(286 days)
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.
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.
The provided FDA 510(k) summary (K232505) for the Zhejiang CuraWay Medical Technology Co., Ltd. Endovenous Radiofrequency Generator and Catheter does not contain explicit acceptance criteria tables or detailed comparative effectiveness studies with human readers (MRMC). The document primarily focuses on demonstrating substantial equivalence to a predicate device (VNUS Radiofrequency Generator K040638 and VNUS®Closure FAST™ Catheter K061373) through non-clinical performance and safety standards testing.
Here's an breakdown based on the information provided, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it describes performance through comparison to the predicate device and compliance with established standards. The qualitative "acceptance" is based on demonstrating substantial equivalence in various aspects.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical to predicate device. | Identical for endovascular coagulation of blood vessels in patients with superficial vein reflux. |
| Monopolar or Bipolar | Identical to predicate (Bipolar). | Bipolar. |
| Catheter Length (cm) | Similar range to predicate (60, 100). | 60, 100. (Also 1, 2, 3, 5, 7 for heating element, predicate only 3, 7). |
| Outer Diameter of Catheter (mm) | Similar to predicate (2.3). | 1.6, 2.0, 2.3. |
| Patient Contact Materials | Identical to predicate (PET, FEP, PEEK). | PET, FEP, PEEK. |
| Disposable/Single-use | Identical to predicate. | Disposable, single-use per patient. |
| Catheter Sterilization | Identical to predicate (EO). | EO. |
| Output Frequency | Not significantly different in effect from predicate (460 kHz). | 480 kHz. (Difference noted as small and not affecting thermal efficiency). |
| Maximum Power Output | Equivalent to predicate for corresponding lengths. | Catheter 7cm: 40W (@200Ω); Catheter 5cm: 30W (@200Ω); Catheter 3cm: 18W (@200Ω); Catheter 2cm: 12W (@200Ω); Catheter 1cm: 6W (@200Ω). (Predicate 7cm: 40W, 3cm: 18W). |
| Drive on Time | Identical to predicate (10 to 40s). | 10 to 40s. |
| Crest Factor | Not significantly different in effect from predicate (1.7). | 1.4. |
| Ex-vivo tissue thermal spread testing | Ablation effect and zones substantial equivalent to predicate and reference devices. | Demonstrated substantial equivalence in ablation effect and ablation zones using bovine liver. |
| In-vivo animal (goat) testing | Absence of significant adverse differences compared to predicate in general observe, blood routine, blood biochemistry, ultrasound, histopathology, intravascular blood coagulation, vascular wall thermal damage, and inflammation. | No significant adverse differences reported. |
| Electrical Safety Standards | Compliance with IEC 60601-1, IEC 60601-2-2. | Complied. |
| EMC Standards | Compliance with IEC 60601-1-2. | Complied. |
| Usability Standards | Compliance with IEC 60601-1-6. | Complied. |
| Biocompatibility Standards | Compliance with ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogen, hemocompatibility, genotoxicity). | Complied. |
| Sterilization Standards | Compliance with ISO 10993-7 (EO residuals), ISO 11135 (EO sterilization), ISO 11137-2 (Radiation sterilization), ASTM F1980-16 (Accelerated aging). | Complied. |
| Software Validation standards | Compliance with IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions. | Complied. |
2. Sample Size for Test Set and Data Provenance
- Ex-vivo tissue thermal spread testing: "bovine liver tissue" was used. The specific number of samples or livers is not provided.
- In-vivo animal (goat) testing: "In-vivo animal (goat) testing" was conducted. The specific number of goats is not provided.
- Data Provenance: The nature of these tests (ex-vivo and in-vivo animal) suggests prospective experimental data generated for the purpose of this submission. The country of origin for the studies is not explicitly stated, but the company is based in China.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a medical device that performs a physical action, like RF ablation) does not typically involve human expert readers establishing ground truth for diagnostic imaging. The "ground truth" here is based on physical and biological measurements.
- For the ex-vivo testing, results are likely analyzed by researchers with expertise in thermal tissue ablation and potentially a pathologist or histologist to assess ablation zones.
- For the in-vivo animal testing, the ground truth would be established through:
- Direct observation (general observe).
- Clinical laboratory tests (blood routine, blood biochemistry) interpreted by veterinary or medical lab experts.
- Ultrasound monitoring interpreted by veterinary radiologists or sonographers.
- Histopathological examination interpreted by veterinary pathologists.
- These assessments would determine the "truth" of the device's effects on the animal models.
The specific number of experts and their detailed qualifications are not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, particularly when there might be disagreement in image interpretation. This 510(k) summary does not indicate such a method, as the "ground truth" is derived from objective physical measurements and biological assessments rather than subjective expert interpretation of images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. This type of study is typically conducted for AI-powered diagnostic devices where the AI assists human readers in interpreting images. The Zhejiang CuraWay device is an Endovenous Radiofrequency Generator and Catheter, a therapeutic device designed to perform an ablation procedure, not a diagnostic imaging interpretation tool. Therefore, a study comparing human readers with and without AI assistance is not applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
No standalone performance study for an algorithm without human-in-the-loop was done or reported. Similarly to the point above, this device performs a physical therapeutic action and is operated by a clinician. While it includes embedded software for monitoring parameters (power, time, impedance, temperature), its "performance" is inherently tied to its physical interaction with tissue under human control, not as an autonomous diagnostic algorithm. The software is part of the control system, not a standalone diagnostic tool.
