(286 days)
Not Found
No
The summary describes a radiofrequency generator and catheter for vessel coagulation. It mentions real-time monitoring of temperature, power, and time, and safety features like automatic power cutoff based on temperature and cable interruption. There is no mention of AI, ML, image processing, or any data-driven decision-making beyond simple threshold-based safety mechanisms. The performance studies focus on thermal spread and in-vivo animal testing, not on the performance of any AI/ML algorithm.
Yes
The device is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux, which is a medical treatment for a health condition.
No
The JM-S40 Endovenous Radiofrequency Generator is described as a device that outputs RF energy for "vessel and tissue coagulation" and "endovascular coagulation of blood vessels," and provides real-time monitoring of temperature, power, and time during RF output. Its purpose is therapeutic (coagulation), not diagnostic.
No
The device description explicitly states that the JM-S40 Endovenous Radiofrequency Generator includes a "host and a power cord" and "outputs RF energy," indicating it is a hardware device that generates and delivers energy, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "endovascular coagulation of blood vessels in patients with superficial vein reflux." This is a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device generates RF energy and is used with a catheter to perform coagulation. This is a treatment mechanism, not a diagnostic one.
- Anatomical Site: The device acts on "blood vessels," which are part of the living body, not a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
In vitro diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay's Endovenous RF Catheter intended for vessel and tissue coagulation.
The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The JM-S40 Endovenous Radiofrequency Generator includes a host and a power cord. The JM-S40 Endovenous Radiofrequency Generator is intended to be used with the Endovenous Radiofrequency Catheter for vessel and tissue coagulation. The JM-S40 Endovenous Radiofrequency Generator outputs RF energy and the Endovenous Radiofrequency Catheter is the applied part. The JM-S40 Endovenous Radiofrequency Generator has simple operation and simple interface, and can accurately provide real-time monitoring of temperature, power and time during RF output.
The generator generates high frequency alternating current and transfers to the catheter. When the cable of the catheter or its connection is interrupted, the host will stop the power output and trigger alarm. When the temperature of catheter detected by the generator exceeds 130 ℃, the device will automatically cut 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
vessel and tissue coagulation, blood vessels
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)
Non-Clinical Performance Testing:
- Ex-vivo tissue thermal spread testing: Performed using bovine liver tissue. Result showed ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device.
- In-vivo animal (goat) testing: Conducted to compare the subject device group and predicate device group in the following aspects: general observe, blood routine, blood biochemistry, Ultrasound Monitoring, Histopathological examination, intravascular blood coagulation, vascular wall thermal damage and vascular wall inflammation.
Safety Standards Testing:
The test results demonstrated that the proposed device complies with the following standards:
- A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- A IEC60601-1-2:2014 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
- A 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
- A ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
- A ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- A ISO 10993-3 Third edition Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Chinese Pharmacopoeia (2020 version) Bacteria Endotoxins Test
- A 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)]
- A 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
May 30, 2024
Zhejiang CuraWay Medical Technology Co., Ltd. Ruiran Song Regulatory Affairs Officer Building 1. No.600. 21st street. Oiantang New Area Hangzhou, Zhejiang 310018 China
Re: K232505
Trade/Device Name: Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: NA Received: April 30, 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/cdrb/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.
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"
1
(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 820.70) 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 (OS) 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.
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 mediation-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-regulatoryassistance/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).
Sincerelv.
Long H. Chen -S Digitally signed by Long H.Chen-S
Date: 2024.05.30 Date: 2024.05.30 17:54:33 -04'00' 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 Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232505
Device Name
Endovenous Radiofrequency Generator Endovenous Radiofrequency Catheter
Indications for Use (Describe)
The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay's Endovenous RF Catheter intended for vessel and tissue coagulation.
The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Type of Use (Select one or both, as applicable):
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| [] Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K232505
510(k) Summary
| Company Name/Owner | Zhejiang CuraWay Medical Technology Co., Ltd. |
|---|---|
| Contact person/Author | Ruiran Song (Miss) |
| Date prepared | 05/29/2024 |
| Contact details Address | Room 106, Building 1,Room 293, Building 2, No. 600, |
| 21st Avenue, Baiyang Sub-district, Qiantang New | |
| District, 310018, Hangzhou City, Zhejiang Province, | |
| China | |
| Trade name | Endovenous Radiofrequency Generator (JM-S40) |
| Endovenous Radiofrequency Catheter | |
| Common name | Electrosurgical device |
| Classification name | Electrosurgical cutting and coagulation device and |
| accessories | |
| Review panel | General & Plastic Surgery (SU) |
| Regulation number | 878.4400 |
| Product code | GEI |
| Predicate device | VNUS Radiofrequency Generator (K040638) |
| VNUS®Closure FAST™ Catheter(K061373) |
4
K232505
Description
The JM-S40 Endovenous Radiofrequency Generator includes a host and a power cord. The JM-S40 Endovenous Radiofrequency Generator is intended to be used with the Endovenous Radiofrequency Catheter for vessel and tissue coagulation. The JM-S40 Endovenous Radiofrequency Generator outputs RF energy and the Endovenous Radiofrequency Catheter is the applied part. The JM-S40 Endovenous Radiofrequency Generator has simple operation and simple interface, and can accurately provide real-time monitoring of temperature, power and time during RF output.
