(90 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on radiofrequency energy delivery and control.
Yes
The device is intended for use in dermatologic procedures for "electrocoagulation and hemostasis of soft tissue," which are therapeutic actions to treat or manage a condition.
No
The device is described as a therapy system for electrocoagulation and hemostasis of soft tissue, indicating a treatment function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a console, handpieces, treatment tips, and accessories like a return pad and footswitch. While software verification and validation are mentioned, the device is clearly a hardware system with integrated software, not a software-only device.
Based on the provided information, the Volnewmer™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a noninvasive monopolar radiofrequency therapy system that delivers energy to the patient's tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to apply energy to tissue for therapeutic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Volnewmer™ does not fit this description.
N/A
Intended Use / Indications for Use
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.
Product codes
GEI
Device Description
Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.
Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
Volnewmer™ consists of the following components:
- Console ●
- . Handpiece x2
- Treatment Tips ●
- Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -
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)
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device.
EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-1-2 Edition 4.0 and IEC 60601-2-2 Edition 6.0
Thermal Effect & Safety In-Vivo Test were conducted for evaluating the safety and performance profile of the subject device. The test results support the substantial equivalence.
Bench testing was performed to ensure that the subject device performs as intended and meets design specifications.
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued on September 8, 2023) to demonstrate biocompatibility of the patient-contacting components of the device.
Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued on June 14, 2023). The software documentation level for the subject device is considered as 'Enhanced Documentation'.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
April 29, 2024
Classys Inc. James Hoon Lim Regulatory Affairs Team Manager, Classys Inc. 208 Teheran-ro. Gangnam-gu Seoul. 06220 Korea, South
Re: K240248
Trade/Device Name: Volnewmer™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 30, 2024 Received: January 30, 2024
Dear James Hoon Lim:
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" (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).
1
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: 2024.04.29 09:23:20 -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 Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Volnewmer TM
Indications for Use (Describe)
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.
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)
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
The assigned 510(k) Number: K240248
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- Name: CLASSYS Inc.
- . Address: 208 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea
- . Postal Code: 06220
- General Telephone: +82-2-1544-3481 .
Contact Person:
- Contact Person: Mr. James Hoon Lim (RA Team Manager, Classys)
- Tel: +82-10-3351-1414
- Email: h.lim@classys.com
2. Date of the summary prepared: April 25, 2024
3. Subject Device Information
- Type of 510(k): Traditional ●
- Trade Name: Volnewmer™ ●
- Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
- Common Name: Radio Frequency Therapy System ●
- Review Panel: General & Plastic Surgery ●
- Product Code: GEI ●
- Regulation: 21 CFR 878.4400 ●
- . Regulatory Class: Class II
4. Predicate Device Information
- 510(k) Number: K170758
- 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 ●
- Manufacturer: Solta Medical, Inc.
4
5. Reference Device Information
- . 510(k) Number: K211562
- Trade/Device Name: Virtue RF ●
- Regulation Number: 21 CFR 878.4400 .
- Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
- Regulatory Class: Class II ●
- . Product Code: GEI
- Manufacturer: ShenB Co., Ltd. .
6. Device Description
Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.
- . Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
- Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
- . Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
Volnewmer™ consists of the following components:
- Console ●
- . Handpiece x2
- Treatment Tips ●
- Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -
7. Indications for Use
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.
8. Comparison to Predicate Device
The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
5
| K240248 | Page 3 of 4 | ||
|---|---|---|---|
| Comparison | |||
| Item | Proposed Device, | ||
| VolnewmerTM | Predicate Device, | ||
| Thermage FLX System, | Reference Device, | ||
| Virtue RF | |||
| 510(k) | |||
| Number | K240248 | K170758 | K211562 |
| Trade/Device | |||
| Name | VolnewmerTM | Thermage FLX System | Virtue RF |
| Regulation | |||
| Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation | |||
| Name | Electrosurgical Cutting and | ||
| Coagulation Device and | |||
| Accessories | Electrosurgical Cutting and | ||
| Coagulation Device and | |||
| Accessories | Electrosurgical Cutting and | ||
| Coagulation Device and | |||
| Accessories | |||
| Regulatory | |||
| Class | Class II | Class II | Class II |
| Product Code | GEI | GEI, ISA | GEI |
| Manufacture | |||
| r | CLASSYS INC., Inc. | Solta Medical, Inc. | ShenB Co., Ltd. |
| Indication | |||
| For Use / | |||
| Intended Use | Dermatologic procedures for | ||
| electrocoagulation and | |||
| hemostasis of soft tissue. | Dermatologic and general | ||
| surgical procedures for | |||
| electrocoagulation and | |||
| hemostasis of soft tissue. | The Virtue RF System is | ||
| intended for use in | |||
| dermatologic and general | |||
| surgical procedures for | |||
| electrocoagulation and | |||
| hemostasis. | |||
| Output | |||
| Frequency | 6.78MHz | 6.78MHz | 0.5 MHz ~ 2 MHz |
| Max Output | |||
| Power | 115 W | 400 W | 220 W |
| User | |||
| Interface | LCD Touchscreen | ||
| Technology for user | |||
| interaction and controls. | LCD Touchscreen | ||
| Technology for user | |||
| interaction and controls. | LCD Touchscreen | ||
| Technology for user | |||
| interaction and controls. | |||
| Tip | |||
| Specification | • 0.25 cm2 | ||
| • 3 cm2 | |||
| • 4 cm2 | |||
| • 16 cm2 | • 0.25 cm2 | ||
| • 3 cm2 | |||
| • 4 cm2 | |||
| • 16 cm2 | • 2.78 cm2 / 36pin | ||
| • 3.12 cm2 / 12pin | |||
| • 6 cm2 / 36pin | |||
| Cooling | |||
| Mechanism | Water cooling system | R-134A Cryogen Gas | |
| Cooling | Water cooling system |
6
9. Summary of Non-Clinical Testing
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device.
EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-1-2 Edition 4.0 and IEC 60601-2-2 Edition 6.0
Thermal Effect & Safety In-Vivo Test were conducted for evaluating the safety and performance profile of the subject device. The test results support the substantial equivalence.
Bench testing was performed to ensure that the subject device performs as intended and meets design specifications.
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued on September 8, 2023) to demonstrate biocompatibility of the patient-contacting components of the device.
Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued on June 14, 2023). The software documentation level for the subject device is considered as 'Enhanced Documentation'.
11. Conclusion
The Volnewmer™ shares the same indications for use, fundamental scientific technology, design and functional features. Non-clinical test results demonstrate that the Volnewmer™ safety and performance are substantially equivalent to the predicate device for the requested indications for use.