The star/VIVA RF Electrodes are a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The star/VIVA RF Electrodes consists of the tubing set, PC pipe, PC plug and grounding pad. The grounding pad is FDA cleared (K163450).

The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. Patient contacting materials of star RF Electrode are stainless steel 304 and polyester, and patient contacting materials of VIVA RF Electrode are stainless steel 304 and polyimide. Cooling of the electrode is provided by chilled water which is pumped the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

The star/VIVA RF Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the star RF Electrode range from 7 cm to 20 cm and VIVA RF Electrode range from 15 cm to 20 cm. The tip exposures available for the star RF Electrode range from 5 mm to 20 mm and VIVA RF Electrode range from 5 mm to 30 mm. The exposed length of the VIVA RF Electrode can be adjusted by the control button on the handle. The diameters available for the star RF Electrode diameters are 17 Gauge. The diameters available for the VIVA RF Electrode diameters are 15 Gauge and 17 Gauge.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the STARmed Co., Ltd. RF Electrodes:

It's important to note that this document is a 510(k) summary for a medical device (RF Electrodes), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study on its performance against specific clinical acceptance criteria. Therefore, the information provided below reflects this context.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific numerical acceptance criteria (e.g., a specific percentage of sensitivity or specificity) for clinical performance. Instead, it demonstrates acceptance primarily through comparative testing against a predicate device and compliance with established international and FDA-recognized consensus standards for safety and biocompatibility.

The "reported device performance" is implicitly that the device performs as safely and effectively as the predicate device and meets the requirements of the listed standards.

Table of Acceptance Criteria (as inferred from the document) and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (as inferred)	Reported Device Performance
Safety - Mechanical	- No mechanical failure after drop test	Met criteria; drop test performed.
	- Withstand bending forces without failure	Met criteria; bending force test performed.
Safety - Electrical	- Proper electric conduction	Met criteria; electric conduction test performed.
	- No short-circuiting	Met criteria; electric conduction test performed.
	- Compliance with IEC 60601-2-2 (sections 101.3)	Met full compliance; standard applied.
	- Compliance with AAMI HF 18 (sections 5.2 and 5.5)	Met full compliance; standard applied.
Safety - Temperature	- Accurate temperature sensing/monitoring	Met criteria; temperature monitoring test performed.
Effectiveness / Thermal Effects	- Demonstrate appropriate width and depth of thermally damaged zone	Met criteria; ex vivo testing performed.
	- Performance comparable to predicate device in tissue ablation	Deemed substantially equivalent to predicate.
Biocompatibility	- No cytotoxicity (ISO 10993-5)	Met full compliance; standard applied.
	- No irritation/skin sensitization (ISO 10993-10)	Met full compliance; standard applied.
	- No systemic toxicity (ISO 10993-11)	Met full compliance; standard applied.
	- Compliance with ISO 10993-1 (risk management process)	Met full compliance; standard applied.
Substantial Equivalence	- Equivalent intended use, technological characteristics, energy, operation principle, sterility, single-use, connector type to predicate.	Achieved; stated to be substantially equivalent.
	- Differences in physical specs/materials do not adversely affect safety/effectiveness.	Demonstrated through testing; stated not to adversely affect use.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in numerical terms for each non-clinical test (e.g., how many electrodes were drop-tested, or how many tissue samples were used for ex vivo testing). The tests are described as types of tests performed (e.g., drop test, bending force test, thermal effects test).
- Data Provenance: The tests are "non-clinical performance tests" and "ex vivo testing." The thermal effects test was performed on liver, kidney, and muscle tissue. The country of origin for the data is implicitly the Republic of Korea, where STARmed Co., Ltd. is based. These are described as retrospective in the sense that they are conducted on manufactured devices/materials in a lab setting, not as part of a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For non-clinical, ex vivo, and bench testing, "ground truth" is typically established by objective measurements and standardized protocols rather than expert consensus on individual cases. For example, for thermal effects, the ground truth would be the objectively measured width and depth of tissue damage.
Adjudication method for the test set:
- This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., imaging reads) to resolve disagreements among experts. The non-clinical tests described here rely on quantitative measurements and compliance with objective standards.
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:
- No MRMC comparative effectiveness study was performed. This is a device (RF electrode) for direct tissue ablation, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm only) performance study was done. This device is an electrosurgical accessory and does not involve an algorithm working independently. It functions in conjunction with an RF generator and is operated by a human.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurements and Compliance with Standards: For the non-clinical tests, the "ground truth" is derived from objective measurements (e.g., physical parameters for drop/bending tests, electrical readings for conduction, temperature measurements, measured dimensions of tissue damage in ex vivo models) and comparison against the quantitative limits and qualitative requirements specified in the international and FDA-recognized consensus standards (IEC 60601-2-2, AAMI HF 18, ISO 10993 series). There is no "pathology" or "outcomes data" in the clinical sense for these validation tests.
The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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March 14, 2018

STARmed Co., Ltd. Jun-Young Jung QMR/Deputy General Manager B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si Gyeonggi-do, Republic of Korea 10355

Re: K172012

Trade/Device Name: Star RF Electrode, VIVA RF Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 9, 2018 Received: February 12, 2018

Dear Jun-Young Jung:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172012

Device Name star RF Electrode, VIVA RF Electrode

Indications for Use (Describe)

star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of 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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

