(8 days)
The Ulthera" System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow.
The Ulthera® System consists of the following components:
● Ulthera® Control Unit
● Handpiece
● Transducers
The Ulthera® System, K122528, is indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow. The submission discusses an accelerated aging study to support the extension of the shelf life for the Ulthera® System Transducers from six months to one year. This study aimed to demonstrate that the transducers would continue to meet performance criteria over the extended shelf life.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain "technological characteristics" over 12 months | Transducers met predetermined acceptance criteria in performance testing after accelerated aging. |
| Maintain "performance criteria" over 12 months | Transducers met predetermined acceptance criteria in performance testing after accelerated aging. |
| No detrimental effect on transducer functionality over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on transducer functionality. |
| No detrimental effect on patient safety over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on patient safety. |
| No detrimental effect on efficacy over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on efficacy. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions an "accelerated aging study (per ASTM Standard F 1980 (2011))" and "performance testing protocol," but does not specify the sample size of transducers tested or the number of units used in the accelerated aging study.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, beyond being a study conducted to support the shelf life extension.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is a technical performance test of the device's shelf life, not a clinical study involving human assessment of ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the relevant study is a technical performance test, not a clinical study requiring human adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided document concerns a shelf life study for device transducers, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a shelf life study for a physical device (transducers), not an algorithm.
7. The Type of Ground Truth Used:
For the shelf-life study, the "ground truth" was the predetermined acceptance criteria identified in the performance testing protocol. These criteria would likely be objective measurements related to the transducers' physical and functional characteristics (e.g., ultrasonic output, structural integrity, electrical performance) that are defined in technical specifications rather than based on expert clinical consensus, pathology, or outcomes data, which are typical for diagnostic or therapeutic efficacy studies.
8. The Sample Size for the Training Set:
Not applicable. The provided information relates to a device's shelf life, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this document does not describe a machine learning study.
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K122528 1/2
AUG 2 8 2012
Attachment 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: | 2150 South Country Club Drive, Suite 21Mesa, AZ 85210 |
| Contact Person: | Suzon Lommel, VP of Regulatory & Quality Affairs |
| Telephone: | 480-649-4069 |
| Fax: | 480-619-4071 |
| Submission Date: | August 17, 2012 |
| Device Trade Name: | Ulthera® System |
| Common Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use |
| Classification: | Regulatory Class II |
| Classification Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use |
| Product Code: | OHV |
| Legally Marketed | Name: Ulthera® System |
| Predicates: | 510(k): #K072505 |
| Applicable Guidance: | The Class II Special Controls Guidance Document: Focused Ultrasound StimulatorSystem for Aesthetic Use was developed in response to Ulthera's DeNovosubmission and 510(k) clearance K072505 for the Ulthera System. |
| Device Description: | The Ulthera® System consists of the following components:● Ulthera® Control Unit● Handpiece● Transducers |
Image /page/0/Picture/6 description: The image shows the word "Ulthera" in a stylized font. The letters are outlined in black, and there are three small circles above the "era" portion of the word. The font appears to be slightly distressed, giving it a textured look.
Attachment 5 - 510(k) Summary
Page | A5 - 1
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08/17/2012
Indications for Use:
The Ulthera" System is indicated for use as a non-invasive dermatological aesthetic treatment to:
. lift the eyebrow
Description of Change:
The proposed change is to extend the current six-month shelf life period to a twelve-month shelf life period for the Ulthera® System Transducers.
Performance Data:
An accelerated aging study (per ASTM Standard F 1980 (2011)) was conducted to support the shelf life extension of the Ulthera® System Transducers from six months to one year. The results from the tests demonstrate that the technological characteristics and performance criteria of the subject device is comparable to the predicate device.
Conclusion:
Based on the design, materials, principle of operation, and intended use, the Ulthera® System is substantially equivalent to the legally marketed predicate i device. The Ulthera System Transducers met the predetermined acceptance criteria identified in the performance testing protocol. The results of the twelve-month shelf life study demonstrate that changing the current six-month shelf life period to a twelve-month shelf life period will have no detrimental effect on transducer Therefore, the predicate device is functionality, patient safety or efficacy. substantially equivalent to the subject device.
Image /page/1/Picture/10 description: The image shows a logo with the word "uthera" in a stylized font. Above the "era" portion of the word, there are three small circles arranged horizontally. The font appears to be outlined, giving it a distinct look. The logo is simple and clean, with a focus on the unique typography of the word.
Attachment 5 - 510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, depicted with flowing lines to represent its wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ulthera, Incorporated % Ms. Suzon Lommel VP of Regulatory & Quality Affairs 2150 South Country Club Drive, Suite 21 Mesa, Arizona 85210
Re: K122528
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 Dated: August 17, 2012 Received: August 20, 2012
Dear Ms. Lommel:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
AUG 28 2012
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Page 2 - Ms. Suzon Lommel
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Attachment 2: Indications for Use Statement
Unknown K122528 510(k) Number:
Device Name: Ulthera® System
Indications for Use:
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow .
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Oslon for mkn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122528
Image /page/4/Picture/14 description: The image shows the word "ulthera" in a stylized font. The letters are tall and thin, with a slightly textured or outlined appearance. Above the "era" portion of the word, there are three solid black circles arranged horizontally. The overall impression is a logo or brand name design.
§ 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.