(266 days)
Not Found
No
The summary describes software control for monitoring and safety features based on predefined thresholds (temperature, impedance, etc.), but does not mention any AI or ML algorithms for decision-making, analysis, or adaptation.
Yes.
The device is used for coagulation of tissue during surgical procedures, which is a therapeutic intervention.
No
Explanation: The device is described as a radiofrequency generator system used for coagulation of tissue during surgical procedures. Its function is to deliver RF power to coagulate tissue, and it monitors parameters like power, impedance, current, and temperature to ensure proper operation and safety. There is no mention of it being used to diagnose conditions or interpret physiological signals for diagnostic purposes.
No
The device description explicitly states that the system consists of a generator, pump, foot switch, and respiratory locator, which are hardware components. While software controls and monitors aspects of the device, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device description focuses on generating and delivering radiofrequency power to tissue for coagulation. It describes components like a generator, pump, foot switch, and electrode, all consistent with a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies described are "Ex-vivo tissue testing" to evaluate thermal effects on tissue and "Software testing" for the embedded software. These are relevant to the safety and performance of a surgical device, not a diagnostic device.
In summary, the device's function is to perform a surgical procedure (tissue coagulation) directly on a patient, which is the defining characteristic of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Radiofrequency Generator System is used in conjunction with Cura RF Electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Radiofrequency Generator System consists of a genstaltic pump for electrode cooling, a foot switch and a respiratory locator. This Radiofrequency Generator System is used in conjunction with the Cura RF electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The Radiofrequency Generator System is capable of delivering up to 250 W of RF power is limited through software control, and the power, impedance, current are monitored by software. The temperature of the electrode's tip is monitored for charring.
The generator generates high frequency alternating current and transferred to the RF electrode and generator is interrupted, the generator will stop the power output and trigger reminder. When the temperature of RF electrode detected by the generator exceeds 99℃, or the temperature of the neutral electrode reaches the setting temperature, the device will automatically out off the power output and give a corresponding reminder. The power output can also be manually stopped.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Software testing: The software system of Radiofrequency Generator System is embedded software. The power, time, impedance and temperature are monitored by embedded software. Software verification and validation testing were conducted as recommended by IEC 62304:2015 and FDA guidance "Content of Premarket Submissions for Device Software Functions" to support enhanced level.
Ex-vivo tissue testing: The test on thermal effects was performed to evaluate the width and depth of thermally damaged zone in relation to the active part length, gauge, working mode and power setting. 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'.
The test results demonstrated that the proposed device complies with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- A IEC60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -A Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]- EO residual test
- ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
- A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
December 11, 2024
Zhejiang CuraWay Medical Technology Co., Ltd. Ruiran Song International Registration Engineer Room 106, Building 1,Room 293, Building 2, No. 600, 21st Avenue, Baiyang Sub-district, Qiantang New District Hangzhou. Zhejiang 310000 China
Re: K240758
Trade/Device Name: Radiofrequency Generator, Cura 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: November 14, 2024 Received: November 14, 2024
Dear Ruiran Song:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Long H. Long H. Chen -Chen -S Date: 2024.12.11 10:39:49 S -05'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240758
Device Name Radiofrequency Generator System Cura RF Electrode
Indications for Use (Describe)
Radiofrequency Generator System is used in conjunction with Cura RF Electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
| 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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4
510(k) Summary
1 SUBMITTER
Company Name: Zhejiang CuraWay Medical Technology Co., Ltd. Contact details Address: Room 106, Building 1, No. 600, 21st Avenue, Baiyang Subdistrict, Qiantang New District, 310018 Hangzhou City, Zhejiang Province, China Phone: +86-057187016876 Contact person: Ruiran Song (Miss) Date prepared: 12/11/2024
2 SUBJECT DEVICE
Trade name: Radiofrequency Generator System
Cura RF Electrode
Common name: Electrosurgical cutting and coagulation device and accessories
Classification name: Electrosurgical cutting & coagulation device & accessories
Review panel: General & Plastic Surgery (SU)
Regulation number: 878.4400
Product code: GEI
3 PREDICATE DEVICES
Primary predicate device: The VIVA combo RF System (K163450)
Secondary predicate device: Star RF Electrode, VIVA RF Electrode (K172012)
5
4 DESCRIPTION
Radiofrequency Generator System consists of a genstaltic pump for electrode cooling, a foot switch and a respiratory locator. This Radiofrequency Generator System is used in conjunction with the Cura RF electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The Radiofrequency Generator System is capable of delivering up to 250 W of RF power is limited through software control, and the power, impedance, current are monitored by software. The temperature of the electrode's tip is monitored for charring.
