(57 days)
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, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, 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.
The LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) device is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with a Covidien electrosurgical generator that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels (arteries, veins, pulmonary arteries, pulmonary veins), tissue bundles, and lymphatics clamped between the jaws using radio frequency (RF) energy. The LF1930T subject can also grasp tissue and perform blunt dissection during general surgical procedures (as indicated).
A hand actuated lever 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 handle. The proposed device has a 30cm length shaft and does not contain software.
The provided document is a 510(k) summary for the LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T). It details the device's technical characteristics, indications for use, and a comparison to predicate devices, along with performance data to support its substantial equivalence.
However, the document does not describe a study in the context of typical AI/ML device evaluations. This submission is for a traditional medical device (an electrosurgical instrument), and therefore the 'acceptance criteria' and 'study' described here are related to hardware performance, electrical safety, and animal studies, not statistical measures of algorithmic performance like accuracy, sensitivity, or specificity. There are no mentions of "test set," "training set," "ground truth experts," or an "AI/ML algorithm" in the provided text.
Therefore, many of the requested fields cannot be answered as they pertain to AI/ML device studies, which is not what this document describes.
Here's an attempt to fill in the table and information based on the provided text, while acknowledging the limitations for AI/ML specific questions:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with relevant portions of IEC 60601-1 and IEC 60601-2-2 standards. | "The system complies with relevant portions of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety." |
| Electromagnetic Compatibility (EMC) | Compliance with the IEC 60601-1-2 standard. | "The system complies with relevant portions of the ... IEC 60601-1-2 standard for EMC." |
| Bench Performance (Mechanical, Electrical, Functional) | Device performs as expected per defined design inputs and product specifications. This likely includes: | "Mechanical, electrical, functional, and ex-vivo vessel burst pressure testing was carried out on validated and representative conditions as appropriate to verify that the new device performs as expected. The subject device conforms to the requirements defined in the related design inputs and subsequent product specifications." |
| - Vessel Sealing | Ability to ligate and divide vessels up to and including 7 mm. Achieve specified burst pressure. | "ex-vivo vessel burst pressure testing was carried out... to verify that the new device performs as expected." (Specific performance metrics not detailed, but conformance is stated). |
| - Cutting | User-actuated blade to divide tissue after seal. | "functional ... testing was carried out ... to verify that the new device performs as expected." (Specific performance metrics not detailed, but conformance is stated). |
| Acute Animal Study (Safety & Effectiveness) | Demonstrate similar acute sealing performance and lateral thermal spread compared to predicate devices. | "These studies demonstrated that the subject device is as safe and effective as the predicate devices." |
| Chronic Animal Study (Seal Quality) | Maintain chronic hemostasis over 21 days; subject survival. | "All animals enrolled in the study survived 21 days post-op and all seals maintained chronic hemostasis." |
| Human Factors/Usability | Compliance with IEC 62366-1; representative users can use the device safely and effectively. | "The usability engineering process applied to the subject device was in compliance with the requirements of IEC 62366-1... The process included analysis of user needs and potential use errors followed by testing to demonstrate that representative users can use the subject device in a safe and effective manner." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not applicable in the context of an AI/ML algorithm evaluation. For the acute and chronic animal studies, specific numbers of animals are not provided. The bench testing involved "validated and representative conditions," but specific sample sizes for vessel burst pressure or other tests are not detailed.
- Data Provenance:
- Bench performance: Ex-vivo (likely animal tissue or synthetic models).
- Animal Studies: Live animal subjects (acute and chronic). No country of origin is specified.
- Study Design: These studies would be considered prospective for the specific tests performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic or prognostic tool. Ground truth would be defined by direct physical measurements, observations by veterinary surgeons/pathologists in animal studies, and engineering specifications. The document does not specify expert qualifications beyond the implicit expertise required to conduct and interpret these types of pre-clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human reader consensus for AI ground truth, which is not relevant here. Decisions about performance in animal studies or bench testing would be based on objective criteria and measurements, likely by a single investigator or team, with standard scientific peer review implicit in the process, but not a formal adjudication akin to expert consensus for image interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed as it is irrelevant to the device's function. The study compares the performance of the new device to predicate (existing) devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual electrosurgical instrument requiring human operation. "Standalone" performance in this context would refer to the device's inherent mechanical and electrical function. The "Bench Performance Testing" and "Animal Studies" serve this purpose by evaluating the device's function on its own or in the hands of trained users without comparison to an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various studies:
- Electrical Safety & EMC: Ground truth established directly from standardized tests and measurements against published limits (e.g., IEC standards).
- Bench Performance: Ground truth established through engineering specifications, direct physical measurements (e.g., burst pressure), and functional tests against design inputs.
