160141 serves as the predicate device for this premarket notification. The miraDry MD4000 System that is the subject of this Special 510(k) has the same technological characteristics and intended use as the device described and cleared in 510(k) number K160141. Furthermore, there have been no changes in design, component materials, chemical composition, or energy source, since FDA's clearance of K160141.

Therefore, the miraDry System MD4000 remains substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act except for one characteristic: the condition of use of the bioTips. This difference is rendered inconsequential by the "single patient use" and disposable nature of the bioTips that eliminates the risk of cross contamination between patients. Summarized in the substantial equivalence tables below are the key technological characteristics and indications for use of the miraDry System compared to the predicate device identified in this Special 510(k).

CharacteristicsmiraDrySystem	Predicate DevicemiraDry MD4000K160141	Modified DevicemiraDry MD4000	Comparison
Device Class	II	II	Same
Energy Type	Microwave	Microwave	Same
Mode of Action	Generation of localizedheat	Generation of localizedheat	Same
Product Code	NEY, OUB, MWY	NEY, OUB, MWY	Same

	miraDry System Substantial Equivalence Comparison Table

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CharacteristicsmiraDrySystem	Predicate DevicemiraDry MD4000K160141	Modified DevicemiraDry MD4000	Comparison
Indications forUse	The miraDry SystemMD4000 is indicated foruse in the treatment ofprimary axillaryhyperhidrosis plusunwanted underarm hairremoval, and permanentreduction of underarmhair of all colors forFitzpatrick skin types I -IV.	The miraDry SystemMD4000 is indicated foruse in the treatment ofprimary axillaryhyperhidrosis plusunwanted underarm hairremoval, and permanentreduction of underarmhair of all colors forFitzpatrick skin types I -IV.	Same
	Permanent hair reductionis defined as long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9 and12 months after thecompletion of a treatmentregime.	Permanent hair reductionis defined as long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9 and12 months after thecompletion of a treatmentregime.	Same
	When used with thetreatment of primaryaxillary hyperhidrosis, themiraDry System mayreduce underarm odor.	When used with thetreatment of primaryaxillary hyperhidrosis, themiraDry System mayreduce underarm odor.	Same
Function	Heat absorption by tissuelocated at the dermal-hypodermal interfacewhere the axillary sweat(wetness and odor) glandsand hair bulbs reside	Heat absorption by tissuelocated at the dermal-hypodermal interfacewhere the axillary sweat(wetness and odor) glandsand hair bulbs reside	Same
Overall Systemstructure	Microwavesource/amplifier, coolantsupply system, operatorinterface, and microwave,electrical and coolantlines that connect to theapplicator	Microwavesource/amplifier, coolantsupply system, operatorinterface, and microwave,electrical and coolantlines that connect to theapplicator	Same
KeyComponents	Console, Handpiece,disposable bioTip	Console, Handpiece,disposable bioTip	Same
Console ControlMechanism	Electronic user interface	Electronic user interface	Same
Coolant usage	Delivers cooling to theskin surface	Delivers cooling to theskin surface	Same
Characteristicsof bioTip	Predicate DevicemiraDry MD4000K160141	Modified DevicemiraDry MD4000	Comparison
Materials	Polyurethane,ThermoplasticElastomer (TPE),Polycarbonate	Polyurethane,ThermoplasticElastomer (TPE),Polycarbonate	Same
Biocompatible	Yes	Yes	Same
PackagingConfiguration	Thermo-formed (PETG)plastic tray with Tyveklid	Thermo-formed (PETG)plastic tray with Tyveklid	Same
TreatmentCondition	Sterile	Clean, non-sterile	Change to how itis provided
Condition of Use	Single patient use,disposable	Single patient use,disposable	Same

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miraDry System bioTip Component Substantial Equivalence Comparison Table

SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES

The Special 510(k) for this device modification to the cleared miraDry System (K160141) utilized Miramar Labs established quality system and design control requirements in accordance with the Quality System Regulation (21 CFR 820).

Miramar Labs Inc. declares conformance to design controls in making this change and utilized the following risk based assessments:

1. Risk assessment including Hazard Analysis
1. Complaints incidence and review
1. Manufacturing environment and process evaluation including bioburden testing and monitoring trends
1. Instructions for Use
1. User interface and clinician user feedback

Risk control measures were focused on manufacturing environment, user interface evaluation, and postmarket surveillance and user feedback. No new risks were identified as a result of this change.

CONCLUSION

Based on all information in this Special 510(k), the miraDry MD4000 System and accessories is substantially equivalent to the identified predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance.

Regulation Number and Section

§ 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.