(101 days)
No
The description mentions a microcontroller-based device with closed-loop control and tissue sensing circuitry that adjusts output based on electrical resistance. This is standard control system technology, not indicative of AI or ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for ML-based devices.
Yes
The device is used to seal (fuse) vessels and tissue during surgical procedures, which is a direct therapeutic intervention to stop bleeding and aid in healing.
No
This device is an electrosurgical generator designed to seal and divide vessels and tissue during surgical procedures; it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is an "electrosurgical generator" and a "microcontroller-based device," indicating it is a hardware device with embedded software (firmware) for control. It also mentions "tissue sensing circuitry" and the application of "radio frequency (RF) energy," which are hardware components and functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Valleylab LS10 is an electrosurgical generator used during surgery to seal vessels and tissue using radio frequency energy. It directly interacts with the patient's body during a surgical procedure.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is to apply energy to tissue in situ.
Therefore, the device's intended use and mechanism of action clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Valleylab LS10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure vessel sealing technology.
The vessel sealing function is indicated for use in sealing (fusing) vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal.
Refer to each instrument's instructions for use (IFU) for additional indications, warnings, and specific contraindications.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures
Product codes
GEI
Device Description
Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN) is a bipolar electrosurgical generator with LigaSure™ vessel sealing output mode. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for LigaSure™ mode implemented in the microcontroller firmware. It incorporates tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.
The generator is used with compatible LigaSure™ instruments to ligate (seal) and divide (cut) vessels up to and including 7mm, tissue bundles, and lymphatics during the general surgical procedures using radio frequency (RF) energy. When a LigaSure™ instrument is applied to a vessel or tissue bundles, and RF energy is activated by the generator, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor within the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (including pulmonary), tissue bundles, lymphatics
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)
Evidence of safety and effectiveness were obtained from bench testing and preclinical testing.
Bench testing to support the intended use of this generator includes:
- Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2
- Testing in accordance with IEC 60601-1-2
- Software verification and validation in accordance with IEC 62304
- Engineering and functional testing including system, mechanical, electrical and general functional testing
- Renal and pulmonary burst pressure
- Thermal profile of the device including maximum external jaw temperature, external jaw cool down time, and maximum shaft temperature
Preclinical testing includes:
- Sealing and dividing vessels up to and including 7 mm
- Ability to achieve hemostasis of tissue, vessels, tissue bundles
- Thermal spread
- Lymphatic burst pressure
- Chronic animal study
The results of the testing demonstrate that the proposed Valleylab™ LS10 generator operated as intended and is substantially equivalent to the predicate generator, ForceTriad™.
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2015
Covidien Mr. Donald Henton Regulatory Affairs Manager 5920 Longbow Drive Boulder, Colorado 80301
Re: K143654
Trade/Device Name: Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 6, 2015 Received: March 9, 2015
Dear Mr. Henton:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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.
Jennifer R. Stevenson -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVIGES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
ValleylabTM LS10. LS Series Single Channel Vessel Sealing Generator (VLLS10GEN)
Indications for Use (Describe)
The Valleylab LS10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure vessel sealing technology.
The vessel sealing function is indicated for use in sealing (fusing) vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal.
Refer to each instrument's instructions for use (IFU) for additional indications, warnings, and specific contraindications.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures
| 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."
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Image /page/3/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a light blue vertical line running through the center of the square. To the right of the square is the word "COVIDIEN" in blue, sans-serif font.
510(k) Summary
Date summary prepared: 12/12/2014
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Donald Henton Regulatory Affairs Manager Telephone: 303-530-6451 Fax: 303-530-6313 Email: donald.henton@covidien.com
Name of Device
| Trade Name: | Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator |
|---|---|
| Catalog Numbers: | VLLS10GEN |
| Common Name: | Bipolar Electrosurgical Vessel Sealing Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, Class II, GEI). |
Predicate Device
The Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN) was compared to and found to be substantially equivalent to the following products of comparable type in commercial distribution:
| Trade Name: | ForceTriad™ Electrosurgical Generator |
|---|---|
| Device Common Name: | Bipolar Electrosurgical Generator |
| Catalog Number: | ForceTriad |
| 510(k) Number: | K110268 (cleared 05/31/2011) |
| Manufacturer: | Covidien |
Device Description
Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN) is a bipolar electrosurgical generator with LigaSure™ vessel sealing output mode. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for LigaSure™ mode implemented in the microcontroller firmware. It incorporates tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.
4
The generator is used with compatible LigaSure™ instruments to ligate (seal) and divide (cut) vessels up to and including 7mm, tissue bundles, and lymphatics during the general surgical procedures using radio frequency (RF) energy. When a LigaSure™ instrument is applied to a vessel or tissue bundles, and RF energy is activated by the generator, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor within the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
Indications for Use
The Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure™ vessel sealing technology.
The vessel sealing function is indicated for use in sealing (fusing) vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal.
Refer to each instrument's instructions for use (IFU) for additional indications, warnings, and specific contraindications.
The LigaSure™ system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures
Technological Characteristics
Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN) has the equivalent LigaSure sealing performance with updated technological characteristics including improved electronics and microprocessors for energy delivery, simplified user interface, integrated radio frequency identification (RFID) technology, smaller overall dimensions, and the addition of a USB port as compared to the predicate, ForceTriad™. Valleylab™ LS10 generator incorporates LigaSure™ technology that provides precise energy delivery with electrode pressure on vessels to achieve a complete and permanent vessel seal.
Valleylab™ LS10 generator has one LigaSure™ port in the front panel allowing for connection of a single LigaSure" instrument, and provides a footswitch port in the rear panel to be used with compatible LigaSure™ single pedal footswitch. It provides visual and audible indicate the compatibility of instruments/footswitch and shows the status of seal cycle until the seal cycle is complete.
Valleylab™ LS10 generator is compatible with intelligent instruments that include a Radio Frequency Identification (RFID) tag and/or Aztec barcodes in the housing of the instrument cable plug. The RFID module is located above the LigaSure™ port of the generator, and is intended to identify the inserted LigaSure™ instrument and configure the generator with the data included in the RFID tag. The RFID tag on the instrument will be read by the proposed generator prior to scanning the barcode label upon detecting an instrument insertion.
Valleylab™ LS10 generator provides a USB Port used for remote service, data output, and data input. It can be connected with Covidien Valleylab 100 Exchange Platform to download the software for the purpose of generator configuration and data exchange.
Performance
Evidence of safety and effectiveness were obtained from bench testing and preclinical testing.
Bench testing to support the intended use of this generator includes:
48
5
- Testing in accordance with IEC 60601-1 ●
- Testing in accordance with IEC 60601-2-2 ●
- Testing in accordance with IEC 60601-1-2
- Software verification and validation in accordance with IEC 62304
- Engineering and functional testing including system, mechanical, electrical and general functional testing
- Renal and pulmonary burst pressure
- . Thermal profile of the device including maximum external jaw temperature, external jaw cool down time, and maximum shaft temperature
Preclinical testing includes:
- Sealing and dividing vessels up to and including 7 mm ●
- . Ability to achieve hemostasis of tissue, vessels, tissue bundles
- Thermal spread
- Lymphatic burst pressure ●
- . Chronic animal study
Conclusion
The results of the testing demonstrate that the proposed Valleylab™ LS10 generator operated as intended and is substantially equivalent to the predicate generator, ForceTriad TM