The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Device Description

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

Scissor like design for opening and closing the instrument jaws and activating RF energy. . The mechanism must be held in the closed position during vessel sealing and cutting.
. An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
. A trigger for actuating the blade.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien ForceTriad Energy Platform and Valleylab FT10 Energy Platform.

The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (K220411) and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

AI/ML Overview

The provided text is a 510(k) summary for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It describes the device, its intended use, comparison with predicate devices, and performance data. However, the document does NOT provide detailed acceptance criteria or the specific results of the studies in the format requested. While it lists types of tests performed, it does not specify quantitative acceptance criteria or the reported device performance against those criteria. It also does not explicitly mention sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be answered from the provided text. I will extract what information is available and state when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several functional performance tests but does not explicitly state the quantitative acceptance criteria or the numerical reported device performance for each. It mentions "verification/comparative testing (to the predicate device)" and "evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, and functional attribute tests," suggesting that the reprocessed device performed comparably to the predicate or met general functional expectations for vessel sealing.

Test Category	Specific Test / Performance Metric	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Biocompatibility	Not specified	Not specified	Performed (implied acceptable)
Reprocessing Validation	Not specified (e.g., cleanliness, resterilization efficacy)	Not specified	Validated (implied acceptable)
Sterilization	Not specified	Not specified	Performed (implied acceptable)
Electrical Safety & EMC	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 conformity	Not explicitly stated (e.g., limits, emissions)	Conformed to standards (implied acceptable)
Functional Performance	Blade Trigger Actuation Force	Not specified	Performed (implied acceptable comparable to predicate)
	Clamp Arm Closing and Seal Button Force	Not specified	Performed (implied acceptable comparable to predicate)
	Clamp Arm Opening Force	Not specified	Performed (implied acceptable comparable to predicate)
	Clamp Arm Deflection	Not specified	Performed (implied acceptable comparable to predicate)
	Jaw Clamp Force	Not specified	Performed (implied acceptable comparable to predicate)
	Blade Excursion	Not specified	Performed (implied acceptable comparable to predicate)
	Jaw Opening Angle	Not specified	Performed (implied acceptable comparable to predicate)
	Burst Pressure (for 1mm to 7mm vessels)	Not specified (e.g., minimum pressure)	Performed, evaluated (implied acceptable for intended use)
	Maximum Jaw Temperature	Not specified (e.g., maximum temp limit)	Performed, evaluated (implied acceptable for intended use)
	Device Reliability	Not specified	Performed (implied acceptable)
	Functional Attribute Testing	Not specified	Performed (implied acceptable comparable to predicate)
	Generator Software Compatibility	Not specified	Performed (implied compatible)
Preclinical (Animal Model)	Thermal spread	Not specified (e.g., acceptable thermal spread limits)	Evaluated (implied acceptable for intended use)
	Ability to achieve hemostasis (for vessels of various sizes, 1-7mm)	Not specified (e.g., success rate, time to hemostasis)	Evaluated (implied acceptable for intended use)

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for any of the test sets (bench, laboratory, or preclinical). It mentions "preclinical laboratory evaluations in an animal model," but does not specify the type or number of animals used. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The studies described are primarily bench testing and animal model evaluations, which typically do not involve human expert interpretation for "ground truth" in the way a diagnostic imaging study would.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation where consensus or a tie-breaking mechanism is needed for ground truth. This was not such a study.

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

Not applicable. The device described is an electrosurgical sealer/divider and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical instrument and requires human operation. The performance studies focused on the instrument's functional characteristics and its ability to achieve its intended effect (sealing vessels).

7. The type of ground truth used

For the bench and laboratory testing, the "ground truth" would be objective measurements and established engineering standards (e.g., force, temperature, burst pressure tolerances, electrical safety standards). For the preclinical animal studies, the "ground truth" would be physiological outcomes observed directly (e.g., successful hemostasis, measured thermal spread, histological analysis) compared against expected performance or predicate device performance.

