(24 days)
No
The device description explicitly states that the proposed devices do not contain software, and there is no mention of AI or ML in the summary.
Yes
The device is used in surgical procedures for therapeutic purposes, specifically for ligation (sealing) and dividing (cutting) vessels, tissue bundles, and lymphatics.
No
The device is an electrosurgical instrument for sealing and dividing tissue during surgery, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The LigaSure Sealer/Divider is an electrosurgical instrument used during surgical procedures to seal and divide vessels and tissues within the body. It directly interacts with the patient's internal anatomy.
- Intended Use: The intended use clearly describes its application in surgical procedures for ligation and division of vessels and tissues. It does not mention any analysis of specimens taken from the body.
Therefore, the LigaSure Sealer/Divider falls under the category of 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF18XX) devices are sterile, single-use, coated, 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 general surgical procedures (as indicated) using radio frequency (RF) energy. The proposed devices come in three shaft lengths 23 cm (LF1823), 37 cm (LF1837), and 44 cm (LF1844). 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 and veins), tissue bundles, 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™ Blunt Tip Sealer/Divider, Nano-coated 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 Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis.
Electrical Safety and Electromagnetic Compatibility (EMC): 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 devices performed as expected. Tests included Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Jaw Hyper-Extension, Bench Grasping Performance, Device Cycle Test.
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. Testing showed equivalent performance between the subject and predicate devices.
Acute Animal Study: In the animal study conducted, 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. These studies demonstrated that the subject devices performed equivalently to 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 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract 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
November 14, 2016
Covidien Mr. Celso Duran Specialist. Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K162941
Trade/Device Name: Ligasure Blunt Tip, Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 20, 2016 Received: October 21, 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 803); good manufacturing practice requirements as set forth in
1
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/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 yours,
Jennifer R. Stevenson -A
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
510(k) Number (if known) K162941
Device Name
Ligasure™ Blunt Tip Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
Date summary prepared: 11/3/2016
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Mr. Celso Duran Specialist, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com
Name of Device
| Trade Name: | LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844) |
|---|---|
| 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 Sealer/Divider (LF1623, LF1637, LF1644) |
|---|---|
| Common Name: | Bipolar Vessel Sealing Device |
| 510(k) Number: | K130744 (cleared 04/05/2013), K141153 (cleared 8/14/2014), K142929 |
| (cleared 01/27/2015) | |
| Manufacturer: | Covidien |
| Reference Devices | |
| Trade Name: | LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano- |
| coated (LF4418) | |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) | |
| 510(k) Number: | K162047 |
| Manufacturer: | Covidien |
Device Description
The LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF18XX) devices are sterile, single-use, coated, 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 general surgical procedures (as indicated) using radio frequency (RF) energy. The proposed devices come in three shaft lengths 23 cm (LF1823), 37 cm (LF1837), and 44 cm (LF1844). 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
4
K162941
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 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 with the Predicate Device
The application of radio frequency (RF) energy to target tissue is fundamental technology 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 addition of a non-stick coating to the jaws of the proposed devices and the replacement of the ceramic dots on the predicate jaw sealplates with DuPont LF500 ceramic dots.
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, Nano-coated 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:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity
- Materials Mediated Pyrogenicity .
- . Hemolysis
Electrical Safety and Electromagnetic Compatibility (EMC)
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 devices performed as expected.
- . Jaw force
- . Jaw gap
- Device resistance, capacitance, and inductance .
- . Jaw Hyper-Extension
- Bench Grasping Performance ●
- Device Cycle Test
5
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. Testing showed equivalent performance between the subject and predicate devices.
Acute Animal Study
In the animal study conducted, 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. These studies demonstrated that the subject devices performed equivalently to 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 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.
Summarv
Based on the preclinical performance as documented in the performance testing, the LigaSure™ Blunt Tip Sealer/Divider, Nano-coated devices were found to have a safety and effectiveness profile that is similar to the predicate devices.
Conclusions
The subject devices have the same indications for use as the legally marketed predicate devices. Furthermore, design changes made to introduce the subject devices do not raise different kinds of safety and effectiveness questions. Verification and validation data support substantial equivalence of the modified LigaSure™ Blunt Tip Sealer/Divider, Nano-coated devices to the legally marketed predicate devices.