(137 days)
No
The summary describes a bipolar electrosurgical instrument that uses RF energy for sealing and cutting. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a bipolar electrosurgical instrument for use in surgical procedures to ligate and divide vessels and tissue, which are therapeutic actions.
No
This device is an electrosurgical instrument for sealing and dividing vessels and tissues during surgical procedures; it does not diagnose medical conditions.
No
The device description clearly states it is a "sterile, single-use, coated, hand-held bipolar vessel sealing device" and mentions "hardware components" like a "hemostat style body" and "jaws," indicating it is a physical medical 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 that the device is a surgical instrument used during open surgical procedures to ligate and divide vessels and tissue. It is used directly on the patient's body.
- Device Description: The description confirms it's a hand-held bipolar electrosurgical instrument for use in surgery.
- 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. This device does not perform any such testing on samples.
The LigaSure Sealer/Divider is a surgical device used for therapeutic purposes (sealing and dividing tissue), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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 and veins) up to and including 7 mm. It is indicated for use in general 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, 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 coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Product codes
GEI
Device Description
The LigaSure™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries and veins), tissue bundles, lymphatics, nerves, parathyroid glands
Indicated Patient Age Range
adults
Intended User / Care Setting
open surgical procedures, open ENT 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)
- Biocompatibility: The biocompatibility evaluation for the LigaSure™ Exact Dissector, Nano-coated device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process," as recognized by FDA.
- Electrical Safety and Electromagnetic Compatibility (EMC): The system complies with relevant clauses of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.
- Mechanical/Functional Testing: Mechanical, electrical, and functional testing was carried out to verify that the proposed devices performed as expected.
- Ex-vivo Vessel Burst Pressure: Ex-vivo burst pressure testing of excised fresh porcine renal arteries and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.
- Acute Animal Study: In the animal study conducted, a porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety of the new device was evaluated. These studies demonstrated that the subject devices are as safe and effective as the predicate devices.
- Chronic Animal Study: A chronic study was conducted to assess seal quality over the course of 21 days. All animals survived 21 days post-op without any major complications. All seals maintained chronic hemostasis and healed as expected.
- Clinical Studies: This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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March 2, 2018
Covidien Celso Duran Senior Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K173281
Trade/Device Name: LigaSure Exact Dissector, Nano-coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2018 Received: February 5, 2018
Dear Celso Duran:
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, 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
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 mediation-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, 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
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Indications for Use
510(k) Number (if known)
K173281
Device Name LigaSure Exact Dissector, Nano-coated
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 and veins) up to and including 7 mm. It is indicated for use in general 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, 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 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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510(k) Summary
Date summary prepared: 10/13/2017
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Celso Duran Senior Specialist, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com
Name of Device
| Trade Name: | LigaSure™ Exact Dissector, Nano-coated |
|---|---|
| Catalog Numbers: | LF2019 |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI) |
Predicate Device
| Predicate Device | |
|---|---|
| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
| Catalog Numbers: | LF1212A |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) | |
| 510(k) Number: | K152286 |
| Manufacturer: | Covidien |
| Reference Device | |
| Trade Name: | LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano- |
| coated | |
| Catalog Number: | LF4418 |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) | |
| 510(k) Number: | K162047 |
| Manufacturer: | Covidien |
Device Description
The LigaSure™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.
4
Indications for Use
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 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 and division 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.
Comparison of Technological Characteristics with the Predicate Device
The application of radio frequency (RF) energy to target tissue is the fundamental technology for both the subject and predicate devices. A seal is created by application of RF energy to structures (vasculature, lymphatics, and tissue bundles) interposed between the jaws of the instrument. A blade within the instrument is user actuated to divide tissue after the seal is created. At a high level, the subject and predicate devices are based on the following same technological elements:
- Bilateral jaws - used to reach target structures (vasculature, lymphatics, and tissue bundles)
- Handle rings allows user to close the jaws to grasp the tissue ●
- Activation button in-line mechanism allows RF energy to be activated by the user ●
- Cutting trigger allows user to divide (cut) sealed structures .
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the LigaSure™ Exact Dissector, Nano-coated device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process," as recognized by FDA.
Electrical Safety and Electromagnetic Compatibility (EMC)
The system complies with relevant clauses of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.
Mechanical/Functional Testing
Mechanical, electrical, and functional testing was carried out to verify that the proposed devices performed as expected.
Ex-vivo Vessel Burst Pressure
Ex-vivo burst pressure testing of excised fresh porcine renal arteries and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.
Acute Animal Study
In the animal study conducted, a porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety
5
of the new device was evaluated. These studies demonstrated that the subject devices are as safe and effective as the predicate devices.
Chronic Animal Study
A chronic study was conducted to assess seal quality over the course of 21 days. All animals survived 21 days post-op without any major complications. All seals maintained chronic hemostasis and healed as expected.
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Summary
Based on the preclinical performance as documented in the performance testing, the LigaSure™ Exact Dissector, Nano-coated device was found to have a safety and effectiveness profile similar to the predicate device.
Conclusion
The subject device has the same indications for use as the legally marketed predicate devices. Verification and validation data support substantial equivalence of the LigaSure™ Exact Dissector, Nano-coated device to the legally marketed predicate device.