(66 days)
Not Found
No
The summary describes a system that uses focused ultrasound for aesthetic treatments and imaging for visualization and proper application. There is no mention of AI or ML in the intended use, device description, or performance studies. The software testing is described as basic, which is less likely to involve complex AI/ML algorithms.
Yes
Explanation: The device is indicated for non-invasive dermatological aesthetic treatments to lift tissue and improve lines and wrinkles, which are considered therapeutic changes to the body's appearance.
No
The Ulthera System is a therapeutic device intended for non-invasive dermatological aesthetic treatments, such as lifting tissue and improving lines and wrinkles, using focused ultrasound energy. While it has an imaging capability to visualize tissue for proper coupling and depth confirmation, this imaging is a supplementary function to aid in the delivery of the treatment, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of a control unit (with software), a handpiece with cable, and interchangeable transducers. It also mentions mechanical testing of the display hinge and ultrasound output testing, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply focused ultrasound energy to the body for temporary changes in the physical appearance of the skin (lifting and improving lines/wrinkles). It also uses ultrasound for visualization to aid in the treatment process (ensuring proper coupling and avoiding bone).
- Device Description: The device description focuses on the mechanism of action (focused ultrasound energy for tissue coagulation) and the components of the system.
- Lack of mention of in vitro testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for testing these types of samples to diagnose, monitor, or screen for diseases or conditions.
The Ulthera System is a therapeutic and imaging device used directly on the patient's body for aesthetic purposes. It does not perform diagnostic tests on biological samples in vitro.
N/A
Intended Use / Indications for Use
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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 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
Product codes (comma separated list FDA assigned to the subject device)
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 visualization
Anatomical Site
body, skin, submental (beneath the chin), neck, décolleté, dermal and subdermal layers of tissue
Indicated Patient Age Range
adult patient population
Intended User / Care Setting
trained medical professional
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)
The following non-clinical data were provided to support the substantial equivalence of the subject device to the predicate device. In all instances, the subject device functioned as intended.
Biocompatibility: Biocompatibility of the user-contacting components of the device was verified in accordance with ISO 10993-1.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC of the subject device were verified in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, and IEC 60601-2-62.
Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA Guidance, "Content of Premarket Submissions Device Software Functions." A basic documentation level was used, as a failure or flaw of any device software function(s) would not present a hazardous situation with a probable risk of death or serious injury prior to the implementation of risk control measures.
Usability: Usability testing was conducted in accordance with IEC 62366-1 and FDA Guidance, "Applving Human Factors and Usability Engineering to Medical Devices." The console's portability, GUI visibility and layout, and display responsiveness were also verified. Testing demonstrated that clinicians were able to use the device in a representative environment and use conditions. No new risks were identified during the stimulated use study.
Mechanical Testing: The display hinge of the console was verified via mechanical cyclic testing.
Packaging, Transit, and Environmental Testing: Packaging and transit testing were conducted per ASTM D4169 and ASTM D4332. Environmental conditioning testing was conducted to verify device functionality at defined operating and storage conditions.
Ultrasound Output Testing: Acoustic reliability was verified using simulated treatment over the device's service life. Power output and imaging were verified to be within specification.
CONCLUSIONS: The modified console has undergone robust performance testing, including software, mechanical, electrical safety, electromagnetic compatibility, packaging, environmental, and usability testing. Imaging and acoustical testing were also conducted to verify the ultrasound signal. These non-clinical performance tests of the Ulthera System demonstrated the modified console continues to operate as intended and that it is as safe and effective as its predicate for the proposed indications for use.