The generator generates high frequency alternating current and transferred to the RF electrode and generator is interrupted, the generator will stop the power output and trigger reminder. When the temperature of RF electrode detected by the generator exceeds 99℃, or the temperature of the neutral electrode reaches the setting temperature, the device will automatically out off the power output and give a corresponding reminder. The power output can also be manually stopped.
5 INDICATIONS FOR USE
Radiofrequency Generator System is used in conjunction with Cura RF Electrode for cosgulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
6
6 SUBSTANTIAL EQUIVALENCE COMPARISON WITH PREDICATE DEVICE
Detailed substantial comparison was made between subject device. Please refer to below tables for details.
| Comparison Elements | Subject Device | Predicate Device | |
|---|---|---|---|
| Classification Regulation | 878.4400 | 878.4400 | |
| Product Code | GEI | GEI | |
| 510(k) Number | K240758 | K172012 | |
| Indications for use | The Cura RF Electrode is to be used with Radiofrequency | ||
| Generator System intended for coagulation and ablation of | |||
| tissue during percutaneous, laparoscopic, and intraoperative | |||
| surgical procedures. | star/VIVA RF Electrode is intended for use | ||
| in percutaneous and intraoperative | |||
| coagulation and ablation of tissue. | |||
| Type of use | Prescription use | Prescription use | |
| Monopolar or bipolar | Monopolar and Bipolar | Monopolar | |
| Model | Cura RF Electrode has three models: |
- Cura RF Electrode Fixed
- Cura RF Electrode Adjustable
- Cura RF Electrode Double | star/VIVA RF Electrode has two models:
- star RF Electrode_Fixed
- VIVA RF Electrode (which is adjustable) | |
| | | | |
| Electrode length (mm) | Monopolar: 70, 100, 150, 200, 250
Bipolar: 43, 103, 143 | | Monopolar: 70, 150, 200 |
| Active part length (mm) | Cura RF Electrode Fixed:
5, 7, 10, 15, 20, 25, 30, 40 | Cura RF Electrode Adjustable: 5 to 40, and adjustable step is continuously. | VIVA RF Electrode (Adjustable): 5 to 30, and adjustable step is 5. |
| | Cura RF Electrode Double: 15, 20 | star RF Electrode Fixed:
5, 7, 10, 20, 30 | |
| Diameter (Gauge) | Monopolar: 15,17,18
Bipolar: 15, 16, 17 | | Monopolar: 15, 17, 18 |
| Patient
contacting
materials | Electrode Materials | Stainless steel SUS 304 | |
| | Insulation film Materials | Polyester, Polyimide | |
Substantial equivalence Comparison table of Cura RF Electrode
7
8
| Connector type | 4 pin | 4 pin | |
|---|---|---|---|
| Neutral | |||
| electrode | Conductive or | ||
| capacitive | Conductive | Conductive | |
| Material | |||
| (Conductive | |||
| area) | Hydrogel | Hydrogel | |
| Single use | Single use | Single use | |
| Electrode sterilization | EO | EO |
9
Substantial equivalence Comparison table of Radiofrequency Generator System
| Comparison Elements | Subject Device | Predicate Device | |
|---|---|---|---|
| Classification Regulation | 878.4400 | 878.4400 | |
| Product Code | GEI | GEI | |
| 510(k) Number | K240758 | K163450 | |
| Indications for use | Radiofrequency Generator System is used in | ||
| conjunction with Cura RF Electrode for | |||
| coagulation and ablation of tissue during | |||
| percutaneous, laparoscopic, and intraoperative | |||
| surgical procedures. | The VIVA combo RF System is intended for use in | ||
| percutaneous and intraoperative coagulation and | |||
| ablation of tissue. | |||
| Principle | The working frequency of the Radiofrequency | ||
| Generator System is 480kHz±10%. When the radio | |||
| frequency current flows through the human tissue, | |||
| the rapid change of the electromagnetic field causes | |||
| the positive and negative ions in the cell to move | |||
| rapidly, so the friction between them, also between | |||
| them and other molecules and ions causes the | |||
| lesion to heat up, causing the water inside and | |||
