(137 days)
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.
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.
The provided text describes a 510(k) premarket notification for the LigaSure Exact Dissector, Nano-coated device, seeking to demonstrate its substantial equivalence to a predicate device. This type of submission generally relies on performance testing rather than extensive clinical studies to prove safety and effectiveness.
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative manner for specific performance metrics with predefined thresholds. Instead, the "acceptance criteria" are implied to be achieving performance comparable to the predicate device, demonstrating safety, and meeting relevant electrical safety, EMC, and biocompatibility standards. The reported device performance is presented as successfully meeting these implied criteria.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies with International Standard ISO 10993-1. |
| Electrical Safety | Complies with relevant clauses of IEC 60601-1 and IEC 60601-2-2 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Mechanical/Functional Performance | Mechanical, electrical, and functional testing verified that the proposed devices performed as expected. |
| Ex-vivo Vessel Sealing Performance (Burst Pressure) | Demonstrated bipolar electrosurgical vessel sealing performance comparable to the predicate devices on excised fresh porcine renal arteries and lymphatics. |
| Acute Sealing Performance and Lateral Thermal Damage | Acute animal study in porcine showed that the subject devices are as safe and effective as the predicate devices, with thermal safety evaluated. |
| Chronic Seal Quality | Chronic animal study (21 days) showed all animals survived without major complications, and all seals maintained chronic hemostasis and healed as expected. |
| Substantial Equivalence to Predicate Device | Based on preclinical performance, the device has a safety and effectiveness profile similar to the predicate device. Verification and validation data support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides the following information:
- Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal arteries and lymphatics" were used. The exact number of vessels or samples is not specified. Data provenance is porcine (animal origin).
- Acute Animal Study: "a porcine" was used. The exact number of animals is not specified, but the use of "a porcine" suggests it might have been a small number, possibly one or a few. Data provenance is porcine (animal origin) and acute (short-term observation).
- Chronic Animal Study: "All animals" (plural) survived 21 days. The exact number of animals is not specified, but it was a cohort observed over 21 days (chronic). Data provenance is porcine (animal origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies conducted (ex-vivo and in vivo animal studies) are preclinical in nature and typically involve researchers and veterinary professionals evaluating outcomes based on physiological measurements, histological analysis, and observed healing, rather than a "ground truth" established by human expert readers in the context of interpretation, like in imaging studies.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth. Since this submission relies on preclinical animal and ex-vivo studies, an adjudication method in this sense is not applicable and therefore not mentioned. The evaluation of outcomes would have been based on objective measurements and observations by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." MRMC studies inherently involve human readers and clinical cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is typically relevant for AI/ML-driven devices. The LigaSure Exact Dissector is a physical electrosurgical instrument. Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable. The device's performance is intrinsically tied to its use by a human surgeon.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the methods used to assess the device's performance and safety. It appears to be a combination of:
- Objective Physiological Measurements: Ex-vivo burst pressure to assess seal strength.
- Direct Observation and Macroscopic Assessment: During acute and chronic animal studies, including observations of hemostasis, healing, and presence/absence of major complications.
- Histological Analysis: Implied by the evaluation of "lateral thermal damage" and "healing" in animal studies, suggesting microscopic examination of tissue.
- Compliance with Standards: Verification against biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-2), and EMC (IEC 60601-1-2) standards.
8. The Sample Size for the Training Set
This question is typically relevant for AI/ML devices. Since the LigaSure Exact Dissector is a physical electrosurgical device, there is no "training set" in the machine learning sense. The device's design and manufacturing rely on engineering principles, materials science, and verified production processes, not on data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this type of medical device, this question is not applicable.
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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
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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 CFR878.4400, 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 CFR878.4400, 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.
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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
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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.
§ 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.