8. The sample size for the training set

Not applicable. This device is a reprocessed surgical instrument, not a machine learning or AI algorithm, so there is no training set in that context. The "training" here refers to the process qualifications and validation of the reprocessing procedure itself.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2023

Stryker Sustainability Solutions Mr. Scott English Principal Regulatory Affairs Specialist 1810 W Drake Drive Tempe, Arizona 85283

Re: K230251

Trade/Device Name: Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: February 28, 2023 Received: March 1, 2023

Dear Mr. English:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MarkTrumbore -S		Digitally signed byMark Trumbore -SDate: 2023.03.2813:08:58 -04'00'
---------------------	--	---------------------------------------------------------------------------------

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230251

Device Name

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

Indications for Use (Describe)

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system 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."

{3}------------------------------------------------

Reprocessed Single-Use Device Model Included in Clearance

Device Model	Device Name	Original Manufacturer
LF1212A	LigaSure Curved, Small Jaw, Open Sealer/Divider	Covidien

{4}------------------------------------------------

510(k) SUMMARY

Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

Contact:

Scott English Principal Regulatory Affairs Specialist 901-451-1456 (o) 480-763-5310 (f) scott.english@stryker.com

Date of Preparation: March 28, 2023

Name of Device:

Trade/Proprietary Name:	Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider(LF1212A)
Common Name:	Electrosurgical cutting and coagulation device and accessories
Classification Information:	Electrosurgical, Cutting & Coagulation Accessories, LaparoscopicEndoscopic, Reprocessed(21 CFR§878.4400, Product Code NUJ, Class II)

Predicate Devices:

510(k)Number	510(k) Title	ProductCode	Manufacturer
K220411	Reprocessed LigaSure Curved, Small Jaw,Open Sealer/Divider	NUJ	Stryker SustainabilitySolutions
K152286	LigaSure Curved, Small Jaw, OpenSealer/Divider	GEI	Covidien

Device Description:

Scissor like design for opening and closing the instrument jaws and activating RF energy. . The mechanism must be held in the closed position during vessel sealing and cutting.

{5}------------------------------------------------

K230251

. An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
. A trigger for actuating the blade.

The instrument is compatible with the Covidien ForceTriad Energy Platform and Valleylab FT10 Energy Platform.

Intended Use:

The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Indications for Use Comparison:

The indications for use for the proposed device are the same in comparison to the predicate device and reference device.

Technological Comparison:

The design, materials, and intended use of the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider are equivalent to the predicate device and reference device. The mechanism of action of the reprocessed device is identical to the predicate device and reference device in that the same standard mechanical design, materials, and size is utilized. There are no changes to the claims, intended use, clinical application, patient population, performance specifications, or method of operation. Stryker Sustainability Solutions'

{6}------------------------------------------------

K230251

reprocessing of the device includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations. The only difference between the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider and the predicate Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider is that the device is reprocessed an additional time. The only differences between the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider and the reference LigaSure Curved, Small Jaw, Open Sealer/Divider are that the device is reprocessed and some device components are replaced with equivalent components during the reprocessing operation.

	Predicate Device	Reference Device	Subject Device
Uses	Single Patient Use	Single Patient Use	Single Patient Use
Device Length	19cm	19cm	19cm
Jaw Length	16.5mm	16.5mm	16.5mm
Jaw Shape	Curved	Curved	Curved
Mechanism for Cutting	Mechanical – Useractuated blade	Mechanical - Useractuated blade	Mechanical – Useractuated blade

Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider. This included the following tests:

Biocompatibility
Validation of Reprocessing ●
Sterilization
Electrical Safety and Electromagnetic Compatibility .
Functional Performance Tests ●
- Blade Trigger Actuation Force O
- Clamp Arm Closing and Seal Button Force o
- Clamp Arm Opening Force O
- Clamp Arm Deflection O
- Jaw Clamp Force O
- Blade Excursion O
- O Jaw Opening Angle
- Burst Pressure O
- Maximum Jaw Temperature O
- Device Reliability O
- Functional Attribute Testing O
- Generator Software Compatibility O

The functional performance testing involved electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, and functional attribute tests.

Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the reprocessed device.

{7}------------------------------------------------

Conclusion:

The results of bench testing and preclinical laboratory evaluations demonstrate that the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein.

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.