(56 days)
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
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.
Here's an analysis of the acceptance criteria and study information for the Ulthera System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint for "lifting lax submental (beneath the chin) and neck tissue": Improvement in lift, though specific quantitative metric for "improvement" is not defined, only that it refers to a lift of ≥20 mm². | - Quantitative Assessment: 51 out of 70 patients (72.9%) had an improvement of ≥20 mm² in lift. |
| Qualitative Assessment from Masked Evaluators: Improvement identified qualitatively. | - Qualitative Assessment: Of the 51 patients with ≥20 mm² lift, 84.3% were identified as showing improvement by masked evaluators. |
| Adverse Events: Mild, short-lived, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs). | - Adverse Events: Adverse events were mild, short-lived in duration, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 70 patients.
- Data Provenance: The document does not explicitly state the country of origin. It describes an "open-label clinical trial," which implies prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document mentions "masked evaluators" but does not specify the number of individuals.
- Qualifications of Experts: Not provided. The term "masked evaluators" suggests they were independent of the treatment process.
4. Adjudication Method
- The document mentions "masked evaluators" identifying improvement. It doesn't detail a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, implying a single assessment per evaluator or a simple consensus if multiple evaluators were involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study described for human readers with and without AI assistance. This study focuses on the device's direct clinical effect on patients. The device itself uses imaging as an aid for the operator, but the clinical trial evaluates the treatment outcome, not the efficacy of the AI component in guiding human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable/Not done. The Ulthera System is a therapeutic device that involves human operation. The performance assessed here is the clinical outcome of the treatment when performed by an operator, not a standalone algorithmic output. The "imaging" component is a visualization aid for the operator, not a diagnostic algorithm with standalone performance metrics.
7. Type of Ground Truth Used
- Clinical Outcomes/Quantitative Measurement: The primary ground truth for the effectiveness of "lifting lax submental and neck tissue" was a quantitative assessment of lift (≥20 mm² improvement) and qualitative assessment by masked evaluators. Adverse events were also monitored as part of the safety profile.
8. Sample Size for the Training Set
- Not applicable/Not provided. This document describes a clinical trial for an aesthetic treatment device. The "Ulthera System" itself is a device that generates focused ultrasound; it's not explicitly described as having an AI component that is "trained" in the typical machine learning sense to perform a task. If the "system software" (Version 1700) has an AI component that processes data and learns, the training set size is not disclosed in this document. The clinical study detailed is a validation study for the device's clinical efficacy for a new indication, not an AI model training or validation set.
9. How Ground Truth for Training Set Was Established
- Not applicable/Not provided. As stated above, the document does not discuss the training of an AI model.
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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.
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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
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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 ●
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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 forUse | Non-invasive dermatological aesthetictreatment to:• lift the eyebrow• lift lax submental (beneath the chin) andneck tissue• improve lines and wrinkles of thedécolletéThe Ulthera® System in conjunction withthe Ulthera® DeepSEE transducer allowsfor ultrasonic visualization of depths up to8 mm below the surface of the skin. Theindicated use of the imaging is to visualizethe dermal and subdermal layers of tissueto:• ensure proper coupling of thetransducerto the skin• confirm appropriate depth oftreatment such as to avoid bone | Non-invasive dermatological aesthetictreatment to:• lift the eyebrow• lift lax submental (beneath the chin)and neck tissue which can also affect theappearance of lax tissue in thesubmental and neck regions• improve lines and wrinkles of thedécolletéThe Ulthera® System in conjunction withthe Ulthera® DeepSEE transducer allowsfor ultrasonic visualization of depths up to8 mm below the surface of the skin. Theindicated use of the imaging is tovisualize the dermal and subdermallayers of tissue to:•ensure proper coupling of the transducerto the skin•confirm appropriate depth of treatmentsuch as to avoid bone |
| Where Used | Clinic/doctor's office | Clinic/doctor's office |
| Anatomical Site | Skin | Skin |
| Type of Energy | Thermal, < 2 J | Thermal, < 2 J |
| Biological Effect | Lifting of tissue and reduction of lines andwrinkles via High Intensity FocusedUltrasound (HIFU) directed beneath theouter dermis in localized points at aspecified depth and distance between | Lifting of tissue and reduction of lines andwrinkles via High Intensity FocusedUltrasound (HIFU) directed beneath theouter dermis in localized points at aspecified depth and distance between |
| Patient ContactMaterial | Biocompatible | Biocompatible |
A table comparing the key features of the subject and predicate devices is provided below.
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| MedicalElectricalEquipmentSafety and EMC | Compliant with relevant standards | Compliant with relevant standards |
|---|---|---|
| ThermalCoagulationPoint | Shallow (< 5 mm) and confined – nothermal coagulation below focal zone. | Shallow (< 5 mm) and confined – nothermal coagulation below focal zone. |
| EpidermalImpact | Non-invasive; no cooling required | Non-invasive; no cooling required |
| PigmentationEffect | Chromophore insensitive | Chromophore insensitive |
| SystemSoftware | Version 1382 | Version 1700 – minor software updates tohave GUI match cleared labeling inK134032, add improved security fortransducer detection, and correct minoranomalies. |
| Device Labeling | Instructions for Use(IFU) and TechnicalInformation Manual (TIM) shipped as twoseparate documents | Integrated Instructions for Use(IFU) andTechnical Information Manual (TIM) into asingle document to simplify translations.Added UDI labelingUpdated symbols for IEC 60601-1-3.1 ed. |
| Packaging | Control Unit and Handpiece: CorrugatedcartonTransducer: Nylon / Aluminum foillaminate bag with very low water vaportransmission rate, enclosed within a | Control Unit and Handpiece: CorrugatedcartonTransducer: Nylon / Aluminum foillaminate bag with very low water vaportransmission rate, enclosed within a |
| Sterilization | Non-sterile | Non-sterile |
| Single-use/Reusable | Controller and handpiece: ReusableTransducers: Single-use | Controller and handpiece: ReusableTransducers: Single-use |
| Shelf Life | 12 months (transducer) | 12 months (transducer) |
Performance Data: 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 mm² 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.
Conclusion: The Ulthera® System is as safe and effective as the predicate Ulthera® System cleared by FDA in K134032. The subject device has the same intended use and very similar technological characteristics and principles of operation as its predicate device. The minor differences in indications do not alter the intended therapeutic use of the device, and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject Ulthera® System and its predicate raise no new types of safety or effectiveness questions. Thus, the Ulthera® System with modified indications for use is substantially equivalent to the legally marketed predicate device (K134032).
§ 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.