Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider

K180451 · Stryker Sustainability Solutions · NUJ · Apr 20, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180451
• Device Name: Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
• Applicant: Stryker Sustainability Solutions
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Apr 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed 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 Reprocessed LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, 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, 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.

Device Story

Bipolar electrosurgical instrument for open surgery; used for vessel/tissue bundle ligation and division. Input: RF energy from compatible electrosurgical generators. Operation: Surgeon-actuated jaws clamp tissue; RF energy applied via activation button or footswitch to create seal; integrated blade divides tissue. Output: Sealed and divided vessels/tissue. Used in OR by surgeons. Benefits: Hemostasis of vessels up to 7mm. Reprocessed version of original manufacturer device; lacks original nano-coating on jaws. Device connects to generator via cable; identifies instrument type to generator.

Clinical Evidence

Bench and laboratory testing included biocompatibility, reprocessing validation, sterilization validation, electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2), and functional performance (burst pressure, jaw temperature, reliability). Preclinical animal model studies (acute and chronic survival) evaluated thermal spread and hemostasis efficacy on vessels up to 7mm. Results confirmed effective cutting and coagulation.

Technological Characteristics

Bipolar electrosurgical instrument. Mechanical design and materials equivalent to predicate. Energy source: RF electrosurgical generator. Connectivity: Cable with connector for generator identification. Reprocessing includes cleaning, decontamination, and functional testing. No nano-coating applied to jaws.

Indications for Use

Indicated for patients undergoing open surgical procedures requiring ligation and division of vessels, tissue bundles, and lymphatics up to 7mm in diameter. Applicable to general, urologic, vascular, thoracic, and gynecologic surgery. 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 Tissue Sealer/Dividers (K141153)
• LigaSure Impact Curved, Large Jaw, Open Sealer/Divider (K123444)

Reference Devices

• Reprocessed LigaSure Impact Curved, Large Jaw, Open Sealer/Divider (K150538)
• LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated (K162047)

Submission Summary (Full Text)

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April 20, 2018

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

## Re: K180451

Trade/Device Name: Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (Model # LF4418) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: February 17, 2018 Received: February 20, 2018

# Dear Mr. English:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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## Page 2 - Mr. Scott English

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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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# K180451

# 510(k) SUMMARY

#### Submitter:

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

Contact:

Scott English Senior Staff Regulatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) [e-mail]

Date of Preparation: April 17, 2018

Name of Device:

| Trade/Proprietary Name: | Reprocessed LigaSure Impact without Nano-coating Large Jaw,<br>Open Sealer/Divider (LF4418) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical, Cutting & Coagulation Accessories,<br>Laparoscopic & Endoscopic, Reprocessed<br>(21 CFR§878.4400, Product Code NUJ, Class II) |

#### Predicate and Reference Devices:

| | Model<br>Number | 510(k)<br>Number | 510(k) Title | Original<br>Manufacturer |
|---------------------|-----------------|------------------|------------------------------------------------------------------------|----------------------------------------|
| Predicate<br>Device | LF4318 | K141153 | LigaSure Tissue Sealer/Dividers<br>(Indications for Use) | Covidien |
| | | K123444 | LigaSure Impact Curved, Large Jaw, Open<br>Sealer/Divider | Covidien |
| Reference<br>Device | LF4318 | K150538 | Reprocessed LigaSure Impact Curved, Large Jaw,<br>Open Sealer/Divider | Stryker<br>Sustainability<br>Solutions |
| Reference<br>Device | LF4418 | K162047 | LigaSure Impact Curved, Large Jaw, Open<br>Sealer/Divider, Nano-coated | Covidien |

#### Device Description:

The Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) 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 LF4418 is

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# K180451

designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

The following controls are located on the instrument handle:

- A lever for opening and closing the instrument iaws. The mechanism incorporates a latch to . hold the jaws in the closed position during vessel sealing and cutting.
- . An activation button for generator power to initiate vessel sealing.
- A triager for actuating the cutter. ●
- . A knob to rotate the instrument jaws.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator.

The instrument attaches to the compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator.

For the LF4418, the Original Manufacturer applies a non-stick coating to the jaws of the device to reduce tissue sticking. When reprocessing the LF4418, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are used to power the device or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generator or footswitch.

## Intended Use:

The Reprocessed 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 Reprocessed LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, 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, 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.

## Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider are equivalent to the predicate device. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. The differences between the predicate

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# K180451

device and the reprocessed device include the replacement of some components with new components. The replacement components are manufactured to the same specifications and from equivalent materials as the components they are replacing. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition. Stryker Sustainability Solutions' reprocessing of LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.

### Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider. This included the following tests:

- Biocompatibility
- Validation of Reprocessing ●
- Sterilization Validation
- . Functional Performance Tests
- Electrical Safety Testing
- . Electromagnetic Compatibility Testing
- . Packaging Validation

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

Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the reprocessed device. The results of the evaluations demonstrate that the Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter.

The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.

## Conclusion:

Stryker Sustainability Solutions concludes that the Reprocessed LigaSure Impact without Nanocoating Large Jaw, Open Sealer/Divider is at least as safe and effective as the predicate device as described herein.

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#### Indications for Use

510(k) Number (if known) K180451

#### Device Name

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418)

#### Indications for Use (Describe)

The Reprocessed 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 Reprocessed LigaSure Sealer/ Divider can be used on yessels (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, 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Reprocessed Single-Use Device Model Included in Clearance

| Device Model | Device Name | Original Manufacturer |
|--------------|------------------------------------------------------------------------|-----------------------|
| LF4418 | LigaSure Impact without Nano-coating Large Jaw, Open<br>Sealer/Divider | Covidien |