The Valleylab LigaSure Advance™ is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSure™ tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriad™ energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of enterotomies or gastrotomies is desired.

Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, ctc.

The Valleylab LigaSure Advance™ can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.

The Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Device Description

The LigaSure Advance™ is a 5mm laparoscopic vessel sealer and divider with integrated monopolar capability for energy-based dissection. The Valleylab LigaSure Advance™ is for use only with the Valleylab ForceTriad™ energy platform (electrosurgical generator), reference 510(k) notification K051644. The device will be offered in two lengths, 34 cm and 44 cm.

The LigaSure Advance™ device will be used to seal vessels, including lymph vessels, up to and including 7mm in diameter and tissue bundles. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that will reside within the shaft of the instrument and extends forward in a slot within the jaws when actuated by a mechanism residing within the handle of the device.

The monopolar capabilities of the device will be used to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). This is accomplished through a small electrode that protrudes from the distal end of one of the jaws of the device.

The controls for the device are all located on the handle. The instrument attaches to the generator with "smart" connectors, that identify the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

AI/ML Overview

The Valleylab LigaSure Advance™ is a laparoscopic electrosurgical instrument with both monopolar and bipolar (LigaSure™ tissue fusion) functionality. It is intended for use in general and gynecological laparoscopic surgical procedures for vessel ligation and division, and for electrical dissection, enterotomies, and gastrotomies using its monopolar feature. The device can be used on vessels up to 7mm in diameter and tissue bundles that fit within its jaws.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it states that "Performance testing and pre-clinical studies were performed to ensure that the LigaSure Advance™ functions as intended, and meets design specifications." The overall acceptance criterion is that the device is "substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

Acceptance Criteria (Implied)	Reported Device Performance
Functions as intended	Confirmed by performance testing and pre-clinical studies.
Meets design specifications	Confirmed by performance testing and pre-clinical studies.
Substantially equivalent to predicate devices (LigaSure LS1500 and Laparoscopic Electrode E2774-28)	Sufficient data obtained to demonstrate substantial equivalence.
Meets safety and effectiveness criteria	Sufficient data obtained to demonstrate safety and effectiveness.
Seals vessels up to 7mm in diameter	Device is specified to seal vessels up to 7mm.
Mechanically divides sealed areas/tissue	Device incorporates a mechanical knife for division.
Monopolar electrode for electrosurgical division/dissection	Device incorporates a monopolar electrode for this purpose.

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

The document mentions "Performance testing and pre-clinical studies" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of pre-clinical studies for a medical device prior to market release, it is highly likely that these were prospective studies, typically conducted in animal models or ex vivo tissue models.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

This device is an electrosurgical instrument for use by surgeons; it is not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm is not applicable to this device. The performance testing would inherently involve the device being used by operators (likely skilled surgeons or technicians) in pre-clinical settings.

7. The Type of Ground Truth Used:

The document does not explicitly state the specific type of ground truth used for performance testing. However, for a surgical device like this, ground truth would typically involve:

Direct observation and measurement of seal integrity, burst pressure of sealed vessels, tissue damage, cutting effectiveness, and performance of monopolar dissection in pre-clinical models (e.g., animal studies, ex vivo tissue).
Histopathological assessment of sealed tissues to confirm effective vessel occlusion and absence of thermal damage affecting surrounding structures.
Functional assessment of mechanical knife deployment and cutting.

8. The Sample Size for the Training Set:

This device is a hardware electrosurgical instrument, not an AI algorithm that requires a training set. Therefore, the concept of a "training set" sample size is not applicable.

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

As explained above, this device is not an AI algorithm, so there is no training set and therefore no ground truth established for a training set.

Summary

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K 063195

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Valleylab LigaSure Advance™

Page 1 of ③

Submitter Information 1.

NOV 2 9 2006

Valleylab 5920 Longbow Drive Boulder, CO 80301 Contact: Charles Copperberg Telephone: 303-530-6469

Date summary prepared: October 18, 2006

Name of Device 2.

Trade or Proprietary Name: LigaSure Advance™

Common Name: Monopolar and Bipolar Laparoscopic Electrosurgical Instrument

Classification Name:

Electrosurgical Cutting and Coagulation Device and Accessories, and .
Gynecologic Electrocautery and Accessories .

Predicate Devices 3.

The Valleylab LigaSure Advance™ is substantially equivalent to the Valleylab LigaSure™LS1500 (K031011 and K043273) and the Valleylab Laparoscopic Electrode E2774-28 (K904560 and K964175).

The LigaSure Advance™ and the LigaSure™ LS1500 are used in laparoscopic surgery to seal vessels by the application of RF enerqy to the vessels and tissues interposed between the jaws of the instrument. Both incorporate a mechanical cutter to cut the tissue after sealing.

In addition, the LigaSure Advance™ also includes a monopolar electrode extending from one of the jaws of the device which can be used for monopolar dissection of tissue planes similar to the Valleylab Laparoscopic electrode, E2774-28.

4. Device Description

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K063195

Page 2 of (3)

5. Intended Use

The Valleylab LigaSure Advance™ is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSure™ tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriad™ energy platform (electrosurgical generator)in general and gynecological, laparoscopic, surgical procedures where ligation and division of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of enterotomies or gastrotomies is desired.

The LigaSure function of the instrument creates a seal by the application of RF electrosurgical energy to vascular structures interposed between the jaws of the instrument. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that will reside within the shaft of the instrument and extends forward in a slot within the jaws.

Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic qastric bypass, laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, laparoscopic colectorny, adhesiolysis, oophorectomy, etc.

The Valleylab LigaSure Advance™ can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.

The Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.

6. Summary of Technological Characteristics

The LigaSure Advance™ has the same basic technological characteristics as the predicate LigaSure device and the laparoscopic electrode noted above. The LigaSure

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K063195

Page 3 of (3)

Advance™ will seal vessels (including lymph vessels) using bipolar RF energy and can mechanically divide the sealed areas or tissue with a mechanical cutting device incorporated into the shaft and jaws. In addition, the device also incorporates a monopolar electrode on one jaw for electrosurgical division of tissue.

7. Performance Data

Performance testing and pre-clinical studies were performed to ensure that the LigaSure Advance™ functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and two intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Valleylab, Inc. % Mr. Charles Copperberg Manager, Regulatory 5920 Longbow Drive Boulder, Colorado 80301-3299

NOV Z 9 2006

Re: K063195

Trade/Device Name: LigaSure Advance™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 19, 2006 Received: October 20, 2006

Dear Mr. Copperberg:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 -- Mr. Charles Copperberg

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 《 0 6 3 | 9 5

Device Name: LigaSure Advance™

Indications for Use:

The Valleylab LigaSure Advance™ can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.

The Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Prescription Use ✔ (Part 21 CFR801 Subpart D)

AND/OR

Over-The-Counter Use (21CFR801 Subpart C) .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pdh²

Division of General, Rest Back Bat and Neurological Devices

(Posted November 13, 2003)

510(k) Number

Page 1 of 1

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.