(92 days)
Not Found
No
The summary describes a radiofrequency (RF) energy device and a mechanical massager, with no mention of AI, ML, image processing, or data training/testing sets typically associated with AI/ML technologies.
Yes
The device is intended for the treatment of selected medical conditions such as pain relief, muscle spasms, and increased local circulation, which are therapeutic purposes.
No
The device's intended use and indications for use describe therapeutic functions (topical heating for pain relief, muscle spasms, circulation, temporary reduction in circumference, and temporary reduction in cellulite appearance), not diagnostic ones.
No
The device description explicitly states it consists of a console, RF handpieces, an umbilical cable, and a mechanical roller, indicating it is a hardware-based device that utilizes RF energy and mechanical massage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that applies RF energy and massage to the body for therapeutic and aesthetic purposes (pain relief, muscle spasms, circulation, circumference reduction, cellulite reduction). This involves direct interaction with the patient's body.
- Device Description: The device description details a console, handpieces that deliver RF energy, and a mechanical roller. These are all components used for external application to the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological samples.
The truSculpt device is a therapeutic and aesthetic device that uses physical energy (RF and mechanical massage) applied to the body.
N/A
Intended Use / Indications for Use
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tor the treatment of selected medical conditions, such as relief of pain and mcrease in local circulation.
Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and flank regions
Indicated Patient Age Range
24 to 60 years of age (inclusive)
Intended User / Care Setting
Not Found
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)
Study Type: Prospective, randomized, controlled, single-center study
Sample Size: 70 subjects enrolled (47 in Treatment group and 23 in Sham group). Sixty-nine subjects completed the study with 1 subject lost to follow-up from the treatment group.
Key Results:
Efficacy: Subjects in the Treatment group demonstrated a statistically significant reduction in circumference of 1.9 cm (Fisher's exact test, two-tailed, p
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/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" around the perimeter. Inside the circle is an image of a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Cutera, Inc. Bradley Renton, Ph.D. Vice President, Regulatory and Medical Affairs, & Compliance Officer 3240 Bayshore Blvd. Brisbane, California 94005
Re: K162512
Trade/Device Name: TruSculpt Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: September 7, 2016 Received: September 8, 2016
Dear Dr. Renton:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -A 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) K162512
Device Name truSculpt
Indications for Use (Describe)
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tor the treatment of selected medical conditions, such as relief of pain and mcrease in local circulation.
Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
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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Section 5 510(K) Summary
This 510(K) Summary of safety and effectiveness for the truSculpt RF device is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Cutera, Inc. |
|---|---|
| Address: | 3240 Bayshore Blvd. |
| Brisbane, CA 94005 | |
| Contact Person: | Bradley Renton |
| Telephone: | 415-657-5568 - phone |
| 415-715-3568 - fax | |
| brenton@cutera.com | |
| Preparation Date: | December 6, 2016 |
| Device Trade Name: | truSculpt |
| Common Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, PBX, |
| 21 CFR 878.4400 | |
| Legally Marketed | |
| Predicate Devices: | Cutera truSculpt RF Device (K133739) |
| BTL XP1000 RF (K143559) | |
| Syneron Transcend (K120510) | |
| Device Description: | The truSculpt device consists of a console, one or more RF handpieces |
| that connect to the console with an umbilical cable, and a truGlide | |
| massage roller. All system functions are controlled through the console. | |
| The handpieces deliver RF energy to generate a heating profile that | |
| produces a moderate temperature rise in the subcutaneous tissue, | |
| while monitoring epidermal temperature. In addition, there is a separate | |
| mechanical roller that can be used as a massager. | |
| Intended Use: | The truSculpt is intended to generate heat within body tissues for the |
| treatment of selected medical conditions, such as the relief of minor | |
| aches, pain, and muscle spasms; an increase in local circulation; and | |
| temporary reduction in circumference of the abdomen. It is also | |
| intended to provide temporary reduction in the appearance of cellulite. | |
| Indications for Use: | The truSculpt RF energy is intended to provide topical heating for the |
| purpose of elevating tissue temperature for the treatment of selected | |
| medical conditions, such as relief of pain and muscle spasms and | |
| increase in local circulation. | |
| Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for | |
| temporary reduction in circumference of the abdomen. | |
| The truSculpt massage device is intended to provide a temporary | |
| reduction in the appearance of cellulite. | |
| Non Clinical | |
| Performance Data: | The truSculpt was successfully tested to the following standards in |
| entirety and there were no exceptions: |
IEC 60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety (Edition 3.0, 2005 + CORR. 1:2006 + CORR.
