LigaSure™ XP Maryland Jaw Sealer/Divider
Device Facts
| Record ID | K223158 |
|---|---|
| Device Name | LigaSure™ XP Maryland Jaw Sealer/Divider |
| Applicant | Covidien, LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jan 23, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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, oophorectomy, 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 Story
Sterile, single-use bipolar electrosurgical instrument; pistol-grip design; available in 23 cm, 37 cm, and 44 cm lengths. Connects to Valleylab™ FT10 generator; applies bipolar energy to tissue between nano-coated Maryland-style jaws to create ligation; features independent cutting blade for tissue division. Includes continuous 360° rotation of jaws and shaft. Used by surgeons in OR for minimally invasive or open procedures. Output is physical tissue seal and division; provides hemostasis and tissue separation. Benefits include efficient vessel/tissue management in various surgical specialties.
Clinical Evidence
No clinical trials conducted. Safety and effectiveness supported by bench testing (mechanical/functional performance, ex vivo vessel/lymphatic burst testing) and animal studies (in vivo acute/chronic hemostasis, thermal spread). Clinical literature evaluated to support indications.
Technological Characteristics
Bipolar electrosurgical instrument; stainless steel shaft; nano-coated Maryland-style jaws; pistol-grip handle (One-Step or Latching). Energy source: Valleylab™ FT10 generator. Sterilization: Ethylene oxide (ISO 11135). Biocompatibility: ISO 10993-1. Electrical safety: IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18.
Indications for Use
Indicated for patients undergoing minimally invasive or open surgical procedures requiring ligation and division of vessels (up to 7 mm), thick tissue bundles, and lymphatics. Applicable to general, colorectal, bariatric, urologic, vascular, thoracic, and gynecologic surgeries. Contraindicated for tubal sterilization or tubal coagulation procedures.
Regulatory Classification
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.
Predicate Devices
- LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated (K170869)
- LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated (K162941)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
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.
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.
| 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<br>(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<br>(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<br>(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K162941 cleared November 14, 2016 |
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## K223158
## 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).
## Indications for Use
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.
## 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:<br>LigaSure™ XP<br>Maryland Jaw,<br>Sealer/Divider,<br>Nano-Coated,<br>One-Step Sealing/<br>Latching Handle | Primary Predicate<br>Device:<br>LigaSure™ Maryland<br>Jaw Sealer/Divider,<br>Nano-Coated, One-Step<br>Sealing<br>(K170869) | Secondary Predicate<br>Device:<br>LigaSure™ Blunt Tip<br>Sealer/Divider, Nano-<br>Coated,<br>(K162941) | Results<br>(compared to predicates) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LigaSure XP<br>Maryland Jaw<br>Sealer/Divider is a<br>bipolar electrosurgical<br>instrument intended for | The LigaSure<br>Sealer/Divider is a<br>bipolar electrosurgical<br>instrument intended for<br>use in minimally | The LigaSure<br>Sealer/Divider is a<br>bipolar electrosurgical<br>instrument intended for<br>use in minimally | The proposed<br>indications for use<br>statement includes<br>colorectal and bariatric<br>specialties, clarifies the |
| | use in minimally<br>invasive or open<br>surgical procedures<br>where ligation and<br>division of vessels, thick<br>tissue (tissue bundles),<br>and lymphatics is<br>desired. The LigaSure<br>XP Maryland Jaw<br>Sealer/Divider can be<br>used on vessels (arteries<br>and veins) up to and<br>including 7 mm. It is<br>indicated for use in<br>general surgery and such<br>surgical specialties as<br>colorectal, bariatric,<br>urologic, vascular,<br>thoracic, and<br>gynecologic. These may<br>include, but are not<br>limited to, such<br>procedures as Nissen<br>fundoplication,<br>colectomy,<br>cholecystectomy,<br>adhesiolysis,<br>hysterectomy,<br>oophorectomy, and so<br>forth.