(57 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the device for sealing and dividing tissue using RF energy. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
Explanation: The device is used to ligate vessels, tissue bundles, and lymphatics, which is a therapeutic action to treat conditions or achieve specific surgical outcomes.
No
The device is an electrosurgical instrument for sealing and dividing tissue, used in surgical procedures. Its purpose is therapeutic (ligation, division), not diagnostic.
No
The device description clearly outlines a physical, electrosurgical instrument with mechanical components (jaws, lever, activation button, trigger, rotation wheel) and electrical connections, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Reprocessed LigaSure Sealer/Divider is a surgical instrument used during surgical procedures to seal and divide vessels and tissue using electrosurgical energy. It directly interacts with the patient's body during surgery.
- Intended Use: The intended use clearly states it's for use in "minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a surgical instrument with jaws, a cutter, and controls for use in a surgical setting.
- Performance Studies: The performance studies focus on the device's ability to seal and divide vessels, electrical safety, biocompatibility, and sterilization – all relevant to a surgical instrument, not an IVD.
Therefore, the Reprocessed LigaSure Sealer/Divider is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NUJ
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. ●
- 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.
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
Minimally invasive or open surgical procedures; general surgery and such surgical speciaties as urologic, vascular, thoracic, and gynecologic.
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
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.
Key results: The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 (DICE@Ida.hhs.gov) or phone (1-800-638-2041 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)
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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) scott.english@stryker.com
Date of Preparation: September 19, 2017
Name of Device:
| Trade/Proprietary Name: | Reprocessed LigaSure Blunt Tip Laparoscopic
Sealer/Divider (LF1637) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar Electrosurgical Laparoscopic Instruments |
| Classification Information: | Electrosurgical, Cutting & Coagulation Accessories
Laparoscopic & Endoscopic, Reprocessed
(21 CFR§878.4400, Product Code NUJ, Class II) |
Predicate Devices:
| Model
Number Number | 510(k) | 510(k) Title | Original
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.