7. Type of Ground Truth Used
- Ex-vivo testing: The ground truth for thermal spread and ablation effect was based on direct observation and measurement of the treated bovine liver tissue. This is a pathology/histology-based ground truth for the physical effect.
- In-vivo animal testing: The ground truth for the device's impact on living tissue was established through a combination of:
- Clinical observation
- Laboratory outcomes data (blood routine, blood biochemistry)
- Imaging data and interpretation (Ultrasound Monitoring)
- Pathology/histology (Histopathological examination, vascular wall thermal damage, vascular wall inflammation)
- This represents a comprehensive outcomes-based and pathology-based ground truth from an animal model.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI algorithm development. The software in this device is described as "embedded software, which is written in C language and is developed on the Atollic TrueSTUDIO integrated development compilation software." This implies traditional software engineering and validation rather than statistical model training. If any internal parameters of the RF generator were optimized through data, that information is not provided.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the context of machine learning is indicated, this question is not applicable. The software validation refers to compliance with IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions, which focus on rigorous software development lifecycle processes, risk management, and verification/validation, rather than data-driven model training and ground truth establishment for a predictive algorithm.
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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.
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"
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(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
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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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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 NewDistrict, 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 andaccessories |
| Review panel | General & Plastic Surgery (SU) |
| Regulation number | 878.4400 |
| Product code | GEI |
| Predicate device | VNUS Radiofrequency Generator (K040638)VNUS®Closure FAST™ Catheter(K061373) |
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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.
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| 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
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| t impact deviced 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 requiremerdition 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 subjecthe 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 EndovenousRadiofrequency Generator isintended for use with CuraWay'sEndovenous RF Catheter intended forvessel and tissue coagulation. | The VNUS Radiofrequency Generatoris intended for use with VNUSradiofrequencydevices intended for vessel and tissuecoagulation. | Identical |
| Principle | The Endovenous RadiofrequencyGenerator JM-S40 will be workedtogether with the EndovenousRadiofrequency Catheter. Thegenerator generates and transfersthe RF current to the catheter andcontrol the current output viasoftware algorithm to heat the veinwall continuously. The hightemperature makes the vascularendothelial degeneration, collagencontraction, tube wall thickening,rapid mechanical and fibrosis toachieve the clinical purpose. | The VNUS Radiofrequency Generator(RFGPLUS) is a product of VNUSMedical Technologies, Inc. It isdesigned to provide controlleddelivery of radiofrequency (RF) energyto RF Devices (e.g., catheters). Thegenerator generates and transfers theRF current to the catheter and controlthe current output via softwarealgorithm so as to heat the vein wallcontinuously. The high temperaturemakes the vascular endothelialdegeneration, collagen contraction,tube wall thickening, rapid mechanicaland fibrosis to achieve the clinicalpurpose. | Identical | |
| Working mode | Coagulation | Coagulation | Identical | |
| EUS | PrescriptionRadiofrequency | PrescriptionRadiofrequency | ||
| Prescription or OTCEnergy Used | ||||
| Component | JM-S40 Endovenous RadiofrequencyGenerator consists of generator andpower cord. | VNUS Radiofrequency Generatorconsists 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 thedevice have difference withthe equivalent device, thisdifference is small and doesnot affect thermal efficiency. | |
| Maximum Power Output | Endovenous RadiofrequencyCatheter 7cm: 40W (@200Ω), | ClosureFAST 7cm: 40W (@200Ω),ClosureFAST 3cm: 18W (@200Ω), | Different.Animaltesting resultsprovided to demonstrateequivalence.Different. There are morelength specificationsavailable for subject devicethan that of predicate | |
| Catheter 5cm: 30W (@200Ω),Endovenous RadiofrequencyCatheter 3cm: 18W (@200Ω),Endovenous RadiofrequencyCatheter 2 cm: 12W (@200Ω),Endovenous RadiofrequencyCatheter 1cm: 6W (@200Ω) | device, different catheterlength has different max.Power output. The longestcatheter is 7cm for bothpredicate device and subjectdevice, their max. Poweroutput is the same. Othershorter lengths catheterhave lower power output,which will not raise anysafety risks, and theeffectiveness of the shorterlengths catheters aredemonstrated by the ex-vivoanimal testing. | Identical | Different. The electricalsafety test has beenperformed on the proposeddevice. The test result showthat the device can operatenormally and comply withrelated standardrequirement. The difference | |
| Drive on time | 10 to 40s | 10 to 40s | 1.7 | |
| Crest factor | 1.4 |
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| 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 |
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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
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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.
§ 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.