'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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "The Oligio" by WON TECH Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Thermage FLX System) for regulatory clearance, rather than presenting a detailed clinical study for performance evaluation against specific acceptance criteria for AI or diagnostic accuracy.

Therefore, many of the requested items related to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for a training set, and detailed clinical study results cannot be extracted from this document because the device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic tool, and the submission explicitly states that no clinical studies were considered necessary and performed.

However, I can provide information based on the product's regulatory submission and its comparison to a predicate device.

Here's a breakdown of the information that can and cannot be extracted:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Equivalence Claim):

The "acceptance criteria" here are not diagnostic accuracy metrics, but rather technical specifications that "The Oligio" device had to meet to demonstrate substantial equivalence to its predicate device. The performance is reported in comparison to the predicate.

Acceptance Criteria (Technical Specification)	Reported Device Performance ("The Oligio")	Predicate Device (Thermage FLX System) Performance	SE Decision (vs. Predicate)
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	Delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis; delivers energy from disposable tip to patient; employs RF tuning.	Delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis; delivers energy from disposable tip to patient; monitors skin contact; employs RF tuning.	Same
Output frequency	6.78MHz ± 1%	6.78MHz	Same
Max output power	145 W	400 W	Different (but covered by range, does not affect SE)
Mode of Operation	Manual or footswitch	Manual or footswitch	Same
Electrical Safety	Complies with IEC 60601-1:2005, IEC 60601-2-2:2017, IEC 60601-1-2:2014, IEC 61000-3-2:2018	(Implied compliance for predicate)	Demonstrated compliance
Software Validation	Was designed and developed according to a software development process and was verified and validated. (Basic Documentation Level software)	(Implied compliance for predicate)	Demonstrated compliance
Biocompatibility (RF tip)	Polyethylene terephthalate, Intact Skin, Limited (< 24 hours) contact, Biocompatibility: Yes	(Implied compliance for predicate)	Demonstrated compliance

Information NOT available in the provided text, as this is a regulatory submission for a non-AI electrosurgical device that did not require clinical trials:

Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data is provided. Non-clinical bench tests were performed to verify electrical safety, software, and biocompatibility, but these are not diagnostic test sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic test set or ground truth established by experts is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI-assisted device. The document explicitly states: "No clinical studies were considered necessary and performed."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this medical device's clearance is its technical compliance with standards and its substantial equivalence to a legally marketed predicate device based on similar intended use and technological characteristics, as demonstrated through non-clinical bench testing.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary of Study (Based on Regulatory Submission):

The "study" described is a regulatory submission to the FDA (510(k) premarket notification) to demonstrate substantial equivalence of "The Oligio" device to a predicate device (Thermage FLX System), rather than a clinical trial proving diagnostic accuracy or human performance improvement.

Objective: To demonstrate that "The Oligio" is substantially equivalent to a legally marketed predicate device (Thermage FLX System) for its stated indications for use (dermatologic and general surgical procedures for electrocoagulation and hemostasis of soft tissue).
Methodology:
- Comparative Analysis: A side-by-side comparison of "The Oligio" with the predicate device on various characteristics including intended use, principle of operation, output frequency, maximum output power, and mode of operation.
- Non-Clinical Testing: Bench tests to ensure compliance with electrical safety standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 61000-3-2), software validation (Basic Documentation Level software), and biocompatibility of device components (RF tip material).
Results: The manufacturer concluded that "The Oligio" is substantially equivalent to the predicate device, stating that "There are no significant differences between The Oligio and the predicate devices that would adversely affect the use of the product." The only difference noted (Maximum output power) was deemed not to affect substantial equivalence because the proposed device's power was within an acceptable range relative to the predicate.
Clinical Studies: None were conducted, as stated in the document: "No clinical studies were considered necessary and performed." This is typical for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to a known safe and effective predicate.

Summary

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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

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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

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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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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]

K221989

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 andAccessories	878.4400	GEI

As stated in 21 CFR, parts 878.4400, this generic types of devices has been classified as Class II.

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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)]

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.

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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 surgicalprocedures for electrocoagulationand hemostasis of soft tissue.	Dermatologic and general surgicalprocedures for electrocoagulationand hemostasis.	Same
Principle/Method ofOperation	'The Oligio' RF System deliversradio frequency energy for selectivecoagulation of tissue whileconductively cooling the epidermis.'The Oligio' delivers energy formthe disposable tip to the patient, andemploys radio frequency turning toprovide radio frequency energyacross a range of impedances fordelivery to the patient through thetip.	The Thermage FLX Systemdelivers RF energy for selectivecoagulation of tissue whileconductively cooling the epidermis.The Thermage FLX Systemdelivers energy from the disposabletip to the patient. The System and itsHandpiece monitor skin contactduring treatment. The Systememploys RF tuning to provide RFenergy across a range ofimpedances for delivery to thepatient through single and multiplepass 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 powerThe Max output power for proposed device is different from the predicate devices. However, the Max output powerof the proposed The Oligio is covered by the range of the Max output power of the predicate device. Therefore, thisdifference does not affect substantially equivalence on safety and effectiveness.
Mode of Operation	Manual or footswitch	Manual or footswitch	Same

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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: Generalrequirements for basic safety and essential performance
IEC 60601-2-2:2017 for use inconjunction with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012	Medical electrical equipment - Part 2-2: Particular requirements for thebasic safety and essential performance of high frequency surgicalequipment and high frequency surgical accessories
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests
IEC 61000-3-2:2018	Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits forharmonic 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	PatientContact	Duration of Contactby ISO 10993-1	Bio-compatibility
RF tip	Polyethyleneterephthalate	Intact Skin	Limited(< 24 hours)	Yes

4) Performance Testing

The performance of The Oligio has been defined as follows.

RF output frequency: 6.78MHz ± 1% -
-Max output power: 145 W
Handpiece vibration: Low (30dB), Medium (40dB), High (50dB) -

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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside, followed by the text "WON" in orange and "TECH" in gray. The "W" in the circle is made up of two curved lines that intersect in the middle.

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that The Oligio is substantially equivalent to predicate devices as described herein.

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.