(52 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
The device is described as a bipolar electrosurgical instrument for use in surgical procedures to ligate and divide vessels and tissues, which directly relates to treating or modifying a physiological function of the body.
No
Explanation: The device is described as a "bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." It is used for sealing and cutting, not for diagnosing medical 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 "open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "hand-held bipolar vessel sealing device" designed to "ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures." This further reinforces its role as a surgical instrument.
- Lack of In Vitro Activity: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens outside the body.
The device is a surgical instrument used in vivo (within the body) during a surgical procedure.
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure Impact™ Curved, Large Jaw. Open Sealer/Divider, Nano-coated (LF4418) is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures (as indicated). 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
vessels (arteries, veins, pulmonary arteries, pulmonary veins), tissue bundles, and lymphatics
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 Impact™ Curved, Large Jaw, Open Sealer/Divider, 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. 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 was conducted on the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device. The system complies with relevant clauses of the ANSI AAMI ES 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 device performed as expected.
- Jaw force
- Jaw gap
- Shaft/Jaw Rotation
- Device resistance, capacitance, and inductance
- 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, two female porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety of the new device 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
A chronic study on five animals to assess seal quality over the course of 21 days was conducted. All animals survived 21 days post-op and all seals maintained chronic hemostasis.
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Covidien Mr. Celso Duran Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K162047
Trade/Device Name: LigaSure Impact Curved, Large Jaw, Open Sealer/divider, Nanocoated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2016 Received: September 1, 2016
Dear Mr. 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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
1
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 Parts 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/ResourcesforYou/Industry/default.htm. 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.
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.
Christopher J. Ronk-S
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
2
Indications for Use
Page 1 of 1
510(k) Number (if known) K162047
Device Name
LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, 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, veins, 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, 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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Image /page/3/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square in the center and a light blue vertical line. To the right of the square is the word "COVIDIEN" in a dark blue sans-serif font.
510(k) Summary Date summary prepared: 8/17/2016
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Celso Duran Specialist, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com
Name of Device
| Trade Name: | LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-
coated |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Numbers: | LF4418 |
| 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 Impact™ Curved, Large Jaw, Open Sealer/Divider |
|---|---|
| Catalog Number: | LF4318 |
| Common Name: | Bipolar Vessel Sealing Device |
| 510(k) Number: | K123444 (cleared 1/30/2013), 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 Impact™ Curved, Large Jaw. Open Sealer/Divider, Nano-coated (LF4418) is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures (as indicated). 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 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.
4
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 difference between the subject and predicate devices is the addition of a non-stick coating to the jaws of the proposed device.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, 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. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation .
- . Systemic Toxicity
- o Hemolysis
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC testing was conducted on the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device. The system complies with relevant clauses of the ANSI AAMI ES 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 device performed as expected.
- Jaw force
- Jaw gap
- Shaft/Jaw Rotation ●
- Device resistance, capacitance, and inductance ●
- 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.
5
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, two female porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety of the new device 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
A chronic study on five animals to assess seal quality over the course of 21 days was conducted. All animals survived 21 days post-op and all seals maintained chronic hemostasis.
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 Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The subject device has the same indications for use as the legally marketed predicate device. Furthermore, design change made to introduce the coated device does not raise different kinds of safety and effectiveness questions. Verification and validation data support substantial equivalence of the modified LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nanocoated devices to the legally marketed predicate device.
5-4