(231 days)
No
The description focuses on standard electrosurgical generator functionality, safety features, and compliance with relevant standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an electrosurgical generator designed to cut and coagulate tissue during surgical procedures, which is an active intervention rather than a therapeutic treatment in itself.
No
The device description states its purpose is for "electrosurgical cutting and coagulating" living human tissue during surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "RF Surgical Generator FW-120A," which is a hardware device containing monopolar and bipolar technology. It also mentions physical components like a generator, IEC Neutral Plate, and a Two Pedal Footswitch. While it contains software, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "surgical procedures where the surgeon requires electrosurgical cutting and coagulating." This describes a device used directly on living tissue during surgery, not for testing samples outside the body.
- Device Description: The description details a "source of high power RF energy" used to "cut and coagulate living human tissue." This aligns with surgical intervention, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is an electrosurgical generator, which is a type of medical device used for surgical procedures.
N/A
Intended Use / Indications for Use
RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue.
The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays
The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit.
The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.
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)
Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for RF Surgical Generator.
- RF Surgical Generator has been evaluated the safety and performance by lab bench testing a) according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and A A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- △ IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
-
IEC 60601-2-2, 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, Edition 6.0 2017-03
- b) RF Surgical Generator has been evaluated the basic mechanical and functional capabilities to determine substantial equivalence to the predicate device. According to the guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the device has been tested for applicable items such as thermal damage, CQM and so on. In particular, tests have been carried out with respect to the following subject areas.
-
- System Performance and waveform outputs test.
-
- Thermal effects testing: the thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal zone in all applicable modes: porcine muscle, liver, and kidney.
-
- c) RF Surgical Generator has performed software verifications to ensure the device worked appropriately as a moderated concern level software according to the Guidance for the Content of Premarket Submissions for Software Contained in 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.
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
November 24, 2020
Fulwell LLC % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China
Re: K200931
Trade/Device Name: RF Surgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 23, 2020 Received: September 28, 2020
Dear Jet Li:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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).
Sincerely.
for 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
Enclosure
2
Indications for Use
510(k) Number (if known) K200931
Device Name RF Surgical Generator, Model: FW-120A
Indications for Use (Describe)
RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary (K200931)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 878.4400, and there were no prior submissions for the subject device.
1 Submitter Information
Sponsor: Fulwell LLC Address: 3411 NW 48 Street, Miami, FL 33142 USA Contact Person: Mrs. Perla Melisa Mcliberty Title: Deputy General Manager Phone: +1-305-535-3568 E-mail: register@fulwell.us.com
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
Subject Device Information 2
Type of 510(k) submission: Traditional Trade/Device Name: RF Surgical Generator Model: FW-120A Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: 2
3 Predicate Device Information
Sponsor: ELLMAN INTL., INC. Trade/Device Name: Surgitron 120 IEC 510K number: K013255 Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Requlation Class: 2
4
Device Description 4
RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue.
The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays
The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit.
The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.
5 Intended Use/Indication for use
RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
6 Performance data
Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for RF Surgical Generator.
- RF Surgical Generator has been evaluated the safety and performance by lab bench testing a) according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and A A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- △ IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
-
IEC 60601-2-2, Medical Electrical Equipment - Part 2-2: Particular Requirements for The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And
5
High Frequency Surgical Accessories, Edition 6.0 2017-03
-
b) RF Surgical Generator has been evaluated the basic mechanical and functional capabilities to determine substantial equivalence to the predicate device. According to the guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the device has been tested for applicable items such as thermal damage, CQM and so on.
In particular, tests have been carried out with respect to the following subject areas. -
- System Performance and waveform outputs test.
- Thermal effects testing: the thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal zone in all applicable modes: porcine muscle, liver, and kidney.
- c) RF Surgical Generator has performed software verifications to ensure the device worked appropriately as a moderated concern level software according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. .
7 Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.
