(175 days)
No
The description mentions a "computer" for monitoring and safety functions, but there is no indication of AI or ML algorithms being used for learning, adaptation, or complex pattern recognition. The functions described appear to be rule-based or deterministic.
Yes
The device is used to perform monopolar and bipolar functions in the surgical operation area, which implies a therapeutic intervention (cutting or coagulating tissue).
No
An electrosurgical generator is used for cutting and coagulating tissue during surgery, not for diagnosing conditions. While it has a "Power ON self diagnostics function," this refers to diagnosing the device's own operational status, not a patient's medical condition.
No
The device description clearly outlines hardware components like monopolar and bipolar modes, CQMS function, PPS system, and power ON self-diagnostics, indicating it is a physical electrosurgical generator, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform monopolar and bipolar functions in the surgical operation area. This describes a device used on a patient during surgery, not a device used to test samples from a patient outside of the body.
- Device Description: The description focuses on features related to surgical procedures (monopolar/bipolar modes, patient pad monitoring, output control, safety features). There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Anatomical Site: The anatomical site is the "surgical operation area," which is a location on or within the patient's body during surgery. IVDs typically analyze samples taken from the body (like blood, urine, tissue) in a laboratory setting.
- Performance Studies: The performance studies described involve lab bench testing, thermal effects testing on animal tissues, and software validation. These are typical for surgical devices, not IVDs which would involve studies demonstrating analytical and clinical performance related to diagnostic testing.
In summary, the description clearly points to a surgical device used for cutting and coagulating tissue during operations, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Electrosurgical Generator - Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
Product codes
GEI
Device Description
Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.
The electrosurgical generator can be compatible with electrosurgical accessories based on their output rating with FDA clearance. For example:
FDA 510k cleared Electrosurgical pencil : 510(k) No.: K092634 or other FDA cleared pencil FDA 510k cleared Electrosurgical pad: 510(k) No.: K102372 or other FDA cleared pad
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)
Electrosurgical Generator – Model FW-350A had been evaluated the safety and performance by lab bench testing as following:
8.1 Safety and EMC Compliance with following standard:
-
IEC 60601-1: 2012: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
-
IEC60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
-
IEC60601-2-2: 2009: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
8.2 Performance testing
To demonstrate that the Electrosurgical Generator meets all design specifications and performance requirements, nonclinical bench testing has been performed in accordance with the internal R&D process in compliance with the proposals and recommendations of FDA quidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.
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 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.
- Preclinical Test/Histology study
Thermal Zone Damage on tissue. Side by side testing was performed on ex vivo animal tissues (liver, kidney, and muscle) and thermal damage was assessed by measuring the depth/length/width of damage at minimum, default, and maximum power settings using histology.
8.3 Software validation
The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
8.4 Clinical testing
Clinical and animal studies were not necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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, 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.
June 13, 2019
FULWELL LLC % Jet Li Regulation Manager Guangzhou LETA Testing Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, China 510060
Re: K183564
Trade/Device Name: Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 14, 2019 Received: May 16, 2019
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/cfpmp/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.
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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 and Part 809): medical device reporting (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
Jennifer R. Stevenson Acting Division 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
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Indications for Use
510(k) Number (if known) K183564
Device Name
Electrosurgical Generator, Model FW-350A
Indications for Use (Describe)
The Electrosurgical Generator – Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
| | X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) | | | | |
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. There is no prior submission for this device.
1 510 (k) submitter
Company Name: FULWELL LLC Address: 3411 NW 48 Street, Miami, FL 33142 USA Phone: +1-305-535-3568 Post code: 33142 Contact Person: Mrs Perla Melisa Mcliberty E-mail: register@fulwell.us.com
Application Correspondent:
Guangzhou LETA Testing Technology Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com
2 Subject Device Information:
Type of 510(k) submission: Traditional Trade Name: Electrosurgical Generator - Model FW-350A Common Name: Electrosurqical cutting and coaqulation device and accessories. Classification Name: electrosurgical, cutting & coagulation & accessories Review Panel: General& Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: II
3 Predicate Device Information:
| Sponsor | Valleylab. Inc. |
|---|---|
| Device Name | Valleylab Force Fx |
| 510(k) Number | K944602 |
| Product Code | GEI |
| Regulation Number | 878.4400 |
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| Regulation Class | 2 | |
|---|---|---|
| ------------------ | --- | -- |
1. Device Description
Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.
The electrosurgical generator can be compatible with electrosurgical accessories based on their output rating with FDA clearance. For example:
FDA 510k cleared Electrosurgical pencil : 510(k) No.: K092634 or other FDA cleared pencil FDA 510k cleared Electrosurgical pad: 510(k) No.: K102372 or other FDA cleared pad
5. Intended Use / Indications for Use
The Electrosurgical Generator - Model FW-350A is a non-sterile, reusablemulti-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
6. Design
Operating principles:
There're two working modes of electrosurgical generator: monopolar and bipolar
A. monopolar mode:
With this mode, cutting and coaqulation of the tissues are accomplished by an integral circuit that consists of electrosurgical generator and its applicable accessories (ESU pencil, split ESU pad, which are not included in this submission, as long as the Up≥4500V of these accessories that will be
compatible, details refer to user manual). In most applications the current goes through the patient body by electrosurgical pencils and then returns to the generator by the circuit made of electrosurgical pad.
B. Bipolar forceps mode:
Bipolar forceps provide high frequency electric power to human body by the two points of the forceps that coagulate the blood to make hemostatic effect through dehydratingthe vessels between the bipolar forceps. However, this function is limited within the area between the two forceps points and its damage on the tissue and influence area is far less than the electrosurgical pencils does, therefore, it is suitable to the ligation of small vessels (diameter 113ohms (a split ESU pad used);
Force Fx (REM): Alarm range