The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and so forth.

The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.

Device Description

The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).

AI/ML Overview

The provided text does not contain information about the acceptance criteria and study proving a digital health device's performance. Instead, it describes a substantial equivalence determination for a surgical instrument, the LigaSure™ XP Maryland Jaw Sealer/Divider.

Therefore, many of the requested categories in your prompt, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set," are not applicable to this medical device submission, which focuses on hardware and electrosurgical performance rather than an AI-powered diagnostic or assistive tool.

However, I can extract the relevant performance testing and acceptance criteria information that is present in the document for the LigaSure™ XP Maryland Jaw Sealer/Divider.

Here's the information structured to the best of my ability given the provided document:

Acceptance Criteria and Study for LigaSure™ XP Maryland Jaw Sealer/Divider

This submission details the substantial equivalence of an electrosurgical cutting and coagulation device, the LigaSure™ XP Maryland Jaw Sealer/Divider. The performance testing described focuses on various engineering, biological, and functional aspects of the surgical instrument, not on the performance of a digital health or AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Predetermined Device Requirements)	Reported Device Performance
Sterilization	Compliance with ISO 11135, ISO 11737-1, ISO 11737-2, ISO 10993-7	Met acceptance criteria for sterilization by ethylene oxide (EO).
Shelf Life	Compliance with ISO 11607-1, ISO 11607-2, ASTM D4169, ASTM F1980	Packaging and product integrity acceptable for five-year shelf life.
Biocompatibility	Compliance with ISO 10993-1 for: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.	Met requirements for all specified endpoints.
Software	N/A (Device does not contain software)	N/A
Electromagnetic Compatibility (EMC) & Electrical Safety	Compliance with IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18	Met applicable clauses of standards.
Bench Performance	Predetermined device requirements for: mechanical/functional performance, visual inspection, device reliability, ex vivo vessel sealing/burst, and ex vivo lymphatic sealing/burst testing.	Met all predetermined device requirements.
Animal Performance	Predetermined device requirements for: in vivo acute hemostasis, acute thermal spread, and chronic hemostasis tissue testing.	Met all predetermined device requirements.
Clinical Performance	Sufficiency of clinical literature to support safety and effectiveness for stated indications.	Clinical literature studies were evaluated to further support safety and effectiveness.
Technological Characteristics	Comparison to predicate devices for aspects like indications for use, sterility, packaging, instrument design, lever latching mechanism, energy activation, shaft/jaws rotation, jaw type/shape, electrical characteristics, compatible energy platform, operating amperage/voltage, direct tissue contacting materials, patient contacting materials, jaw coating, and shaft material.	Differences (e.g., continuous 360° rotation, removal of heat shrink on shaft) were deemed not to affect safety and effectiveness and not to raise different questions of safety and effectiveness as demonstrated through performance testing.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set (e.g., number of vessels, lymphatic segments, or animals).

Provenance: The tests described (bench, animal) are laboratory-based performance studies, likely conducted by the manufacturer Covidien, llc. The document does not mention data provenance in terms of country of origin or whether human data was retrospective or prospective, as clinical trials for efficacy/safety in humans were not the primary evaluation method shown (literature review was used for clinical support).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device's performance would be objective measurements in engineering, biological models, and animal studies (e.g., burst pressure, hemostasis, thermal spread), not expert consensus on interpretations.

4. Adjudication method for the test set
This is not applicable and not provided. Performance outcomes are likely based on direct measurement against predefined physical/biological thresholds.

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 is not applicable. This device is a surgical instrument, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is based on:

Engineering standards (e.g., ISO, ASTM, IEC for sterilization, packaging, electrical safety).
Biocompatibility standards (ISO 10993-1).
Predefined physical and biological thresholds/measurements from ex vivo (vessel/lymphatic sealing/burst) and in vivo (hemostasis, thermal spread) studies.
"Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use." This implies that existing clinical evidence for similar devices and principles contributes to the overall justification, but no new clinical study data from the sponsor is explicitly referenced.

8. The sample size for the training set
This is not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established
This is not applicable.

Summary

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January 23, 2023

Covidien, Ilc Miranda Miles Regulatory Affairs Specialist 5920 Longbow Dr. Boulder, Colorado 80301

Re: K223158

Trade/Device Name: LigaSure™ XP Maryland Jaw Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 21, 2022 Received: December 27, 2022

Dear Miranda Miles:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

Jessica Carr -S

for Long Chen, 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

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Indications for Use

510(k) Number (if known) K223158

Device Name LigaSure™ XP Maryland Jaw Sealer/Divider

Indications for Use (Describe)

The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, thick tissue (tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, and so forth.

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)

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K223158

Image /page/3/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle inside, bisected by a light blue vertical line. To the right of the square is the word "COVIDIEN" in a bold, dark blue font.

