ULTHERA SYSTEM

K134032 · Ulthera, Inc. · OHV · Jun 20, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K134032
• Device Name: ULTHERA SYSTEM
• Applicant: Ulthera, Inc.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow • lift lax submental (beneath the chin) and neck tissue • improve lines and wrinkles of the décolleté The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • ensure proper coupling of the transducer to the skin • confirm appropriate depth of treatment such as to avoid bone

Device Story

Ulthera System uses High Intensity Focused Ultrasound (HIFU) to deliver thermal energy beneath the skin surface; creates localized thermal coagulation points at specified depths to induce tissue lifting and wrinkle reduction. System comprises control unit, handpiece, and DeepSEE transducers. Used in clinical/doctor's office settings by trained professionals. Imaging component provides real-time ultrasonic visualization (up to 8 mm depth) to guide transducer placement, ensure skin coupling, and avoid bone. Output is visual feedback for the clinician to optimize treatment delivery. Non-invasive; no cooling required; chromophore insensitive. Benefits include non-surgical tissue lifting and aesthetic improvement of lines/wrinkles.

Clinical Evidence

Prospective safety and efficacy study (IDE G120004) enrolled 130 female subjects (ages 35-60). Primary endpoint: masked assessment of pre/post-treatment photographs. Due to scale validation issues, analysis performed on a subset of 54 evaluable subjects with consistent photo quality. Results: 36/54 (67%) showed improvement at 180 days. Secondary measures included Clinician Global Aesthetic Improvement Scores (CGAIS) and patient satisfaction questionnaires. No serious adverse events or unanticipated adverse device effects reported; all adverse events were mild or moderate and resolved.

Technological Characteristics

HIFU-based thermal tissue stimulator. Components: control unit, handpiece, DeepSEE transducers. Energy: <2 J thermal. Imaging: ultrasonic visualization up to 8 mm. Biocompatible patient-contact materials. Non-sterile. Shelf life: 12 months. Compliant with electromagnetic compatibility and medical electrical equipment safety standards.

Indications for Use

Indicated for non-invasive dermatological aesthetic treatment in adults to lift eyebrows, lift lax submental and neck tissue, and improve lines and wrinkles of the décolleté. Includes ultrasonic visualization of dermal/subdermal layers to ensure transducer coupling and avoid bone.

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

• Ulthera System (K132028)

Submission Summary (Full Text)

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# 5. 510(k) Summary

This 510(k) Summary for the Ulthera "System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Ulthera, Inc. | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Address: | 1840 South Stapley Drive<br>Suite 200<br>Mesa, AZ 85204 | | | |
| Contact Person: | Ashley Fickett, Regulatory Affairs Manager | | | |
| Telephone: | [phone] | | | |
| Fax: | [phone] | | | |
| Submission Date: | February 19, 2014 | | | |
| Device Trade Name: | Ulthera® System | | | |
| Common Name: | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption<br>System, Imaging, Pulsed Echo, Ultrasonic | | | |
| Classification: | Regulatory Class II | | | |
| Classification Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use | | | |
| Regulation Number: | 878.4590 | | | |
| Product Code: | OHV<br>IYO | | | |
| Legally Marketed | Name: Ulthera® System | | | |
| Predicate: | Ulthera, Inc., Ulthera System - K132028<br>510(k): | | | |
| Applicable Guidance: | The following guidance is applicable to the Ulthera System: | | | |
| | The Class II Special Controls Guidance Document: Focused Ultrasound<br>Stimulator System for Aesthetic Use was developed in response to | | | |
| | Ulthera's DeNovo submission and 510(k) clearance K072505 for the<br>Ulthera System. | | | |
| | Conformance to Guidance for Industry and FDA Staff: Information for<br>Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound<br>Systems and Transducers was determined in the predicate 510(k)<br>submission clearance K132028 for the Ulthera System. | | | |
| | Guidance for the Content of Premarket Submission for Software<br>Contained in Medical Devices. | | | |
| Device Description: | The Ulthera® System consists of the following components: | | | |
| | • Ulthera® Control Unit | | | |
| | • Handpiece | | | |
| | • Transducers | | | |
| Indications for Use: | The Ulthera® System is indicated for use as a non-invasive dermatological<br>aesthetic treatment to: | | | |
| | • lift the eyebrow (current cleared indication) | | | |
| | • lift lax submental (beneath the chin) and neck tissue (current cleared<br>indication) | | | |
| | • improve lines and wrinkles of the décolleté (requested indication) | | | |
| | The Ulthera System in conjunction with the Ulthera DeepSEE transducer<br>allows for ultrasonic visualization of depths up to 8 mm below the surface | | | |
| | of the skin. The indicated use of the imaging is to visualize the dermal and<br>subdermal layers of tissue to: | | | |
| | • ensure proper coupling of the transducer to the skin (current cleared<br>indication) | | | |

