(175 days)
No
The summary describes a bipolar electrosurgical instrument that uses RF energy for sealing and cutting tissue. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an electrosurgical instrument used for surgical procedures like sealing and dividing vessels, which is a surgical tool, not a therapeutic device designed for treatment or therapy.
No.
The device is described as a bipolar electrosurgical instrument intended for surgical procedures to ligate (seal) and divide (cut) vessels, tissue, and lymphatics. Its function is to perform surgical actions, not to diagnose a condition or disease.
No
The device description clearly states it is a "sterile, single-use, coated, hand-held bipolar vessel sealing device" and mentions hardware components like jaws, a body, and an activation button. It also relies on a compatible electrosurgical generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in "open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." This describes a surgical instrument used on the patient's body during a procedure.
- Device Description: The description details a "hand-held bipolar vessel sealing device" that uses RF energy to "ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics." This is a description of a surgical tool.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological material outside the body.
The device is a surgical instrument used directly on the patient during a procedure, which is distinct from an in vitro diagnostic device.
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 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, breast procedures, 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.
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 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, bowel, gall bladder, breast, thyroid, neck, parotid, tonsils, nerves, parathyroid glands
Indicated Patient Age Range
adults
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)
No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device. Evidence of safety and effectiveness was presented in the previously submitted 510(k) and includes the following:
- Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2
- Biocompatibility (ISO 10993-1)
- Device functionality
- Bench burst pressure
- In vivo acute and chronic animal studies
Clinical Literature Summary: A study of literature for breast procedures performed using LigaSure™ devices show that the hemostat-style open LigaSure™ devices have been used successfully in breast procedures including mastectomy, flap reconstruction, and axillary lymph node dissection. The safety and effectiveness outcomes reported in the literature were associated with effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications, the same types of outcomes that are reported for other surgical procedures carried out with LigaSure™ devices. There are no new risk concerns for the LigaSure™ Exact Dissector, Nano-coated (LF2019) device when used to perform these procedure types. LigaSure™ technology performed well in the published studies.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2021
Covidien Nancy Sauer Director, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K202917
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 22, 2021 Received: February 24, 2021
Dear Nancy Sauer:
We have reviewed your Section 5100k) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202917
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 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, breast procedures, 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
Image /page/3/Picture/2 description: The image shows the logo for Covidien. The logo consists of a blue square with a white horizontal line in the middle and a light blue vertical line. To the right of the square is the word "COVIDIEN" in blue sans-serif font.
510(k) Summary
Date summary prepared: February 17, 2021
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Nancy Sauer Director, Regulatory Affairs Telephone: 720-361-5290 Fax: 303-530-6313 Email: nancy.k.sauer@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
| 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) | |
| 510(k) Number: | K173281 |
| Manufacturer: | Covidien |
Reference Device
| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
|---|---|
| Catalog Number: | LF1212/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 |
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.
4
A hemostat style body allows the user to open or close the instrument jaws during and cutting, with a single activation button incorporated into the body of the device.
How Provided
The LigaSure™ Exact Dissector, Nano-coated (LF2019) device is provided sterile and is intended for single use.
Compatible Electrosurgical Generators:
- ForceTriad™ Energy Platform (ForceTriad) ●
- Valleylab™ LS10 Generator (VLLS10GEN) ●
- Valleylab™ FT10 Energy Platform (VLF10GEN) .
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, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, breast procedures, 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.
Patient Contacting Materials
Twenty-seven parts were determined to come into direct contact with the patient or user. The materials that comprise these parts, their location within the proposed (LF2019) device, and full biocompatibility information were identified in the original premarket submission for the LF2019 device (K173281).
Comparison of Technological Characteristics with the Predicate Device
The LigaSure™ Exact Dissector. Nano-coated (LF2019) device is unchanged from the predicate device, as cleared under K173281, in terms of intended use, design, performance and technological characteristics. The only difference is that the indications for use have been updated to include breast procedures.
5
| Characteristic | Subject Device
LigaSure™ Exact Dissector, Nano-coated
(LF2019) | Predicate Device
LigaSure™ Exact Dissector, Nano-
coated (LF2019) [K173281] | Results
(compared to
predicate) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Classification Regulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| 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, breast procedures, 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. | 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. | Addition of
surgical
specialties and
procedures,
same intended
use |
| Contraindications | None | None | Same |
| Maximum Vessel
Diameter | 7 mm | 7 mm | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization Method | EtO | EtO | Same |
| Packaging | HDPE die cut card in a Tyvek/Nylon pouch | HDPE die cut card in a Tyvek/Nylon
pouch | Same |
| Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same |
| Compatible Energy
Platform* | ForceTriad energy platform
(K110268)
Valleylab™ LS10 (K143654)
Valleylab™ FT10 (K191601) | ForceTriad energy platform
(K110268)
Valleylab™ LS10 (K143654)
Valleylab™ FT10 (K191601) | Same |
| Energy Activation | Handswitch or footswitch | Handswitch or footswitch | Same |
| Hand-activated Button
Design | Two-stage | Two-stage | Same |
| Proprietary Connector | Yes | Yes | Same |
| Corded | Yes | Yes | Same |
| Jaw Type | Bilateral | Bilateral | Same |
| Jaw Shape | Curved | Curved | Same |
| Instrument Design | Hemostat style | Hemostat style | Same |
6
Performance Data
No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device. Evidence of safety and effectiveness was presented in the previously submitted 510(k) and includes the following:
- Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2
- . Biocompatibility (ISO 10993-1)
- Device functionality
- Bench burst pressure
- In vivo acute and chronic animal studies
Relevance of Reference Predicate Device
The LF1212A LigaSure™ Curved, Small Jaw Open Vessel Sealer/Divider is used as a reference device in this submission. This is a valid reference device because it is used for the same intended use as the subject device and it uses the same principle of operation. It is very similar to the LigaSure™ Exact in terms of design and materials. It served as the predicate device for the initial clearance of the LigaSure Exact in premarket notification K173281.
The purpose of the reference device in this submission is to provide reference data for hemostasis performance and thermal spread in a LigaSure™ device for which there is a substantial body of literature showing successful use in breast procedures. The performance comparison between the LigaSure™ Exact and the LigaSure™ Curved Small Jaw supports the conclusion that the published data can be extrapolated to the LigaSure™ Exact device.
Clinical Literature Summary
A study of literature for breast procedures performed using LigaSure™ devices show that the hemostatstyle open LigaSure™M devices have been used successfully in breast procedures including mastectomy, flap reconstruction, and axillary lymph node dissection. The safety and effectiveness outcomes reported in the literature were associated with effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications, the same types of outcomes that are reported for other surgical procedures carried out with LigaSure™ devices. There are no new risk concerns for the LigaSure™ Exact Dissector, Nano-coated (LF2019) device when used to perform these procedure types. LigaSure™ technology performed well in the published studies.
Conclusions
The proposed LigaSure™ Exact Dissector. Nano-coated (LF2019) device for use in breast surgical procedures is substantially equivalent to the predicate LigaSure™ Exact Dissector, Nano-coated (LF2019) for its indicated use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. The previously conducted bench and animal studies and clinical literature discussed in this submission have demonstrated that the device is suitable for the proposed expanded indications and that no new safety issues are identified with these indications.