(17 days)
Not Found
No
The summary describes a standard electrosurgical instrument that uses RF energy for sealing and a mechanical blade for cutting. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is used to ligate and divide vessels during surgical procedures, which is a surgical tool, not a therapeutic treatment for a disease.
No
Explanation: The device is described as a surgical instrument used for ligation, division, and sealing of vessels and tissues, and for blunt dissection during laparoscopic procedures. Its function is to perform surgical actions, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical, hand-held bipolar electrosurgical instrument with mechanical components (jaws, blade, lever, latching mechanism) designed for use with a separate energy platform. It is not solely 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LF1637 LigaSure is a surgical instrument used during a surgical procedure to seal and divide vessels and tissue within the patient's body. It uses RF energy and a physical blade.
- Intended Use: The intended use clearly describes its application in laparoscopic surgical procedures for ligation and division of vessels and lymph. This is an in vivo (within the living body) application, not an in vitro (in glass/outside the body) diagnostic test.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on those samples.
Therefore, the LF1637 LigaSure is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy 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 laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, 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 Blunt Tip Laparoscopic Sealer/Divider 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 Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively 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 laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, laparoscopic general surgical procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures.
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 was 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 latching/unlatching 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
- Lymphatic burst pressure
- Chronic animal study
The results of the testing demonstrate that the proposed device, the LF1637, operated as intended and is as safe and effective as the predicate device.
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.
K092879 (cleared 10/16/2009)
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
Image /page/0/Picture/1 description: The image shows the word "COVIDIEN" in bold, sans-serif font. To the left of the word is a black and white logo. The logo is a square with a white cross in the center.
APR 0 5 2013
510(k) Summary
Date summary prepared: 3/18/2013
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Diane Reed Sr. Regulatory Affairs Product Specialist Telephone: 303-581-7093 Fax: 303-530-6313 Email: diane.reed@covidien.com
Name of Device
| Trade Name: | LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider |
|---|---|
| Catalog Number: | LF1637 |
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, |
| class II GEI) |
Predicate Device
The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) was compared to and found to be substantially equivalent to the following product of comparable type in commercial distribution:
| Trade Name: | LigaSureTM 5 mm Blunt Tip Laparoscopic Sealer/Divide |
|---|---|
| Device Common Name: | Bipolar Electrosurgical Instrument |
| Catalog Number: | LF1537 |
| 510(k) Number: | K092879 (cleared 10/16/2009) |
| Manufacturer: | Covidien |
Device Description
The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively 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 laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.
Indications for Use
The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
1
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, 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 Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Technological Characteristics
The LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider has the same technological and performance characteristics as the predicate, K092879. This Special 510(k) presents proposed modifications relating to the jaw, handle, and component material changes. The function of the device has not changed. Similar to the predicate, this new device seals vessels and lymphatics 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 was 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 latching/unlatching 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
- t Lymphatic burst pressure
- Chronic animal study .
The results of the testing demonstrate that the proposed device, the LF1637, operated as intended and is as safe and effective as the predicate device.
510(k): LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider - LF1637
2
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Letter dated: April 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Covidien % Ms. Diane Reed Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K130744
Trade/Device Name: LigaSure™ 5mm Blunt Tip Laparoscopic 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: March 18, 2013 Received: March 19, 2013
Dear Ms. Reed:
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 - Ms. Diane Reed
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Mark N. Mielkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K130744
Device Name: LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637)
Indications for Use:
The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy 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 laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny. Nissen fundoplication, colectorny, adhesiolysis, oophorecotmy, 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 Blunt Tip Laparoscopic Sealer/Divider 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)
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For
(Division Sign-Off)
Division of Surgical Devices
510(k) Number K130744