(31 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 spasms, increased local circulation, reduction in circumference of the abdomen, and non-invasive lipolysis, which are all therapeutic purposes.
No
The device description and intended use indicate that the truSculpt RF energy system is used for therapeutic purposes (topical heating, pain relief, muscle spasms, increased circulation, circumference reduction, lipolysis) and massage, not for diagnosing medical conditions.
No
The device description explicitly mentions hardware components like a console, RF handpieces, umbilical cables, and a massage roller, which are integral to its function.
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 device uses RF energy and massage to treat conditions like pain, muscle spasms, increase circulation, reduce abdominal circumference, and reduce the appearance of cellulite. These are all in vivo treatments, meaning they are applied directly to the living body.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device interacts directly with the patient's tissues.
Therefore, the truSculpt device falls under the category of therapeutic or aesthetic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
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 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.
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)
• Skin temperature testing on 3 human subjects to demonstrate that the 2 cm² RF applicator can maintain therapeutic temperatures of 40°-45°C on the skin surface and that skin temperatures do not exceed 45°C during the course of the treatment
• Software verification and validation testing
Performance data demonstrates that any differences between the modified and existing truSculpt iD devices do not raise new safety or effectiveness questions. Skin temperature testing with the 2 cm2 RF applicator on three human subjects further demonstrates that the modified truSculpt iD device can maintain therapeutic temperatures of 40°-45°C on the skin surface and that maximum skin temperatures do not exceed 45°C.
The addition of the 2 cm² RF applicator only impacts the relief of pain and muscle spasms and increase in local circulation indications. The reduction in circumference and lipolysis indications are achieved through the use of the 2 MHz setting for the 40 cm2 handpiece, and the cellulite indication is achieved through the use of the truSculpt massage device.
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
November 3, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cutera Inc. Julia Brown Sr Manager, Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005
Re: K223110
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: September 30, 2022 Received: October 3, 2022
Dear Julia Brown:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 medical devices and radiation-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) K223110
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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This 510(k) Summary of safety and effectiveness for the truSculpt iD 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: | Ms. Julia Brown |
| Sr. Manager, Regulatory Affairs | |
| 3240 Bayshore Blvd | |
| Brisbane, CA 94005 | |
| jbrown@cutera.com | |
| m. (415) 672-1858 | |
| o. (415) 657-5575 | |
| f. (415) 715-3575 | |
| Preparation Date: | September 30, 2022 |
| Device Trade Name: | truSculpt iD |
| Common Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Codes: | GEI, PBX |
| Primary Predicate | |
| Device: | truSculpt iD (K221407) |
| 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 modified truSculpt iD device has similar technological |
| characteristics as the existing truSculpt iD device (K221407). Both | |
| devices comprise a console and RF applicators. The consoles for | |
| both devices consist of a mechanical enclosure, an RF generator, | |
| control electronics, a touchscreen user interface, and a control | |
| microprocessor. |
The modified truSculpt iD device includes a new 2 cm² RF applicator.
The RF applicators of the modified and existing truSculpt iD devices
are constructed of the same materials and have similar functional
features and capabilities.
The modified truSculpt iD device heats tissue through delivery of RF
energy at 1 MHz and 2 MHz, which is identical to the existing
truSculpt iD device. |
| Performance Data: | • Skin temperature testing on 3 human subjects to demonstrate that
the 2 cm² RF applicator can maintain therapeutic temperatures of
40°-45°C on the skin surface and that skin temperatures do not
exceed 45°C during the course of the treatment
• Software verification and validation testing |
| Clinical Data: | Not applicable; non-clinical performance testing (as provided above)
is sufficient to demonstrate substantial equivalence |
4
5
| Table 5A-Technical Specification Comparison of Modified Device to Existing Device | ||||
|---|---|---|---|---|
| ----------------------------------------------------------------------------------- | -- | -- | -- | -- |
| | Modified truSculpt iD Device
(current submission) | Existing truSculpt iD Device
(K221407) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy type | Radiofrequency | Radiofrequency |
| Massage | Yes | Yes |
| Temperature sensing | Yes | Yes |
| Temperature sensing
active control | Yes | Yes |
| Treatment activation | Control screen button or
fingerswitch | Control screen button or
fingerswitch |
| Area treated | Handheld: 2-40 cm²
Hands-free: 40-240 cm² | Handheld: 16-40 cm²
Hands-free: 40-240 cm² |
| Electrode shape | Square or Rectangle | Square or Rectangle |
| RF frequency | 1 MHz and 2 MHz | 1 MHz and 2 MHz |
| RF type | Bipolar/Monopolar | Bipolar/Monopolar |
| Max RF power | 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 | • 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 |
| Attachment of hands-
free handpieces to
patient | Adhesive patient decals and
cummerbund | Adhesive patient decals and
cummerbund |
6
Conclusion: The modified truSculpt iD device has equivalent technological characteristics and principles of operation as the existing truSculpt iD device (K221407). Cutera performed a detailed risk analysis of the modified device to assess the impact of the changes, and no new risks were identified.
Performance data demonstrates that any differences between the modified and existing truSculpt iD devices do not raise new safety or effectiveness questions. Skin temperature testing with the 2 cm2 RF applicator on three human subjects further demonstrates that the modified truSculpt iD device can maintain therapeutic temperatures of 40°-45°C on the skin surface and that maximum skin temperatures do not exceed 45°C.
The addition of the 2 cm² RF applicator only impacts the relief of pain and muscle spasms and increase in local circulation indications. The reduction in circumference and lipolysis indications are achieved through the use of the 2 MHz setting for the 40 cm2 handpiece, and the cellulite indication is achieved through the use of the truSculpt massage device.
The modified truSculpt iD device is substantially equivalent to the existing truSculpt iD device.