(171 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware components and ultrasonic visualization for guidance, not automated analysis or decision-making.
Yes
The device is indicated for non-invasive dermatological aesthetic treatment, explicitly for lifting tissue and improving lines/wrinkles, which aligns with therapeutic purposes.
Yes
The device uses ultrasonic visualization to "visualize the dermal layers of tissue" to "ensure proper coupling of the transducer to the skin" and "confirm appropriate depth of treatment such as to avoid bone." These activities involve obtaining information about the patient's anatomy to inform a medical procedure.
No
The device description explicitly lists hardware components: Ulthera® Control Unit, Handpiece, and Transducers.
Based on the provided information, the Ulthera® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is described as a "non-invasive dermatological aesthetic treatment" for lifting and improving lines and wrinkles. This is a therapeutic and aesthetic purpose, not a diagnostic one.
- Mechanism of Action: The device uses ultrasound for visualization and treatment. While it visualizes tissue, the primary purpose is to guide the treatment and ensure proper application, not to diagnose a disease or condition based on analysis of biological samples.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ulthera System does not perform this function.
The ultrasonic visualization component is used for guiding the treatment and ensuring proper device application, not for analyzing biological samples to make a diagnosis.
N/A
Intended Use / Indications for 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 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
Product codes (comma separated list FDA assigned to the subject device)
OHV, IYO
Device Description
The Ulthera® System consists of the following components:
• Ulthera® Control Unit
• Handpiece
• Transducers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic visualization
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinic/doctor's office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A prospective safety and efficacy study was conducted.
Sample size: Enrolled up to 130 female subjects, 108 subjects were Per Protocol, 54 subjects were evaluable after eliminating those with poor quality photographs.
Data source: Clinical trial data.
Annotation protocol:
Initially, the Fabi-Bolton Scale was prospectively defined to evaluate wrinkle improvement, but validation could not be accomplished.
The primary endpoint was changed to a post-hoc retrospective masked assessment of pre and post treatment photographs. No pre-specified success criteria were established for the masked assessment.
An unmasked assessment called the Clinician Global Aesthetic Improvement Scores (CGAIS) was also performed.
Patient satisfaction questionnaires were measured.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: 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.
Sample Size: 125 (N), 108 (Subject Per Protocol), 54 (Evaluable Subjects)
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results:
Masked Assessment Results of Evaluable Subject Photos (N=54):
Improvement: 36 (~67%)
Incorrect: 13 (24%)
No Change: 5 (9%)
CGAIS and Patient Assessments Stratified By Masked Assessment Results for Sub-Set of Evaluation Photos (N=54):
For subjects with masked assessment improvement (n=36):
CGAIS Improved: 27 (75%)
Patient Satisfaction Satisfied: 23 (64%)
Patient Reported Improvement: 32 (89%)
Overall Safety: No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment. All but two adverse events were mild; all resolved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Improvement from masked assessment of pre and post treatment photographs in 36 of 54 evaluable subjects (~67%) showed improvement.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
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.(b)
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.
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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 | |||
| Suite 200 | ||||
| Mesa, AZ 85204 | ||||
| Contact Person: | Ashley Fickett, Regulatory Affairs Manager | |||
| Telephone: | (480) 619-4069 | |||
| Fax: | (480) 214-0330 | |||
| Submission Date: | February 19, 2014 | |||
| Device Trade Name: | Ulthera® System | |||
| Common Name: | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | |||
| 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 | |||
| IYO | ||||
| Legally Marketed | Name: Ulthera® System | |||
| Predicate: | Ulthera, Inc., Ulthera System - K132028 | |||
| 510(k): | ||||
| Applicable Guidance: | The following guidance is applicable to the Ulthera System: | |||
| The Class II Special Controls Guidance Document: Focused Ultrasound | ||||
| Stimulator System for Aesthetic Use was developed in response to | ||||
| Ulthera's DeNovo submission and 510(k) clearance K072505 for the | ||||
| Ulthera System. | ||||
| Conformance to Guidance for Industry and FDA Staff: Information for | ||||
| Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound | ||||
| Systems and Transducers was determined in the predicate 510(k) | ||||
| submission clearance K132028 for the Ulthera System. | ||||
| Guidance for the Content of Premarket Submission for Software | ||||
| 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 | |||
| aesthetic treatment to: | ||||
| • lift the eyebrow (current cleared indication) | ||||
| • lift lax submental (beneath the chin) and neck tissue (current cleared | ||||
| indication) | ||||
| • improve lines and wrinkles of the décolleté (requested indication) | ||||
| 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 (current cleared | ||||
| 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.
2
Substantial Equivalence Comparison:
| | Predicate Device :
Ulthera® System
(K132028) | Subject Device
Ulthera® System;
Expanded Indication for Use |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 878.4590 | 878.4590 |
| Product Code | OHV, IYO | Same
OHV, IYO |
| Intended Use/
Indications for Use | Non-invasive dermatological aesthetic
treatment to:
• lift the eyebrow (current cleared
indication)
• lift lax submental (beneath the chin)
and neck tissue
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 | Same
Non-invasive dermatological aesthetic
treatment to:
• lift the eyebrow (current cleared
indication)
• lift lax submental (beneath the chin)
and neck tissue
• improve lines and wrinkles of the
décolleté (requested indication)
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
Clinical Performance Data Provided for
Expanded Indication |
| Where Used | Clinic/doctor's office | Clinic/doctor's office |
| Anatomical Site | Skin | Same
Skin |
| Type of Energy | Thermal
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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