The generator generates high frequency alternating current and transfers to the catheter. When the cable of the catheter or its connection is interrupted, the host will stop the power output and trigger alarm. When the temperature of catheter detected by the generator exceeds 130 ℃, the device will automatically cut off the power output and give a corresponding reminder. The power output can also be manually stopped.
Indications for use
The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay's Endovenous RF Catheter intended for vessel and tissue coagulation.
The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Substantial equivalence comparison with predicate device
Detailed substantial comparison was made between subject device and predicate device. Please refer to below tables for details.
5
| Comparison Elements | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Classification Regulation | 878.4400 | 878.4400 | Identical |
| Product Code | GEI | GEI | Identical |
| 510(k) Number | K232505 | K061373 | Identical |
| Indications for use | The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux. | The VNUS®Closure FAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. | Identical |
| Monopolar or bipolar | Bipolar | Bipolar | Identical |
| Catheter length(cm) | 60, 100 | 60, 100 | Identical |
| Heating element length(cm) | 1, 2, 3, 5, 7 | 3, 7 | Different. More available catheter dimensions are designed for different clinical application, it will not impact device safety and effectiveness. |
| Outer diameter of catheter(mm) | 1.6, 2.0, 2.3 | 2.3 | Identical |
| Patient contact Materials | PET, FEP, PEEK | PET, FEP, PEEK | Identical |
| Connector type | 8 pin | 7 pin | Different. Connector type is dependent on design specifications. The difference |
Substantial equivalence Comparison table of Endovenous Radiofrequency Cathete
5-3
6
| | | | t impact device
d effectiver |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------|
| | he RF catheters are disposable a | RF catheters are disposable | |
| sposable /Single-us | re to be used within a single patie | to be used within a single p | dentica |
| Device | procedure only | orocedure on | |
| Catheter sterilizatio | EO | EO | dentica |
| | est for Cytotoxicity, irritati | | |
| | ensitization,Acute system toxici | | |
| ological te | Pyrogen, Hemocompatibil | availa | |
| | Genotoxicity was performe | | |
| | ccording to ISO 10993-1 Fif | | |
| | .8-08 requiremer
dition 201 | | |
| | ubstantial equivalence Comparison table of Endovenous Radiofrequency Gener | | |
| | | | |
| | heter, when working with different catheter, the parameters of the VNUS Radiofrequency Generator are subjectly different. The subject
he predicate device VNUS Radiofrequency Generator can worked with two types of catheters: Closure FAST™ Catheter and Closure | | |
| | evice (Endovenous Radiofrequency Catheter) is equivalent to the Closure FAST™ Catheter (predicate device), so the comparison | | |
| generator will only be applied to the following condition | | | |
| ● | ิ้นbject device: JM-S40 Endovenous Radiofrequency Generator working with the Endovenous Radiofrequency Cath | | |
| 0 | edicate device: VNUS Radiofrequency Generator working with Closure FAST™ Cathe | | |
| The following is the detailed comparison table: | | | |
The following is the desired comparison table:
| Comparison Elements | Classification Regulation | 878.4400 | 878.4400 | Identical |
|---|---|---|---|---|
| Subject Device | Product Code | GEI | GEI | Identical |
| Predicate Device | 510(k) Number | K232505 | K040638 | |
| Comment | Indications for use | TheJM-S40 Endovenous | ||
| Radiofrequency Generator is | ||||
| intended for use with CuraWay's | ||||
| Endovenous RF Catheter intended for | ||||
| vessel and tissue coagulation. | The VNUS Radiofrequency Generator | |||
| is intended for use with VNUS | ||||
| radiofrequency | ||||
| devices intended for vessel and tissue | ||||
| coagulation. | Identical | |||
| Principle | The Endovenous Radiofrequency | |||
| Generator JM-S40 will be worked | ||||
| together with the Endovenous | ||||
| Radiofrequency Catheter. The | ||||
| generator generates and transfers | ||||
| the RF current to the catheter and | ||||
| control the current output via | ||||
| software algorithm to heat the vein | ||||
| wall continuously. The high | ||||
| temperature makes the vascular | ||||
| endothelial degeneration, collagen | ||||
| contraction, tube wall thickening, | ||||
| rapid mechanical and fibrosis to | ||||
| achieve the clinical purpose. | The VNUS Radiofrequency Generator | |||
| (RFGPLUS) is a product of VNUS | ||||
| Medical Technologies, Inc. It is | ||||
| designed to provide controlled | ||||
| delivery of radiofrequency (RF) energy | ||||
| to RF Devices (e.g., catheters). The | ||||
| generator generates and transfers the | ||||
| RF current to the catheter and control | ||||
| the current output via software | ||||
| algorithm so as to heat the vein wall | ||||
| continuously. The high temperature | ||||
| makes the vascular endothelial | ||||
| degeneration, collagen contraction, | ||||
| tube wall thickening, rapid mechanical | ||||
| and fibrosis to achieve the clinical | ||||