- Acute Animal Study: Ground truth based on direct observation of sealing performance and histological assessment of lateral thermal spread.
- Chronic Animal Study: Ground truth based on animal survival, direct observation of hemostasis, and potentially post-mortem pathological examination of sealed vessels.
- Human Factors: Ground truth based on observing user interaction against safety protocols and effectiveness criteria defined by usability engineering principles.
8. The sample size for the training set
Not applicable. This refers to AI/ML model training, which is not described.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML model training, which is not described.
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June 21, 2018
Covidien Mr. James Davis Senior Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K181085
Trade/Device Name: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 24, 2018 Received: April 25, 2018
Dear Mr. Davis:
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 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 comprehensive regulatory information about medical devices and radiation-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 -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)
Device Name
LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T)
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, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv Date summary prepared: April 24, 2018
510(k) Submitter/Holder
Covidien, Ilc. 5920 Longbow Drive Boulder, CO 80301
Contact
James R. Davis Sr. Regulatory Affairs Specialist Telephone: 303-581-6964 Fax: 303-530-6313 Email: james.r.davis(@medtronic.com
Name of Device
| Trade Name: | LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing,Nano-coated |
|---|---|
| Catalog Numbers: | LF1930T |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Class II, GEI) |
| Predicate Devices: | Primary |
| Trade Name: | LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated (LF4418) |
| Common Name: | Bipolar Vessel Sealing Device |
| Catalog Number: | LF4418 |
| 510(k) Number: | K162047 (cleared 9/15/16) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
| Secondary | |
| Trade Name: | LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coate |
| Common Name: | Bipolar Vessel Sealing Device |
| Catalog Number: | LF1923, LF1937, LF1944 |
| 510(k) Number: | K133338 (cleared 12/20/2013), K141153 (cleared 8/14/2014), K170869(cleared 04/21/2017) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
No reference devices were used in this submission.
Device Description
The LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) device is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with a Covidien electrosurgical generator that include vessel sealing capabilities
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to ligate (seal) and divide (cut) vessels (arteries, veins, pulmonary arteries, pulmonary veins), tissue bundles, and lymphatics clamped between the jaws using radio frequency (RF) energy. The LF1930T subject can also grasp tissue and perform blunt dissection during general surgical procedures (as indicated).
A hand actuated lever 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 handle. The proposed device has a 30cm length shaft and does not contain software.
Indications for use:
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, veins, pulmonary arteries, 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.
Comparison of Technological Characteristics to the Predicate Devices
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 both the primary/secondary predicate devices are based on the following same technological elements:
- . Lever - closes the jaw to grasp the tissue
- Jaws Used to grasp tissue and to deliver RF energy to seal target structures ●
- Activation Button - Allows RF energy to be activated by the user
- Cutting Trigger Allows the user to divide (cut) sealed structures ●
- Device Materials - Materials are identical to the LF19XX secondary predicate devices only
The following technological differences exist between the subject and both the primary/secondary predicate devices:
- . Shaft Length – Provides the jaw assembly access to the surgical site
- Jaw Assembly Specifications Minor restrictions of the jaw assembly specification range ● within the specification range of the LF19XX secondary predicate devices
- . Device Identifiers - Changes to product identifiers on the device, packaging, and labeling
These changes in conjunction with the performance data outlined below support the changes to the indications for use of the subject device and have demonstrated to be substantially equivalent to the predicate devices.
Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
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Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC testing were conducted on the LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) or equivalent device as appropriate. The system complies with relevant portions of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.
Bench Performance Testing
Mechanical, electrical, functional, and ex-vivo vessel burst pressure testing was carried out on validated and representative conditions as appropriate to verify that the new device performs as expected. The subject device conforms to the requirements defined in the related design inputs and subsequent product specifications.
Acute Animal Study
In the acute animal study conducted, subjects underwent procedures to assess acute sealing performance and lateral thermal spread by the subject and predicate devices as appropriate. These studies demonstrated that the subject device is 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 enrolled in the study survived 21 days post-op and all seals maintained chronic hemostasis.
Human Factors and Usability
The usability engineering process applied to the subject device was in compliance with the requirements of IEC 62366-1 "Medical devices-Application of usability engineering to medical devices". The process included analysis of user needs and potential use errors followed by testing to demonstrate that representative users can use the subject device in a safe and effective manner.
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Summarv
Based on the pre-clinical performance as documented in the performance testing, the LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) subject device was found to have a safety and effectiveness profile that is similar to the predicate devices.
Conclusions
The subject device has the same intended use as the predicate devices and the design changes made to the subject device does not raise different kinds of safety and effectiveness questions. The comparison of device characteristics and review of the performance verification/validation data demonstrate substantial equivalence of the LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated subject device to the legally marketed predicate devices.
§ 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.