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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the truSculpt iD device, which includes a new 2 cm² RF applicator. The focus of the performance data is on demonstrating the safety and effectiveness of this new applicator for therapeutic heating.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Maintain therapeutic temperatures on the skin surface with the 2 cm² RF applicator	The 2 cm² RF applicator maintained therapeutic temperatures of 40°-45°C on the skin surface.
Maximum skin temperatures do not exceed 45°C during treatment with the 2 cm² RF applicator	Maximum skin temperatures did not exceed 45°C during the course of the treatment with the 2 cm² RF applicator.

2. Sample size used for the test set and the data provenance

Sample Size: 3 human subjects.
Data Provenance: The study was conducted on human subjects, implying a prospective study. The country of origin is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for the skin temperature testing. The criteria for therapeutic temperature (40°-45°C) and maximum safe temperature (45°C) are established medical knowledge for this type of device. The test appears to directly measure these physical parameters.

4. Adjudication method for the test set

Not applicable. The study involved direct measurement of skin temperature, not subjective evaluations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device that performs a therapeutic action, not a software algorithm. The "performance data" refers to the device's physical interaction with human tissue.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this specific performance testing is objective physiological measurements: skin temperature values. The criteria (40°-45°C therapeutic, ≤45°C maximum) are based on established safety and efficacy thresholds for therapeutic heating devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The performance testing is a direct validation of the device's physical characteristics.

9. How the ground truth for the training set was established

Not applicable as there is no training set mentioned or implied for this device.

Summary

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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

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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

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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)

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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 BlvdBrisbane, CA 94005
Contact Person:	Ms. Julia BrownSr. Manager, Regulatory Affairs3240 Bayshore BlvdBrisbane, CA 94005jbrown@cutera.comm. (415) 672-1858o. (415) 657-5575f. (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 PredicateDevice:	truSculpt iD (K221407)
Intended Use:	The truSculpt iD device is intended to generate heat within bodytissues for the treatment of selected medical conditions, such as therelief of minor aches, pain, and muscle spasms; an increase in localcirculation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlideroller is intended to provide temporary reduction in the appearance ofcellulite.
Indications for Use:	The truSculpt RF energy is intended to provide topical heating for thepurpose of elevating tissue temperature for the treatment of selectedmedical conditions, such as relief of pain and muscle spasms andincrease in local circulation.Additionally, the 2 MHz setting for the 40 cm² handpiece is indicatedfor reduction in circumference of the abdomen and non-invasivelipolysis (breakdown of fat) of the abdomen.The truSculpt massage device is intended to provide a temporaryreduction in the appearance of cellulite.
Device Description:	The truSculpt iD device consists of a console, one or more RFhandpieces that connect to the console with umbilical cables, and atruGlide massage roller. All system functions are controlled throughthe console. The handpieces deliver RF energy to generate aheating profile that produces a moderate temperature rise in thesubcutaneous tissue, while monitoring epidermal temperature. ThetruGlide is a separate mechanical roller that can be used as amassager.
Summary ofTechnologicalCharacteristics:	The modified truSculpt iD device has similar technologicalcharacteristics as the existing truSculpt iD device (K221407). Bothdevices comprise a console and RF applicators. The consoles forboth devices consist of a mechanical enclosure, an RF generator,control electronics, a touchscreen user interface, and a controlmicroprocessor.The modified truSculpt iD device includes a new 2 cm² RF applicator.The RF applicators of the modified and existing truSculpt iD devicesare constructed of the same materials and have similar functionalfeatures and capabilities.The modified truSculpt iD device heats tissue through delivery of RFenergy at 1 MHz and 2 MHz, which is identical to the existingtruSculpt iD device.
Performance Data:	• Skin temperature testing on 3 human subjects to demonstrate thatthe 2 cm² RF applicator can maintain therapeutic temperatures of40°-45°C on the skin surface and that skin temperatures do notexceed 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

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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 sensingactive control	Yes	Yes
Treatment activation	Control screen button orfingerswitch	Control screen button orfingerswitch
Area treated	Handheld: 2-40 cm²Hands-free: 40-240 cm²	Handheld: 16-40 cm²Hands-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 patientdecals (for hands-freehandpieces)• Silicone for cummerbund (forhands-free handpieces)• Hydrogel for neutral electrodepads• Stainless steel for massage roller	• Polyvinylidene fluoride (PVDF)for handheld handpieces• Liquid resin adhesive for patientdecals (for hands-freehandpieces)• Silicone for cummerbund (forhands-free handpieces)• Hydrogel for neutral electrodepads• Stainless steel for massage roller
Attachment of hands-free handpieces topatient	Adhesive patient decals andcummerbund	Adhesive patient decals andcummerbund

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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.

Regulation Number and Section

§ 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.