Image /page/0/Picture/4 description: The image shows the word "Ulthera" in a stylized font. The word is vertically oriented, with the letters stacked on top of each other. Above the word, there are three small circles arranged horizontally. The font appears to be bold and slightly textured, giving it a distinct visual appearance.

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- confirm appropriate
cleared indication)
Image /page/1/Picture/3 description: The image shows a logo with the word "uthera" in a stylized font. Above the word "uthera" are three small, circular shapes arranged horizontally. The font used for "uthera" appears to be textured or distressed, giving it a slightly rough or vintage look. The overall design is simple yet distinctive, with the circular shapes adding a visual element above the text.

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## Substantial Equivalence Comparison:

| | Predicate Device :<br>Ulthera® System<br>(K132028) | Subject Device<br>Ulthera® System;<br>Expanded Indication for Use |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 878.4590 | 878.4590 |
| Product Code | OHV, IYO | Same<br>OHV, IYO |
| Intended Use/<br>Indications for Use | Non-invasive dermatological aesthetic<br>treatment to:<br>• lift the eyebrow (current cleared<br>indication)<br>• lift lax submental (beneath the chin)<br>and neck tissue<br>The Ulthera System in conjunction with<br>the Ulthera DeepSEE transducer allows<br>for ultrasonic visualization of depths up<br>to 8 mm below the surface of the skin.<br>The indicated use of the imaging is to<br>visualize the dermal and subdermal<br>layers of tissue to:<br>• ensure proper coupling of the<br>transducer to the skin<br>• confirm appropriate depth of<br>treatment such as to avoid bone | Same<br>Non-invasive dermatological aesthetic<br>treatment to:<br>• lift the eyebrow (current cleared<br>indication)<br>• lift lax submental (beneath the chin)<br>and neck tissue<br>• improve lines and wrinkles of the<br>décolleté (requested indication)<br>The Ulthera System in conjunction with<br>the Ulthera DeepSEE transducer allows<br>for ultrasonic visualization of depths up<br>to 8 mm below the surface of the skin.<br>The indicated use of the imaging is to<br>visualize the dermal and subdermal<br>layers of tissue to:<br>• ensure proper coupling of the<br>transducer to the skin<br>• confirm appropriate depth of treatment<br>such as to avoid bone<br><i>Clinical Performance Data Provided for<br/>Expanded Indication</i> |
| Where Used | Clinic/doctor's office | Clinic/doctor's office |
| Anatomical Site | Skin | Same<br>Skin |
| Type of Energy | Thermal<br>< 2 J | Same<br>Thermal<br>< 2 J |
| Biological Effect | Lifting of tissue via High Intensity<br>Focused Ultrasound (HIFU)<br>directed beneath the outer dermis in<br>localized points at a specified depth and<br>distance between points | Same<br>Reduction of lines and wrinkles via High<br>Intensity Focused Ultrasound (HIFU)<br>directed beneath the outer dermis in<br>localized points at a specified depth and<br>distance between points. |
| | Predicate Device :<br>Ulthera® System<br>(K132028) | Subject Device<br>Ulthera® System;<br>Expanded Indication for Use |
| | | Same method of action |
| Demonstrated Safety<br>and Efficacy in treated<br>area | Provided in K072505 cleared September<br>11, 2009<br><br>Provided in K121700 cleared October 2,<br>2012<br><br>Provided in K132028 cleared December<br>11, 2013 | Performance Testing - Clinical<br><br>Clinical Performance Data Provided for<br>Expanded Indication |
| Patient Contact<br>Material | Biocompatible | Biocompatible |
| | | Same |
| Electromagnetic<br>Compatibility<br>Standards | Compliant | Compliant |
| | | Same |
| Medical Electrical<br>Equipment Safety<br>Standards | Compliant | Compliant |
| | | Same |
| Thermal Coagulation<br>Point | Confined to focal zone;<br>shallow (< 5 mm); no thermal<br>coagulation below focal zone | Confined to focal zone;<br>shallow (< 5 mm); no thermal<br>coagulation below focal zone |
| | | Same |
| Epidermal Impact | Non-invasive; no cooling required | Non-invasive; no cooling required |
| | | Same |
| Pigmentation Effect | Chromophore insensitive | Chromophore insensitive |
| | | Same |
| Packaging | Nylon / Aluminum foil laminate bag with<br>very low water vapor transmission rate.<br>The bag is enclosed within a cardboard<br>box for storage. | Nylon / Aluminum foil laminate bag with<br>very low water vapor transmission rate.<br>The bag is enclosed within a cardboard<br>box for storage. |
| | | Same |
| Sterilization | Provided non-sterile | Provided non-sterile |
| | | Same |
| Shelf Life | 12 months | 12 months |
| | | Same |

