Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider

K172856 · Stryker Sustainability Solutions · GEI · Nov 16, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172856
• Device Name: Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
• Applicant: Stryker Sustainability Solutions
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 16, 2017
• 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 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, 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; used in minimally invasive/open surgery; operated by surgeons. Input: RF energy from compatible Covidien generators (ForceTriad/Valleylab FT10). Mechanism: RF energy seals vascular structures between jaws; manual trigger actuates internal blade for tissue division. Output: Sealed and divided tissue. Device features: 5mm shaft, 37cm length, jaw rotation wheel, jaw latching mechanism, activation button/footswitch control. Reprocessing by Stryker involves cleaning, decontamination, and functional testing of components. Benefits: Effective hemostasis and tissue division for various surgical specialties.

Clinical Evidence

No human clinical data. Evidence includes bench testing (biocompatibility, sterilization, electrical safety per IEC 60601-1/2/18, electromagnetic compatibility, packaging) and preclinical animal studies (acute/chronic survival). Animal models confirmed effective hemostasis and thermal spread characteristics for vessels up to 7mm.

Technological Characteristics

Bipolar electrosurgical instrument; 5mm shaft diameter; 37cm working length. Energy source: external RF generator (Covidien ForceTriad/Valleylab FT10). Materials: equivalent to original manufacturer specifications. Connectivity: cable-based connection to generator. Sterilization: validated reprocessing cycle. Operation: manual jaw control, rotation, and cutting trigger.

Indications for Use

Indicated for patients undergoing minimally invasive or open surgical procedures (general, urologic, vascular, thoracic, gynecologic) requiring ligation/division of vessels, tissue bundles, and lymphatics up to 7mm. 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)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 16, 2017

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

Re: K172856

Trade/Device Name: Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (Model: LF1637) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: September 19, 2017 Received: September 20, 2017

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 (OS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 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/MedicalDeviceRegulationandGuidance/) 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, Jennifer R. Stevenson -S3 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K172856

Device Name

Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (LF1637)

#### Indications for Use (Describe)

The Reprocessed 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 speciaties 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 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

# Reprocessed Single-Use Device Models Included Clearance

| Device Model | Device Name | Original Manufacturer |
|--------------|------------------------------------------------|-----------------------|
| LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider | Covidien |

{4}------------------------------------------------

# SECTION 5: 510(k) SUMMARY

#### Submitter:

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

#### Contact:

Mr. Scott English, BS, RAC Staff Requlatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) [e-mail]

#### Date of Preparation: September 19, 2017

#### Name of Device:

| Trade/Proprietary Name: | Reprocessed LigaSure Blunt Tip Laparoscopic<br>Sealer/Divider (LF1637) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar Electrosurgical Laparoscopic Instruments |
| Classification Information: | Electrosurgical, Cutting & Coagulation Accessories<br>Laparoscopic & Endoscopic, Reprocessed<br>(21 CFR§878.4400, Product Code NUJ, Class II) |

## Predicate Devices:

| Model<br> Number Number | 510(k) | 510(k) Title | Original<br>Manufacturer |
|----------------------------|---------|---------------------------------|--------------------------|
| LF1637 | K141153 | LigaSure Tissue Sealer/Dividers | Covidien |

## Device Description:

The Covidien™ LigaSure™ Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a bipolar electrosurgical instrument intended for use with the Covidien Electrosurgical Generators in general and gynecologic laparoscopic/open surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The outer diameter of the instrument shaft is 5 mm with a working length of 37 cm. The following controls are located on the instrument handle:

- . A lever for opening and closing the instrument jaws. 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. ●

{5}------------------------------------------------

- A trigger for actuating the cutter. The cutter can only be actuated when the jaws . are closed and latched.
- . A rotation wheel 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 generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform and Valleylab™ FT10 Energy Platform.

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 generators or footswitch.

#### Intended Use:

The Reprocessed 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, 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:

Reprocessed LigaSure Blunt Tip Laparoscopic 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 design, materials, and intended use of the reprocessed device 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 size is utilized. The differences between the predicate 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 the LigaSure Blunt Tip Laparoscopic Sealer/Dividers 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.

{6}------------------------------------------------

## Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed LigaSure Blunt Tip Laparoscopic 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, IEC 60601-2-2, and IEC 60601-2-18, 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 7mm, including: burst pressure, maximum jaw 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. The studies were done to evaluate thermal spread and the ability to achieve hemostasis of the reprocessed device. The results of the evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic 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:

The results of bench testing and preclinical laboratory evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers are at least as safe and effective and perform as well as the identified legally marketed predicate device as described herein.