(89 days)
Not Found
No
The document describes a standard electrosurgical unit and does not mention any AI or ML components or functionalities.
Yes
The device is used for electrocoagulation and hemostasis in surgical procedures, which are therapeutic interventions. Its predicate device, Thermage FLX System (K170758), is also recognized as a therapeutic device.
No
Explanation: The device is described as an electrocoagulation and hemostasis unit used in surgical procedures, which are therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components including a main body, handpiece, electrodes, return pad connector, coupling fluid, cooling gas, power cable, and foot switch. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis" in dermatologic and general surgical procedures. This involves directly treating tissue on the patient's body.
- Device Description: The device description explains that it generates heat through electrical resistance in the skin to coagulate tissue. This is a therapeutic action performed on the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or conditions. This device is used for surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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)
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.
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 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"
1
(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
2
Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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4
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: +82-2-538-9140 | |
| Email: 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 Coagulation |
| Device And Accessories | |
| Classification Name: | Electrosurgical Cutting And Coagulation |
| Device 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 Device
K170758 |
|-------------------|-----------------|-------------------------------------|
| 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:
5
10THERMA
| Classification Name | Electrosurgical Cutting And
Coagulation Device And
Accessories | Electrosurgical Cutting And
Coagulation Device And
Accessories |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| Indications for Use | 10THERMA indicated for use in
dermatologic and general surgical
procedures for electrocoagulation
and hemostasis. | The radiofrequency-energy only
delivery components of the
Thermage FLX System are
indicated for use in:
• Dermatologic and general
surgical procedures for
electrocoagulation 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 Technology
for user interaction and
controls | LCD / Touchscreen Technology
for user interaction and
controls |
510(k) Summary
5.4 Device Description
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.
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 |
|---|---|
| -------------------- | ---------------- |
6
10THERMA
510(k) Summary
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance -Collateral standard:
Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability |
| IEC 60601-2-2 | 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 62366-1 | Medical devices — Part 1: Application of usability engineering to
medical 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 and |
| testing within a risk management process | |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization | |
| ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests tor |
| irritation |
5.6.4. Risk Analysis
| Standard (Edition) | Standard title |
|---|---|
| ISO 14971 | Medical devices - Application of risk management to medical |
| devices. |
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.
7
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.