(99 days)
Not Found
No
The summary describes a standard radio frequency therapy system with no mention of AI or ML capabilities, image processing, or data training/testing.
Yes
The device is described as a radio frequency therapy system intended for electrocoagulation and hemostasis of soft tissue, which are therapeutic actions.
No
Explanation: The device is intended for electrocoagulation and hemostasis of soft tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly lists multiple hardware components including a main body, handpiece, cables, tips, cooling gas, coupling fluids, and a power cable.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for electrocoagulation and hemostasis of soft tissue." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a radio frequency therapy system that delivers energy to the patient's tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. "The Oligio" does not fit this description.
N/A
Intended Use / Indications for Use
'The Oligio' is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
'The Oligio' is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 145 W. "The Oligio" consists of a main body including touch LCD monitor, a RF handpiece, return pad cable, non-sterile treatment tips, cooling gas, coupling fluids and a power cable.
'The Oligio' RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. "The Oligio' delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005, AMD1:2012
IEC 60601-2-2:2017 for use in conjunction with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
IEC 60601-1-2:2014
IEC 61000-3-2:2018
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 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" on top and "ADMINISTRATION" on the bottom.
10/13/2022
WON TECH Co., Ltd. Hyun Yoon General Manager 64 Techno 8-ro Yuseong-gu, Daejeon 34028 Korea, South
Re: K221989
Trade/Device Name: The Oligio Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 13, 2022 Received: October 13, 2022
Dear Hyun Yoon:
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
1
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 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
2
Indications for Use
510(k) Number (if known) K221989
Device Name The Oligio
Indications for Use (Describe)
'The Oligio' is intended for use in dermatologic and general surgical 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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
September 13, 2022
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
-
Name of Manufacturer: WON TECH Co., Ltd.
-
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea - Contact Name: Hyun Sik Yoon - Telephone No.: +82-10-6750-5346
-
Fax No.: +82-70-7836-0110
-
Email Address: yoonhs21@wtlaser.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Common name: Radio Frequency Therapy System Trade name: The Oligio
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Electrosurgical Cutting and Coagulation Device and | ||
| Accessories | 878.4400 | GEI |
As stated in 21 CFR, parts 878.4400, this generic types of devices has been classified as Class II.
4
Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray. The logo appears to be for a technology company.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow:
Predicate device
- 510(k) Number: K170758
- Applicant: Solta Medical Inc. ●
- Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
- Trade Name: ● Thermage FLX System
ട്. Description of the Device [21 CFR 807.92(a)(4)]
'The Oligio' is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 145 W. "The Oligio" consists of a main body including touch LCD monitor, a RF handpiece, return pad cable, non-sterile treatment tips, cooling gas, coupling fluids and a power cable.
'The Oligio' RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. "The Oligio' delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.
Indications for Use [21 CFR 807.92(a)(5)] 6.
'The Oligio' is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis of soft tissue.
5
Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the word "WONTECH" in orange and gray. The "WON" part of the word is in orange, while the "TECH" part is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between The Oligio and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device | SE Decision | |
|---|---|---|---|
| K Number | K221989 | K170758 | - |
| Manufacturer | WON TECH Co., Ltd. | Solta Medical Inc. | - |
| Model | The Oligio | Thermage FLX System | - |
| Intended Use | Dermatologic and general surgical | ||
| procedures for electrocoagulation | |||
| and hemostasis of soft tissue. | Dermatologic and general surgical | ||
| procedures for electrocoagulation | |||
| and hemostasis. | Same | ||
| Principle/Method of | |||
| Operation | 'The Oligio' RF System delivers | ||
| radio frequency energy for selective | |||
| coagulation of tissue while | |||
| conductively cooling the epidermis. | |||
| 'The Oligio' delivers energy form | |||
| the disposable tip to the patient, and | |||
| employs radio frequency turning to | |||
| provide radio frequency energy | |||
| across a range of impedances for | |||
| delivery to the patient through the | |||
| tip. | The Thermage FLX System | ||
| delivers RF energy for selective | |||
| coagulation of tissue while | |||
| conductively cooling the epidermis. | |||
| The Thermage FLX System | |||
| delivers energy from the disposable | |||
| tip to the patient. The System and its | |||
| Handpiece monitor skin contact | |||
| during treatment. The System | |||
| employs RF tuning to provide RF | |||
| energy across a range of | |||
| impedances for delivery to the | |||
| patient through single and multiple | |||
| pass stamping motions of the tip. | Same | ||
| Output frequency | 6.78MHz ± 1% | 6.78MHz | Same |
| Max output power | 145 W | 400 W | Different |
| Different - Max output power | |||
| The Max output power for proposed device is different from the predicate devices. However, the Max output power | |||
| of the proposed The Oligio is covered by the range of the Max output power of the predicate device. Therefore, this | |||
| difference does not affect substantially equivalence on safety and effectiveness. | |||
| Mode of Operation | Manual or footswitch | Manual or footswitch | Same |
6
Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Standard
| (Edition) | Standard Title |
|---|---|
| IEC 60601-1:2005, | |
| AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-2-2:2017 for use in | |
| conjunction with IEC 60601- | |
| 1:2005, IEC 60601- | |
| 1:2005/AMD1:2012 | 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 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 61000-3-2:2018 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for |
| harmonic current emissions (equipment input current ≤16 A per phase) |
2) Software Validation
The Oligio contains Basic Documentation Level software. Software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.
3) Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|--------|-------------------------------|--------------------|---------------------------------------|-----------------------|
| RF tip | Polyethylene
terephthalate | Intact Skin | Limited
(