| Elements of
| comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Fulwell LLC | ELLMAN INTL., INC. | -- |
| 510K number | K200931 | K013255 | -- |
| Product Name | RF Surgical Generator | ||
| FW-120A | Surgitron 120 IEC | ||
| Also known as Surgitron 4.0 Dual RF | -- | ||
| Classification | |||
| Name | Electrosurgical, Cutting & Coagulation | ||
| & Accessories | Electrosurgical, Cutting & Coagulation | ||
| & Accessories | SE | ||
| Regulation | |||
| Class | 2 | 2 | SE |
| Regulation | |||
| Number | 21 CFR 878.4400 | 21 CFR 878.4400 | SE |
| OTC & Rx | Rx | Rx | SE |
| Indications for Use | |||
| Indications for | |||
| Use | RF Surgical Generator FW- | ||
| 120A is an electrosurgical | |||
| generator containing | |||
| monopolar and bipolar | |||
| technology. It is intended for | |||
| use with accessories during | |||
| surgical procedures where the | |||
| surgeon requires | |||
| electrosurgical cutting and | |||
| coagulating. | Cutting: snoring, submucosal palatal | ||
| shrinkage, traditional uvulopalatoplasty | |||
| (RAUP), myringotomy with effective | |||
| hemorrhage control, epistaxis | |||
| treatment, turbinate shrinkage, skin | |||
| incisions, biopsy, cysts, abscesses, | |||
| tumors, cosmetic repairs, development | |||
| of skin flaps, skin tags and | |||
| blepharoplasty. | |||
| Blend cutting and coagulation: snoring, | |||
| submucosal palatal shrinkage | SE, | ||
| Minor | |||
| Difference. | |||
| We remove | |||
| the specified | |||
| indication | |||
| for use for | |||
| subject | |||
| device; it do | |||
| not raise | |||
| safety and | |||
| traditional uvulopalatoplasty (RAUP), | |||
| myringotomy with effective hemorrhage | |||
| control, epistaxis treatment, turbinate | |||
| shrinkage, skin tags, papilloma keloids, | |||
| keratosis, verrucae, basal cell | |||
| carcinoma, nevi, fistulas, epithelioma, | |||
| cosmetic repairs, cysts, abscesses, | |||
| development of skin flaps. | |||
| Hemostasis: control of bleeding, | |||
| epilation, telangiectasia. | |||
| Fulguration: basal cell carcinoma, | |||
| papilloma, cyst destruction, tumors, | |||
| verrucae, hemostasis. | |||
| Bipolar: pinpoint precise coagulation, | |||
| pinpoint hemostasis in any field (wet or | |||
| dry), snoring, submucosal palatal | |||
| shrinkage, traditional uvulopalatoplasty | |||
| (RAUP), myringotomy with effective | |||
| hemorrhage control, epistaxis treatment | |||
| and turbinate shrinkage. | effectivenes | ||
| s issue. | |||
| Device Design | |||
| Working | |||
| Theory | ■ Monopolar: RF generator connects | ||
| its accessories of a handpiece and an | |||
| IEC Neutral Plate (adhered to patient | |||
| skin) to form a cyclic circuit, the RF | |||
| current generated from the generator | |||
| and through the Monopolar handpiece | |||
| to achieve CUT or COAG, then return | |||
| to generator by the IEC Neutral Plate. | |||
| ■ Bipolar: RF current generated from | |||
| the generator and the cyclic circuit | |||
| formed between the two tips of the | |||
| bipolar forceps, the RF power through | |||
| the two tips to work on patient obtaining | |||
| COAG. | ■ Monopolar: RF generator connects | ||
| its accessories of a handpiece and an | |||
| IEC Neutral Plate (adhered to patient | |||
| skin) to form a cyclic circuit, the RF | |||
| current generated from the generator | |||
| and through the Monopolar handpiece | |||
| to achieve CUT or COAG, then return | |||
| to generator by the IEC Neutral Plate. | |||
| ■ Bipolar: RF current generated from | |||
| the generator and the cyclic circuit | |||
| formed between the two tips of the | |||
| bipolar forceps, the RF power through | |||
| the two tips to work on patient obtaining | |||
| COAG. | SE | ||
| Appearance | Image: FW-120A | Image: Ellman Surgitron Dual 11 | SE |
| Note 1 | |||
| Interface | |||
| Accessories | Two Pedal Footswitch, Handpieces, IEC | ||
| Neutral Plate, Power Cord | Triple Footswith, Handpieces, Neutral | ||
| Pad, Power Cord | SE | ||
| Note 1 | |||
| Operation | |||
| Mode | Cutting, Blend cutting and coagulation, | ||
| Hemostasis, Fulguration, Bipolar | Cutting, Blend cutting and coagulation, | ||
| Hemostasis, Fulguration, Bipolar | SE | ||
| Waveforms | Cutting:4.0MHz Sinusoid | ||
| Blend cutting and coagulation: 4.0MHz | |||
