(59 days)
No
The description focuses on the electrosurgical mechanism, mechanical controls, and reprocessing procedures. There is no mention of AI, ML, or any computational analysis of tissue properties or sealing parameters that would suggest the use of these technologies. The device relies on RF energy application and surgeon-actuated cutting.
Yes
The device is described as a bipolar electrosurgical instrument for ligation and division of vessels and tissue, which is a therapeutic function.
No
The device is an electrosurgical instrument for ligating and dividing vessels and tissues during open surgical procedures, not for diagnosing conditions.
No
The device is a physical electrosurgical instrument with mechanical controls and a blade, clearly indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in open surgical procedures for the ligation and division of vessels, tissue bundles, and lymphatics. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical instrument that applies radiofrequency (RF) electrosurgical energy to tissue and has a blade for cutting. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Anatomical Site: The anatomical sites mentioned are vessels, tissue bundles, and lymphatics, which are structures within the living body.
- Performance Studies: The performance studies focus on metrics relevant to surgical device performance, such as burst pressure, maximum jaw temperature, device functionality, reliability, thermal spread, and hemostasis. These are measures of how the device performs in vivo or in simulated in vivo conditions, not on in vitro samples.
IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro to provide information for diagnosis, monitoring, or screening. This device does not fit that description. It is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) scott.english@stryker.com
Date of Preparation: April 17, 2018
Name of Device:
| Trade/Proprietary Name: | Reprocessed LigaSure Impact without Nano-coating Large Jaw,
Open Sealer/Divider (LF4418) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical, Cutting & Coagulation Accessories,
Laparoscopic & Endoscopic, Reprocessed
(21 CFR§878.4400, Product Code NUJ, Class II) |
Predicate and Reference Devices:
| | Model
Number | 510(k)
Number | 510(k) Title | Original
Manufacturer |
|---------------------|-----------------|------------------|------------------------------------------------------------------------|----------------------------------------|
| Predicate
Device | LF4318 | K141153 | LigaSure Tissue Sealer/Dividers
(Indications for Use) | Covidien |
| | | K123444 | LigaSure Impact Curved, Large Jaw, Open
Sealer/Divider | Covidien |
| Reference
Device | LF4318 | K150538 | Reprocessed LigaSure Impact Curved, Large Jaw,
Open Sealer/Divider | Stryker
Sustainability
Solutions |
| Reference
Device | LF4418 | K162047 | LigaSure Impact Curved, Large Jaw, Open
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
3
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
4
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.
5
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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6
Reprocessed Single-Use Device Model Included in Clearance
| Device Model | Device Name | Original Manufacturer |
|---|---|---|
| LF4418 | LigaSure Impact without Nano-coating Large Jaw, Open | |
| Sealer/Divider | Covidien |