(83 days)
No
The summary describes a standard electrosurgical instrument and energy platform. There is no mention of AI or ML in the intended use, device description, or performance studies. The device relies on controlled energy delivery for tissue fusion, not data-driven algorithms.
Yes
The device is described as a bipolar electrosurgical instrument for use in surgical procedures to ligate and divide vessels, and cut, grasp, and dissect tissue, which directly relates to treating or managing a medical condition.
No
This device is an electrosurgical instrument used for cutting and sealing vessels and tissue during surgical procedures. Its purpose is therapeutic (ligation and division), not diagnostic.
No
The device description clearly states it is a "sterile, single-use, hand-held bipolar electrosurgical instrument" and describes physical components like a handle, jaw, and cord, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The LigaSure Impact™ is an electrosurgical instrument used during open surgical procedures to cut and seal vessels and tissue within the body. It directly interacts with the patient's internal anatomy.
- Intended Use: The intended use clearly states "for use in open surgical procedures where ligation and division of vessels is desired." This is an in-vivo (within the living organism) application, not an in-vitro one.
- Device Description: The description details a hand-held instrument used with an energy platform to perform surgical actions on tissue and vessels.
The device's function and intended use are entirely focused on surgical intervention within the body, which is the opposite of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
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.
Product codes
GEI
Device Description
The LigaSure Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries, veins, pulmonary vasculature, and lymph), 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)
The testing of the LF4318 involved extensive functional, bench and pre-clinical testing. The functional testing involved safety and performance testing in accordance with IEC 60601-1 and IEC 60601-2-2 and verification/comparative testing (to the predicate devices). The bench testing involved evaluation of the devices performance and ability to seal and divide vessels up to 7mm. The pre-clinical testing involved both acute and chronic testing evaluating the thermal spread and ability to achieve hemostasis of tissue and vessels in a variety of simulated clinical setting confirmed that the LF4318 is as safe and effective as the predicate devices and operated as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K1 23 444
Image /page/0/Picture/1 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with a white rectangle in the middle and two smaller white rectangles above and below it. The word is written in a simple, sans-serif font and is the main focus of the image.
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510(k) Summary
Date summary prepared: November 7, 2012
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Dawn D. Tindall Sr. Associate, Regulatory Affairs Telephone: 303-581-7034 Fax: 303-530-6313 Email: dawn.tindall@covidien.com
Name of Device
Trade Name: Catalog Number: Common Name: Classification Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer / Divider LF4318 Bipolar electrosurgical instrument Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, GEI).
Predicate Devices
The LigaSure Impact™ Curved, Large Jaw, Open Sealer / Divider was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:
Device Common Name: Bipolar electrosurgical instrument Trade Name: Enseal G2 Tissue Sealer Catalog Number: NSEALX22L 510(k) Number: K112033 Manufacturer: Ethicon Endo-Surgery, LLC
Device Common Name: Bipolar electrosurgical instrument Trade Name: LigaSure Atlas, Tissue Fusion Open Instrument Catalog Number: LS1020 510(k) Number: K010013 Manufacturer: Covidien
Device Common Name: ForceTriad Electrosurgical Generator; LigaSure Instruments Trade Name: ForceTriad generator 510(k) Number: K070162 Manufacturer: Covidien
Device Description
The LigaSure Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion
JAN 3 0 2013
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510(k): LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider - LF4318
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(LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.
Intended Use
The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectornies, Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
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.
Performance
The testing of the LF4318 involved extensive functional, bench and pre-clinical testing. The functional testing involved safety and performance testing in accordance with IEC 60601-1 and IEC 60601-2-2 and verification/comparative testing (to the predicate devices). The bench testing involved evaluation of the devices performance and ability to seal and divide vessels up to 7mm. The pre-clinical testing involved both acute and chronic testing evaluating the thermal spread and ability to achieve hemostasis of tissue and vessels in a variety of simulated clinical setting confirmed that the LF4318 is as safe and effective as the predicate devices and operated as intended.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Covidien, Formerly ValleyLab, A Division of Tyco Healthcare % Ms. Dawn Tindall Senior Associate, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
January 30, 2013
Re: K123444
Trade/Device Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider (LF4318) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 07, 2012 Received: November 08, 2012
Dear Ms. Tindall:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Dawn Tindall
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K123444
Device Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer / Divider (LF4318)
Indications for Use:
The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies. Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
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.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen
(Division Sign-Off) Division of Surgical Devices 510(k) Number K123444
20