The 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. Procedures 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 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.

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 general surgery and such surgical specialities 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 sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The 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, veins, pulmonary 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.

Device Description

The LigaSure™ Sealer/Dividers are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a knife, which divides the tissue along the seal line.

AI/ML Overview

This document is a 510(k) premarket notification for electrosurgical devices (LigaSure Sealer/Dividers). It primarily concerns a change in the indications for use for existing, legally marketed devices, rather than the introduction of a completely new device or a new AI algorithm. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria and performance studies in the context of AI (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) is largely not applicable to this document.

The document discusses performance in the context of the physical device's functionality and safety, not the performance of an AI algorithm.

Here's an analysis based on the provided text, addressing your questions where applicable and explaining why some are not relevant:

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

The document does not provide explicit acceptance criteria in the format of a table with numerical targets for performance metrics like sensitivity, specificity, or accuracy that would typically be associated with an AI device. Instead, it refers to general performance testing for electrosurgical devices.

The "reported device performance" is described qualitatively as:

Compatibility with the ForceTriad™ Energy Platform.
Ability to seal and divide vessels up to and including 7 mm.
Ability to achieve hemostasis of tissue and vessels.
Ability to fuse tissue bundles.
Maintenance of hemostasis during recovery from surgery.
Lack of delayed adverse events in chronic animal studies.

A simplified interpretation of "acceptance criteria" related to the device's functionality, derived from the "Performance" section:

Acceptance Criteria (Inferred from Performance Testing)	Reported Device Performance
Compliance with electrical safety standards	Testing in accordance with IEC 60601-1 and IEC 60601-2-2.
Mechanical functionality and integrity (e.g., blade return, grasping, jaw force, button/knife deployment, lever force)	Mechanical testing performed, including blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, and lever force.
Effective vessel sealing and burst pressure resistance	Renal and pulmonary vessel burst pressure testing performed. Sealing and dividing vessels up to and including 7 mm demonstrated.
Ability to achieve and maintain hemostasis for tissue and vessels	Demonstrated ability to achieve hemostasis of tissue and vessels. Chronic animal study demonstrated hemostasis is maintained during recovery from surgery and no delayed adverse events.
Tissue fusion capability	Demonstrated ability to fuse tissue bundles.
Acceptable thermal spread	Thermal spread measurements performed. (No specific threshold or result provided, but implied to be acceptable for the intended use and safety profile). For LF1212A, indicated for ENT procedures 2-3 mm away from thermally-sensitive structures.
Lymphatic vessel sealing and burst pressure resistance	Lymphatic vessel burst pressure testing performed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench and preclinical testing" and "chronic animal study," but does not specify sample sizes (e.g., number of vessels, animals) or data provenance (country, retrospective/prospective nature). This is typical for submissions focused on physical device modifications or indications without AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The performance studies are related to the physical electrosurgical functionality (e.g., burst pressure, hemostasis, thermal spread), not diagnostic interpretations or image analysis that would require expert human review to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessment, which is not the case for the physical performance testing described here.

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

This information is not applicable. This document is not about an AI device, so MRMC studies involving human readers improving with AI assistance are irrelevant.

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

This information is not applicable. The device is a physical electrosurgical instrument, not an algorithm.

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

The "ground truth" for the performance studies would be based on:

Physical measurements and scientific principles: e.g., pressure sensors for burst pressure, thermometers for thermal spread, visual inspection and objective criteria for hemostasis, histological analysis in chronic animal studies for tissue fusion and adverse events.
Compliance with engineering standards: IEC 60601-1, IEC 60601-2-2.

There's no mention of human-interpreted ground truth like expert consensus or pathology reports in the context of determining the device's fundamental physical performance.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no "training set."

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

This information is not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant.