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.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
February 22, 2024
Ulthera, Inc. Kim Kelly Sr. Director, Regulatory Affairs 1840 S. Stapley Dr. Suite 200 Mesa, Arizona 85204
Re: K233996
Trade/Device Name: Ulthera System (UC-1 Control Unit PRIME) Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System For Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: January 23, 2024 Received: January 23, 2024
Dear Kim Kelly:
We have reviewed vour 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.22 15:01:25 -05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233996
Device Name
Ulthera System (UC-1 Control Unit PRIME)
Indications for Use (Describe)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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 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
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------- |
Description 3.0 (Part 2: Support & Support 2)
I he-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
APPLICANT
| Company's Name: | Ulthera, Inc. |
|---|---|
| Company's Address: | 1820 South Stapley Drive. Suite 200 |
| Mesa, AZ 85204 | |
| Telephone: | (984) 286-9190 |
| Contact Person: | Kim Kelly, Senior Director, Regulatory Affairs |
| Date Prepared: | February 22, 2024 |
DEVICE
| Device Name: | Ulthera System (UC-1 Control Unit PRIME) |
|---|---|
| Classification Name: | Focused Ultrasound Stimulator System for Aesthetic Use |
| Classification Name: | 21 C.F.R § 878.4590, Focused Ultrasound Stimulator Use |
| Regulatory Class: | Class II |
| Product Codes: | OHV, IYO |
| Applicable Guidances: | Focused Ultrasound Stimulator System for Aesthetic Use |
| Applicable Guidances: | Marketing Clearance of Diagnostic Ultrasound Systems and |
| Transducers | |
| Applicable Guidances: | Content of Premarket Submissions for Software Contained |
| in Medical Devices. |
PREDICATE DEVICE
Ulthera System, Ulthera, Inc., K180623
5
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.
INTENDED USE / INDICATIONS FOR USE
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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 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
The purpose of this 510(k) notification relates to modifications to the console of the Ulthera System. Low-intensity, highly focused ultrasound is the main technological principle of both the subject and the predicate device. In both devices, focused ultrasound energy is delivered below the skin and produces discrete points of thermal coagulation that results in contraction of the skin, which produces a lifting or tightening effect and improves appearance of lax tissue, lines, and wrinkles. Both the subject and predicate device share the following similar technological elements:
- · Identical ultrasound signal energy and ultrasound treatment guidelines
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- · Same main components, including a console with integrated touchscreen, connected handpiece, and interchangeable transducers
- · An imaging mode of operation to visualize the treatment area and aid in assuring full/proper skin contact of the transducer to the skin
The following differences between the subject and predicate device do not significantly affect clinical functionality or performance specifications of the device and have been verified and tested:
- · Updates to the console's industrial design and modernization of the graphics within the graphical user interface (GUI)
- Hardware updates to comply with the latest electromedical standards and address end-of-life components
Comparison between the subject and predicate device are summarized in Table 1 below:
| Ulthera Modified Console | Ulthera Console K180623 | |
|---|---|---|
| Subject Device | (Predicate) | |
| Intended Use | The Ulthera System is intended to apply | |
| focused ultrasound energy to the body to | ||
| achieve temporary changes in the | ||
| physical appearance of the skin. | The Ulthera System is intended to apply | |
| focused ultrasound energy to the body to | ||
| achieve temporary changes in the | ||
| physical appearance of the skin. | ||
| Indications for | ||
| Use | The Ulthera® System is indicated for use | |
| as a non-invasive dermatological | ||
| aesthetic treatment to: | The Ulthera® System is indicated for | |
| use as a non-invasive dermatological | ||
| aesthetic treatment to: | ||
| ● lift the eyebrow | ● 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 | ● 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. | ● 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: | 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 | ● ensure proper coupling of the | |
| transducer to the skin | ||
| ● confirm appropriate depth of | ||
| treatment such as to avoid bone | ● confirm appropriate depth of | |
| treatment such as to avoid bone |
| Table 1: Substantial Equivalence Table Comparing Subject & Predicate Devices |
|---|
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| User Population | Treatment of adult patient population by trained medical professional | Treatment of adult patient population by trained medical professional |
|---|---|---|
| Main System Components | • Control console | |
| • Handpiece | ||
| • Transducers | • Control console | |
| • Handpiece | ||
| • Transducers | ||
| Additional Components Required for Operation | • ACLF Power Cord with pigtail adapter | |
| • USB Access Key | • Power cord | |
| • USB Access Key | ||
| Dimensions | ||
| (l x w x h) | Height: |