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 for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 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: 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 K150419 and prior submissions, the miraDry MD4000 System also includes Class I components/accessories. The MD4000-TS template system is a required component for the miraDry treatment as well as the MD4000-PK priming kit and the MD4000-BT-DE demonstration bioTip. 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 has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for success. Instead, it defines primary and secondary endpoints for the clinical trial and then reports the study results against these. The "acceptance criteria" are implicitly understood as achieving statistical significance for the primary endpoint.

Endpoint Category	Specific Endpoint	Acceptance Criteria (Implicit from Primary Endpoint)	Reported Device Performance	Met Criteria?
Primary Endpoint	Percentage of subjects with at least a 2-point lower odor score in the treated underarm compared to the untreated underarm (responders) when assessed 1 month after treatment.	Statistically significant (p < 0.05) proportion of subjects experiencing a 2-point difference greater than 50%.	23/35 (66%) reached this, but p=0.09, which is not statistically significant.	No
Secondary Endpoint	Statistically significant difference in % of subjects with at least a 2-point drop in underarm odor score in the treated underarm compared to the untreated underarm at 3 and 6 months.	Statistically significant (p < 0.05) proportion of subjects experiencing a 2-point difference.	3 months: 14/36 (39%); 6 months: 13/36 (36%). Not statistically significant.	No
Secondary Endpoint	Average difference in odor in the treated underarm compared to the untreated underarm at all follow-up visits.	Statistically significant average difference in odor (p < 0.05).	1 month: 2.84 (±0.73) with p < 0.0001 3 months: 1.27 (±0.74) with p = 0.0005 6 months: 1.56 (±0.56) with p < 0.0001	Yes
Additional Information	Patient-rated satisfaction (general satisfaction)	Not explicitly defined acceptance criteria.	29/35 (83%) reported being at least somewhat satisfied.	-
Additional Information	Patient-rated satisfaction (willingness to treat untreated arm for free)	Not explicitly defined acceptance criteria.	15/36 (42%) would like to undergo treatment of the untreated underarm at no cost.	-
Safety	No significant safety concerns/adverse events.	Low incidence of severe adverse events; expected post-treatment effects.	Expected post-treatment effects (edema, discomfort) reported by half; one mild infection, one pain likely due to infection (both cleared).	-
Histo-pathology	Reduction in apocrine glands and/or increase in fibrosis in treated arm.	Not explicitly defined acceptance criteria.	7/10 cases: control had more apocrine glands. 8/10 cases: treated had higher fibrosis.	-

In summary, the primary endpoint and secondary endpoint related to the percentage of responders (2-point reduction) were NOT met. However, the secondary endpoint regarding the average difference in odor was statistically significant at all time points, indicating that the treated underarm did have lower odor scores.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 40 adult subjects.
Data Provenance: Prospective, split-patient, randomized, single-center trial. The country of origin is not explicitly stated, but the FDA submission implies a US-based study or one conducted under US regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: 4
Qualifications of Experts: Described as "blinded, trained odor assessors." Specific professional qualifications (e.g., dermatologists, specialized clinicians) are not provided, but the term "trained" suggests they underwent a specific calibration or education process for odor assessment.

4. Adjudication Method for the Test Set

Adjudication Method: The odor scores for each underarm were obtained by "averaging the scores from the four judges." This is a form of consensus-based assessment, where individual expert scores are combined mathematically. It is not an adjudication method like "2+1" or "3+1" where a third reviewer resolves disagreements; rather, all scores are given equal weight and averaged.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

This was not an MRMC comparative effectiveness study in the typical sense of AI vs. human readers or human readers with AI vs. without AI. The study evaluated the effectiveness of the miraDry device itself, with human odor assessors providing the "ground truth" (or assessment) of the odor.
Therefore, there is no effect size reported for how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this was not a standalone algorithm performance study. The device being evaluated (miraDry System MD4000) is a physical device that treats patients. Its performance was assessed by human experts (odor assessors) and patient self-reports. There is no AI algorithm being evaluated for standalone performance in this context.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for odor assessment was established by expert consensus (average scores from four trained odor assessors) and patient self-reported odor scores and satisfaction. For the histological component, it was pathology results (blinded histopathologist review of biopsies).

8. The Sample Size for the Training Set

This document describes a clinical trial evaluating the performance of a medical device (miraDry System MD4000), not the development or training of an AI algorithm.
Therefore, there is no training set sample size mentioned, as this concept is not applicable to the study described. The miraDry system itself is not an AI device that requires a training set in this context.

