The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

Device Description

The ELRA Electrode is a bipolar electrode. ELRA 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 ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.

The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the non-clinical tests all met the acceptance criteria specified in the standards, and similarly for the clinical trials. However, the specific quantitative acceptance criteria are not detailed in a table format within the provided text. Instead, it refers to compliance with established international and FDA-recognized consensus standards.

Here's an attempt to infer and structure the information:

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Non-Clinical Testing
Mechanical Failure	Minimized risks associated with mechanical failure (evaluated by drop and bending force tests)	Met acceptance criteria (implied by statement that tests "all met the acceptance criteria specified in the standards").
Temperature Sensing Function	Demonstrated function of temperature sensor	Met acceptance criteria (performance testing conducted to demonstrate this function).
Thermal Effects on Tissue	Equivalent ablation performance to predicate device (evaluated by ex vivo testing on width and depth of thermally damaged zones on liver, kidney, and muscle tissue according to FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery').	Substantially equivalent ablation performance to predicate device, meeting acceptance criteria.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-2	Complies with stated standards.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Complies with stated standard.
Biocompatibility	Compliance with ISO 10993 (Parts 1, 5, 10, 11)	Complies with stated standards.
Clinical Testing
Stenting Procedure Success	Successful stent placement	100% success rate in 30 patients.
Device-Related Adverse Events	No direct side effects associated with the device	No major complications identified. Three minor inflammatory reactions noted, but not directly associated with the device.
Safety and Effectiveness	Deemed "safe and effective"	Concluded as safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

The document describes two clinical studies:

Prospective Clinical Trial:
- Sample Size: 30 patients
- Data Provenance: Not explicitly stated, but clinical trial implies prospective data collection. The manufacturer is based in the Republic of Korea, which might suggest the trial was conducted there, but this is not confirmed.
Retrospective Study:
- Sample Size: 10 patients
- Data Provenance: Retrospective study. The patients had malignant biliary hilar duct obstruction. Country of origin not specified, but again, likely related to the manufacturer's location.

For non-clinical tests (e.g., thermal effects): The sample size isn't specified in terms of "cases," but it mentions testing on "liver, kidney, and muscle tissue."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications for either the clinical trials or the non-clinical tests.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in either the clinical or non-clinical studies. The clinical outcomes (stent success, complications) appear to be directly observed or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is an electrosurgical electrode and does not involve AI for interpretation or assistance with human readers. The comparative effectiveness assessment was against a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical electrosurgical electrode, not an AI algorithm. Its performance is intrinsic to its design and how it affects tissue, not based on an algorithm's output. The performance studies detailed are for the device's physical and functional characteristics.

7. The Type of Ground Truth used

Clinical Trials: The ground truth appears to be based on direct clinical outcomes (successful stent placement, incidence of complications, absence of direct device-related side effects). This aligns with outcomes data.
Non-Clinical (Thermal Effects): The ground truth was based on objective measurements of "width and depth of thermally damaged zone" in tissue samples. This is a form of objective measurement/pathology-like assessment on ex vivo tissue samples.
Non-Clinical (Safety & Biocompatibility): Ground truth is established by adherence to and successful completion of tests outlined in international consensus standards (e.g., IEC 60601-1, ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable as the ELRA Electrode is a hardware medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 11, 2019

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

Re: K181758

Trade/Device Name: ELRA Electrode Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: March 11, 2019 Received: March 13, 2019

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. 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

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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 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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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).

Sincerelv.

Shanil P. Haugen -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181758

Device Name ELRA Electrode

Indications for Use (Describe)

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

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)]

03/11/2019

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:	STARmed Co.,Ltd.

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

Trade Name: ELRA Electrode
Common Name: Endoscopic Electosurgical Unit
Classification Name: Endoscopic Electrosurgical Unit and Accessories
Regulation Number: 21 CFR 876.4300
Product Code: KNS
Device Class: II

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

510(k) Number:	K180165
Applicant:	EMcision LTD.
Trade Name:	Habib EndoHPB
Common Name:	Endoscopic Electrosurgical Unit
Classification Name:	Endoscopic Electrosurgical Unit and Accessories
Regulation Number:	21 CFR 876.4300
Product Code:	KNS
Device Class:	II

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

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

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

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

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 ELRA Electrode and the predicate device that would adversely affect the use of the product.