In summary: K141153 is a 510(k) submission for changes to the Indications for Use of existing electrosurgical devices, not for a new AI/ML device. Therefore, most of the requested information pertaining to AI algorithm evaluation (sample sizes, expert ground truth, MRMC studies etc.) is not present or applicable in this document. The "performance" section describes engineering and preclinical testing for the physical function and safety of the electrosurgical tools.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be made of flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2014

Covidien Ms. Nancy Sauer Regulatory Affairs Product Manager 5920 Longbow Drive Boulder, Colorado 80301

Re: K141153 Trade/Device Name: LigaSure Sealer / Dividers, Models LF1212A, Precise Plus, LF1637, LF1720, LF1737, LF1744, and LF4318 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 19, 2014 Received: May 20, 2014

Dear Ms. Sauer:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Sincerely yours,

David Krause -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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Indications for Use

510(k) Number (if known) K141153

Device Name

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

Indications for Use (Describe)

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lympatics 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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Indications for Use

510(k) Number (if known) K141153

Device Name

5 mm Blunt Tip Sealer/Divider (LF1637) Maryland Jaw Sealer/Dividers One Step Sealing (LF1720, LF1737, LF1744)

Indications for Use (Describe)

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 general surgery and such surgical specialities as urologic, vascular, and gyneoologic. 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

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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Indications for Use

510(k) Number (if known) K141153

Device Name

Impact Curved, Large Jaw, Open Sealer/Divider (LF4318)

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

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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Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square in the center and a light blue vertical line and horizontal line. To the right of the square is the word "COVIDIEN" in blue sans-serif font.

510(k) Summary

Date summary prepared: 5/19/14

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Nancy Sauer Regulatory Affairs Product Manager Telephone: 303-581-6791 Fax: 303-530-6313 Email: nancy.sauer@covidien.com

Name of Device

Trade Name:	LigaSure™ Tissue Sealer/Dividers
Catalog Numbers:	LF1212A, LF 1637, LF1723, LF1737, LF1744, LF4318, LF5544
Common Name:	Bipolar Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI).

Predicate Devices

All of these devices are legally marketed devices, manufactured by Covidien llc. Each instrument serves as its own predicate device. The 510(k) numbers for these devices are listed below.

K113572: Precise Plus (LF1212A) ●
K130744: 5mm Blunt Tip Instrument (LF1637)
K133338: Maryland Instruments (LF1723, LF1737, LF1744) ●
K123444: Impact Instrument (LF4318) ●

Device Description

Indications for Use

This 510(k) is for changes to the indications for use of these devices. The indications for use vary slightly among the devices included in this 510(k) premarket notification.

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LF1212A:

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.

LF1637, LF1723, LF1737, LF1744:

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 specialities 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 sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

LF4318:

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.

Technological Characteristics

The LigaSure™ Sealer/Dividers work in conjunction with Covidien electrosurgical generators. They use bipolar radiofrequency energy to seal tissues, blood vessels, and lymphatics. The devices also use mechanical action to divide tissue along the seal line.

The Advance instrument works in conjunction with Covidien electrosurgical generators to deliver monopolar energy for tissue dissection and creation of openings in organs.

There are no changes in technical characteristics, only a restatement of the indications for use.

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Performance

Evidence of safety and effectiveness was presented in the previously submitted 510(k)s, which also demonstrated the compatibility of these instruments with the ForceTriad™ Energy Platform. Supporting data obtained from both bench and preclinical testing to support the indications for use of this device family includes:

. Testing in accordance with IEC 60601-1
Testing in accordance with IEC 60601-2-2
. Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever force, and power curve performance
. Renal and pulmonary vessel burst pressure testing

Preclinical testing for this device family includes:

Sealing and dividing vessels up to and including 7 mm
. Ability to achieve hemostasis of tissue and vessels
Ability to fuse tissue bundles
Thermal spread measurements
Lymphatic vessel burst pressure
. Chronic animal study to demonstrate that hemostasis is maintained during recovery from surgery and to demonstrate lack of delayed adverse events

Conclusion

The previously submitted data remain valid, and the devices with the restated indications for use remain substantially equivalent to the devices with the original indications for use statements.

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.