(101 days)
Not Found
No
The summary describes a standard electrosurgical instrument that uses RF energy for sealing and dividing tissue. There is no mention of AI, ML, image processing, or any data-driven decision-making process within the device's operation. The performance studies focus on mechanical and biological outcomes, not algorithmic performance.
Yes
Explanation: The device is intended for use in surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics, which are therapeutic actions aimed at treating a medical condition.
No
Explanation: The device is an electrosurgical instrument for sealing and dividing tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a "sterile, single-use, hand-held bipolar electrosurgical instrument" and describes physical components like jaws, a hand actuated mechanism, and a knife. It also mentions being used with "Covidien electrosurgical generators," indicating a hardware component is required for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bipolar electrosurgical instrument used in surgical procedures for ligating and dividing vessels, tissue bundles, and lymphatics within the body. IVD devices are used to examine specimens outside the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a hand-held surgical instrument that uses RF energy to seal and cut tissue during surgery. This is a direct surgical intervention device, not a diagnostic test performed on samples.
- Anatomical Site: The anatomical sites mentioned are internal structures within the body (vessels, tissue bundles, lymphatics, nerves, parathyroid glands). IVD devices typically analyze bodily fluids or tissues collected from the patient.
- Performance Studies: The performance studies described involve testing the device's mechanical properties, sealing capabilities, and hemostasis in vivo (in living organisms or models). This is consistent with a surgical device, not an IVD.
In summary, the LF1212A LigaSure Sealer/Divider is a surgical instrument used for therapeutic purposes during surgery, not a device used for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The LF1212A 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 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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.
The 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 specialities 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.
The 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 LigaSure Sealer/ Divider can be used on vessels (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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure™ Sealer/Dividers are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a knife, which divides the tissue along the seal line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, nerves, parathyroid glands
Indicated Patient Age Range
adults (for ENT procedures)
Intended User / Care Setting
Not Found
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)
Evidence of safety and effectiveness was presented in the previously submitted 510(k)s, which also demonstrated the compatibility of these instruments with the ForceTriad™ Energy Platform. Supporting data obtained from both bench and preclinical testing to support the indications for use of this device family includes:
- Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2
- Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever force, and power curve performance
- Renal and pulmonary vessel burst pressure testing
Preclinical testing for this device family includes:
- Sealing and dividing vessels up to and including 7 mm
- Ability to achieve hemostasis of tissue and vessels
- Ability to fuse tissue bundles
- Thermal spread measurements
- Lymphatic vessel burst pressure
- Chronic animal study to demonstrate that hemostasis is maintained during recovery from surgery and to demonstrate lack of delayed adverse events
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.
K113572, K130744, K133338, K123444
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2014
Covidien Ms. Nancy Sauer Regulatory Affairs Product Manager 5920 Longbow Drive Boulder, Colorado 80301
Re: K141153 Trade/Device Name: LigaSure Sealer / Dividers, Models LF1212A, Precise Plus, LF1637, LF1720, LF1737, LF1744, and LF4318 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 19, 2014 Received: May 20, 2014
Dear Ms. Sauer:
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- 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) K141153
Device Name
LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A, Precise Plus)
Indications for Use (Describe)
The LF1212A 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 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lympatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
Indications for Use
510(k) Number (if known) K141153
Device Name
5 mm Blunt Tip Sealer/Divider (LF1637) Maryland Jaw Sealer/Dividers One Step Sealing (LF1720, LF1737, LF1744)
Indications for Use (Describe)
The 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 specialities as urologic, vascular, and gyneoologic. 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 coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
4
Indications for Use
510(k) Number (if known) K141153
Device Name
Impact Curved, Large Jaw, Open Sealer/Divider (LF4318)
Indications for Use (Describe)
The 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 LigaSure Sealer/ Divider can be used on vessels (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, 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
5
Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square in the center and a light blue vertical line and horizontal line. To the right of the square is the word "COVIDIEN" in blue sans-serif font.
510(k) Summary
Date summary prepared: 5/19/14
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Nancy Sauer Regulatory Affairs Product Manager Telephone: 303-581-6791 Fax: 303-530-6313 Email: nancy.sauer@covidien.com
Name of Device
| Trade Name: | LigaSure™ Tissue Sealer/Dividers |
|---|---|
| Catalog Numbers: | LF1212A, LF 1637, LF1723, LF1737, LF1744, LF4318, LF5544 |
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI). |
Predicate Devices
All of these devices are legally marketed devices, manufactured by Covidien llc. Each instrument serves as its own predicate device. The 510(k) numbers for these devices are listed below.
- K113572: Precise Plus (LF1212A) ●
- K130744: 5mm Blunt Tip Instrument (LF1637)
- K133338: Maryland Instruments (LF1723, LF1737, LF1744) ●
- K123444: Impact Instrument (LF4318) ●
Device Description
The LigaSure™ Sealer/Dividers are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a knife, which divides the tissue along the seal line.
Indications for Use
This 510(k) is for changes to the indications for use of these devices. The indications for use vary slightly among the devices included in this 510(k) premarket notification.
6
LF1212A:
The LF1212A 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 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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.
LF1637, LF1723, LF1737, LF1744:
The 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 specialities 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.
LF4318:
The 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 LigaSure Sealer/ Divider can be used on vessels (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, 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.
Technological Characteristics
The LigaSure™ 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 Advance instrument works in conjunction with Covidien electrosurgical generators to deliver monopolar energy for tissue dissection and creation of openings in organs.
There are no changes in technical characteristics, only a restatement of the indications for use.
7
Performance
Evidence of safety and effectiveness was presented in the previously submitted 510(k)s, which also demonstrated the compatibility of these instruments with the ForceTriad™ Energy Platform. Supporting data obtained from both bench and preclinical testing to support the indications for use of this device family includes:
- . Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2
- . Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever force, and power curve performance
- . Renal and pulmonary vessel burst pressure testing
Preclinical testing for this device family includes:
- Sealing and dividing vessels up to and including 7 mm
- . Ability to achieve hemostasis of tissue and vessels
- Ability to fuse tissue bundles
- Thermal spread measurements
- Lymphatic vessel burst pressure
- . Chronic animal study to demonstrate that hemostasis is maintained during recovery from surgery and to demonstrate lack of delayed adverse events
Conclusion
The previously submitted data remain valid, and the devices with the restated indications for use remain substantially equivalent to the devices with the original indications for use statements.