Parameter	Subject Device	Predicate Device
510(k) Number	K181758	K180165
Trade Name	ELRA Electrode	Habib EndoHPB
Manufacturer	STARmed Co., Ltd.	EMcision LTD.
Common Name	Endoscopic Electrosurgical Unit	Endoscopic Electrosurgical Unit
Classification Name	Endoscopic Electrosurgical Unitand Accessories	Endoscopic Electrosurgical Unitand Accessories
Parameter	Subject Device	Predicate Device
Classification Panel	Gastroenterology and Urology	Gastroenterology and Urology
Classification Regulation	21 CFR 876.4300	21 CFR 876.4300
Product Code	KNS	KNS
Device Class	Class II
Intended Use	The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.	The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete the ablation of tissue in the pancreatic and biliary tracts. The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
Energy Used	Radiofrequency	Radiofrequency
Operation Principle	Bipolar	Bipolar
PhysicalSpecifications	Tip Length	11, 18, 22, 33 mm	Two 8 mm electrodes
	Tip Diameters	7 French	2.7 mm (8 French)
	Flexible Shaft Length	400, 1750 mm	1800 mm
	Electrode exposed sites	2 part(active electrode: 1/return electrode: 1)4 part(active electrode: 2/return electrode: 2)	2 part(active electrode: 1/return electrode: 1)
Patient Contacting Materials	Stainless Steel 304, Teflon-ETFE,UV adhesive, Nylon,PEEK, and Polyether Block Amides	Stainless Steel, Pebax & Stainless Steel
Sterile	EO Sterilization	EO Sterilization
Single Use	Single Use	Single Use
Temperature Sensor	Available	Not Known
Parameter	Subject Device	Predicate Device
Electrical Safety	IEC 60601-1IEC 60601-2-2	IEC 60601-1IEC 60601-2-2
Performance	Conduction	Conduct electricity between circuits	Conduct electricity between circuits
	Impedance	within 5Ω	within 5Ω
	Short-circuit	Active Tip and Receive Tip are short-circuited	Active Tip and Receive Tip are short-circuited
	Opening condition of the wire guide wire passage.	No distortion and blockage	No distortion and blockage

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

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When compared to the predicate devices (K180165), the ELRA Electrode presented in this submission have the same of the followings:

Intended Use
Technological Characteristics
· Energy Used
· Operation Principle
· Sterile
Single Use
· Electrical Safety
· Performance (conduction, impedance, short-circuit and opening conduction)

A few differences are as follows

· Physical Specifications
Patient Contacting Materials
Temperature Sensor
· Electrode exposed sites

There is no significant difference between the ELRA 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 devices does not affect the efficacy because the subject devices utilized the same technology of Bipolar 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.

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Furthermore, the subject device is qualified with electrical safety according to IEC 60601-1, IEC 60601-2-2 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 thermal effects testing was completed to demonstrate the substantially equivalent ablation performance of the subject device and predicate device. The results demonstrated that the subject device is substantially equivalent to those obtained with the predicate device. Furthermore, the subject device is qualified with electrical safety according to IEC 60601-2-2 and electromagnetic compatibility according to the IEC 60601-1-2.

Difference in the temperature sensor

The temperature sensor measures a temperature of a tissue in the near the sensor, and to be used automatically cut off the current in instances of excessive heat. The performance testing was conducted in order to demonstrate a function of temperature sensor in the subject device. In addition, the temperature sensor 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 provided that the efficacy of the subject device was not affected.

Difference in the electrode exposed sites

The subject device has 2 or 4 exposed electrodes. A bipolar electrosurgical system basically requires two electrodes (active and return). The reason for adding four electrodes is to assist ablation by more uniform energy by reducing the distance between the active electrode and the return electrode when ablation of the long electrode is performed. Basically there is no difference in using active and return.

Due to these identical clauses and high similarities, the ELRA Electrode is at least 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 including predicate comparative testing, and the comparison to predicate devices, the ELRA Electrode is substantially equivalent to the previously cleared predicate devices.

9. Summary of Non-Clinical Data

The non-clinical performance tests were conducted to evaluate the effectiveness and safety of the ELRA Electrode and its equivalence to the predicate device. A drop test and bending force test were performed to minimize the risks associated with mechanical failure. 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 of activation for different tissue types. The test was performed on liver, kidney, and muscle tissue according to the FDA

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Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'.

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

IEC 60601-1:	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005,MOD)
IEC 60601-2-2:	Medical electrical equipment - Part 2-2: Particularrequirements for the safety of high frequency surgicalequipment
ISO 10993-1:	Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process
ISO 10993-5:	Biological evaluation of medical devices - Part 5: Tests for invitro 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 non-clinical tests all met the acceptance criteria specified in the standards.

10. Summary of Clinical Data

A clinical trial of stent insertion using a subject device was conducted in 30 patients. Clinical trials were conducted for 120 seconds at a power of 7 w or 12 w to deliver 80 degrees of heat to the lesion tissue. The stenting procedure was successful and had three minor inflammatory reactions, but no direct side effects associated with the device. Clinical trials have concluded that this product is safe and effective.

In a retrospective study of 10 patients with malignant biliary hilar duct obstruction who underwent percutaneous intraductal RFA using 400mm electrode followed by dual stent placement, percutaneous intraductal RFA followed by dual stent placement was successful in all patients. There is no major complications were identified.

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, IEC 60601-1, IEC 60601-2-2 and ISO 10993-10, ISO 10993-10, ISO 10993

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11, bench testing, drop testing, temperature monitoring 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 ELRA Electrode meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical 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

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).