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.
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.
The provided text describes a 510(k) summary for a medical device and outlines various tests performed to demonstrate its safety and effectiveness. However, it does not present a table of specific acceptance criteria with corresponding performance data. It also does not involve a study related to AI or human readers, as it is a physical surgical device.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that evidence of safety and effectiveness was obtained from both bench and preclinical testing. While specific quantifiable acceptance criteria and their precise results are not explicitly listed in a table format, the document indicates that the device's performance was compared to predicate devices and found to be substantially equivalent.
Here's a breakdown of the types of tests performed:
| Type of Test | Implied Acceptance Criteria (Not Explicitly Stated) | Device Performance (Implied from "operated as intended" and "substantially equivalent") |
|---|---|---|
| Bench Testing | ||
| IEC 60601-1 Compliance | Adherence to general requirements for basic safety and essential performance. | Compliant |
| IEC 60601-2-2 Compliance | Adherence to particular requirements for high frequency surgical equipment and accessories. | Compliant |
| Blade Return | Proper and consistent return mechanism. | Satisfactory |
| Grasping Performance | Secure and effective tissue grasping. | Satisfactory |
| Jaw Temperature | Within safe operating limits to prevent thermal injury. | Satisfactory |
| Jaw Force | Adequate force for effective sealing and grasping. | Satisfactory |
| Button Activation Force | Operable within ergonomic limits. | Satisfactory |
| Knife Deployment Force | Operable within ergonomic limits. | Satisfactory |
| Lever Force | Operable within ergonomic limits. | Satisfactory |
| Power Curve Performance | Consistent and effective energy delivery. | Satisfactory |
| Preclinical Testing | ||
| Renal and Pulmonary Burst Pressure | Ability to withstand physiological pressure after sealing. | Effective sealing up to and including 7 mm vessels. |
| Sealing of Vessels & Lymphatics (up to 7mm) | Effective and durable seal formation. | Effective sealing. |
| Hemostasis of Tissue & Vessels | Ability to stop bleeding effectively. | Achieved hemostasis. |
| Tissue Bundles | Effective sealing and division of tissue bundles. | Effective sealing and division. |
| Thermal Spread | Minimal spread of thermal energy to surrounding tissue. | Minimal and acceptable. |
| Lymphatic Burst Pressure | Ability to withstand physiological pressure after sealing. | Effective sealing. |
| Chronic Animal Study | Long-term safety and effectiveness in vivo. | Satisfactory, results support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test. It broadly mentions "bench and preclinical testing." It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given that this is a physical electrosurgical device for which "ground truth" would be established through physical measurements, physiological responses, and potentially expert observation during preclinical studies (e.g., assessing hemostasis), the concept of "experts establishing ground truth for a test set" as described in the prompt (e.g., radiologists) is not directly applicable in the same way it would be for an AI-powered diagnostic device.
4. Adjudication Method for the Test Set
This information is not provided and would not typically be relevant for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are more commonly used in studies involving human interpretation of data, such as medical image analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human performance in diagnostic tasks, which is not applicable to this physical electrosurgical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable. The device is a physical electrosurgical instrument and does not involve an "algorithm only" component in the sense of a software-based diagnostic tool. The performance studies described are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be established through:
- Physical measurements and engineering standards: For bench tests like blade return, jaw temperature, forces, and power curves. These would be compared against predefined specifications and industry standards (e.g., IEC 60601).
- Physiological outcomes in preclinical (animal) studies: For burst pressure, hemostasis, thermal spread, and the success of vessel/tissue bundle sealing and division. These outcomes would be assessed by observing the effects on biological tissue.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device development process described does not involve a "training set" in the context of machine learning (AI). The device's design and engineering are based on established principles and iterative development, not data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated above (no AI training set).
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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
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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
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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
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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
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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
§ 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.