(28 days)
Not Found
No
The description focuses on the mechanical and electrosurgical functions of the device, with no mention of AI or ML capabilities. The "Smart" connector identifies the instrument type, which is a simple identification mechanism, not indicative of AI/ML.
Yes
The device is used in surgical procedures to ligate and divide vessels and lymph, which is a therapeutic intervention.
No
The device is described as a surgical instrument used for sealing and dividing tissue (vessels and lymphatics) during laparoscopic procedures, making it a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical electrosurgical instrument with a shaft, jaws, controls, and a 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider is a surgical instrument used during a surgical procedure to seal and divide vessels and tissue within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its function in surgical procedures for ligation and division of vessels and lymph.
- Device Description: The description details its mechanical and electrical functions for sealing, cutting, grasping, and dissection during surgery.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a bipolar electrosurgical accessory. It is intended for use with the ForceTriad™ Electrosurgical Generator in general and gynecological, laparoscopic, surgical procedures where the ligations of vasculature (vessels and lymph) is desired.
The device creates a scal by the application of RF electrosurgical energy to vascular structures interposed between the jaws of the instrument. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that resides within the shaft of the instrument and extends forward in a slot within the jaws.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider can be used to seal Pulmonary Vasculature when used with the ForceTriad™ Electrosurgical generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a multifunctional electrosurgical instrument for use with the ForceTriad™ generator when performing laparoscopic surgery. The instrument is capable of sealing vessels and lymphatics, dividing tissue (including vessels) clamped between the jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, 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 knob to rotate the instrument jaws. The jaws can rotate 179 degrees to facilitate surgeon access and visibility.
All controls can be operated with either the right or left hand. Vessel scaling can be initiated using the activation button, or utilizing a footswitch connected to the generator.
The instrument attaches to the ForceTriad generator via a ten foot cord with a "Smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vascular structures (vessels and lymph), tissue bundles, Pulmonary Vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical setting
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)
Non-clinical testing consisted of ex-vivo tissue studies, in-vivo tissue studies (porcine and canine model), and performance verification. The data obtained showed that the device is substantially equivalent to the predicate and meets the safety and effectiveness criteria.
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.
Not Found
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
510(k) Summary or 510/k) Statement
510(k) Summary
OCT 1 6 2009
- Submitter Information: 1.
Valleylab, a Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO Contact: Philip E. Ake Senior Regulatory Associate Phone: 303-581-6934 Fax: 303-516-8307 Email: Philip.Ake@Covidien.com
- Name of Device
Trade name: LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider Common: Bipolar Laparoscopic Electrosurgical Instrument Classification name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)
- Predicate Devices
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is substantially equivalent to the LigaSure 5mm Laparoscopic Sealer and Divider submitter under K031011. The substantial equivalence letter was dated 5/29/03. This Special 510(k) releases a blunt tip version of 5mm Laparoscopic sealer divider. The primary difference between the LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider and the predicate LigaSure 5mm is the jaw. The jaw of the Blunt Tip version is shaped in a more oval fashion, has a textured surface to improve tissue grasping, and has a longer cut length than the original.
- Device Description
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a multifunctional electrosurgical instrument for use with the ForceTriad™ generator when performing laparoscopic surgery. The instrument is capable of sealing vessels and lymphatics, dividing tissue (including vessels) clamped between the jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. The following controls are located on the instrument handle
1
- 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 knob to rotate the instrument jaws. The jaws can rotate 179 degrees to facilitate surgeon access and visibility.
All controls can be operated with either the right or left hand. Vessel scaling can be initiated using the activation button, or utilizing a footswitch connected to the generator.
The instrument attaches to the ForceTriad generator via a ten foot cord with a "Smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.
- . Intended Use
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a bipolar electrosurgical accessory. It is intended for use with the ForceTriad™ Electrosurgical Generator in general and gynecological, laparoscopic, surgical procedures where the ligations of vasculature (vessels and lymph) is desired.
The device creates a scal by the application of RF electrosurgical energy to vascular structures interposed between the jaws of the instrument. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that resides within the shaft of the instrument and extends forward in a slot within the jaws.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.
2
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider can be used to seal Pulmonary Vasculature when used with the ForceTriad™ Electrosurgical generator.
6. Summary of Technology Characteristics
This is a Special 510(k). The changes associated with this 510(k) are primarily related to the device jaw and increased force delivery. This modified 5mm Blunt Tip Laparoscopic Sealer-Divider has the same basic technological characteristics as the predicate LigaSure device. The device will seal vessels and lymph using bipolar RF energy and can mechanically divide the sealed areas or tissue with a mechanical cutting device incorporated into the shaft and jaws. The device can only operate with the ForceTriad Generator.
Summary Non-clinical testing 7.
The Non-clinical testing consisted of ex-vivo tissue studies, in-vivo tissue studies (porcine and canine model), and performance verification. The purpose of the testing was to ensure that the device functions as intended, and meets design specifications. This also included testing to the relevant safety standards. The data obtained showed that the device is substantially equivalent to the predicate and meets the safety and effectiveness criteria.
- Summary of Clinical testing
No clinical testing was conducted. Clinical testing was not necessary to establish substantial equivalence.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Valleylab, a Division of Tyco Healthcare Group LP % Mr. Philip E. Ake, Senior Regulatory Associate 5920 Longbow Drive Boulder, CO 80301
OCT 1 6 2009
Re: K092879
Trade/Device Name: LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 17, 2009 Received: September 18, 2009
Dear Mr. Ake:
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 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Philip E. Ake
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): _
Device Name: LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider
Indications for Use:
The LigaSure 5mm. Blunt tip. Laparoscopic Sealer- Divider is a bipolar electrosurgical instrument intended for use the ForceTriad Generator in general and gynecologic 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.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.
Over-The-Counter Use Prescription Use __ X (Part 21 CFR 801 Subpart AND/OR 21 CFR 801 Subpart D) C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M-MELKERSON
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092879