9. How the Ground Truth for the Training Set Was Established

As stated in point 8, there was no AI algorithm or associated training set in the context of this document. The miraDry device is a microwave energy device, not an AI system.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2016

Miramar Labs Incorporated Ms. Kathy O'Shaughnessy Consultant, Regulatory Affairs 2790 Walsh Avenue Santa Clara, California 95051

Re: K160141

Trade/Device Name: miraDrv System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OUB, NEY, MWY Dated: September 19, 2016 Received: September 20, 2016

Dear Ms. O'Shaughnessy:

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 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -A

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) K160141

Device Name miraDry System

Indications for Use (Describe)

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

When used for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 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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1. 510(k) Summary
GENERAL INFORMATION
Classification:	Class II (special controls)
Classification No.:	21 CFR 878.4400
Classification Name:	Electrosurgical cutting and coagulationdevice and accessories.
Product Code(s):	OUB, NEY, MWY
Common Name:	Instrument for Treatment of HyperhidrosisSystem, Ablation, Microwave AndAccessoriesSystem, Microwave, Hair Removal
Trade Name:	miraDry MD4000 System
Submitter:	Miramar Labs, Inc.2790 Walsh AvenueSanta Clara, CA 95051, USATel: 408-940-8700Fax: 408-940-8795FDA Registration No.: 3008082710
Contact:	Kathy O'Shaughnessy, PhDVP, Clinical/Regulatory/QA (Consulting)
Date prepared:	10/27/16

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 for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 may reduce underarm odor.

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PREDICATE DEVICE

The miraDry MD4000 System (K150419).

DEVICE DESCRIPTION

The miraDry MD4000 that is the subject of this 510(k) is identical to the device described and cleared in K150419, except for the proposed labeling changes that resulted in this 510(k) submission.

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.

SUMMARY OF SUBSTANTIAL EQUIVALENCE

The miraDry MD4000 System described and cleared in 510(k) number K150419 serves as the predicate device for this premarket notification. The miraDry MD4000 System that is the subject of this 510(k) has the same intended use and technological characteristics as the device described and cleared in 510(k) number K150419. Furthermore, there have been no changes in design, material, chemical composition, energy source, or manufacturing process since FDA's clearance of K150419.

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Substantial Equivalence Comparison Table

Characteristics	Predicate DevicemiraDry MD4000K150419	Subject DevicemiraDry MD4000
Device Class	II	II
Energy Type	Microwave	Microwave
Mode of Action	generation of localized heat	generation of localized heat
Product Code	NEY, OUB, MWY	NEY, OUB, MWY
Indications for Use	The miraDry System MD4000 isindicated for use in thetreatment of primary axillaryhyperhidrosis plus unwantedunderarm hair removal, andpermanent reduction ofunderarm hair of all colors forFitzpatrick skin types I - IV.Permanent hair reduction isdefined as long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after the completionof a treatment regime.	The miraDry System MD4000 isindicated for use in thetreatment of primary axillaryhyperhidrosis plus unwantedunderarm hair removal, andpermanent reduction ofunderarm hair of all colors forFitzpatrick skin types I - IV.Permanent hair reduction isdefined as long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after the completion ofa treatment regime.
		When used for the treatmentof primary axillaryhyperhidrosis, the miraDrySystem MD4000 may reduceunderarm odor.
Function	Heat absorption by tissuelocated at the dermal-hypodermal interface wherethe axillary sweat (wetnessand odor) glands and hairbulbs reside	Heat absorption by tissuelocated at the dermal-hypodermal interface wherethe axillary sweat (wetnessand odor) glands and hairbulbs reside
Overall System structure	microwave source/amplifier,coolant supply system,operator interface, andmicrowave, electrical andcoolant lines that connect tothe applicator	microwave source/amplifier,coolant supply system,operator interface, andmicrowave, electrical andcoolant lines that connect tothe applicator
Key Components	Console, handpiece,disposable applicator tip	Console, handpiece,disposable applicator tip
Console ControlMechanism	Electronic user interface	Electronic user interface
Coolant usage	Delivers cooling to the skinsurface	Delivers cooling to the skinsurface

NON-CLINICAL TESTING

There was no additional non-clinical testing that was completed, as the device being used is the same as the cleared device (miraDry MD4000 System, cleared under K150419).

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CLINICAL TESTING

In support of this 510(k), a prospective, split-patient, randomized, single center trial was conducted. Forty adult subjects with high underarm odor were enrolled. Subjects were treated in one underarm (randomly selected) with the miraDry MD4000 System using the standard miraDry procedure, which at the time of the study was two treatment sessions 3 months apart. The other underarm was untreated and served as the control.