2:2007)
IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General
Requirements for Safety - Collateral Standard: Electromagnetic
Compatibility (Edition 3, 2007)
truSculpt Software Verification and Validation Testing Report:
This document describes the specific tests that were used to verify and
validate the software used in the truSculpt system. Testing included
verification of correct Startup/Flash Screens, Operating Screens and
screen selection; Software Version confirmation; Checksum verification;
clearing of log files; Frequency verification for all handpieces and
operating modes; correct function of displays and indicators; correct
function of controls, buttons, and inputs; temperature limits; treatment
countdown indicator; calibrated delivery; screen data accuracy; date
and time entry; data pop-up screens; error conditions; induced fault
conditions; Shot and Error log capture and printing; and anomalies, if
any, encountered during testing. No anomalies were encountered
during testing. |
| Substantial
Equivalence
Comparison: | The truSculpt RF device that is the subject of this submission has the
same indications for use as the previously cleared truSculpt RF device,
with the exception of the addition of a new indication for use that is
identical to the cleared indication for use for the BTL XP1000 RF and
Syneron Transcend.
For the requested indication for use, the subject device uses
radiofrequency energy, which is the same energy type used by the BTL
XP1000 RF, and Syneron Transcend; uses temperature sensing, which
is the same as the BTL XP1000 RF and Syneron Transcend; treats an
area of 40 cm², which is in between the areas treated for the BTL
XP1000 RF (201 cm²) and the Syneron Transcend (1.3, 7.5, and 12.5
cm²); and uses a RF frequency of 2 MHz, which is between the 1 MHz
operating frequency of the Syneron Transcend and the 27.12 MHz
operating frequency of the BTL XP1000 RF. See Table 5A - Technical
Specification Comparison below.
To ensure the technology differences between the subject device and
the predicate devices for the same indication for use did not raise any
new questions of safety or efficacy a clinical trial was conducted. |
| Clinical Performance
Data: | An IRB-approved single-center, controlled, randomized, pivotal study
was conducted to evaluate the safety and efficacy of treatment with the
Cutera truSculpt RF device for circumferential reduction in the
abdominal and flank regions using the 2 MHz frequency. Seventy
subjects were enrolled and treated in this study, with 47 subjects in the |
| Study Design | Prospective, randomized, controlled, single-center study |
| Sample Size | 70 subjects enrolled (47 in Treatment group and 23 in Sham group) |
| Main Criteria for Inclusion | Male or female, 24 to 60 years of age (inclusive); Fitzpatrick Skin Type I – VI; has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region; has a Body Mass Index (BMI) ≥ 20 and ≤ 30 |
| Follow-up Intervals | 4 and 12 weeks post-treatment |
| Endpoints | |
| | Primary
Difference in circumferential measurement related
to Sham and Treatment groups at 12 weeks post- treatment |
| | Secondary Subject assessment of improvement at 12 weeks post-treatment Subject satisfaction level at 12 weeks post-treatment Subject discomfort and pain levels during treatment |
| | Safety
Incidence and severity of adverse device effects
during the study period, including subject pain
level at follow-up visits |
| Summary
Results | Efficacy Subjects in the Treatment group demonstrated
a statistically significant reduction in
circumference of 1.9 cm (Fisher's exact test, two-tailed, p