LIPSONIX(R) SYSTEM MODEL 2

K112626 · Medicis Technologies Corporation · OHV · Oct 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112626
• Device Name: LIPSONIX(R) SYSTEM MODEL 2
• Applicant: Medicis Technologies Corporation
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.

Device Story

LipoSonix system Model 2 is a cart-based device for non-invasive disruption of subcutaneous adipose tissue (SAT). It utilizes high intensity focused ultrasound (HIFU) energy to induce thermal cellular disruption and collagen contraction in soft tissue. The device consists of a cart, a detachable handpiece, and a user interface display. It is operated by a clinician in a clinical setting. The thermal energy targets adipose tissue, which is subsequently cleared by the body's natural inflammatory and lymphatic processes. The device output is controlled energy delivery to the target area. Clinical benefits include waist circumference reduction, potentially equivalent to one dress or pant size. The system is designed to provide a non-invasive aesthetic alternative to surgical procedures.

Clinical Evidence

Multicenter, randomized study evaluated waist circumference reduction. Primary endpoint met: 59 J/cm² treatment group showed 1.01 cm greater reduction compared to sham control. Mean change from baseline to 12 weeks in the 59 J/cm² group was -2.44 cm. Safety assessed through 24 weeks; adverse events were mild, short-lived, and resolved without incident. No serious adverse events or unanticipated adverse device effects reported.

Technological Characteristics

Cart-based system with detachable handpiece and user interface. Employs high intensity focused ultrasound (HIFU) for thermal tissue disruption. Conforms to FDA consensus and international harmonized standards for thermal, electrical, electromagnetic, and mechanical safety. Addresses risks including thermal/mechanical injury, ocular injury, electrical shock, and inflammation.

Indications for Use

Indicated for non-invasive waist circumference reduction in patients with at least 1.0 cm of adipose tissue thickness beyond the selected treatment focal depth. Contraindicated in pregnant or lactating females, patients with a hernia in the treatment area, or patients with insufficient adipose tissue thickness.

Regulatory Classification

Identification

A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• LipoSonix® system Model 1 (K100874)

Submission Summary (Full Text)

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LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation

## 510(k) Summary

In accordance with 21 CFR 807.92(c) the following summary of information is provided:

| Date Prepared: | September 8, 2011 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medicis Technologies Corporation<br>11818 North Creek Parkway North<br>Bothell, WA 98011 USA |
| Contact Person: | Michael A. Hoffman, MPH<br>Vice President - Regulatory Affairs and Quality Systems<br>Medicis Technologies Corp.<br>11818 North Creek Parkway North<br>Bothell, WA 98011 USA |
| Telephone: | 425.420.2135 |
| Facsimile: | 425.420.2335 |
| FR Number: | 21 CFR 878.4590 |
| Product Code: | OHV |
| Classification Name | Focused Ultrasound Stimulator System for Aesthetic Use |
| Common Name: | Focused Ultrasound Stimulator System for Aesthetic Use |
| Trade Name: | LipoSonix® system Model 2 |
| Regulatory Class: | Class II |
| Classification<br>Advisory<br>Committee: | Division of General, Restorative and Neurological<br>Devices; General Surgery Devices Branch |
| Special Controls: | Class II Special Controls Guidance Document: Focused<br>Ultrasound Stimulator System for Aesthetic Use (July 20,<br>2011) |
| Predicate Device(s): | K100874, LipoSonix® system Model 1 |
| Intended<br>Use/Indications for<br>Use: | The LipoSonix system delivers high intensity focused<br>ultrasound (HIFU) energy that can disrupt subcutaneous<br>adipose tissue (SAT) to provide a non-invasive approach<br>to achieve a desired aesthetic effect.<br>The LipoSonix system is specifically indicated for non-invasive waist circumference reduction |
| Contraindications: | A patient is ineligible for treatment with the LipoSonix system if any of the following criteria are met:<br>The patient is a female who is pregnant, may be pregnant, or is lactating. Female patients of child bearing age should have a negative pregnancy test before being treated with the LipoSonix system. The patient has less than 1.0 cm of adipose tissue thickness beyond the selected treatment focal depth in the area to be treated. Hernia in the area to be treated. |
| Device Description: | The LipoSonix system is a cart-based medical device intended for non-invasive disruption of subcutaneous adipose tissue (SAT) by employing ultrasound energy. The system consists of a cart, a detachable handpiece and a user interface display in one unit. |
| Technology: | The LipoSonix system accomplishes its intended use through the use of precisely targeted high intensity focused ultrasound energy that produces a thermal cellular disruption in the subcutaneous adipose tissue (soft tissue). This thermal energy also causes collagen to contract. Thus creating a dual tissue response. The destroyed adipose tissue is subsequently cleared via an |

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LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation

lymphatic system.

inflammatory response by macrophages that transported the destroyed cells and their contents to the liver via the

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LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation

## Summary of Non-Clinical Tests: Determination of

The system has been found to conform to the system Substantial essential specifications, thermal. electrical. Equivalence: electromagnetic and mechanical safety, and has been found to conform to FDA consensus, medical device safety standards and international harmonized standards.

> The following risks as identified in the FDA special control quidance document entitled, "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" have been addressed.

- Thermal Injury from Focused Ultrasound Exposure . (Thermal Damage)
- Mechanical Injury from Focused Ultrasound Exposure .
- (Cavitation or other Mechanical Damage) .
- . Ocular Injury
- Electrical Shock
- Inflammation/Foreign Body Response ●
- Use Error ●

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LipoSonix® system Model 2 Special 510(k) Premarket Notification

The LipoSonix system was evaluated in a multicenter, Performance Data: randomized study. Treatment with the LipoSonix system was shown to be superior to a sham control in reducing waist circumference, meeting the pre-specified primary endpoint of the study. The 59 J/cm² treatment group demonstrated a 1.01 cm greater waist circumference reduction as compared to sham. The least square (LS) mean change from baseline to 12 weeks of the waist circumference in the same 59 J/cm2 group was -2.44 cm. On average, the mean change in waist circumference of approximately 2.55 cm (1 inch) compared to baseline that was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.

> The safety of treatment with the LipoSonix system was assessed through 24 weeks post-treatment. The AEs resulting from treatment with the LipoSonix system during this study were mostly mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the investigational device.

The LipoSonix system is substantially equivalent to the Substantial LipoSonix system Model1 (K100874) device. Equivalence:

> The LipoSonix system Model 2 has the same intended use as the Model 1 system, namely performing a noninvasive treatment to achieve a desired aesthetic effect. Both systems use the same technological principles, namely HIFU, to thermally disrupt soft tissues which result in the aesthetic affect. The mechanism of action for both devices is essentially the same as well. Disrupted soft tissue is removed by normal healing processes of the body resulting in an aesthetic affect. Both devices can deliver more than one energy dose.

Therefore, the LipoSonix system Model 2 is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Medicis Technologies Corporation % Michael A. Hoffman, MPH Vice President - Regulatory Affairs and Quality Systems 11818 North Creek Parkway North Bothell, Washington 98011

Re: K112626

Trade/Device Name: LipoSonix® System Model 2 Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: October 04, 2011 Received: October 04, 2011

Dear Mr. Hoffman:

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, Orug, 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 musicading.

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 tan 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.

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Page 2 - Michael A. Hoffman, MPH

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Evin L. Keith

For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): This Submission

Device Name: LipoSonix® system Model 2

Indications For Use:

The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.

The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.

Prescription Use

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

NilkRedden for mkm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K112626

Section 18 - Indications for Use