Image /page/2/Picture/3 description: The image shows a stylized logo or wordmark that reads "Ulthera". The letters are bold and have a textured appearance, giving them a slightly rough or vintage feel. Above the "era" portion of the word, there are three small circles arranged horizontally, adding a design element to the logo.

. .

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:

Image /page/3/Picture/2 description: The image shows the word "ulthera" in a stylized font. The letters are tall and thin, and there are three small circles above the "e" in "ulthera". The circles are arranged horizontally and are evenly spaced. The word "ulthera" is in a dark color, and the background is white. There is a trademark symbol to the right of the word.

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#### Performance Data:

Clinical analysis was conducted in clinical trials to support the clinical performance of the Ulthera® System. Sufficient safety data has been gathered to determine that the Ulthera® System performs as clinically intended.

To support the expanded indication, the Ulthera System was evaluated in a prospective safety and efficacy study investigating the clinical response following treatment with the Ulthera System to achieve improvement of lines and wrinkles of the décolleté. The clinical study's protocol was approved under IDE G120004 for enrolling up to 130 female subjects between the ages of 35-60 at up to 4 sites with a 90 and 180 day follow up. The Fabi-Bolton Scale, a published validated scale, was prospectively defined to evaluate wrinkle improvement. However, successful validation of the Fabi-Bolton Scale during the clinical trial could not be accomplished due to kappa scores for both intra-rater and inter-rater reproducibility being low. Therefore, the primary endpoint was changed from the Fabi-Bolton Scale to a post-hoc retrospective masked assessment of pre and post treatment photographs. There were no pre-specified success criteria of the masked assessment established at the beginning of the clinical trial. In addition to masked assessment, there was also an unmasked assessment called the Clinician Global Aesthetic Improvement Scores (CGAIS). Finally, patient satisfaction questionnaires were also measured to assess improvement.

| | | | | | Table 1. Patient Accountability | | | |
|--|--|--|--|--|---------------------------------|--|--|--|
|--|--|--|--|--|---------------------------------|--|--|--|

| N | 125 |
|---------------------------------------------------------|-----|
| Subject Drop out | 17 |
| Subject Per Protocol | 108 |
| Subject Eliminated based on<br>Poor Quality Photographs | 54 |
| Evaluable Subjects | 54 |

Upon analysis of the all the photographs used in the clinical study, 54 of 108 day 180 photos were identified as having inconsistencies in photo quality (changes in lighting, color, focus, patient positioning, cropping, etc.). Therefore a sub-set analysis was conducted using the primary endpoint of masked assessment on the remaining 54 day 180 evaluable photo sets that were deemed the most consistent in photo quality.

Image /page/4/Picture/7 description: The image shows the word "Ulthera" in a stylized font. The letters are tall and thin, with a slightly distressed or textured appearance. Above the "thera" portion of the word, there are three small, circular shapes, possibly representing dots or spheres. The overall design has a modern and somewhat minimalist aesthetic.

