10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.

The 10THERMA is comprised of a main body with a touch LCD monitor, a handpiece, nonsterile mono-polar electrodes (handpiece tips), return pad connector, coupling fluid, cooling gas (cryogen), a power cable, and a foot switch. Among the consisting items, the mono-polar electrodes, return pads, and coupling fluid are single-use and disposable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the 10THERMA device, which is an Electrosurgical Cutting And Coagulation Device And Accessories.

However, the document states:
"No clinical studies were considered necessary and performed."

Therefore, I cannot provide information on acceptance criteria based on clinical performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth establishment, as these types of studies were explicitly stated as not being performed or necessary for this submission.

The document primarily focuses on non-clinical test summaries to demonstrate substantial equivalence to a predicate device, as detailed below.

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

Since no clinical studies were performed, there are no reported clinical performance metrics directly tied to specific acceptance criteria for device efficacy in human subjects. The acceptance criteria described are primarily against recognized electrical safety, software validation, biocompatibility, and risk management standards.

Acceptance Criteria Category	Standard(s) Met / Compliance
Electrical Safety	IEC 60601-1
	IEC 60601-1-2
	IEC 60601-1-6
	IEC 60601-2-2
	IEC 62366-1
Software Validation	IEC 62304
Biocompatibility	ISO 10993-1
	ISO 10993-5
	ISO 10993-10
	ISO 10993-23
Risk Analysis	ISO 14971

The document states, "The safety and performance of the product were performed. Thus, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices." This implies that the device successfully met the requirements of the listed standards, thereby demonstrating its safety and performance equivalently to the predicate.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies were performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies were performed.

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, as this device is an electrosurgical unit and not an AI-assisted diagnostic tool. No clinical studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is an electrosurgical unit and does not involve an algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies were performed. The "ground truth" for the device's functional integrity was established through compliance with recognized performance and safety standards.

8. The sample size for the training set: Not applicable, as no clinical studies or machine learning components were described.

9. How the ground truth for the training set was established: Not applicable, as no clinical studies or machine learning components were described.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 20, 2023

Tentech Inc. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. 06210 South Korea

Re: K232992

Trade/Device Name: 10therma Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 22, 2023 Received: September 22, 2023

Dear Do Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.12.20

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

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Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K232992

Device Name 10THERMA

Indications for Use (Describe)

10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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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10THERMA 510(k) Summary

5. 510(k) Summary

5.1 General Information

Applicant/Submitter:	Tentech Inc.
Address:	3F, Hyunkyung Building, 611, Seolleung-ro,Gangnam-gu,Seoul, 06103, Republic of Korea
Contact Person:	Do Hyun Kim, BT Solutions, Inc.
Address:	Unit 904, Eonju-ro 86gil 5,Gangnam-gu, Seoul 06210, Korea.Tel: +82-2-538-9140Email: ceo@btsolutions.co.kr
Preparation Date:	September 22, 2023

5.2 Device Name and Code

Device Trade Name:	10THERMA
Model Name:	TMSY02
Common Name:	Electrosurgical Cutting And CoagulationDevice And Accessories
Classification Name:	Electrosurgical Cutting And CoagulationDevice And Accessories
Product Code:	GEI
Regulation Number:	21 CFR 878.4400
Classification:	Class II
Review Panel:	General & Plastic Surgery

5.3 Technical Characteristics in Comparison to Predicate Devices

	Proposed device	Primary Predicate DeviceK170758
Applicant	Tentech Inc.	Solta Medical Inc.
Device Trade Name	10THERMA	Thermage FLX System
K number	N/A	K170758
Product code	GEI	GEI, ISA
Regulation Number	21 CFR 878.4400	21 CFR 878.4400

The 10THERMA, is substantially equivalent to the following legally marketed predicate device:

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10THERMA

Classification Name	Electrosurgical Cutting AndCoagulation Device AndAccessories	Electrosurgical Cutting AndCoagulation Device AndAccessories
Classification	Class II	Class II
Review Panel	General & Plastic Surgery	General & Plastic Surgery
Indications for Use	10THERMA indicated for use indermatologic and general surgicalprocedures for electrocoagulationand hemostasis.	The radiofrequency-energy onlydelivery components of theThermage FLX System areindicated for use in:• Dermatologic and generalsurgical procedures forelectrocoagulation and hemostasis;
Output Frequency	6.78MHz	6.78MHz
Electrode Type	Monopolar	Monopolar
Maximum	400 W	400 W
Average Power
Mode of Operation	Manual or footswitch	Manual or footswitch
User Interface	LCD / Touchscreen Technologyfor user interaction andcontrols	LCD / Touchscreen Technologyfor user interaction andcontrols

510(k) Summary

5.4 Device Description

5.5 Indications / Intended Use

10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

5.6 Non-Clinical Test Summary

No clinical studies were considered necessary and performed. The safety and performance of the product were performed. Thus, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices. Please see below.

5.6.1. Electrical Safety

Standard (Edition)	Standard title
--------------------	----------------

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10THERMA

510(k) Summary

IEC 60601-1	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance.
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard:Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 60601-2-2	Medical electrical equipment - Part 2-2: Particular requirementsfor the basic safety and essential performance of high frequencysurgical equipment and high frequency surgical accessories
IEC 62366-1	Medical devices — Part 1: Application of usability engineering tomedical devices

5.6.2. Software Validation

The 10THERMA is a medical device whose level of concern for software is classified as 'Moderate'. The software verification and validation report are provided.

Standard (Edition)	Standard title
IEC 62304	Medical device software. Software life-cycle processes

5.6.3. Biocompatibility

Standard (Edition)	Standard title
ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process
ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
ISO 10993-23	Biological evaluation of medical devices - Part 23: Tests torirritation

5.6.4. Risk Analysis

Standard (Edition)	Standard title
ISO 14971	Medical devices - Application of risk management to medicaldevices.

5.7 Substantial Equivalence

The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for 10THERMA, Tentech Inc. believes that no significant differences in usage of its underlying technological principles between 10THERMA and the predicate device.

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510(k) Summary

5.8 Conclusions

On the basis of the information provided in this Summary, Tentech Inc. believes that 10THERMA is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.

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.