(50 days)
No
The summary describes a standard electrosurgical generator and does not mention any AI or ML capabilities.
Yes
The device is used for cutting and coagulating tissue in surgical procedures, which are therapeutic interventions.
No
This device is an electrosurgical generator designed to cut and coagulate tissue using heat, not to diagnose conditions.
No
The device is described as a "high frequency electrosurgical generator" and a "radio-frequency (RF) electrosurgical generator" that "delivers energy to compatible surgical instruments." This clearly indicates a hardware component responsible for generating and delivering energy, not solely software. While software is mentioned as being verified and validated, it is part of a larger hardware system.
Based on the provided information, the Valleylab FX8 FX Series Energy Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "cutting and coagulating tissue" using high frequency electrosurgical energy. This is a direct surgical intervention on living tissue, not a test performed on samples taken from the body.
- Device Description: The description details how it delivers energy to surgical instruments to produce heat for surgical effects. This aligns with a surgical device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Valleylab FX8 is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Product codes
GEI
Device Description
Valleylab FX8 FX Series Energy Platform is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes.
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
Valleylab FX8 FX Series Energy Platform is used in hospitals and other health care facilities where surgical procedures are carried out.
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
Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
System verification showed that the Valleylab FX8 FX Series Energy Platform has all required functionality and that it meets system specifications.
Software verification and validation testing was conducted and documentation provided in accordance with FDA's, Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 2, 2017
Covidien LLC Ms. Sharon McDermott Sr. Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K172757
Trade/Device Name: Valleylab FX8 FX Series Energy Platform Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 11, 2017 Received: September 13, 2017
Dear Sharon 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, 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 of medical 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.
1
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 (DICE) 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. 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 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 (DICE) 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, Jennifer R. Stevenson -S3
For 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
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Indications for Use
510(k) Number (if known) K172757
Device Name Valleylab FX8 FX Series Energy Platform
Indications for Use (Describe)
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
| Type of Use (Select one or both, as applicable) | |
|---|---|
لله | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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6 510(k) Summary
510(k) Summary
Date summary prepared: November 1, 2017
510(k) Submitter/Holder
Covidien 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@medtronic.com
Identification of Device
| Trade Name: | Valleylab™ FX8 FX Series Energy Platform |
|---|---|
| Catalog Number: | VLFX8GEN |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) |
ldentification of Predicate Device
| Trade/Proprietary Name: | Valleylab FT10 Energy Platform |
|---|---|
| Common/Usual Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Class/Panel: | Class II, General and Plastic Surgery |
| Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| 510(k) Submitter / Holder: | Covidien |
| 5920 Longbow Drive | |
| Boulder, CO, 80301 | |
| Predicate 510(k) #: | K151649, K170170 |
Identification of Reference Predicate
| Trade/Proprietary Name: | Force FX Generators |
|---|---|
| Common/Usual Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Class/Panel: | Class II, GEI, 21 CFR 878.4400 |
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| 006_510(k) Summary | K172757 | Page 2 of 3 |
|---|---|---|
| 510(k) Submitter / Holder: | Covidien | |
| 5920 Longbow Drive | ||
| Boulder, CO, 80301 | ||
| 510(k) #: | K944602, K143161 |
A reference predicate, Force FX Electrosurgical Generators, (K944602, K143161) was used for comparison testing of the "FX Bipola" modes included on the subject Valleylab FX8 FX Series Energy Platform.
Substantial Equivalence Overview
The proposed Valleylab FX8 FX Series Energy Platform was compared and found to be substantially equivalent to the predicate Valleylab FT10 Energy Platform. Characteristics identified as important for substantial equivalence comparison purposes are shown in the tables below, and similarities and differences of aspects found to be relevant to the potential impact on safety and performance are discussed in this section. None of the differences raise new questions of safety or effectiveness when compared to the predicate device.
Valleylab FX8 FX Series Energy Platform is used in hospitals and other health care facilities where surgical procedures are carried out.
Valleylab FX8 FX Series Energy Platform can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The Valleylab FX8 FX Series Energy Platform connects to electrical mains and operates at an input line frequency of 47-63 Hz.
Principle of Operation
Valleylab FX8 FX Series Energy Platform is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes.
Indications for Use
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Technological Characteristics
The technological characteristics of the proposed Valleylab FX8 FX Series Energy Platform are the same as the predicate, VLFT10. Both are full-featured general-surgery energy platform. The monopolar and bipolar sections of the generator are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.
During monopolar electrosurgery, radio frequency (RF) energy exits/enters a monopolar pencil and electrode in high concentration and disperses as it enters/exits the return pad. The concentration of energy at the monopolar pencil in conjunction with tissue characteristics produces heat that provides the desired surgical effect.
5
Performance Characteristics
Extensive verification and validation activities were successfully completed that the Valleylab FX8 FX Series Energy Platform performs as intended and is substantially equivalent to its predicate, VLFT10. Testing included the following:
- Compliance with Electrical Safety and EMC standards:
| IEC 60601-1:2005/A1:2012 | Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance – Edition 3.1 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2014 | Medical electrical equipment, Part 1-2: General requirements
for basic safety and essential performance – Collateral
standard: Electromagnetic compatibility – Requirements and
tests |
| IEC 60601-2-2:2009 | 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 5.0 |
- Ex vivo testing using porcine tissue showed comparable performance with regard to thermal ● effects.
- System verification showed that the Valleylab FX8 FX Series Energy Platform has all required functionality and that it meets system specifications.
- Software verification and validation testing was conducted and documentation provided in accordance with FDA's, Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices
The minor differences that were seen during testing are consistent with design changes and do not raise safety or effectiveness concerns.
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion
Verification and validation testing demonstrates the proposed Valleylab FX8 FX Series Energy Platform is substantially equivalent to the predicate, Valleylab VLFT10 Energy Platform. The two electrosurgical generators have the same intended use and fundamental technology with the exception that the subject platform does not include vessel sealing functionality. The new generator has similar performance when compared to the predicate device. The differences do not raise any new questions of safety and efficacy when compared with the predicate.