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Table 2 provides results from the masked assessment of the evaluable subject photos.

| N | 54 |
|-------------|-----------|
| Improvement | 36 (~67%) |
| Incorrect | 13 (24%) |
| No Change | 5(9%) |

| | | | Table 2. Masked Assessment Results of Evaluable Subject Photos | | | | | | | |
|--|--|--|-----------------------------------------------------------------|--|--|--|--|--|--|--|
|--|--|--|-----------------------------------------------------------------|--|--|--|--|--|--|--|

in the sub-set of evaluable photos, there were 36 of 54 (~67%) subjects that showed improvement by masked assessment of pre and post treatment photographs at the primary endpoint of 180 days.

Table 3 provides CGAIS and Patient Assessments stratified by results of the primary endpoint of masked assessment for the subject sub-set with the most consistent photo quality.

### Table 3. CGAIS and Patient Assessments Stratified By Masked Assessment Results for Sub-Set of Evaluation Photos

| D180 | | | | | | | | |
|-------------------|--------------------------------------------------------------|-----------|--------|----------------------------------------------|---------------------------------------|-------------------------------------------------------|---------------------------------|---------|
| | CGAIS | | | Patient Satisfaction | | | Patient Reported<br>Improvement | |
| Masked Assessment | Improved (improved,<br>much improved, very<br>much improved) | No Change | Worse | Satisfied<br>(satisfied & very<br>satisfied) | Neither Satisfied<br>nor Dissatisfied | Dissatisfied<br>(dissatisfied &<br>very dissatisfied) | Yes | No |
| Improvement n=36 | 27 (75%) | 9 (25%) | 0 (0%) | 23 (64%) | 9 (25%) | 4 (11%) | 32 (89%) | 4 (11%) |
| Incorrect n=13 | 5 (38%) | 7 (54%) | 1 (8%) | 8 (61%) | 4 (31%) | 1 (8%) | 10 (77%) | 3 (23%) |
| No Change n=5 | 3 (60%) | 2 (40%) | 0 (0%) | 4 (80%) | 0 (0%) | 1 (20%) | 4 (80%) | 1 (20%) |
| TOTAL - n = 54 | 35 (65%) | 18 (33%) | 1 (2%) | 35 (65%) | 13 (24%) | 6 (11%) | 46 (85%) | 8 (15%) |

The results of the sub-set analysis demonstrate improvement of lines and wrinkles based on masked assessment of pre and post treatment photographs in 36 of 54 evaluable subjects with the most consistent photo quality after one Ultherapy treatment 180 days post-treatment.

Please note that treatment efficacy was achieved at the pre-set energy levels of Level 4 for the 7 - 3.0 and 4 - 4.5 transducers and energy Level 3 for the 10 - 1.5 transducer. Changes in energy may impact efficacy.

Device safety was demonstrated as there were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the Ulthera System. Of the adverse events, all but two were mild. Only

Image /page/5/Picture/11 description: The image shows the word "Ulthera" in a stylized font. The letters are tall and thin, with a dotted line above the "thera" portion of the word. The font appears to be outlined, giving it a distinct look.

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two events were moderate, one of which was not device related. All events resolved.

Based on the design, materials, principle of operation, and intended use, the Conclusion: subject device (Ulthera® System) is substantially equivalent to the legally marketed predicate device (Ulthera System, K132028) as demonstrated in the substantial equivalence comparison table. Clinical data determined that the subject device is as safe and effective and performs as well as the predicate device for the expanded indication.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 20, 2014

Ulthera Incorporated Ms. Ashley Fickett Regulatory Affairs Manager 1840 South Stapley Drive, Suite 200 Mesa, Arizona 85204

Re: K134032 Trade/Device Name: Ulthera System Regulation Number: 21 CFR 878.4590 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHV, IYO Dated: December 30, 2013 Received: December 31, 2013

Dear Ms. Fickett:

We have reviewed your Section 510(k) promarket 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

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Page 2 - Ms. Ashley Fickett

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 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/ResourcesforYow/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 vours.

## David Krause -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K134032

Device Name Ulthera® System

Indications for Use (Describe)

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

- · lift the eyebrow
- · lift lax submental (beneath the chin) and neck tissue
- · improve lines and wrinkles of the décolleté

The Uthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal layers of tissue to:

- ensure proper coupling of the transducer to the skin
· confirm appropriate depth of treatment such as to avoid bone

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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A LA FOR FOR FOR FOR FOA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.6.3. Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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