The Reprocessed 5 mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is actuated to divide tissue.

Indications for use include general laparoscopic surgical procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vacinal hysterectomy, Nissen fundoplication, colectomy, ad hesiolysis, oophorectomy, etc. The Reprocessed 5mm Vessel Sealer-Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Reprocessed 5mm Vessel Sealer-Divider 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.

Device Description

The Vessel Sealer/divider is an electrosurgical instrument for use with the LigaSure™ Vessel Sealing Generator (not within the scope of this submission). The device is able to seal vessels, divide vessels and tissue clamped between its jaws, grasp tissue, and is capable of blunt dissection. The diameter of the shaft is 5mm and the working length is 37cm. Device controls are located on the instrument handle. The instrument is supplied sterile for single patient use.

AI/ML Overview

The provided 510(k) summary for the Reprocessed LigaSure Vessel Sealer/divider does not contain information typically associated with clinical studies or performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI-assisted workflows. This document primarily focuses on demonstrating substantial equivalence through bench and laboratory testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission defines "performance" as safety and effectiveness demonstrated through specific types of bench and laboratory tests, without providing numerical acceptance criteria or specific quantitative results beyond a general statement of performance.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety: Device meets biocompatibility standards.	Biocompatibility testing was conducted.
Safety: Reprocessing methods are validated.	Validation of reprocessing was conducted.
Safety: Sterilization methods are validated.	Sterilization Validation was conducted.
Effectiveness: Device functions as originally intended.	Function test(s) were conducted. Performance testing demonstrates that Reprocessed Vessel Sealer/dividers perform as originally intended.
Safety/Effectiveness: Packaging maintains sterility and device integrity.	Packaging Validation was conducted.

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

Sample Size: Not specified for any of the tests. The document indicates "Each individual Vessel Sealer/divider is tested for appropriate function of its components prior to packaging and labeling operations," suggesting testing of individual reprocessed units, but a specific sample size for validation studies is not provided.
Data Provenance: The tests are described as "Bench and laboratory testing." This indicates the data is generated in a controlled lab environment. There is no mention of human subject data, country of origin, or whether the data is retrospective or prospective, as this is bench testing.

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

This information is not applicable and not provided in the context of bench and laboratory testing for a reprocessed medical device. "Ground truth" in this context would refer to established engineering and material standards, and the proper functioning of the device as per its original design. The experts involved would likely be engineers, microbiologists, and other technical specialists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Bench and laboratory tests typically involve objective measurements against predefined specifications, rather than expert adjudication of qualitative outcomes.

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 MRMC study was done. This submission is for a reprocessed electrosurgical instrument, not an AI-powered diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study and effect size for human readers with/without AI assistance are not relevant and not discussed.

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

No standalone algorithm performance was done. This device is a physical electrosurgical instrument; it does not contain an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device lies in:

Original Device Specifications and Performance: The reprocessed device is compared against the performance characteristics of the new, original (predicate) LigaSure™ 5mm Laparoscopic Sealer/divider (K031011).
Established Standards: Biocompatibility, sterilization, and packaging tests would adhere to established regulatory standards and best practices for medical device reprocessing and manufacturing.
Functional Parameters: Discrete functional tests (e.g., sealing strength, blade actuation, electrical integrity) measured against specified operational ranges.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a reprocessed medical device's performance validation. The device does not learn or use algorithms that require training data.

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

Not applicable. As there is no training set, this question is not relevant.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its implicitly defined acceptance criteria consisted of a series of bench and laboratory tests. These tests covered:

Biocompatibility: To ensure the reprocessed device is safe for contact with human tissue.
Reprocessing Validation: To confirm that the reprocessing methods effectively clean, disinfect, and prepare the device for reuse.
Sterilization Validation: To ensure the device achieves the required sterility assurance level.
Function Test(s): To verify that all components and mechanisms of the device (e.g., sealing, dividing, grasping, blunt dissection) operate as intended and perform equivalently to a new device. The statement "Each individual Vessel Sealer/divider is tested for appropriate function of its components prior to packaging and labeling operations" suggests a 100% functional check during manufacturing.
Packaging Validation: To confirm the integrity of the packaging over its shelf life and its ability to maintain sterility.

