EUSRA RF Electrode

K181249 · Starmed Co., Ltd. · GEI · Sep 4, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181249
• Device Name: EUSRA RF Electrode
• Applicant: Starmed Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

Device Story

EUSRA RF Electrode is a sterile, single-use monopolar electrosurgical accessory; used with VIVA combo RF generator (K163450). Device consists of electrode tip, insulation, handle, and tubing set. Chilled water circulates through an enclosed system within the electrode for cooling; water does not contact patient. Physician operates device during surgical procedures to deliver high-frequency current to target tissue for coagulation/ablation. Exposed tip length is manually adjustable via handle controller. Device benefits patients by providing controlled thermal tissue effects. Grounding pad is required for operation.

Clinical Evidence

No clinical data. Bench testing only. Included drop tests, bending force tests, length control verification, and ex vivo thermal effect studies on liver, kidney, and muscle tissue. Compliance with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and ISO 10993 (biocompatibility) standards confirmed.

Technological Characteristics

Monopolar RF electrode. Materials: stainless steel 304, polyimide, polyether block polyamide copolymer, PTFE. Cooling: closed-loop chilled water. Dimensions: 19 gauge, flexible shaft 1393mm. Adjustable tip exposure. Sterilization: EO. Connectivity: requires compatible RF generator.

Indications for Use

Indicated for coagulation of soft tissue in patients requiring electrosurgical intervention using a compatible radio frequency generator.

Regulatory Classification

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.

Predicate Devices

• Habib EUS RFA 6700 (K150029)

Reference Devices

• VIVA combo RF generator (K163450)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

September 4, 2018

STARmed Co., Ltd. Mr. Jun-Young Jung B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si, 10355 Kr

Re: K181249

Trade/Device Name: EUSRA RF Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: June 21, 2018 Received: June 27, 2018

Dear Mr. 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. 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/ofdocs/ofpmn.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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jennifer R. Stevenson -S3

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K181249

Device Name EUSRA RF Electrode

Indications for Use (Describe)

The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

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

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}------------------------------------------------

# 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)]

06/21/2018

# 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-si,<br>Gyeonggi-do, Republic of Korea |
| Contact Name: | Jun-Young Jung |
| Telephone #: | [phone] |
| Fax #: | [phone] |
| Email: | [e-mail] |
| Registration Number: | 3013557681 |
| Name of Manufacturer: | Same as Sponsor |

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

| Model Name: | EUSRA RF Electrode |
|----------------------|----------------------------------------------------------------|
| Common Name: | Electrosurgical Cutting and Coagulation Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, JOS |
| Device Class: | 2 |

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

| 510(k) Number: | K150029 |
|----------------------|------------------------------------------------|
| Applicant: | EMcision LTD. |
| Model Name: | Habib EUS RFA 6700 |
| Common Name: | Monopolar electrosurgical device |
| Classification Name: | Electrosurgical Cutting and Coagulation device |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, JOS |
| Device Class: | 2 |

{4}------------------------------------------------

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

The EUSRA RF Electrode is a monopolar electrode. The EUSRA RF Electrode is 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 EUSRA RF Electrode consists of the tubing set and grounding pad. The grounding pad is FDA cleared (K163450).

The EUSRA RF Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF 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.

| Model Name | Flexible Length (mm) | Tip Exposure Length (mm) | Gauge |
|------------|----------------------|--------------------------|-------|
| 19-05E | 1393 ± 20 | 05 | 19 |
| 19-07E | 1393 ± 20 | 07 | 19 |
| 19-10E | 1393 ± 20 | 10 | 19 |
| 19-15E | 1393 ± 20 | 15 | 19 |
| 19-20E | 1393 ± 20 | 20 | 19 |

The length of the flexible tube, tip exposures length and diameter of EUSRA RF Electrode are available as in the following table:

The exposed length of the EUSRA RF Electrode can be adjusted by the exposure length controller on the handle.

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

The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

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

The EUSRA RF Electrode consists of an electrode tip, insulation part, handle and tubing. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF 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.

{5}------------------------------------------------

| Parameter | Subject Device | Predicate Device | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 510(k) Number | Unknown | K150029 | |
| Model Name | EUSRA RF Electrode | Habib EUS RFA 6700 | |
| Manufacturer | STARmed Co., Ltd. | EMcision Ltd. | |
| Common Name | Electrosurgical Cutting and<br>Coagulation Accessories | Monopolar electrosurgical<br>device | |
| Classification Name | Electrosurgical Cutting and<br>Coagulation Device and<br>Accessories | Electrosurgical Cutting and<br>Coagulation Device and<br>Accessories | |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | |
| Classification Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | |
| Product Code | GEI, JOS | GEI, JOS | |
| Device Class | Class II | Class II | |
| Intended Use | The EUSRA RF Electrode is<br>indicated for coagulation and<br>ablation of soft tissue when used<br>in conjunction with compatible<br>radio frequency generator. | The habib EUS RFA 6700 is<br>indicated for coagulation and<br>ablation of soft tissue when<br>used in conjuntion with<br>compatible radio frequecny<br>generator. | |
| Energy Used | Radiofrequency | Radiofrequency | |
| Operation Principle | Monopolar | Monopolar | |
| Physical<br>Specificati<br>ons | Tip Length | 5, 7, 10, 15, 20 mm | 20mm |
| | Tip Diameters | 19 Gauge | 19 Gauge, 22 Gauge |
| | Flexible Shaft<br>Length | 1393 mm | 2200 mm |
| Patient Contacting Materials | Stainless Steel 304, Polyimide,<br>Polyether Block Polyamide<br>Copolymer,<br>Stainless Steel 304 and<br>PTFE | Stainless Steel, PTFE | |
| Neutral<br>Electrodes<br>for<br>EUSRA<br>RF<br>Electrode | Conductive or<br>Capacitive | Conductive | |
| | Physical<br>specifications | 187 x 145 (mm) | Not Known |
| | Materials<br>(Conductive area) | Hydrogel | |
| Sterile | EO Sterilization | Gamma Irradiation | |
| Single Use | Single Use | Single Use | |
| Extensible Tip Length | Extensible Tip Length | Not Extensible Tip Length | |