510(k) Summary

Date summary prepared: January 19, 2023

510(k) Submitter/Holder

Covidien llc 5920 Longbow Drive Boulder, CO 80301

Contact

Miranda Miles, Regulatory Affairs Specialist Telephone: 303-530-6205 Email: miranda.r.miles@medtronic.com

Proposed Device

Trade Name:	LigaSure™ XP Maryland Jaw Sealer/Divider
Catalog Numbers:	LXMJ23S, LXMJ37S, LXMJ44S, LXMJ23L, LXMJ37L, LXMJ44L
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Class II, GEI)

Predicate Devices

The primary predicate device is the LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated cleared under K170869 and the secondary predicate device is the LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated cleared under K162941.

Primary

Trade Name:	LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated
Catalog Numbers:	LF1923, LF1937, LF1944
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Class II, GEI)
510(k) Number:	K170869 cleared April 21, 2017

Secondary

Trade Name:	LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated
Catalog Numbers:	LF1823, LF1837, LF1844
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Class II, GEI)
510(k) Number:	K162941 cleared November 14, 2016

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K223158

Device Description

Indications for Use

Comparison of Technological Characteristics with the Predicate Devices

The LigaSure™ XP Maryland Jaw Sealer/Divider has the same intended use compared to the predicates with different indications and some different technological characteristics. A summary comparison is provided in the table below.

Characteristic	Proposed Device:LigaSure™ XPMaryland Jaw,Sealer/Divider,Nano-Coated,One-Step Sealing/Latching Handle	Primary PredicateDevice:LigaSure™ MarylandJaw Sealer/Divider,Nano-Coated, One-StepSealing(K170869)	Secondary PredicateDevice:LigaSure™ Blunt TipSealer/Divider, Nano-Coated,(K162941)	Results(compared to predicates)
Indications for Use	The LigaSure XPMaryland JawSealer/Divider is abipolar electrosurgicalinstrument intended for	The LigaSureSealer/Divider is abipolar electrosurgicalinstrument intended foruse in minimally	The LigaSureSealer/Divider is abipolar electrosurgicalinstrument intended foruse in minimally	The proposedindications for usestatement includescolorectal and bariatricspecialties, clarifies the
	use in minimallyinvasive or opensurgical procedureswhere ligation anddivision of vessels, thicktissue (tissue bundles),and lymphatics isdesired. The LigaSureXP Maryland JawSealer/Divider can beused on vessels (arteriesand veins) up to andincluding 7 mm. It isindicated for use ingeneral surgery and suchsurgical specialties ascolorectal, bariatric,urologic, vascular,thoracic, andgynecologic. These mayinclude, but are notlimited to, suchprocedures as Nissenfundoplication,colectomy,cholecystectomy,adhesiolysis,hysterectomy,oophorectomy, and soforth.The LigaSure XPMaryland JawSealer/Divider has notbeen shown to beeffective for tubalsterilization or tubalcoagulation forsterilization procedures.Do not use the LigaSureXP Maryland JawSealer/Divider for theseprocedures.	invasive or opensurgical procedureswhere ligation anddivision of vessels,tissue bundles, andlymphatics is desired.The LigaSureSealer/Divider can beused on vessels (arteriesand veins) up to andincluding 7 mm. It isindicated for use ingeneral surgery and suchsurgical specialties asurologic, vascular,thoracic, andgynecologic. These mayinclude, but are notlimited to, suchprocedures as Nissenfundoplication,colectomy,cholecystectomy,adhesiolysis,hysterectomy,oophorectomy, etc.The LigaSure Systemhas not been shown tobe effective for tubalsterilization or tubalcoagulation forsterilization procedures.Do not use theLigaSure™ system forthese procedures.	invasive or open surgicalprocedures whereligation and division ofvessels, tissue bundles,and lymphatics isdesired. The LigaSureSealer/Divider can beused on vessels (arteriesand veins) up to andincluding 7 mm. It isindicated for use ingeneral surgery and suchsurgical specialties asurologic, vascular,thoracic, andgynecologic. Proceduresmay include, but are notlimited to, suchprocedures as Nissenfundoplication,colectomy,cholecystectomy,adhesiolysis,hysterectomy,oophorectomy, etc.The LigaSure Systemhas not been shown tobe effective for tubalsterilization or tubalcoagulation forsterilization procedures.Do not use theLigaSure™ system forthese procedures.	term tissue bundles withthe term thick tissue andreplaced 'etc.' with 'andso forth'. Differences donot change the intendeduse of the device and donot affect safety andeffectiveness asdemonstrated throughperformance testing.
Sterile	Yes	Yes	Yes	Same
Product Packaging	Single sterile barrier	Single sterile barrier	Single sterile barrier	Same
Instrument Design	Pistol Grip	Pistol Grip	Pistol Grip	Same
Lever LatchingMechanism	LXMJxxS: NoLXMJxxL: Yes	No	Yes	Same; Sametechnologicalcharacteristic.
Energy ActivationMechanisms	Button or footswitch	Button or footswitch	Button or footswitch	Same
Shaft/Jaws RotationDistance	Continuous 360°	350°	180°	The proposed device canrotate continuously 360°in both directions.Differences do not affectthe safety andeffectiveness and do notraise different questionsof safety andeffectiveness asdemonstrated throughperformance testing.
Jaw Type	Unilateral	Unilateral	Bilateral	Same; Sametechnologicalcharacteristic.
Jaw Shape	Curved	Curved	Blunt	Same; Sametechnologicalcharacteristic.
Electrical Characteristics
Energy Type	bipolar electrosurgical	bipolar electrosurgical	bipolar electrosurgical	Same
Compatible EnergyPlatform	VLFT10GEN(K191601)	VLFT10GEN(K191601)VLLS10GEN(K143654)FORCETRIAD(K110268)	VLFT10GEN(K191601)VLLS10GEN(K143654)FORCETRIAD(K110268)	Same; VLFT10GEN iscompatible with thepredicates.
Operating Amperage(Maximum)	VLFT10GEN: 5.5 A	VLFT10GEN: 5.5 AVLLS10GEN: 6.1 AFORCETRIAD: 6.1 A	VLFT10GEN: 5.5 AVLLS10GEN: 6.1 AFORCETRIAD: 6.1 A	Same; VLFT10GEN iscompatible with thepredicates.
Operating Voltage(Maximum)	VLFT10GEN: 244 Vpk (@ 434kHz	VLFT10GEN: 244 Vpk (@ 434kHzVLLS10GEN: 250 Vpk @ 400kHzFORCETRIAD: 288 Vpk (a)472 kHz	VLFT10GEN: 244 Vpk @ 434kHzVLLS10GEN: 250 Vpk @ 400kHzFORCETRIAD: 288 Vpk (a)472 kHz	Same; VLFT10GEN iscompatible with thepredicates.
Direct Tissue Contacting Materials
Patient ContactingMaterialsBiocompatible	Yes	Yes	Yes	Same
Jaw Coating	Yes	Yes	Yes	Same
Shaft Material	Stainless steel	Stainless steel withblack heat shrink wrap	Stainless steel withblack heat shrink wrap	Removal of heat shrinkdoes not affect the safetyand effectiveness anddoes not raise differentquestions of safety andeffectiveness asdemonstrated throughperformance testing.

