(26 days)
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 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™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.
The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a handswitch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.
The purpose of this submission is to propose the use of an alternate dot material for the LigaSure Curved, Small Jaw, Open Sealer/Divider devices (K141153). There have been no prior submissions for the proposed change. The proposed devices do not contain software.
This document is a 510(k) summary for a medical device called the "LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A)". This submission is for a modification to an existing device, specifically changing the material of ceramic spacers and adding an etched wetting ring feature. Therefore, the information provided focuses on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not negatively impact its safety or performance.
The document does not describe a study involving AI, human readers, or a typical diagnostic device's acceptance criteria like sensitivity, specificity, or AUC. Instead, it describes hardware device performance criteria based on engineering specifications and safety standards.
Here's an analysis of the provided text in relation to the requested information, acknowledging that many requested points are not directly applicable due to the nature of this particular device submission (a modification to a non-AI surgical instrument):
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the format typically seen for AI/diagnostic devices (e.g., sensitivity/specificity thresholds). Instead, it states that "design verification testing... confirmed the continued conformance to applicable technical design specifications and performance requirements". These performance requirements are listed as:
| Acceptance Criterion (Type of Testing) | Reported Device Performance |
|---|---|
| Biocompatibility evaluation | Conforms to ISO 10993-1:2009 |
| Basic safety and essential performance | Conforms to IEC 60601-1:2005, A1:2012 and IEC 60601-2-2:2009 |
| Electromagnetic compatibility | Conforms to IEC 60601-1-2:2007, CORR: July 31, 2010 |
| Design verification testing: Jaw gap | Conformance confirmed |
| Design verification testing: Force | Conformance confirmed |
| Design verification testing: Cut length | Conformance confirmed |
| Design verification testing: Hyperextension | Conformance confirmed |
| Design verification testing: Resistance | Conformance confirmed |
| Design verification testing: Renal burst pressure | Conformance confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of data for an AI algorithm. The device is a surgical instrument, and testing involves physical evaluation and engineering measurements. The document states "design verification testing", which implies a set of physical devices were tested. However, the exact sample size (number of devices or tests performed) is not provided. No data provenance related to "country of origin for data" is relevant here, nor is retrospective or prospective as it's not a data-driven model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The device is a surgical instrument, not an AI diagnostic tool. "Ground truth" for this device is based on objective engineering specifications and international safety standards, not expert consensus on medical images or diagnoses. The "truth" is whether the physical properties and performance characteristics of the instrument meet defined regulatory and design standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no "test set" in the context of medical images or diagnoses requiring adjudication by experts.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument and does not involve AI or human readers for diagnostic interpretation. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device does not contain an AI algorithm. The document explicitly states: "The proposed devices do not contain software."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications, international safety standards (ISO, IEC), and design verification requirements. For example, "renal burst pressure" testing has an objective, measurable outcome that is compared against a predefined standard for acceptable sealing strength.
8. The sample size for the training set
This question is not applicable as the device does not involve an AI algorithm or a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device does not involve an AI algorithm or a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2015
Covidien Ms. Dawn Tindall Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K152286
Trade/Device Name: LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 11, 2015 Received: August 13, 2015
Dear Ms. Tindall:
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
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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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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
LigaSureTM Curved, Small Jaw, Open Sealer/Divider (LF1212A)
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, 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: August 11, 2015
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Dawn D. Tindall Sr. Regulatory Affairs Product Specialist Telephone: 303-581-7034 Fax: 303-530-6313 Email: dawn.d.tindall@medtronic.com
Name of 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) |
Predicate Device
| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
|---|---|
| Common Name: | Bipolar Vessel Sealing Device |
| Catalog Number: | LF1212A |
| 510(k) Number: | K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012) |
| K102470 (cleared 2/7/2011) | |
| 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™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.
The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a handswitch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.
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The purpose of this submission is to propose the use of an alternate dot material for the LigaSure Curved, Small Jaw, Open Sealer/Divider devices (K141153). There have been no prior submissions for the proposed change. The proposed devices do not contain software.
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 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 LigaSure™ Curved, Small Jaw, Open Sealer/Divider devices have the same technological and performance characteristics as the predicate. This Special 510(k) proposes changes to the material of the ceramic spacers on the jaws of the device. The addition of an etched wetting ring feature is also included. The function of the device has not changed.
Performance Data
The modification to the LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) device was found to not affect safety or performance through design verification testing which confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- . Biocompatibility evaluation in accordance with ISO 10993-1:2009
- . Basic safety and essential performance in accordance with IEC 60601-1: 2005, A1: 2012 and IEC 60601-2-2: 2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2: 2007, CORR: July 31, 2010
- . Design verification testing including jaw gap and force, cut length, hyperextension, resistance and renal burst pressure
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusions
The results of testing demonstrate the device is as safe, effective, and performs as well as the LigaSure™ Curved, Small Jaw, Open Sealer/Divider, the legally marketed device identified herein.
§ 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.