(283 days)
No
The 510(k) summary describes a radiofrequency ablation catheter and its use with a specific RF generator. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or analysis. The device's function is purely based on delivering RF energy for tissue ablation.
Yes
The device uses bipolar energy for partial or complete ablation of tissue in the pancreatic and biliary tracts, which is a therapeutic action.
No
The device is an RF catheter used for ablation of tissue in the pancreatic and biliary tracts, which is a therapeutic procedure, not a diagnostic one.
No
The device is a physical catheter with an electrode tip, insulation, and handle, intended for surgical procedures. It is explicitly described as a hardware device.
Based on the provided information, the ELRA Electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to perform partial or complete ablation of tissue in vivo (within the body) in the pancreatic and biliary tracts using radiofrequency energy.
- Device Description: The device is a surgical accessory used in conjunction with an RF generator for a therapeutic procedure performed directly on the patient's tissue.
- Mechanism of Action: It delivers energy to ablate tissue, which is a direct intervention on the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ELRA Electrode's function is therapeutic (tissue ablation), not diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
KNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pancreatic and biliary tracts
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)
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 Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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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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-si |
| Gyeonggi-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)]
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.
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 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 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 Unit | ||
| and Accessories | Endoscopic Electrosurgical Unit | ||
| and 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 | |
| Physical | |||
| Specifications | 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 60601-1 | ||
| IEC 60601-2-2 | IEC 60601-1 | ||
| IEC 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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6
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
8
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 for
basic safety and essential performance (IEC 60601-1:2005,
MOD) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-2: | Medical electrical equipment - Part 2-2: Particular
requirements for the safety of high frequency surgical
equipment |
| 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 for in
vitro cytotoxicity |
| ISO 10993-10: | Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization |
| ISO 10993-11: | Biological evaluation of medical devices - Part 11: Tests for
systemic 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
9
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.