MIRADRY SYSTEM

K131162 · Miramar Labs, Inc. · OUB · Oct 25, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131162
• Device Name: MIRADRY SYSTEM
• Applicant: Miramar Labs, Inc.
• Product Code: OUB · General, Plastic Surgery
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

The miraDry System is a microwave-based device used in clinical settings to treat primary axillary hyperhidrosis. It consists of a console, a handpiece, and a sterile, disposable bioTip. The system delivers microwave energy to the dermal-hypodermal interface where axillary sweat glands are located. The console integrates a microwave generator, vacuum, and cooling systems, controlled via a touch-screen interface. The handpiece, equipped with the disposable bioTip, contacts the patient's skin to deliver energy while cooling the surface. The healthcare provider uses the system to thermally target and reduce sweat glands. The procedure is non-invasive and intended to provide relief from excessive underarm sweating.

Clinical Evidence

Bench testing and pre-clinical testing were performed to ensure conformance to product specifications and equivalence to the predicate. No clinical trial data was required or presented for this 510(k) submission.

Technological Characteristics

Microwave therapy system; surface contact applicator; integrated vacuum and cooling systems. Components: MD4000-MC Console, MD4000-HP Handpiece, MD4000-BT bioTip. Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 60601-2-6 (Microwave therapy). Software-driven console with touch-screen interface.

Indications for Use

Indicated for treatment of primary axillary hyperhidrosis. Not indicated for generalized hyperhidrosis or hyperhidrosis in other body areas.

Regulatory Classification

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.

Predicate Devices

• miraDry System (K103014)

Submission Summary (Full Text)

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# 2. 510(k) Summary

| General Information | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II (special controls) |
| Classification No.: | 21 CFR 878.4400 |
| Common Name: | Electrosurgical cutting and coagulation device<br>and accessories. |
| Product Code(s): | OUB, NEY |
| Trade Name: | miraDry System |
| Submitter: | Miramar Labs, Inc.<br>445 Indio Way<br>Sunnyvale, CA 94085<br>USA<br>Tel: [phone]<br>Fax: [phone]<br>FDA Registration No.: 3008082710 |
| Contact: | Kathy O'Shaughnessy, PhD<br>VP, Clinical/Regulatory/Quality |
| Date prepared: | 10/8/2013 |

#### Intended Use

The miraDry System bears the following Indications for Use statement that is identical to the FDA authorized indications for use for the predicate.

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.

Predicate Device

miraDry System - K103014 Cleared: January 28, 2011

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### Device Description

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.

### Materials

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 under the anticipated conditions of use associated with the device. There are no changes in materials that raise questions of safety or effectiveness.

#### Testing

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.

The miraDry System has been shown to conform to the applicable requirements of the following:

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- . IEC 60601-1:2005 + A1:2012 Medical Electrical Equipment Part 1: General Requirements for Safety: Safety Requirements for Medical Electrical Systems
- . IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility
- . IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability
- IEC 60601-2-6:2012 Medical electrical equipment Part 2-6: Particular requirements . for the safety of microwave therapy equipment.

### Summary of Substantial Equivalence

The MD4000 miraDry System is substantially equivalent to the predicate device, the miraDry System cleared under K103014. The indications for use and technological characteristics are equivalent; therefore, the miraDry System is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

October 25, 2013

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

Miramar Labs, Incorporated Ms. Kathy O'Shaughnessy Vice President, Clinical/Regulatory/Quality 445 Indio Way Sunnyvale, California 94085

Re: K131162

:

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: OUB, NEY Dated: October 8, 2013 Received: October 9, 2013

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kathy O'Shaughnessy

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark Nielkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1. Indications for Use Statement

| 510(k) Number:<br>(if known) | K131162 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | miraDry System |
| Indications for Use: | The miraDry System is indicated for use in the<br>treatment of primary axillary hyperhidrosis. |
| | Note: The miraDry System is not indicated for use in<br>the treatment of hyperhidrosis related to other body<br>areas or generalized hyperhidrosis. |

× Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H Chen -A

for MXM

(Division Sign-off) Division of Surgical Devices 510(k) Number: K131162