(157 days)
No
The description focuses on the RF energy delivery mechanism and software control for electrocoagulation, with no mention of AI or ML technologies.
No
The device is described for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, which falls under surgical/electrosurgical devices rather than therapeutic devices that treat a disease or condition.
No
The device description clearly states its purpose is for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components, including an electrosurgical unit, handpiece, electrode tips, neutral electrode pad, foot switch, and power cord. While it is software-controlled, it is not a software-only device.
Based on the provided information, the DENSITY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue.
- Device Description: The description details how the device generates and delivers radiofrequency energy to tissue to cause coagulation and hemostasis. This is a physical interaction with the body, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The DENSITY is an electrosurgical device used for therapeutic purposes in surgical procedures.
N/A
Intended Use / Indications for Use
DENSITY 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
The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.
The DENSITY consists of the following components:
•Electrosurgical Unit - Main body
•Handpiece
•6 different electrode tips
•Neutral electrode pad and neutral electrode pad cable, cleared under K201685
•Foot switch
•Power cord
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 performance testing was performed.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
August 14, 2023
Jeisys Medical Inc. % Sanghwa Myung Regulatory Affairs Consultant E&m D-1474, 230, Simin-daero, Dongan-gu Seoul, Gyeonggi-do 14067 Korea, South
Re: K230663
Trade/Device Name: Density Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 14, 2023 Received: July 14, 2023
Dear Sanghwa Myung:
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
1
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 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, Digitally signed Mark by Mark Trumbore - Trumbore - S Date: 2023.08.14 S 14:21:44 -04'00' 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 Ouality Center for Devices and Radiological Health
Enclosure
2
5. Indication for use
See next pages
3
Indications for Use
510(k) Number (if known) K230663
Device Name DENSITY
Indications for Use (Describe)
DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
6. 510(k) Summary
K230663
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter: Jeisys Medical Incorporated 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul, 08501, South Korea Telephone: +82-70-7435-4930 Fax: 82-10-2843-3547 E-mail: brkim@jeisys.com
- Contact Person: E&M Regulatory Affair/Sang Hwa Myung Telephone: +80-70-7807-0550 FAX: +82-31-388-9263 Cellphone: +82-10-4952-6638 E-mail: mshenmc@gmail.com Primary Contact: Sanghwa Myung
Date 510(k) summary Prepared: July 14, 2023
Trade Name: DENSITY
Common Name: Electrosurgical Device Classification: II Product Code: GEI Regulation Numbers: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ Review Panel: General & Plastic Surgery (ODE)
Description of Device:
The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.
The DENSITY consists of the following components:
•Electrosurgical Unit - Main body
5
- •Handpiece
- •6 different electrode tips
- •Neutral electrode pad and neutral electrode pad cable, cleared under K201685
- •Foot switch
- •Power cord
Indication for use:
DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Predicate Device:
| Predicate Devices | K170758
Applicant: Solta Medical, Inc
Trade/Device Name: Thermage FLX System
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting and Coagulation
Device and Accessories
Regulatory Class: Class II
Product Code: GEI, ISA |
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Substantial Equivalence:
Comparison table is as follows.
Table 1: Substantial equivalence comparison
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | Pending | K170758 |
| Manufacturer | Jeisys | So;ta Medical, Inc |
| Trade/Device Name | DENSITY | Thermage FLX System |
| Classification Name | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories | ||
| Indication for use | DENSITY 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 energy type | Radio Frequency | Radio Frequency |
| User interface | Color Touch Panel | Color Touch Panel |
| Operating Frequency | 6.78MHz | 6.78MHz |
| Max Power | 400 W | 400W |
| Electrode tip | 3 types (0.25 cm², 4 cm²) | 4 types (0.25 cm², 3.0 cm², |
6
| 16cm²) | 4 cm², 16cm²) | |
|---|---|---|
| Coolant solution | Cryogen | Cryogen |
| Temperature range | 65~75°C | 65~75°C |
| RF Time | 50 ~ 800 ms | 50 ~ 1000 ms |
| Impedance | 75 - 400 Ω | 75 - 400 Ω |
| Communication to | ||
| generator | LCD touch screen | LCD touch screen |
| Style of electrode tip | Monopolar, Bipolar | Monopolar |
| Number of active | ||
| electrodes per applicator | Number of output patterns |
- I-Tip(Around eye) I, F-
Tip(Face): 1ea - I-Tip II(Around eye), F-
Tip II(Face): 2ea - B-Tip(Body), B-Tip(Body)
II: 4ea | Number of output patterns - EYE Tip 0.25: 1ea
- TOTAL Tip 3.0: 1ea
- NEW TOTAL TIP 4.0: 1ea
- BODY TIP 16.0: 4ea |
| Coolant control
parameters
(valve type; valve
activation, power supply,
solution) | Type of gas: 1234ze
Method of gas control:
Handpiece solenoid
control operation
Mouth valve specifications:
12V
Solenoid valve
specifications:
1.8V 24.8 BAR | Type of gas: 1234ze
Method of gas control:
Handpiece solenoid control
operation
Mouth valve specifications:
12V
Solenoid valve
specifications:
1.8V 24.8 BAR |
- Discussion
- Electrosurgical Unit:
- Operating frequency of 6.78 MHz: same as for the predicate device. ●
- Max power, same as for the predicate device.
- . Electrode tip: our device's tip types are including the predicate device.
- Temperature range: same as for the predicate device.
- o Impedance: same as for the predicate device.
- Coolant solution: same as the reference device.
- 0 Style of electrode tip: Subject device have two type of electrode tip that is monopolar and bipolar. Predicate device is monopolar type. This mode difference should not affect performance or safety.
- 0 Different #1 Subject device and predicate device are divided into types of TIP depending on the area to be applied. This difference does not affect performance or safety.
- 0 Coolant control parameters: DENSITY and predicate devices have the same parameters, but the exact technical specifications are unknown.
There are no significant differences between DENSITY and the predicate devices (K170758) that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics
7
Non-clinical Performance Data:
- -. Basic safety and essential performance of the DENSITY is evaluated in accordance with IEC 60601-1:2005/AMDI:2012
- -. Effect to the device by electromagnetic disturbances is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-2:2014.
- -. 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 60601-2-2
- -. General Requirements for Basic Safety and Essential Performance Collateral Standard: Usability is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-6:2013.
- -. The software for DENSITY is verified and validated in accordance with its moderate level of concern. Software life cycle processes are evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- -. Application of usability engineering to medical devices is evaluated in accordance with IEC 62366:2008 based on Human Factor Engineering
- -. Biocompatibility of DENSITY is documented in the reference of ISO 10993-1:2009, ISO 10993-5:2009, and 10993-10:2010.
Risk Management
A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices
Clinical Data:
No clinical performance testing was performed.
Conclusion
Subject device is substantially equivalent to its predicate devices with same indication for use and technological characteristics. Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device.