[As required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

06/30/2017

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor:	STARmed Co.,Ltd.
Address:	B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-siGyeonggi-do, Republic of Korea
Contact Name:	Jun-Young Jung
Telephone #:	+82-70-4673-8657
Fax #:	+82-31-816-4546
Email:	jjy3412@starmed4u.com
Registration Number:	3013557681
Name of Manufacturer:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Model Name:	star RF Electrode, VIVA RF Electrode
Common Name:	Electrosurgical Cutting and Coagulation Accessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Device Class:	2
Review Panel:	General and Plastic Surgery

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number:	K163450
Applicant:	STARmed Co.,Ltd.
Model Name:	VIVA combo RF System
Common Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Device Class:	2

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5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a) (5)]

star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

7. Technological Characteristics [21 CFR 807.92(a) (6)]

The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. The electrode tip of star RF Electrode is composed of stainless steel 304 and polyester, and the electrode tip of VIVA RF Electrode is composed of stainless steel 304 and polymide. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

The conductive electrode tip delivers high frequency current onto a target tissue for coagulation and/or ablation during a surgical operation.

The subject device is substantially equivalent to the predicate device in intended use and technological characteristics. There is no significant difference between the star/VIVA RF Electrodes and the predicate device that would adversely affect the use of the product.

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Parameter	Subject Device	Predicate Device
510(k) Number	Unknown	K163450
Model Name	star/VIVA RF Electrodes	star RF Electrodes(17-15s30F, 17-20s30F)
Manufacturer	STARmed Co., Ltd.
Common Name	Electrosurgical Cutting and Coagulation Accessories
Classification Name	Electrosurgical, Cutting & Coagulation & Accessories
Classification Panel	General and Plastic Surgery
Classification Regulation	21 CFR 878.4400
Product Code	GEI
Device Class	Class II
Intended Use	star/VIVA RF Electrode isintended for use in percutaneousand intraoperative coagulationand ablation of tissue.	star RF Electrode isintended for use inpercutaneous andintraoperative coagulationand ablation of tissue.
Energy Used	Radiofrequency	Radiofrequency
Operation Principle	Monopolar	Monopolar
PhysicalSpecifications	Electrode Length(mm)	star RF 70, 150, 200VIVA RF 150, 200	150, 200
	Exposure Length(mm)	star RF 5, 7, 10, 20VIVA RF 5, 10, 15, 20, 25, 30	30
	Diameters(Gauge)	star RF 17, 18VIVA RF 15, 17	17
PatientContactingMaterials	Electrode TipMaterials	Stainless Steel 304	Stainless Steel 304
	Insulation PartMaterials	star RF PolyesterVIVA RF Polyimide	Polyester
NeutralElectrodes	Conductive orCapacitive	Conductive	Conductive
	Physicalspecifications	187 x 145 (mm)	187 x 145 (mm)
	Materials(Conductive area)	Hydrogel	Hydrogel
Sterile		EO Sterilization	EO Sterilization
Single Use		Single Use	Single Use
Parameter	Subject Device	Predicate Device
Connector Type	4 Pin	4 Pin

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

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When compared to the predicate devices (K163450), the star/VIVA RF Electrodes presented in this submission has the same of the followings:

Intended Use
· Technological Characteristics
· Energy Used
· Operation Principle
· Sterile
Single Use
Connector Type

A few differences are as follows

· Physical Specifications
· Patient Contacting Materials (VIVA RF Electrode)

There is no significant difference between the star/VIVA RF Electrodes and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in intended use, technological characteristics, used energy, operation principle, sterile and single use.

Even though the physical specifications and patient contacting materials of the predicate device and the subject device are different, the results of the safety testive electrode (IEC 60601-2-2 and AAMI HF 18), bench testing, ex vivo testing (thermal effects on tissue) and biocompatibility testing proved that the subject devices are substantially equivalent to the predicate device.

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9. Summary of Non-Clinical Data

The non-clinical performance tests were conducted to evaluate the effectiveness and safety of the star/VIVA RF Electrodes and its equivalence to the predicate device. A drop test, bending force test, electric conduction and flow rate test were performed to minimize the risks associated with mechanical failure and short circuiting. The temperature monitoring test was performed to demonstrate that the temperature sensing.

The test on thermal effects was performed to evaluate the width and depth of thermally damaged zone in relation to the tip length, gauge, power setting, and duration for different tissue types. The test was performed on liver, kidney, and muscle tissue according to the FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'.

star/VIVA RF Electrodes comply with the following international and FDA-recognized consensus standards:

IEC 60601-2-2:	Medical electrical equipment - Part 2-2: Particularrequirements for the safety of high frequency surgicalequipment
AAMI HF 18:	Electrosurgical Devices
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 forin vitro cytotoxicity
ISO 10993-10:	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
ISO 10993-11:	Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity

The IEC 60601-2-2 standard only applies to the sections (101.3) and the AAMI HF 18 standard only applies to the sections (5.2 and 5.5) since the subject device only consists of active electrodes.

The non-clinical tests all met the acceptance criteria specified in the standards.

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10. Summary of Clinical Data

No clinical studies were considered necessary and performed.

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

The subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-2-2, AAMI HF 18, ISO 10993-10, ISO 10993-11, ISO 10993-11, bench testing and ex vivo testing (thermal effects on tissue), which complied with the requirements specified in the CDRH's Guidance for Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.

The results of these tests demonstrate that star/VIVA RF Electrodes meet the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.

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.