(270 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on RF energy and mechanical massage.
Yes
The device is intended to treat selected medical conditions such as pain relief, muscle spasms, and increased local circulation, as well as temporary reduction in the appearance of cellulite. These are all therapeutic purposes.
No
The device's intended uses are topical heating for pain relief, muscle spasm treatment, and increased circulation, as well as temporary reduction of cellulite appearance. These are therapeutic, rather than diagnostic, purposes.
No
The device description clearly outlines hardware components including a console, RF handpieces, umbilical cable, and a mechanical roller (truGlide massage roller).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for therapeutic purposes (relief of pain, muscle spasms, increased circulation, temporary reduction in cellulite appearance) through topical heating and massage. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device delivers RF energy and provides massage. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the truSculpt device, as described, falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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, muscle spasms, and increase in local circulation.
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
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
Not Found
Indicated Patient Age Range
Not Found
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)
Results of Clinical Study: None
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
§ 878.4400 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Cutera Incorporated Dr. Bradley Renton Vice President of Regulatory and Medical Affairs 3240 Bayshore Boulevard Brisbane, California 94005
Re: K133739
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 Dated: June 6, 2014 Received: June 9, 2014
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 (reporting of medical
1
device-related 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.
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/Resourcesfor You/Industry/default.htm. 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 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.
for
Sincerely yours,
David Krause -S
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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Section 4 Indications for Use
510(k) Number (if known): K133739
Device Name: _ truSculpt
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, muscle spasms, and increase in local circulation.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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 |
| Fax: | 415-715-3568 - fax |
| Email: | brenton@cutera.com |
| Preparation Date: | June 6, 2014 |
| 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 | |
| Device: | Cutera truSculpt RF Device (K122389) |
| 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 and pain, muscle spasms, | |
| and an increase in local circulation. It is also intended to | |
| provide temporary reduction in the appearance of cellulite. | |
| Specific Indications: | 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 o | |
| pain, muscle spasms, and increase in local circulation. | |
| The truSculpt massage device is intended to provide a | |
| temporary reduction in the appearance of cellulite. |
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Attachment 5 510(K) Summary
Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility
truSculpt Software Verification and Validation Testing Report (V0005 rN)
Results of Clinical Study: None
Summary of Technological See table below Characteristics:
Conclusion:
Cutera believes that the requested changes are substantially equivalent to the predicate device and do not raise any new issues of safety or effectiveness.
| Feature/Parameter | Current | Cutera truSculpt RF Device (K122389) |
|---|---|---|
| Infrared light | No | Yes (optional); up to 20 W max, 700 – 2000 nm |
| Massage | Yes – as a separate handpiece | Yes – as a separate handpiece |
| Vacuum (suction) | No | Yes |
| Temperature sensing | Yes | Yes |
| Temperature sensing | ||
| active control | Yes | Yes |
| Treatment activation | Fingerswitch | Footswitch |
| Area treated | 16 – 40 cm² | 16 – 40 cm² |
| Electrode shape | Square or Rectangle | Square |
| RF frequency | 300kHz – 50 MHz | 300kHz – 50 MHz |
| RF type | Bipolar / Monopolar | Bipolar / Monopolar |
| Max RF power | 300 W | 300 W |
| Duty cycle | 0 – 100% | 0 – 100% |
| Patient contact | ||
| material | Polyethylene (3M Tegaderm) and 316 SS | Polyethylene (3M Tegaderm) and 316 SS |