(51 days)
Not Found
No
The description focuses on the electrosurgical mechanism, mechanical features, and performance testing related to sealing and cutting tissue. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
Yes
Explanation: The device is intended for use in general, minimally invasive, and open surgical procedures for the ligation and division of vessels and lymphatics, which are therapeutic interventions.
No
The device is an electrosurgical instrument for ligating and dividing tissue, not for diagnosis. Its function is to perform a surgical action (sealing and cutting vessels), not to identify or determine a disease or condition.
No
The device description clearly outlines a physical, hand-held electrosurgical instrument with mechanical components (jaws, blade, lever, button, trigger) and relies on RF energy from a separate generator. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in "general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired." This describes a surgical tool used on the patient during a procedure.
- Device Description: The description details a "hand-held bipolar electrosurgical instrument" designed to "ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws." This is a physical instrument used for surgical manipulation.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's condition.
- Using reagents or assays.
The device is a surgical instrument used for sealing and cutting tissue during surgery, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The LigaSure™ 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular. thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny. Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing devices can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the ForceTriad™ energy platform (generator) 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 using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSure™ mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
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)
Evidence of safety and effectiveness were obtained from both bench and preclinical testing to support the intended use of this device includes:
- . Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2 .
- . Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever force, and power curve performance
- Renal and pulmonary burst pressure .
Preclinical testing includes:
- Sealing and dividing vessels up to and including 7 mm .
- . Ability to achieve hemostasis of tissue and vessels
- . Tissue bundles
- Thermal spread .
- . Lymphatic burst pressure
- Chronic animal study .
The results of the testing demonstrate that the proposed devices, the LF 17XX series, operated as intended and are substantially equivalent to the predicate devices.
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.
Not Found
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
5 510(k) Summary
Date summary prepared: 10/29/2013
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Donald Henton Regulatory Affairs Mgr. Telephone: 303-530-6451 Fax: 303-530-6313 Email: donald.henton@covidien.com
Name of Device
| Trade Name: | LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) |
|---|---|
| Catalog Numbers: | LF1723, LF1737, LF1744 |
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, Class II. GEI). |
Predicate Devices
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series, LF1723, LF1737, LF1744) were compared to and found to be substantially equivalent to the following products of comparable type in commercial distribution:
| Trade Name: | LigaSure™ 5 mm, Laparoscopic, Sealer/Divider |
|---|---|
| Device Common Name: | Bipolar Electrosurgical Instrument |
| Catalog Number: | LF1537 |
| 510(k) Number: | K092879 (cleared 10/16/2009) |
| Manufacturer: | Covidien |
| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
| Device Common Name: | Bipolar Electrosurgical Instrument |
| Catalog Number: | LF1212A |
| 510(k) Numbers: | K102470 (cleared 2/7/2011), K113572 (cleared 9/7/2012) |
Device Description
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the ForceTriad™ energy platform (generator) 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 using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSure™ mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
Indications for Use
510(k): LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing - LF17XX series
DEC 2 0 2013
1
K133338
The LigaSure™ 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular. thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny. Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing devices can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Technological Characteristics
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) has the same technological and performance characteristics as the predicates, LF1537 K092879. and LF1212A K 113572. This Traditional 510(k) presents proposed modifications relating to the hand actuated lever that allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSure™ mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
The function of the devices remain the same as the predicates, where the new devices seal vessels and Ivmphatics using radio frequency (RF) energy to achieve its intended use and can mechanically divide the sealed areas or tissue with a mechanical cutting device.
Performance
Evidence of safety and effectiveness were obtained from both bench and preclinical testing to support the intended use of this device includes:
- . Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2 .
- . Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever force, and power curve performance
- Renal and pulmonary burst pressure .
Preclinical testing includes:
- Sealing and dividing vessels up to and including 7 mm .
- . Ability to achieve hemostasis of tissue and vessels
- . Tissue bundles
- Thermal spread .
- . Lymphatic burst pressure
- Chronic animal study .
Conclusion
The results of the testing demonstrate that the proposed devices, the LF 17XX series, operated as intended and are substantially equivalent to the predicate devices.
510(k): LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing - LF17XX series
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Covidien Mr. Donald Henton Regulatory Affairs Manager 5920 Longbow Drive Boulder, Colorado 80301
December 20, 2013
Re: K133338
Trade/Device Name: LigaSure 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 29, 2013 Received: October 30, 2013
Dear Mr. Henton:
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
3
Page 2 - Mr. Donald Henton
device-related adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
K133338 510(k) Number (if known):
Device Name: LigaSure™ Smm Maryland Jaw Sealer/Divider One-step Sealing (LFI 7XX series)
Indications for Use:
The LigaSure™ 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of versels and lymphatics is desired. The instrument creates a seal by application of RF electrosirgical onergy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic. and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted, vaginal hysterectomy, Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5 mm Maryland Jaw Sealer/Dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Prescription Use - and/or (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Long H. Chen -A
for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K133338
510(k): LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing - LF17XX series
4-2