<br>The LigaSure XP<br>Maryland Jaw<br>Sealer/Divider has not<br>been shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures.<br>Do not use the LigaSure<br>XP Maryland Jaw<br>Sealer/Divider for these<br>procedures. | invasive or open<br>surgical procedures<br>where ligation and<br>division of vessels,<br>tissue bundles, and<br>lymphatics is desired.<br>The LigaSure<br>Sealer/Divider can be<br>used on vessels (arteries<br>and veins) up to and<br>including 7 mm. It is<br>indicated for use in<br>general surgery and such<br>surgical specialties as<br>urologic, vascular,<br>thoracic, and<br>gynecologic. These may<br>include, but are not<br>limited to, such<br>procedures as Nissen<br>fundoplication,<br>colectomy,<br>cholecystectomy,<br>adhesiolysis,<br>hysterectomy,<br>oophorectomy, etc.<br>The LigaSure System<br>has not been shown to<br>be effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures.<br>Do not use the<br>LigaSure™ system for<br>these procedures. | invasive or open surgical<br>procedures where<br>ligation and division of<br>vessels, tissue bundles,<br>and lymphatics is<br>desired. The LigaSure<br>Sealer/Divider can be<br>used on vessels (arteries<br>and veins) up to and<br>including 7 mm. It is<br>indicated for use in<br>general surgery and such<br>surgical specialties as<br>urologic, vascular,<br>thoracic, and<br>gynecologic. Procedures<br>may include, but are not<br>limited to, such<br>procedures as Nissen<br>fundoplication,<br>colectomy,<br>cholecystectomy,<br>adhesiolysis,<br>hysterectomy,<br>oophorectomy, etc.<br>The LigaSure System<br>has not been shown to<br>be effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures.<br>Do not use the<br>LigaSure™ system for<br>these procedures. | term tissue bundles with<br>the term thick tissue and<br>replaced 'etc.' with 'and<br>so forth'. Differences do<br>not change the intended<br>use of the device and do<br>not affect safety and<br>effectiveness as<br>demonstrated through<br>performance 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 Latching<br>Mechanism | LXMJxxS: No<br>LXMJxxL: Yes | No | Yes | Same; Same<br>technological<br>characteristic. |
| Energy Activation<br>Mechanisms | Button or footswitch | Button or footswitch | Button or footswitch | Same |
| Shaft/Jaws Rotation<br>Distance | Continuous 360° | 350° | 180° | The proposed device can<br>rotate continuously 360°<br>in both directions.<br>Differences do not affect<br>the safety and<br>effectiveness and do not<br>raise different questions<br>of safety and<br>effectiveness as<br>demonstrated through<br>performance testing. |
| Jaw Type | Unilateral | Unilateral | Bilateral | Same; Same<br>technological<br>characteristic. |
| Jaw Shape | Curved | Curved | Blunt | Same; Same<br>technological<br>characteristic. |
| Electrical Characteristics | | | | |
| Energy Type | bipolar electrosurgical | bipolar electrosurgical | bipolar electrosurgical | Same |
| Compatible Energy<br>Platform | VLFT10GEN<br>(K191601) | VLFT10GEN<br>(K191601)<br>VLLS10GEN<br>(K143654)<br>FORCETRIAD<br>(K110268) | VLFT10GEN<br>(K191601)<br>VLLS10GEN<br>(K143654)<br>FORCETRIAD<br>(K110268) | Same; VLFT10GEN is<br>compatible with the<br>predicates. |
| Operating Amperage<br>(Maximum) | VLFT10GEN: 5.5 A | VLFT10GEN: 5.5 A<br>VLLS10GEN: 6.1 A<br>FORCETRIAD: 6.1 A | VLFT10GEN: 5.5 A<br>VLLS10GEN: 6.1 A<br>FORCETRIAD: 6.1 A | Same; VLFT10GEN is<br>compatible with the<br>predicates. |
| Operating Voltage<br>(Maximum) | VLFT10GEN: 244 Vpk (@ 434<br>kHz | VLFT10GEN: 244 Vpk (@ 434<br>kHz<br>VLLS10GEN: 250 Vpk @ 400<br>kHz<br>FORCETRIAD: 288 Vpk (a)<br>472 kHz | VLFT10GEN: 244 Vpk @ 434<br>kHz<br>VLLS10GEN: 250 Vpk @ 400<br>kHz<br>FORCETRIAD: 288 Vpk (a)<br>472 kHz | Same; VLFT10GEN is<br>compatible with the<br>predicates. |
| Direct Tissue Contacting Materials | | | | |
| Patient Contacting<br>Materials<br>Biocompatible | Yes | Yes | Yes | Same |
| Jaw Coating | Yes | Yes | Yes | Same |
| Shaft Material | Stainless steel | Stainless steel with<br>black heat shrink wrap | Stainless steel with<br>black heat shrink wrap | Removal of heat shrink<br>does not affect the safety<br>and effectiveness and<br>does not raise different<br>questions of safety and<br>effectiveness as<br>demonstrated through<br>performance 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.