| with fully rectified envelope | |||
| Hemostasis: 4.0MHz with partially | |||
| rectified envelope | |||
| Fulguration: 4.0MHz with modulated | |||
| Bipolar: 1.7MHz | Cutting:4.0MHz CW Sin-Wave | ||
| Blend cutting and coagulation: 4.0MHz | |||
| with rectified full-wave envelope | |||
| Hemostasis: 4.0MHz with square wave | |||
| rectified envelope | |||
| Fulguration: 4.0MHz Sin-Wave | |||
| Modulated | |||
| Bipolar: 1.7MHz for Fulgurating Spark- | |||
| Gap | SE | ||
| Note 2 | |||
| Activation | Cutting: via footswitch or finger switch | ||
| Blend cutting and coagulation: via | |||
| footswitch or finger switch | |||
| Hemostasis: via footswitch or finger | |||
| switch | |||
| Fulguration: via footswitch or finger | |||
| switch | Cutting: via footswitch or finger switch | ||
| Blend cutting and coagulation: via | |||
| footswitch or finger switch | |||
| Hemostasis: via footswitch or finger | |||
| switch | |||
| Fulguration: via footswitch or finger | |||
| switch | SE |
6
7
| K200931 | |
|---|---|
| --------- | -- |
| Rated Duty
| Cycle | 10s on, 30s off | 10s on, 30s off | SE |
|---|---|---|---|
| Energy type | RF | RF | SE |
| Feedback | |||
| system | Indicators, audio alarm, Error codes | Indicators, audio alarm, Error codes | SE |
| Neutral | |||
| Electrode | |||
| monitor | |||
| resistance | MAX 1000Ω | MAX 1000Ω | SE |
| Input Pow er | Nominal line voltage and frequency: | ||
| 120Vac~ ±10%, 60 Hz. | |||
| /230Vac~ ±10%, 50 Hz. | |||
| Input current at max output pow er: | |||
| 3.3/1.5A. | Voltage: 240/220/120/100V, ±10% | ||
| 240/230/120/100V, ±10% | |||
| Frequency: 50Hz | |||
| Current: For 240~220V: 3.3A, | |||
| For 120~100V: 1.5A | SE | ||
| Note 1 | |||
| Output Pow er | Cutting: 120W@500Ω | ||
| Blend cutting and coagulation: | |||
| 80W@500Ω | |||
| Hemostasis: 60W@500Ω | |||
| Fulguration: 40W@500Ω | |||
| Bipolar: 120W@200Ω | Cutting: 120W@500Ω | ||
| Blend cutting and coagulation: | |||
| 80W@500Ω | |||
| Hemostasis: 40W@500Ω | |||
| Fulguration: 40W@500Ω | |||
| Bipolar: 120W@200Ω | SE | ||
| Note 2 | |||
| Fuses | T 2.0A, 250V, Tw o pieces for 230Vac | ||
| T 4.0A, 250V, Two pieces for 120Va | 2* T 2.0AL, for 250V | ||
| 2* T 4.0AL, for 110V | SE | ||
| Note 1 | |||
| Electric shock | |||
| protection | Class I | Class Ilb | SE |
| Note 1 | |||
| Defibrillation | |||
| protection | Type BF | Type BF | SE |
| Dimensions | 235mm120mm340mm(WHD) | 9"5"13" (WHD) | |
| ≈228mm127mm330mm | SE | ||
| Note 1 | |||
| Weight | 11Kg | 18lbs, ≈8.16kg | SE |
| Note 1 | |||
| Working | |||
| condition | -10°C- +40°C | ||
| 30% - 75% | -10°C- +40°C | ||
| 30% - 75% | SE | ||
| Transport and | |||
| Storage | -10°C- +50°C, 10% - 95% | ||
| 500hPa-1060hPA | -10°C- +50°C, 10% - 95% | ||
| 500hPa-1060hPA | SE | ||
| Sterility | Non-sterile | Non-sterile | SE |
| FDA-Recognized Standards | |||
| Safety | |||
| Performance | ANSI AAMI ES60601-1 | ||
| IEC 60601-2-2 | UL2601, IEC 601-1, IEC 601-2-2 | ||
| BS15724:2.2 | SE | ||
| Note 2 | |||
| EMC | |||
| Performance | IEC 60601-1-2 | / | SE |
| Note 3 |
Note 1
Although the subject device design and specification parameters, such as appearance / dimensions / weight / power supply / electric shock protection, have a little difference to the predicate device, these minor differences do not affect the device' mainly function, which are has been testing the electrical safety via the IEC 60601 standards tests, and these differences will not create any new safety risks to the performance and safety.
Note 2
Although the waveform and output power of subject device has a little different to predicate device, the performance test has proved that the performance of subject device is substantial equivalence
8
to the predicate device. So the differences do not affect the safety and effectiveness.
Note 3
Although the complied standards of electrical safety and EMC performance are different to the predicate device, it's only because the version of predicate device's complied standards are invalidated and been updated. The subject device has complied to the necessary standards as existing similar products, so the differences do not affect the safety and effectiveness.
9 Conclusion
The subject device RF Surgical Generator has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.
10 Summary Prepared Date
22 Nov. 2020