(58 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RF energy delivery and temperature monitoring, with no mention of AI/ML capabilities.
Yes
The device is intended for the treatment of selected medical conditions such as pain relief, muscle spasm relief, and increased local circulation, which are therapeutic applications.
No
The intended uses described are for treatment (relief of aches/pain, reduction in circumference/lipolysis, cellulite reduction) and not for diagnosing medical conditions. The device description also focuses on delivering RF energy for heating, which is a therapeutic action.
No
The device description explicitly mentions hardware components such as a console, RF handpieces, umbilical cables, and a truGlide massage roller. It also describes the delivery of RF energy and monitoring of epidermal temperature, which are hardware-dependent functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The truSculpt iD device uses radiofrequency (RF) energy and massage to generate heat within body tissues for therapeutic purposes (pain relief, circulation, fat reduction, cellulite reduction). It acts directly on the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to apply energy and massage externally or topically.
Therefore, the truSculpt iD device falls under the category of therapeutic devices, not in vitro diagnostics.
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 and muscle spasms and increase in local circulation.
Additionally, the 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) 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)
GEI, PBX
Device Description
The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, 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. The truGlide 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance Data: IEC 60601-1/A1:2012 Medical Electrical Equipment – Part 1: General Requirements for Safety IEC 60601-2-2:2009 Medical Electrical Equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-1-6:2010/A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests Software Verification and Validation Testing Biocompatibility testing of patient-contact materials according to ISO-10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process Skin temperature testing on 3 human subjects to demonstrate the skin temperatures do not exceed 45°C during the course of the treatment
Clinical Data: None
Performance data demonstrates that any differences between the truSculpt iD and its predicate devices do not raise new safety or effectiveness questions. Skin temperature testing on three subjects further demonstrates that the truSculpt iD device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin and that maximum skin temperatures do not exceed 45°C.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym 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 to the right of the square.
July 13, 2022
Cutera Inc. Mr. Amogh Kothare, M.S. VP Clinical and Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005
Re: K221407
Trade/Device Name: truSculpt iD Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: May 31, 2022 Received: June 2, 2022
Dear Mr. Kothare:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221407
Device Name truSculpt iD
Indications for Use (Describe)
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 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) 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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3
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: | Mr. Amogh Kothare, MS |
| VP Clinical and Regulatory Affairs | |
| 3240 Bayshore Blvd | |
| Brisbane, CA 94005 | |
| akothare@cutera.com | |
| m. (415) 690-6796 | |
| o. (415) 657-5730 | |
| f. (415) 715-3730 | |
| Preparation Date: | July 12, 2022 |
| Device Trade Name: | truSculpt iD |
| Common Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| GEI, PBX, 21 CFR 878.4400 | |
| Primary Predicate | |
| Device: | truSculpt RF Device (K172004) |
| Secondary | |
| Predicate Device: | truSculpt RF Device; truSculpt; truSculpt 3D (K180709) |
| Intended Use: | The truSculpt iD device 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; a reduction in circumference of the abdomen; and non- | |
| invasive lipolysis (breakdown of fat) of the abdomen. The truGlide | |
| roller is 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 reduction in circumference of the abdomen and non-invasive
lipolysis (breakdown of fat) of the abdomen.
The truSculpt massage device is intended to provide a temporary
reduction in the appearance of cellulite. |
| Device Description: | The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, 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. The truGlide is a separate mechanical roller that can be used as a massager. |
| Summary of
Technological
Characteristics: | The truSculpt iD device has similar technological characteristics as the primary and secondary predicate devices. The truSculpt RF Device, truSculpt, truSculpt 3D, and truSculpt iD are all comprised of a console and RF applicators. The consoles for all devices consist of a mechanical enclosure, an RF generator, control electronics, a touchscreen user interface, and a control microprocessor.
The shape and dimensions of the truSculpt iD RF handpieces are identical to those of the primary predicate device. The handpieces are now held in place by adhesive decals and a silicone belt, which are manufactured from biocompatible materials.
The truSculpt iD device heats tissue through delivery of RF energy at 1 MHz and 2 MHz, which is identical to the primary and secondary predicate devices. |
| Performance Data: | IEC 60601-1/A1:2012 Medical Electrical Equipment – Part 1: General Requirements for Safety IEC 60601-2-2:2009 Medical Electrical Equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-1-6:2010/A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests Software Verification and Validation Testing Biocompatibility testing of patient-contact materials according to ISO-10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process Skin temperature testing on 3 human subjects to demonstrate the skin temperatures do not exceed 45°C during the course of the treatment |
| Clinical Data: | None |
4
5
Technical Comparison to Predicate Devices:
| | truSculpt iD Device
(current submission) | Primary Predicate Device
Cutera truSculpt RF Device
(K172004) | Secondary Predicate Device
Cutera truSculpt RF Device
(K180709) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Energy type | Radiofrequency | Radiofrequency | Radiofrequency |
| Massage | Yes | Yes | Yes |
| Temperature sensing | Yes | Yes | Yes |
| Temperature sensing
active control | Yes | Yes | Yes |
| Treatment activation | Control screen button or fingerswitch | Control screen button or fingerswitch | Fingerswitch |
| Area treated | Handheld: 16 and 40 cm²
Hands-free: 40 to 240 cm² | Handheld: 16 and 40 cm²
Hands-free: 40 to 240 cm² | Handheld: 16 and 40 cm² |
| Electrode shape | Square or Rectangle | Square or Rectangle | Square or Rectangle |
| RF frequency | 1 MHz and 2 MHz | 1 MHz and 2 MHz | 1 MHz and 2 MHz |
| RF type | Bipolar/Monopolar | Bipolar/Monopolar | Bipolar/Monopolar |
| Max RF power | 300 W | 300 W | 300 W |
| Patient contact
material | · Polyvinylidene fluoride (PVDF) for
handheld handpieces
· Liquid resin adhesive for patient
decals (for hands-free handpieces)
· Silicone for cummerbund (for hands-
free handpieces)
• Hydrogel for neutral electrode pads
· Stainless steel for massage roller | · Polyethylene (3M Tegaderm) for
handheld and hands-free
handpieces
• Hydrogel for neutral electrode pads
· Stainless steel for massage roller | · Polyethylene (3M Tegaderm) for
handheld handpieces
· Hydrogel for neutral electrode pads
· Stainless steel for massage roller |
| Attachment of hands-
free handpieces to
patient | Adhesive patient decals and
cummerbund | Cloth belt | Not Applicable |
6
The truSculpt iD device has equivalent technological characteristics and Conclusion: principles of operation as the primary and secondary predicate devices.
Performance data demonstrates that any differences between the truSculpt iD and its predicate devices do not raise new safety or effectiveness questions. Skin temperature testing on three subjects further demonstrates that the truSculpt iD device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin and that maximum skin temperatures do not exceed 45°C.
The truSculpt iD device is substantially equivalent to the predicate devices.