The odor assessments were conducted by four blinded, trained odor assessors, where each assessor qave a score to each underarm between 0 (no malodor) and 10 (extremely strong malodor). Scores for each underarm were obtained by averaging the scores from the four judges. Patients also self-reported their odor scores and rated their satisfaction with the procedure. The mean subject age was 49 years; 63% of the subjects were female and 57% were African American, with the remainder Caucasian.

Study Design	Prospective, split-patient, randomized, single center trial
Sample Size	40 patients – one underarm treated, one underarm untreated
OdorAssessmentMethod	Panel of 4 blinded, trained odor assessors; each underarm ratedon a scale of 0 (none, no malodor) to 10 (extremely strongmalodor) and averaged
PrincipalEligibilityCriteria	Score of at least 5 in each underarm; less than a 2 point difference between underarms Willing to comply with washout period instructions prior to each odor assessment Willing to receive the miraDry treatments and available for the follow-up period
Follow-ups	1 month, 3 months and 6 months after last treatment
Endpoints	Primary:Percentage of the subjects that scored at least a 2 point lowerodor score in the treated underarm compared to the untreatedunderarm (responders) when assessed 1 month after treatmentSecondary: Statistically significant difference in % of subjects with at least a 2 point drop in underarm odor score in the treated underarm compared to the untreated underarm at 3 and 6 months. Average difference in odor in the treated underarm compared to the untreated underarm at all follow-up visits. Patient-rated satisfaction scores on odor specific questions, as measured at the follow-up visits that are 1, 3 and 6 months post final treatment

The study design and results are summarized in the table below.

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Effectiveness	The results for the responder analysis are shown in the table below
results	for the subjects that attended the study visits.

			Table 1: Percentage of subjects with at least 2 point lower odor
		score in the treated underarm compared to the untreated
	underarm
		# of	Percentage of subjects with at
		Evaluable	least 2 point lower odor score in
		subjects	the treated underarm compared
			to the untreated underarm 1
			month after treatment.
	1 month after	35	23/35 (66%)*
	treatment
	3 months after	36	14/36(39%)
	treatment
	6 months aftertreatment	36	13/36(36%)
			*p=0.09, indicating the proportion of subjects experiencing a 2
			point difference (between the treated and untreated underarm)
		was not significantly greater than 50%.

			The primary endpoint and a secondary endpoint were not met,
			since the percentage of patients with at least a 2 point lower

	score on the treated underarm compared to the untreatedunderarm was not statistically significant at the three time points.
	However, the treated underarm was scored as having lower odor
	at all time points.

	Table 2: Average difference in odor in the treated underarm
		compared to the untreated underarm at all follow-up visits.
		Average difference in odor	P value
		between the treated and
		untreated underarm (±
		95%CI)
	1 month	2.84 (±0.73)	<0.0001
	3 months	1.27 (±0.74)	0.0005
	6 months	1.56 (±0.56)	<0.0001

	The treated underarm was rated by judges as having lower odor
	scores than the untreated underarm at every time point.
	Therefore, although the primary endpoint of statistically significant
	responder rate of 2 point reduction in odor was not met, the study
	data demonstrate some reduction of underarm odor when used
		for the treatment of primary axillary hyperhidrosis.

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	Finally, subjects were asked about their general satisfaction and ifthey would be willing to receive treatment for free on theuntreated arm. In response to the general satisfaction question,29/35 or 83% reported being at least somewhat satisfied.However, only 15/36 or 42% responded that they would likeundergo treatment of the untreated underarm at no cost.
Safety results	About half the treated subjects reported expected post-treatmenteffects such as localized edema and discomfort (Grade 0 events).One patient reported a mild infection that cleared in 10 days;another patient reported pain likely due to an infection after theoptional biopsy; this cleared in 12 days.
Histo-pathologyresults	An optional component of the study was to obtain small biopsiesfrom each of the treated and untreated (control) underarms afterthe final follow-up visit (6 months post-treatment). A blindedhistopathologist review of the available pairs with adequatesamples found:
	(1) In 7/10 cases the control sample had more apocrine glands
	(2) In 8/10 cases the treated sample had a higher degree offibrosis.

CONCLUSION

The changes in Indications for Use do not pose any new questions of safety or efficacy. As demonstrated through clinical testing, the subject device miraDry MD4000 System's safety and effectiveness are substantially equivalent to those of the legally marketed predicate device (K150419).

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.