The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 gerry and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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 LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (LF19XX) devices are sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy.

A hand actuated lever allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the handle. The proposed devices come in three shaft lengths (23, 37, and 44 cm) and do not contain software.

AI/ML Overview

This document, a 510(k) summary for the LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, does not describe a study involving an AI/ML algorithm or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through pre-clinical performance data, primarily related to the physical and functional characteristics of an electrosurgical device.

Therefore, many of the requested details regarding AI/ML-specific study design (such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable to the information provided in this 510(k) summary.

However, I can extract the acceptance criteria as demonstrated by the device performance tests outlined in the document, which primarily focus on a traditional medical device's safety and efficacy.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present explicit numerical "acceptance criteria" in a table format with corresponding "reported device performance" in the same way one might for an AI/ML model's metrics (e.g., sensitivity/specificity thresholds). Instead, it lists types of performance tests conducted and generally states that the device "performed as expected" or "demonstrated that the subject devices are as safe and effective as the predicate devices."

Implied Acceptance Criteria and Reported Performance (based on tests conducted):

Acceptance Criteria Category (Implied by Test)	Reported Device Performance
Biocompatibility	Compliant with ISO 10993-1.
- Cytotoxicity	(Implicitly passed)
- Sensitization	(Implicitly passed)
- Intracutaneous Irritation	(Implicitly passed)
- Acute Systemic Toxicity	(Implicitly passed)
- Materials Mediated Pyrogenicity	(Implicitly passed)
- Hemolysis	(Implicitly passed)
Electrical Safety and EMC	Compliant with ANSI AAMI ES 60601-1, IEC 60601-2-2, and IEC 60601-1-2.
Mechanical/Functional Testing	"Performed as expected."
- Jaw force	(Implicitly passed)
- Jaw gap	(Implicitly passed)
- Device resistance, capacitance, inductance	(Implicitly passed)
- Jaw Hyper-Extension	(Implicitly passed)
- Reliability Use Case Test	(Implicitly passed)
Ex-vivo Vessel Burst Pressure	Demonstrated "similar bipolar electrosurgical vessel sealing performance" compared to predicate.
Acute Animal Study (Sealing & Thermal)	Demonstrated subject devices are "as safe and effective as the predicate devices."
Chronic Animal Study (Seal Quality)	All animals survived 21 days post-op and all seals maintained chronic hemostasis.

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

Test Set Sample Size:
- Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal arteries and lymphatics" (Number not specified)
- Acute Animal Study: "porcine underwent various procedures" (Number not specified)
- Chronic Animal Study: "All animals" (Number not specified, but this refers to a continuous assessment over 21 days on the animals used in the chronic study).
Data Provenance:
- The animal studies indicate data from in vivo porcine models, which are animal data, not human patient data.
- The ex-vivo studies indicate in vitro data using excised porcine tissue.
- The document does not specify a country of origin for the data, but the submitter is based in Boulder, CO, USA.
Retrospective or Prospective: These are laboratory/pre-clinical studies, so the terms "retrospective" or "prospective" as applied to clinical trials are not directly applicable. They were conducted specifically for this submission.

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

Not Applicable. This device is a physical electrosurgical instrument, not an AI/ML diagnostic device requiring expert interpretation of images or patient data to establish "ground truth." The "ground truth" for its performance is established through direct measurements (e.g., burst pressure), physiological outcomes (e.g., hemostasis in animal models), and adherence to safety standards.

4. Adjudication method for the test set:

Not Applicable. See point 3. The outcomes are objective measurements or direct observations in animal models.

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. This product is an electrosurgical device, not an image analysis or diagnostic AI/ML system. Therefore, MRMC studies involving human readers are not relevant.

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

Not Applicable. No algorithm is involved in the operation of this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this electrosurgical device, the "ground truth" is established by:
- Physical and Electrical Standards: Adherence to defined industry and regulatory standards (e.g., ISO 10993-1, ANSI AAMI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2) for material properties and electrical safety.
- Direct Objective Measurement: Mechanical properties (jaw force, gap), electrical characteristics (resistance, capacitance, inductance).
- Physiological Outcomes in Animal Models: Successful vessel sealing (demonstrated by burst pressure, lack of acute bleeding, chronic hemostasis) and acceptable thermal damage in live porcine models.
- Functional Performance: The device's ability to ligate, divide, grasp, and perform blunt dissection as intended.

