The LigaSure™ Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSure™ Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF anerizy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.

Indications for use include general, open procedures including urologic, vascular, thoracic, and plastic and reconstructive, procedures where dissection, ligation and division of vessels are performed such as: spleenectomies, thryoidectomies, nephrectomies, prostatectomies, bowel resection are clobe vomy.

The LigaSure Vessel Sealing System 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 Open Dissector Divider is a multi-functional, electrosurgical instrument intended for use with the LigaSure Vessel Sealing Generator (K981916) when performing open surgery. The instrument is capable of sealing and dividing vessels and tissue clamped between its jaws, grasping tissue, and dissection. Sealing of vessels and tissue containing vessels can be activated using the activation button on the device or via a footswitch. The instru incorporates a mechanical cutting mechanism that divides tissue.

The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single-use.

AI/ML Overview

The provided text describes the Valleylab LigaSure™ Open Dissector Divider (K041587) and its clearance by the FDA without extensively detailing specific acceptance criteria or a comprehensive study report in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against pre-defined acceptance criteria.

However, based on the information provided, I can infer and extract some relevant details regarding the device's performance and the nature of the evaluation.

Inferred Acceptance Criteria and Reported Device Performance (based on the summary's scope):

The document states that performance (bench) testing and a preclinical study were conducted to ensure the device "functions as intended" and "meets design specifications," and that "sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." While specific numerical targets for acceptance criteria are not explicitly given, the general criteria can be inferred from the device's intended use and comparison to predicates.

Acceptance Criteria (Inferred from intended use and comparison to predicates)	Reported Device Performance (as stated or implied)
Ability to seal and divide vessels up to 7mm in diameter.	The device can be used for vessels up to and including 7 mm in diameter. Performance data from bench testing and preclinical studies deemed sufficient to show effectiveness.
Ability to seal and divide tissue bundles as large as will fit into the jaws.	Tissue bundles as large as will fit into the jaws of the instrument can be sealed and divided. Performance data from bench testing and preclinical studies deemed sufficient to show effectiveness.
Effective ligation through application of bipolar RF energy and pressure.	Device creates ligation by application of bipolar electrosurgical RF energy and pressure. Performance data from bench testing and preclinical studies deemed sufficient.
Effective transection using the built-in cutting mechanism.	Ligation can then be transected using the built-in cutting mechanism. Performance data from bench testing and preclinical studies deemed sufficient.
Functional with the LigaSure Vessel Sealing Generator (K981916).	Instrument intended for use with the LigaSure Vessel Sealing Generator. The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type.
Substantial equivalence to predicate devices (Valleylab LS1200 LigaSure™ Precise Instrument for configuration, sealing, dissection; Valleylab LS1500 LigaSure™ 5mm Laparoscopic Sealer-Divider Instrument for cutting).	The sponsor determined and the FDA concurred that the device is substantially equivalent to the listed predicate devices based on technological characteristics and performance data.
Safety and effectiveness in open, general, and gynecologic surgical procedures for specified indications (e.g., spleenectomies, thyroidectomies).	Performance data from bench testing and preclinical studies deemed sufficient to show it meets safety and effectiveness criteria for its intended use.

Study Details:

The provided text only briefly mentions the types of studies conducted without providing extensive details on their methodology or results.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only states "Performance (bench) testing and a preclinical study were done."
- Data Provenance: Not specified, but generally, bench testing and preclinical studies for FDA submissions are conducted domestically (USA) or in accredited labs globally. The document does not indicate if it was retrospective or prospective, though preclinical studies are inherently prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention the involvement of experts in establishing ground truth for the performance studies, other than the general oversight and review by the manufacturer's regulatory and R&D teams.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document does not describe any expert adjudication process for the performance testing.
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. This device is an electrosurgical instrument, not an AI/imaging device. Therefore, an MRMC study with human readers/AI assistance is not applicable to its evaluation. The "improvement with AI vs. without AI" is not relevant here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Performance (bench) testing" and "preclinical study" described are likely standalone evaluations of the device's physical and functional capabilities, independent of human interaction for interpretation (as would be the case for an imaging algorithm). The device's performance (e.g., sealing strength, cutting efficacy) is assessed directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing, ground truth would be based on engineering specifications and measurements (e.g., burst pressure for sealed vessels, tensile strength, cut precision).
- For the preclinical study, ground truth would involve direct observation, potentially physiological measurements, and possibly pathology if tissue samples were analyzed for sealing integrity or thermal damage. The document does not specify.
The sample size for the training set:
- Not applicable. This device is a physical electrosurgical instrument, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Valleylab LigaSure™ Open Dissector Divider

K041587

Submitter Information 1.

Valleylab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Charles M. Copperberg Manager, Regulatory Telephone: 303-530-6247

Page ① of 2

Date summary prepared: September 20, 2004

Name of Device 2.

Trade or Proprietary Name: LigaSure™ Open Dissector Divider, Catalog Number LS4100

Common Name: Bipolar, Open Electrosurgical Instrument

Classification Name:

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

Predicate Devices 3.

The LigaSure™ Open Dissector Divider (catalog number LS4100) is substantially equivalent to the following legally marketed devices:

For configuration, sealing and dissection capabilities the LS4100 is . substantially equivalent to the Valleylab LS1200 LigaSure™ Precise Instrument (K010010)
For cutting capabilities, the LS4100 is substantially equivalent to the Valleylab . LS1500 LigaSure™ 5mm Laparoscopic Sealer-Divider Instrument (K031011)

4. Device Description

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Page ② of 2

using the activation button on the device or via a footswitch. The instru incorporates a mechanical cutting mechanism that divides tissue.

5. Intended Use

The LigaSure™ Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in open, general and gynecologic surgical procedures where ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF energy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.

The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

6. Summary of Technological Characteristics

The LigaSure™ Open Dissector Divider has the same basic technological characteristics as the predicate devices noted above.

7. Performance Data

Performance (bench) testing and a preclinical study were done to ensure that the LigaSure™ Open Dissector Divider 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/2/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 eagle with three stripes extending from its head, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Public Health Service

SEP 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles M. Copperberg Manager, Regulatory Valleylab 5920 Longbow Drive Boulder, Colorado 80301

Re: K041587

K041387
Trade/Device Name: LigaSure™ Open Dissector Divider Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFR 078. Proo
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 14, 2004 Received: September 15, 2004

Dear Mr. Copperberg:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interestate referenced above and have determined the arrest and devices marketed in interstate for use stated in the encrosure) to regally manated provice Amendments, or to commerce prior in May 28, 1970, the classified in accordance with the Federal Food, Drug, devices that have been icclassified in accerative who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous actuals groups and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general magatesti You may, merceiole, market the devices, boojes requirements for annual registration, listing of general controls provisions of the Her Herman somments of and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (soc aboro) ins. Existing major regulations affecting your device can may be subject to such additional controller is notions.
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachas oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meant Please be advised that I DA 3 issuance or our device complies with other requirements of the Act that TDA has made a decormination administered by other Federal agencies. You must of any Federal statutes and regulations annualing, but not limited to: registration and listing (21 comply with an the Act 3 requirements, morealing practice requirements as set CFK Fart 807), fabeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charles M. 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 premaintented 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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 Usc

510(k) Number (if known): K041587

Device Name: LigaSure™ Open Dissector Divider

Indications for Use:

The LigaSure Vessel Sealing System 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 X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Page | of | |

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Ko 41587

(Posted November 13, 2003)

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.