(46 days)
Not Found
No
The description focuses on microcontroller-based control and impedance sensing, which are traditional control system functionalities, not AI/ML. The "Instant Response™ Technology" and "Autobipolar function" describe automated responses based on sensed parameters, but not learning or complex pattern recognition characteristic of AI/ML.
Yes
The device is intended for use in surgical procedures for electrosurgical cutting and coagulation to achieve therapeutic effects like resecting, dividing, separating, and achieving hemostasis in tissues.
No
The device is an electrosurgical generator designed for surgical procedures involving cutting and coagulation of tissue, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a microcontroller, output generators, ports (RF activation, RS-232 serial, expansion), and mentions features like Instant Response™ Technology and REM™ Contact Quality Monitoring System, which are indicative of integrated hardware and software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating) and coagulating (hemostasis)." This describes a device used on a patient during surgery, not a device used to test samples from a patient in a lab setting.
- Device Description: The description details the electrosurgical functions (cutting, coagulating, different modes, etc.) and safety features related to applying electrical energy to tissue. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Force FX™ Electrosurgical Generator does not fit this description.
N/A
Intended Use / Indications for Use
The Force FX™ Electrosurgical Generator 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 (resecting, dividing, or separating) and coagulating (hemostasis).
Product codes
GEI
Device Description
The Force FX™ Electrosurgical Generators are microcontroller-based isolated output generators that provide power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. Features included are:
- . Instant Response™ Technology - Automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density.
- Three bipolar modes: precise, standard, and macro Low voltage, continuous current provides faster . desiccation without sparking.
- Three monopolar Cut modes: low, pure, blend Allows a wide range of power settings necessary to ● perform diverse surgical procedures.
- . Three monopolar Coag modes: desiccate, fulgurate, and spray - Helps control the size of the area and the depth of penetration during tissue coagulation.
- Support for Simultaneous Activation ●
- Covidien Energy-based Devices REM™ Contact Quality Monitoring System Monitors the quality . of electrical contact between the return electrode and the patient to eliminate risk of pad site burns.
- Handswitch or footswitch activation
- . Recall of most recently used mode and power settings
- Adjustable activation tone volume
- An RF activation port, RS-232 serial port, and expansion port .
The precise and standard bipolar modes of the Force FX™-8CA(S) models are equipped with an Autobipolar function. The autobipolar feature senses tissue impedance between the two bipolar electrodes and then uses the impedance information to automatically start or stop bipolar RF activation. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation.
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
surgical procedures
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)
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
The modifications made to the Force FX generator were found to not affect safety or performance through design verification testing, which continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- Basic safety and essential performance in accordance with IEC 60601-1:2005 and IEC 60601-2-. 2:2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2007
- . Design verification testing including application of multiple AC mains voltages and temperatures to ensure the proposed modifications perform within design parameters under varying environmental conditions.
- . Software regression/validation
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Covidien Ms. Sharon McDermott Senior Product Regulatory Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K143161 Trade/Device Name: Force FX Generators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2014 Received: December 5, 2014
Dear Ms. McDermott:
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. 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.
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita SDAshar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143161
Device Name Force FX Generators
Indications for Use (Describe)
The Force FX™ Electrosurgical Generator 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 (resecting, dividing, or separating) and coagulating (hemostasis).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date summary prepared: December 18, 2014
510(k) Submitter/Holder
Covidien (formerly Valleylab, Inc.) 5920 Longbow Drive Boulder, CO 80301
Contact
Sharon McDermott Sr. Regulatory Affairs Product Specialist Telephone: 303-581-6789 Fax: 303-530-6313 Email: sharon.mcdermott@covidien.com
Name of Device
| Trade Name: | Force FX TM electrosurgical generators |
|---|---|
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, GEI) |
Predicate Device
| Trade Name: | Force FX |
|---|---|
| Common Name: | Electrosurgical Generator |
| Catalog Number: | Force FX |
| 510(k) Number: | K944602 (cleared 6/5/1995) |
| Manufacturer: | Covidien |
Device Description
The Force FX™ Electrosurgical Generators are microcontroller-based isolated output generators that provide power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. Features included are:
- . Instant Response™ Technology - Automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density.
- Three bipolar modes: precise, standard, and macro Low voltage, continuous current provides faster . desiccation without sparking.
- Three monopolar Cut modes: low, pure, blend Allows a wide range of power settings necessary to ● perform diverse surgical procedures.
- . Three monopolar Coag modes: desiccate, fulgurate, and spray - Helps control the size of the area and the depth of penetration during tissue coagulation.
- Support for Simultaneous Activation ●
- Covidien Energy-based Devices REM™ Contact Quality Monitoring System Monitors the quality . of electrical contact between the return electrode and the patient to eliminate risk of pad site burns.
- Handswitch or footswitch activation
- . Recall of most recently used mode and power settings
4
- Adjustable activation tone volume
- An RF activation port, RS-232 serial port, and expansion port .
The precise and standard bipolar modes of the Force FX™-8CA(S) models are equipped with an Autobipolar function. The autobipolar feature senses tissue impedance between the two bipolar electrodes and then uses the impedance information to automatically start or stop bipolar RF activation. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation.
Indications for Use
The Force FX™ Electrosurgical Generator 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 (resecting, dividing, or separating) and coagulating (hemostasis).
Technological Characteristics
The Force FX generators have the same technological and performance characteristics as the predicate, K944602. This Special 510(k) proposes changes to five printed circuit board assemblies (PCBAs), firmware/software, and a minor modification to the simultaneous (coag) activation tone. The function of the devices has not changed.
Performance Characteristics
The modifications made to the Force FX generator were found to not affect safety or performance through design verification testing, which continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- Basic safety and essential performance in accordance with IEC 60601-1:2005 and IEC 60601-2-. 2:2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2007
- . Design verification testing including application of multiple AC mains voltages and temperatures to ensure the proposed modifications perform within design parameters under varying environmental conditions.
- . Software regression/validation
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusions
The intended use of the Force FX generator was not altered. In addition, the results of testing demonstrate that the modifications to the Force FX generator do not affect the safety or performance of the generator which is substantially equivalent to the predicate Force FX.