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

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN). The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a quantitative format typical for AI/ML device performance alongside reported device performance. Instead, it focuses on demonstrating that the new device (VLLS10GEN) operates "as intended" and is "substantially equivalent" to its predicate device (ForceTriad™ Electrosurgical Generator) through various bench and preclinical tests.

The performance is primarily evaluated against established medical device standards and functional objectives, rather than specific numerical thresholds for a diagnostic outcome that would have clear acceptance criteria (e.g., sensitivity > X%, specificity > Y%).

Acceptance Criteria (Implied from testing intent)	Reported Device Performance (Summary from submission)
Compliance with Electromedical Safety Standards (IEC 60601-1, 60601-2-2)	Demonstrated compliance through testing.
Compliance with Electromagnetic Compatibility (EMC) Standards (IEC 60601-1-2)	Demonstrated compliance through testing.
Software Verification & Validation (IEC 62304)	V&V performed in accordance with standards.
Engineering, Mechanical, Electrical, and General Functional Testing	Device operated as intended, demonstrating proper function.
Vessel Sealing Performance: Up to 7mm vessel sealing (e.g., maintaining burst pressure)	Demonstrated ability to seal and divide vessels up to and including 7mm.
Hemostasis of tissue and tissue bundles	Demonstrated ability to achieve hemostasis.
Thermal Profile (e.g., max jaw temp, cool down, shaft temp)	Thermal profile characterized; device performed within safe limits.
Lymphatic Burst Pressure	Demonstrated sufficient lymphatic burst pressure.
Chronic Animal Study Outcomes	Performed to assess long-term effects and efficacy. (Specific outcomes not detailed in summary, but implied acceptable).
Equivalent LigaSure sealing performance to predicate	Achieved equivalent LigaSure sealing performance.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of AI/ML models (i.e., a dataset of cases used to evaluate an algorithm's performance). Instead, it refers to various bench and preclinical testing regimes. The sample sizes for these tests are not provided in this summary.

Bench Testing: Includes renal and pulmonary burst pressure, thermal profile, and general functional/electrical/mechanical tests. The number of samples for each specific test (e.g., number of vessels tested for burst pressure) is not disclosed.
Preclinical Testing: Includes animal studies for sealing and dividing vessels, hemostasis, thermal spread, lymphatic burst pressure, and chronic animal studies. The number of animals or vessels/tissues tested is not disclosed.
Data Provenance: The tests were conducted by Covidien, the manufacturer. The location of these tests (e.g., country of origin) is not specified, but Covidien's address is Boulder, Colorado. The data is prospective as it was generated specifically to test the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is generally relevant for AI/ML diagnostic devices where human experts independently review cases to establish a "ground truth" diagnosis. Since this device is an electrosurgical generator, the "ground truth" is established by direct physical measurements and observations during bench and preclinical testing (e.g., direct measurement of burst pressure, visual assessment of hemostasis, pathological examination from animal studies). Therefore:

Number of experts: Not applicable in the traditional sense of human readers reviewing cases.
Qualifications of experts: The scientific and engineering staff conducting the testing would have the relevant qualifications (e.g., biomedical engineers, veterinarians, surgeons performing or observing preclinical studies), but specific numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the AI/ML diagnostic context. The results of the physical and functional tests are typically objective measurements or observations following defined protocols, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/ML diagnostic or assistive tools where human readers are involved in interpreting medical images or data, and the AI's impact on their performance is being evaluated.
The Valleylab™ LS10 is an electrosurgical generator, not a diagnostic AI tool. Its performance is assessed through its physical operation and effect on tissue.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in spirit, standalone performance was done. The entire bench and preclinical testing described (IEC standards compliance, engineering tests, burst pressure, thermal profiles, chronic animal studies) represents the "standalone" performance of the device itself.
The device (generator) operates autonomously to deliver energy and seal vessels, with the surgeon as the operator, not as an "interpreter" of an algorithm's output. The performance metrics listed directly assess the device's functional integrity and its intended biological effects.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Direct physical measurements: Pressure readings for burst pressure, temperature measurements for thermal profiles, electrical output measurements.
Pathological assessment: Tissue analysis (e.g., from preclinical animal studies) to confirm seal integrity, thermal spread, and absence of adverse effects.
Functional observation: Direct observation of device operation and its effects during preclinical procedures (e.g., visual confirmation of hemostasis).
Compliance with validated standards: Meeting predefined safety and performance requirements outlined in IEC standards.

8. The Sample Size for the Training Set

Not applicable. This device is hardware (an electrosurgical generator) with embedded firmware/software for control. It is not an AI/ML system that learns from a "training set" of data in the conventional sense (e.g., images for classification).
The device's algorithms (e.g., for tissue sensing and energy adjustment) are programmed based on engineering principles and extensive prior knowledge of electrosurgical physics and biology, not "trained" on a dataset in the way a neural network is.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" for an AI/ML algorithm in this context, there is no ground truth to be established for it. The underlying principles of the device's operation are based on validated scientific and engineering models.

Summary

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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

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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)

K143654

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.

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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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

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Indications for Use

The Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure™ vessel sealing technology.

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:

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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

Regulation Number and Section

§ 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.