| outside the cell to evaporate, dry, shrink and fall | |||
| off, resulting in aseptic necrosis, thereby achieving | |||
| the purpose of treatment. | The RF generator works at 480kHz±10%. The | ||
| frequency flows to the electrode's tip and then is | |||
| applied to the tissue. Frictional heat occurs and | |||
| causes the ions to move from the negative pole to | |||
| the positive pole and from the positive pole to the | |||
| negative pole forty to fifty thousand times per | |||
| second. Tissue necrosis is the principle that occurs | |||
| by using heat generated from the tissue impedance. | |||
| Type of use | Prescription | Prescription | |
| Energy Used | Radiofrequency | Radiofrequency | |
| Component | Radiofrequency Generator System consists of a generator, a peristaltic pump for electrode cooling, a foot switch and a respiratory locator. | The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. | |
| Bipolar or monopolar | Bipolar and Monopolar | Monopolar | |
| Temperature Monitoring | Available | Available | |
| Impedance monitor | Available | Available | |
| Voltage Supply | 100-240VAC 50/60 Hz | 100-240VAC 50/60 Hz | |
| Continuity monitor | Yes | Yes | |
| Output frequency | 480kHZ± 10 % | 480kHZ± 10 % | |
| Maximum Power Output | Up to 250 watts at 50 ohm | Up to 200 watts at 50 ohm | |
| Drive on time | Up to 15 minutes | Up to 30 minutes | |
| Crest factor | 1.4 | 1.4 | |
| Physical dimension | 360(L) x 334(W) x 185(H) mm | 260mm (W) x 348mm (L) x 115 mm (H) | |
| Foot | Function | Control the starting and stopping of the energy | Control the starting and stopping of the energy |
| switch | output. | output. | |
| Performance | |||
| specification | Single trigger, IPX 8 | Single trigger, IPX 8 | |
| Peristaltic | |||
| pump | Pump type | Peristaltic pump | Peristaltic pump |
| Flow rate | With load : 80ml or higher | ||
| (no load: 120 ml or higher) | With load: 90ml or higher | ||
| (no load: 120 ml or higher) | |||
| Electrical tests | Complied with IEC 60601-1, IEC 60601-2-2 and | ||
| IEC60601-2-18 | Complied with IEC 60601-1 and IEC 60601-2-2 | ||
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
10
11
12
7 SUMMARY OF NON-CLINICAL DATA
The following performance data were provided in support of the substantial equivalence determination.
Software testing
The software system of Radiofrequency Generator System is embedded software. The power, time, impedance and temperature are monitored by embedded software. Software verification and validation testing were conducted as recommended by IEC 62304:2015 and FDA guidance "Content of Premarket Submissions for Device Software Functions" to support enhanced level.
Ex-vivo tissue testing
The test on thermal effects was performed to evaluate the width and depth of thermally damaged zone in relation to the active part length, gauge, working mode and power setting. 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'.
The test results demonstrated that the proposed device complies with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- A IEC60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
-
IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
-
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
13
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -A Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
-
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]- EO residual test
-
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
-
ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
- A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
8 CONCLUSION
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. The standards testing and nonclinical performance testing demonstrates the subject device technological characteristics are equivalent to the predicate device for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative. In conclusion, the subject device is substantially equivalent to the predicate device.