8. The sample size for the training set:

Not Applicable. No AI/ML model with a "training set" is described for this device.

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

Not Applicable. No AI/ML model or training set.

In summary, the provided document details the pre-clinical validation of a traditional electrosurgical device, not an AI/ML-enabled medical device. Therefore, the information pertains to physical, electrical, and biological performance characteristics rather than data-driven AI model performance metrics.

Summary

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April 21, 2017

Covidien Mr. Celso Duran Senior Specialist, Regulatory Affairs 5920 Longbow Drive Boulder. Colorado 80301

Re: K170869

Trade/Device Name: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nanocoated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 22, 2017 Received: March 23, 2017

Dear Mr. Duran:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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.

Sincerelv. 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 SERVICES 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)

Device Name

LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated

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)
-------------------------------------------------	--

X 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: 4/21/2017

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Celso Duran Senior Specialist, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com

Name of Device

Trade Name:	LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
Catalog Numbers:	LF1923, LF1937, LF1944
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI)

Predicate Device

Predicate Device
Trade Name:Catalog Numbers:Common Name:Classification Name:510(k) Number:Manufacturer:	LigaSure™ Maryland Jaw Sealer/Divider One-step SealingLF1723, LF1737, LF1744Bipolar Vessel Sealing DeviceElectrosurgical cutting and coagulation device and accessories (21 CFR878.4400, Class II, GEI)K133338 (cleared 12/20/2013), K141153 (cleared 8/14/2014)Covidien
Reference Devices
Trade Name:	LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated
Catalog Number:	LF4418
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR878.4400, Class II, GEI)
510(k) Number:	K162047
Manufacturer:	Covidien
Trade Name:	LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider
Catalog Number:	LF5637 and LF5644
Common Name:	Bipolar and Monopolar Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR878.4400, Class II, GEI)
510(k) Number:	K161804
Manufacturer:	Covidien

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Device Description

Indications for Use

The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.

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.

Comparison of Technological Characteristics with the Predicate Device

The application of radio frequency (RF) energy to target tissue is the fundamental technology for both the subject and predicate devices. A seal is created by application of RF energy to structures (vasculature, lymphatics, and tissue bundles) interposed between the jaws of the instrument. A blade within the instrument is user actuated to divide tissue after the seal is created. At a high level, the subject and predicate devices are based on the following same technological elements:

. Unilateral jaws - used to reach target structures (vasculature, lymphatics, and tissue bundles)
Lever -closes the jaws to grasp the tissue
Activation button - in-line mechanism allows RF energy to be activated by the user
Cutting trigger allows user to divide (cut) sealed structures ●

The only differences between the subject and predicate devices are the addition of a non-stick coating to the jaws of the proposed devices and minor manufacturing changes.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated devices was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process," as recognized by FDA. The battery of testing included the following:

Cytotoxicity ●
Sensitization
Intracutaneous Irritation ●
. Acute Systemic Toxicity
. Materials Mediated Pyrogenicity

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. Hemolysis

Electrical Safety and Electromagnetic Compatibility (EMC)

The system complies with relevant clauses of the ANSI AAMI ES 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.

Mechanical/Functional Testing

Mechanical, electrical, and functional testing was carried out to verify that the proposed devices performed as expected.

Jaw force
Jaw gap
Device resistance, capacitance, and inductance ●
. Jaw Hyper-Extension
Reliability Use Case Test .

Ex-vivo Vessel Burst Pressure

Ex-vivo burst pressure testing of excised fresh porcine renal arteries and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.

Acute Animal Study

In the animal study conducted, porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety of the new device was evaluated. These studies demonstrated that the subject devices are as safe and effective as the predicate devices.

Chronic Animal Study

A chronic study was conducted to assess seal quality over the course of 21 days. All animals survived 21 days post-op and all seals maintained chronic hemostasis.

Clinical Studies

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Summarv

Based on the preclinical performance as documented in the performance testing, the LigaSure™ Maryland Sealer/Divider One-step Sealing, Nano-coated devices were found to have a safety and effectiveness profile that is similar to the predicate devices.

Conclusions

The subject devices have the same indications for use as the legally marketed predicate devices. Furthermore, design changes made to introduce the subject devices do not raise different kinds of safety and effectiveness questions. Verification and validation data support substantial equivalence of the modified LigaSure™ Maryland Sealer/Divider Once-step Sealing, Nanocoated devices to the legally marketed predicate devices.

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.