(110 days)
No reference devices were used in this submission.
No
The device description explicitly states that the proposed devices do not contain software, and there are no mentions of AI, DNN, or ML in the summary.
Yes
Explanation: The device is intended for use in surgical procedures to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics, which are direct interventions for treating medical conditions.
No
The device is described as an electrosurgical instrument for sealing and dividing tissue during surgical procedures (ligation and cutting), not for diagnosing conditions.
No
The device description explicitly states, "The proposed devices do not contain software."
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 surgical procedures to ligate and divide vessels and tissue. This is an in vivo application, meaning it is used directly on living tissue within the body.
- Device Description: The description details a surgical instrument that uses RF energy to seal and cut tissue. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, tissue biopsies) or provide diagnostic information based on those analyses. IVDs are designed to provide information about a patient's health status through the examination of samples.
Therefore, the LigaSure Sealer/Divider is a surgical device, not 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 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 and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure™ Blunt Tip Sealer/Divider (LF1623, LF1644) devices are sterile (EtO), single-use, hand held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not contain software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Biocompatibility
The biocompatibility evaluation for the LigaSure™ Blunt Tip Sealer/Divider devices 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. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC testing were conducted on the LigaSure™ Blunt Tip Sealer/Divider devices. The system complies with relevant portions of the IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 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 devices with the new shaft lengths perform as expected. Tested aspects include: Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Knife deployment force, Lever latching/unlatching/opening force.
Ex-vivo Vessel Burst Pressure
Ex-vivo burst pressure testing of excised fresh porcine renal, pulmonary arteries, and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.
Thermal Profile
Bench thermal profile testing using porcine tissue was conducted to evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate.
Acute Animal Study
In the animal study conducted, one female pig underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. Hemostasis rates met the predefined acceptance criteria. The thermal safety of the new LigaSure™ Blunt Tip Sealer/Divider devices was evaluated by macroscopic and histological evaluation of the tissue that was sealed and divided. These studies demonstrated that the subject devices are as safe and effective as the predicate device.
Chronic Animal Study
Because of similarity to the previously cleared design, the chronic animal study results reported in K130744 are valid for these devices.
Human Factors and Usability
The usability engineering process applied to these products was in compliance with the requirements of IEC 62366:2007 "Medical devices – Application of usability engineering to medical devices", as recognized by FDA. The process included analysis of user needs and potential use errors. This was followed by testing to demonstrate that representative users can use the instruments safely and correctly.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2015
Covidien Celso Duran Product Associate, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K142929
Trade/Device Name: LigaSure™ Blunt Tip Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 25, 2014 Received: November 26, 2014
Dear 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 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 (reporting of medical
1
device-related 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.
for
Sincerely yours,
David Krause -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name LigaSure™ Blunt Tip Sealer/Divider
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 and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a blue vertical line running through it. To the right of the square is the word "COVIDIEN" in blue, sans-serif font.
510(k) Summary Date summary prepared: 1/27/2015
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Celso Duran Product Associate, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: Celso.Duran@Covidien.com
Name of Device
| Trade Name: | LigaSure™ Blunt Tip Sealer/Divider |
|---|---|
| Catalog Numbers: | LF1623, LF1644 |
| 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™ Blunt Tip Laparoscopic Sealer/Divider |
|---|---|
| Common Name: | Bipolar Vessel Sealing Device |
| Catalog Number: | LF1637 |
| 510(k) Number: | K130744 (cleared 4/17/2013), K141153 (cleared 8/14/2014) |
| 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™ Blunt Tip Sealer/Divider (LF1623, LF1644) devices are sterile (EtO), single-use, hand held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do 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 and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as
4
urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, 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 with the Predicate Device
The application of radio frequency (RF) energy is the principle for both the subject and predicate devices. A seal is created by application of RF energy to structures (vascular and lymphatics) 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 (vascular and lymphatics)
- Lever –incorporates a latch mechanism to hold the jaws in the closed position ●
- . Activation button - allows RF energy to be activated by the user
- Cutting trigger allows user to divide (cut) sealed structures .
The only differences between the subject and predicate devices are the length of the shaft.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the LigaSure™ Blunt Tip Sealer/Divider devices 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. The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation .
- Systemic Toxicity ●
- Hemolysis
The patient-contacting materials are: stainless steel, ceramic; and polymers including ETFE, polycarbonate, polyamide, polyester, polypthalamide, ABS, and thermoplastic elastomer.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC testing were conducted on the LigaSure™ Blunt Tip Sealer/Divider devices. The system complies with relevant portions of the IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 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 devices with the new shaft lengths perform as expected.
- Jaw force
- Jaw gap
- . Device resistance, capacitance, and inductance
- . Knife deployment force
5
- . Lever latching/unlatching/opening force
Ex-vivo Vessel Burst Pressure
Ex-vivo burst pressure testing of excised fresh porcine renal, pulmonary arteries, and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.
Thermal Profile
Bench thermal profile testing using porcine tissue was conducted to evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate.
Acute Animal Study
In the animal study conducted, one female pig underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. Hemostasis rates met the predefined acceptance criteria.
The thermal safety of the new LigaSure™ Blunt Tip Sealer/Divider devices was evaluated by macroscopic and histological evaluation of the tissue that was sealed and divided. These studies demonstrated that the subject devices are as safe and effective as the predicate device.
Chronic Animal Study
Because of similarity to the previously cleared design, the chronic animal study results reported in K130744 are valid for these devices.
Human Factors and Usability
The usability engineering process applied to these products was in compliance with the requirements of IEC 62366:2007 "Medical devices – Application of usability engineering to medical devices", as recognized by FDA. The process included analysis of user needs and potential use errors. This was followed by testing to demonstrate that representative users can use the instruments safely and correctly.
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™ Blunt Tip Sealer/Divider devices were found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The subject devices have the same indications for use as the legally marketed predicate device. The design changes made to introduce the two new device lengths do not raise new kinds of safety and effectiveness questions. Verification and validation data support the substantial equivalence of the modified LigaSure™ Blunt Tip Sealer/Divider devices to the legally marketed predicate device.