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Performance Testing

The following testing performance data are provided in support of the substantial equivalence determination of the LigaSure™ XP Maryland Jaw Sealer/Divider.

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K223158

Sterilization and Shelf Life

The LigaSure™ XP Maryland Jaw Sealer/Divider met the acceptance criteria for sterilization by ethylene oxide (EO) in accordance with the applicable validation standards ISO 11135, ISO 11737-1, ISO 11737-2, and ISO 10993-7. In addition, the LigaSure™M XP Maryland Jaw Sealer/Divider packaging and product integrity were found to be acceptable for the five-year shelf life in accordance with the applicable packaging standards ISO 11607-1, ISO 11607-2, ASTM D4169 and ASTM F1980.

Biocompatibility

The LigaSure™ XP Maryland Jaw Sealer/Divider met the requirements of biocompatibility standard ISO 10993-1 for the following endpoints: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.

Software

The LigaSure™ XP Maryland Jaw Sealer/Divider does not contain software.

Electromagnetic Compatibility and Electrical Safety

The LigaSure™ XP Maryland Jaw Sealer/Divider met the applicable clauses of electromagnetic compatibility and electrical safety verification standards IEC 60601-1-2. IEC 60601-1-2. IEC 60601-2-2, and IEC 60601-2-18.

Performance Testing - Bench

The LigaSure™ XP Maryland Jaw Sealer/Divider bench testing studies met the predetermined device requirements (acceptance criteria) for mechanical/functional performance, visual inspection, device reliability, ex vivo vessel sealing/burst and ex vivo lymphatic sealing/burst testing.

Performance Testing - Animal

The LigaSure™ XP Maryland Jaw Sealer/Divider met all predetermined device requirements (acceptance criteria) for in vivo acute hemostasis, acute thermal spread and chronic hemostasis tissue testing.

Performance Testing – Clinical

Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use.

Conclusion

The proposed LigaSure™ XP Maryland Jaw Sealer/Divider device family is substantially equivalent to the predicate device families LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated and LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated.

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.