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

{6}------------------------------------------------

When compared to the predicate device (K150029), the EUSRA RF Electrode presented in this submission has the same of the followings:

- Intended Use
- Technological Characteristics
- · Energy Used
- · Operation Principle
- · Sterile
- Single Use

A few differences are as follows

- · Physical Specifications
- · Patient Contacting Materials
- Neutral Electrodes
- · Extensible Tip Length

There is no significant difference between the EUSRA RF Electrode 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.

#### Difference in the electrode length and the flexible shaft length

The difference in the electrode length for the subject device does not affect the efficacy because the subject device utilized the same technology of Monopolar RF with the same purpose. Generally, the efficacy of the device for the intended use is affected by the method of RF delivery, output power and the area of the tip; the difference in the electrode length does not affect these factors. Therefore, the difference in the electrode length does not affect the efficacy of the subject device. Furthermore, the subject device is qualified with electrical safety according to IEC 60601-1, IEC 60601-2-2 and IEC 60601-2-18 and electromagnetic compatibility according to the IEC 60601-1-2.

#### Difference in the tip diameters

The difference in the tip diameters for the subject device affects the area of the ablation, but does not affect the method of RF delivery and output power, which is affected by the efficacy. These factors were taken into account when designing the ex vivo testing (thermal effects on tissue), the results of the test provide that the efficacy of the subject device was not affected. Furthermore, the subject device is qualified with electrical safety according to IEC 60601-2-2 and IEC 60601-2-18 and electromagnetic compatibility according to the IEC 60601-1-2.

#### Difference in the neutral electrode

The subject device is used with a different neutral electrode than the predicate device. However, The neutral electrode is FDA cleared (K163450). Therefore, the difference between the subject device and the predicate device do not raise new safety or effectiveness issues.

{7}------------------------------------------------

#### Difference in the extensible tip length

The ESURA RF Electrode has extendable function that enables the exposure length of to be changed. The exposure length can be adjusted manually by the length controller as the picture below. The performance testing for extensible tip and insulation part was conducted in order to verify the adjustable length for each stage.

Image /page/7/Figure/2 description: The image shows a medical device in different stages of deployment. The first image shows the device in the loading stage, with a green arrow indicating the direction of loading. The second image shows the device deployed to 1cm, the third image shows the device deployed to 5cm, and the fourth image shows the device deployed to 8cm. A pink arrow is above the loading stage.

In addition, the extensible length of the subject device does not affect the method of RF delivery and output power, which is affected by efficacy. These factors were taken into account when designing the ex vivo testing (thermal effects on tissue), the results of the test provide that the efficacy of the subject device was not affected. Furthermore, the subject device is qualified with electrical safety according to IEC 60601-1 and IEC 60601-2-2 and electromagnetic compatibility according to the IEC 60601-1-2.

Due to these identical clauses and high similarities, the ESURA RF Electrode is at least as safe as and as effective as the predicate device. The differences between the subject device and the predicate device do not raise new safety or effectiveness issues as explained above. Based on the electromagnetic compatibility and electrical safety testing, performance testing, and the comparison to predicate device, the ESURA RF Electrode is substantially equivalent to the previously cleared predicate device.

#### 9. Summary of Non-Clinical Data

The non-clinical performance tests were conducted to evaluate the effectiveness and safety of the EUSRA RF Electrode and its equivalence to the predicate device. A drop test, bending force test and length control test were performed to minimize the risks associated with mechanical failure.

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 of activation 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'.

EUSRA RF Electrode complies with the following international and FDA-recognized consensus standards:

{8}------------------------------------------------

| IEC 60601-1: | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance (IEC 60601-1:2005,<br>MOD) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-2: | Medical electrical equipment - Part 2-2: Particular<br>requirements for the safety of high frequency surgical<br>equipment |
| IEC 60601-2-18: | Medical electrical equipment - Part 2-18: Particular<br>requirements for the basic safety and essential performance of<br>endoscopic equipment |
| ISO 10993-1: | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process |
| ISO 10993-5: | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10: | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |
| ISO 10993-11: | Biological evaluation of medical devices - Part 11: Tests for<br>systemic toxicity |

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

# 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 device 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, IEC 60601-1, IEC 60601-2-2 and IEC 60601-2-18, ISO 10993-5, ISO 10993-10, ISO 10993-11, bench testing, drop 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.