| purpose. | Identical | |||
| Working mode | Coagulation | Coagulation | Identical | |
| EUS | Prescription | |||
| Radiofrequency | Prescription | |||
| Radiofrequency | ||||
| Prescription or OTC | ||||
| Energy Used | ||||
| Component | JM-S40 Endovenous Radiofrequency | |||
| Generator consists of generator and | ||||
| power cord. | VNUS Radiofrequency Generator | |||
| consists of generator and power cord. | Identical | |||
| Bipolar or monopolar | Bipolar | Bipolar | Identical | |
| Temperature Monitoring | Available | Available | Identical | |
| Temperature control range | 95~120°C | 95~120°C | Identical | |
| Impedance monitor | Available | Available | Identical | |
| Voltage Supply | 100-240VAC 50/60 Hz | 100-240VAC 50/60 Hz | Identical | |
| Continuity monitor | Yes | Yes | Identical | |
| Output frequency | 480kHz | 460 kHz | Different. | |
| The Output Frequency of the | ||||
| device have difference with | ||||
| the equivalent device, this | ||||
| difference is small and does | ||||
| not affect thermal efficiency. | ||||
| Maximum Power Output | Endovenous Radiofrequency | |||
| Catheter 7cm: 40W (@200Ω), | ClosureFAST 7cm: 40W (@200Ω), | |||
| ClosureFAST 3cm: 18W (@200Ω), | Different. | |||
| Animal | ||||
| testing results | ||||
| provided to demonstrate | ||||
| equivalence. | ||||
| Different. There are more | ||||
| length specifications | ||||
| available for subject device | ||||
| than that of predicate | ||||
| Catheter 5cm: 30W (@200Ω), | ||||
| Endovenous Radiofrequency | ||||
| Catheter 3cm: 18W (@200Ω), | ||||
| Endovenous Radiofrequency | ||||
| Catheter 2 cm: 12W (@200Ω), | ||||
| Endovenous Radiofrequency | ||||
| Catheter 1cm: 6W (@200Ω) | device, different catheter | |||
| length has different max. | ||||
| Power output. The longest | ||||
| catheter is 7cm for both | ||||
| predicate device and subject | ||||
| device, their max. Power | ||||
| output is the same. Other | ||||
| shorter lengths catheter | ||||
| have lower power output, | ||||
| which will not raise any | ||||
| safety risks, and the | ||||
| effectiveness of the shorter | ||||
| lengths catheters are | ||||
| demonstrated by the ex-vivo | ||||
| animal testing. | Identical | Different. The electrical | ||
| safety test has been | ||||
| performed on the proposed | ||||
| device. The test result show | ||||
| that the device can operate | ||||
| normally and comply with | ||||
| related standard | ||||
| requirement. The difference | ||||
| Drive on time | 10 to 40s | 10 to 40s | 1.7 | |
| Crest factor | 1.4 |
5-4
7
8
9
10
| Physical dimension | will not affect the safety and effectiveness. | |||
|---|---|---|---|---|
| 320mm(L)×270mm(W)×145mm(H) | 38 cm x 38 cm x 19 cm (15 in. x 15 in. x 7.5 in.) | Different. Size difference will not impact device safety and effectiveness. | ||
| Electrical tests | Complied with IEC 60601-1 and IEC 60601-2-2 | Not available | ||
| EMC | Complied with IEC 60601-1-2 | Not available |
11
Software description
The software system of JM-S40 Endovenous Radiofrequency Generator is embedded software, which is written in C language and is developed on the Atollic TrueSTUDIO integrated development compilation software. The power, time, impedance, and temperature are monitored by embedded software. IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions were used as reference documents during software design verification/validation.
Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the subject devices met all design specifications.
Ex-vivo tissue thermal spread testing using bovine liver tissue was performed. The result showed the ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device.
In-vivo animal (goat) testing was conducted to compare the subject device group and predicate device group in following aspects: general observe, blood routine, blood biochemistry,Ultrasound Monitoring, Histopathological examination, intravascular blood coagulation, vascular wall thermal damage and vascular wall inflammation.
Safety Standards Testing
The test results demonstrated that the proposed device complies with the following standards:
- A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- A IEC60601-1-2:2014 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
- A 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
- A ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part
12
11: Test for systemic toxicity--Pyrogen test
- A ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- A ISO 10993-3 Third edition Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
Chinese Pharmacopoeia (2020 version) Bacteria Endotoxins Test
- A 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)]
- A 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
Conclusion
The indications for use of subject device are equivalent to the predicate device. The standards testing and nonclinical performance testing demonstrates the subject device technological characteristics are equivalent to the predicate device for endovascular coagulation of blood vessels in patients with superficial vein reflux.ln conclusion, the subject device is substantially equivalent to and as safe and effective as the predicate.