(56 days)
Not Found
No
The document describes a device that uses focused ultrasound for aesthetic treatments and includes ultrasonic visualization for operator guidance. There is no mention of AI, ML, or any automated image analysis or decision-making processes that would typically involve these technologies. The imaging is described as supplemental and used by the operator to visualize tissue and ensure proper contact.
Yes
The device is intended for non-invasive dermatological aesthetic treatments to lift and improve the appearance of tissue, which constitutes a therapeutic effect.
No
The device is indicated for non-invasive dermatological aesthetic treatment, and its imaging capability is for visualizing tissue to ensure proper transducer coupling and appropriate treatment depth, not for diagnosing medical conditions.
No
The device description explicitly states that the Ulthera® System consists of a control unit (with software), a handpiece with cable, and interchangeable transducers. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Ulthera® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Ulthera® System's Intended Use: The Ulthera® System is intended for non-invasive dermatological aesthetic treatment to lift and improve the appearance of skin tissue. While it uses ultrasonic visualization, this is for guiding the treatment and ensuring proper application, not for analyzing biological specimens.
- Device Description: The device description focuses on delivering focused ultrasound energy to tissue below the skin surface for therapeutic effect (tissue coagulation), not for analyzing samples.
The Ulthera® System is a therapeutic device that uses imaging as a tool to facilitate the treatment, but its primary function is not the in vitro examination of specimens for diagnostic purposes.
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; which can also affect the appearance of lax tissue in the submental and neck regions
· 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 inaging 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
Product codes
OHV, IYO
Device Description
The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To support the expanded indication, the Ulthera® System was evaluated in an open-label clinical trial investigating the clinical response following treatment with the Ulthera System to achieve lifting of lax submental (beneath the chin) and neck tissue. Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires. There were 51/70 patients that had an improvement of 20 mm or more in lift, of these patients 84.3% were identified as showing improvement by masked evaluators. The adverse events resulting from treatment with the Ulthera® System during this study were 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 Ulthera® System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Ulthera®, Inc. Ulthera® System (K134032)
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2018
Ulthera, Inc Mr. Steven J. Kachelmeyer Executive Director, Regulatory Affairs 1840 South Stapley Drive Suite 200 Mesa, Arizona 85204
Re: K180623
Trade/Device Name: Ulthera System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Product Code: OHV, IYO Dated: March 7, 2018 Received: March 9, 2018
Dear Mr. Kachelmeyer:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K180623
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
• Ift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions
· 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 inaging 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Applicant: | Ulthera®, Inc. |
|---|---|
| Address: | 1840 South Stapley Drive, Suite 200 |
| Mesa, AZ 85204 | |
| Contact: | Steven J. Kachelmeyer - Executive Director, Regulatory Affairs |
| Telephone: | (480) 619-4069 |
| Fax: | (480) 619-4071 |
Date Prepared: May 2, 2018 Device Trade Name: Ulthera® System
Common Name: Focused Ultrasound for Tissue Heat or Mechanical Cellular Disruption System, Imaging, Pulsed Echo, Ultrasonic Classification Name: 21 C.F.R. § 878.4590, Focused Ultrasound Stimulator Use System for Aesthetic Use Regulatory Class: Class II Product Codes: OHV, IYO Predicate Device: Ulthera®, Inc. Ulthera® System (K134032)
Applicable Guidance: Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.
The device also conforms to Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Device Description: The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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; which can also affect the appearance of lax tissue in the submental and neck regions
- improve lines and wrinkles of the décolleté ●
4
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 ●
Summary of Technological Characteristics: High Intensity Focused Ultrasound (HIFU) is the underlying technological principle for both the subject and predicate devices. The Ulthera System functions by directing ultrasonic energy beneath the outer dermis in localized points at a specified distance and depth between points. The design and performance characteristics of the subject and predicate devices are identical. The only technological differences between the devices are minor and do not raise different questions of safety or effectiveness for the subject device as compared to the predicate.
| | Predicate Device: Ulthera® System
(K134032) | Subject Device: Ulthera® System,
Expanded Indications for Use |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 C.F.R. § 878.4590 | 21 C.F.R. § 878.4590 |
| Product Code | OHV, IYO | OHV, IYO |
| Intended Use/
Indications for
Use | 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 | Non-invasive dermatological aesthetic
treatment to:
• lift the eyebrow
• lift lax submental (beneath the chin)
and neck tissue which can also affect the
appearance of lax tissue in the
submental and neck regions
• 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 |
| Where Used | Clinic/doctor's office | Clinic/doctor's office |
| Anatomical Site | Skin | Skin |
| Type of Energy | Thermal,