The overall conclusion from these tests was that "Reprocessed Vessel Sealer/dividers perform as originally intended," leading to the determination that they are "safe, effective, and substantially equivalent to the predicate devices." No specific quantitative results or detailed methodologies of these tests are provided in the summary, which is common for 510(k) summaries where the detailed reports are held by the manufacturer.

Summary

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KO62525

SECTION 5: 510(k) SUMMARY

Ascent Healthcare Solutions

Submitter:

Pages 1 of ②

	10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Moira BartonRegulatory Affairs Manager(480) 763-5394 (o)(480) 763-6089 (f)mbarton@ascenths.com	MAY 16 2007
Date of preparation:	March 27, 2006
Name of device:	Trade/Proprietary Name: Reprocessed LigaSure VesselSealer/divider
	Classification Name: Electrosurgical cutting and coagulationdevice and accessories
Predicate DeviceK031011	510(k) TitleLigaSure™ 5mm LaparoscopicSealer/divider	ManufacturerValleylab, Inc.
Device description:	The Vessel Sealer/divider is an electrosurgical instrument foruse with the LigaSure™ Vessel Sealing Generator (not withinthe scope of this submission). The device is able to sealvessels, divide vessels and tissue clamped between its jaws,grasp tissue, and is capable of blunt dissection. The diameter ofthe shaft is 5mm and the working length is 37cm. Devicecontrols are located on the instrument handle. The instrument issupplied sterile for single patient use.
Indications for Use:	Reprocessed Vessel Sealer/dividers are bipolar electrosurgicalinstruments intended for use with the LigaSure Generator ingeneral and gynecologic laparoscopic surgical procedures whereligation and division of vessels is desired. The instrument createsa seal by application of RF electrosurgical energy to vascularstructures (vessels) interposed between the jaws of theinstrument. A blade within the instrument is surgeon-actuated todivide tissue.
	Indications for use include general laparoscopic proceduresincluding urologic, vascular, thoracic and thoracoscopic, andgynecologic laparoscopic procedures where ligation and divisionof vessels is performed, including such procedures aslaparoscopically assisted vaginal hysterectomy, Nissenfundoplication, colectomy, adhesiolysis, oophorectomy, etc.
Technologicalcharacteristics:	The design, materials, and intended use of Reprocessed VesselSealer/dividers are identical to the predicate devices. Themechanism of action of Reprocessed Vessel Sealer/Dividers isidentical to the predicate devices in that the same standardmechanical design, materials, and size are utilized. There areno changes to the claims, intended use, clinical applications,patient population, performance specifications, or method ofoperation. In addition, Ascent Healthcare Solutions'sreprocessing of Vessel Sealer/dividers includes removal ofadherent visible soil and decontamination. Each individualVessel Sealer/divider is tested for appropriate function of itscomponents prior to packaging and labeling operations.
Performance data:	Bench and laboratory testing was conducted to demonstrate

Reprocessed LigaSure Vessel Sealer/divider

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0 62 525

Page 2 of 2

up to and including 7mm diameter, and bundles of tissue as large as will fit in the jaws of the instrument.

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Vessel Sealer/dividers. This included the following tests:

Biocompatibility .
. Validation of reprocessing
. Sterilization Validation
. Function test(s)
t Packaging Validation

Performance testing demonstrates that Reprocessed Vessel Sealer/dividers perform as originally intended.

Conclusion: Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Vessel Sealer/dividers) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2007

Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K062525

Trade/Device Name: Reprocessed LigaSure Vessel Sealer/divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, NUJ Dated: April 2, 2007 Received: April 4, 2007

Dear Ms. Barton:

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 - Ms. Moira Barton

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 vours. 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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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed LigaSure Vessel Sealer/divider

Indications For Use: The Reprocessed 5 mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is actuated to divide tissue.

The Reprocessed 5mm Vessel Sealer-Divider 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.

R.O. Rumm

Division of Genei and Neurological I

510(k) Numbe

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)

Ascent Healthcare Solutions Reprocessed LigaSure Vessel Sealer/divider Traditional 510(k)

Page 10

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To whom it may concern: K062525

· The predicate OEM device is LS1500 LigSure™ 5mm Laparoscopic Sealer/Divider (K031011) manufactured and distributed by Valleylab.
· The reprocessed device is "Reprocessed LS 1500 LigaSure 5mm Laparoscopic Sealer/Divider reprocessed by Ascent Healthcare Solutions

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.