(56 days)
Not Found
No
The document describes a bipolar electrosurgical instrument that uses RF energy and a mechanical blade for sealing and dividing tissue. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is based on direct application of energy and mechanical action, not data analysis or learning algorithms.
Yes
The device is an electrosurgical instrument used in various surgical procedures to ligate and divide vessels and tissue, which are actions performed to treat or mitigate diseases or conditions.
No
The device is an electrosurgical instrument used for ligation and division of vessels and tissues during open surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device is a bipolar electrosurgical instrument with physical components (jaws, blade, handle, cable) and relies on radiofrequency energy for its function, clearly indicating it is a hardware device.
Based on the provided text, 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 for ligation and division of vessels, tissue bundles, and lymphatics. This is a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The description details a bipolar electrosurgical instrument with jaws, a blade, and controls for activating RF energy and cutting tissue. This is consistent with a surgical tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The description of the LigaSure Sealer/Divider does not mention any interaction with patient specimens or any diagnostic purpose.
Therefore, the Remanufactured LigaSure Sealer/Divider is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Remanufactured 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 and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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
NUJ
Device Description
The Remanufactured LigaSure Exact Dissector Without Nano-coating (LF2019) 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 instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:
- . Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
- . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
- . A trigger for actuating the blade.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.
For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the jaws of the device.
The instrument is compatible with the Covidien Valleylab FT10 Energy Platform.
The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Remanufactured LigaSure Exact Dissector Without Nano-coating (K220481) and not the Covidien Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.
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. Specific procedures mentioned include bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy.
Indicated Patient Age Range
Adults (for open ENT procedures).
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Remanufactured LigaSure Exact Dissector Without Nano-coating. This included the following tests:
- Biocompatibility
- Validation of Reprocessing
- Sterilization
- Electrical Safety and Electromagnetic Compatibility
- Functional Performance Tests
- Blade Trigger Actuation Force
- Clamp Arm Closing and Seal Button Force
- Clamp Arm Opening Force
- Clamp Arm Deflection
- Jaw Clamp Force
- Blade Excursion
- Jaw Opening Angle
- Burst Pressure
- Maximum Jaw Temperature
- Device Reliability
- Functional Attribute Testing
- Generator Software Compatibility
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, device reliability, and functional attribute tests.
Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the remanufactured device.
Key results: The results of bench testing and preclinical laboratory evaluations demonstrate that the Remanufactured LigaSure Exact Dissector Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2023
Stryker Sustainability Solutions Mr. Scott English Principal Regulatory Affairs Specialist 1810 W Drake Drive Tempe, Arizona 85283
Re: K230255
Trade/Device Name: Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: March 1, 2023 Received: March 2, 2023
Dear Mr. English:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.03.28 15:15:02 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230255
Device Name
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
Indications for Use (Describe)
The Remanufactured 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 and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Remanufactured Single-Use Device Model Included in Clearance
| Device Model | Device Name | Original Manufacturer |
|---|---|---|
| LF2019 | LigaSure Exact Dissector Without Nano-coating | Covidien |
4
510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
Contact:
Scott English Principal Regulatory Affairs Specialist 901-451-1456 (o) 480-763-5310 (f) scott.english@stryker.com
Date of Preparation: March 28, 2023
Name of Device:
| Trade/Proprietary Name: | Remanufactured LigaSure Exact Dissector Without Nano-coating
(LF2019) |
|-----------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Information: | Electrosurgical, Cutting & Coagulation Accessories
(21 CFR§878.4400, Product Code GEI, Class II) |
Predicate Devices:
| 510(k)
Number | 510(k) Title | Product
Code | Manufacturer |
|------------------|-----------------------------------------------------------------|-----------------|----------------------------------|
| K220481 | Remanufactured LigaSure Exact Dissector
Without Nano-coating | GEI | Stryker Sustainability Solutions |
| K173281 | LigaSure Exact Dissector, Nano-coated | GEI | Covidien |
Device Description:
The Remanufactured LigaSure Exact Dissector Without Nano-coating (LF2019) 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 instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:
- . Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
5
K230255
- . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
- . A trigger for actuating the blade.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.
For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the jaws of the device.
The instrument is compatible with the Covidien Valleylab FT10 Energy Platform.
The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Remanufactured LigaSure Exact Dissector Without Nano-coating (K220481) and not the Covidien Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.
Intended Use:
The Remanufactured LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation and division 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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.
Indications for Use Comparison:
The indications for use for the proposed device are the same in comparison to the predicate device and reference device.
Technological Comparison:
The design, materials, and intended use of the Remanufactured LigaSure Exact Dissector Without Nano-coating are equivalent to the predicate device and reference devices. The mechanism of action of the reprocessed device is identical to the predicate device and reference device in that the same standard mechanical design, materials, and size is utilized.
6
K230255
There are no changes to the claims, intended use, clinical application, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of the device includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations. The only differences between the Remanufactured LigaSure Exact Dissector Without Nano-coating and the predicate Remanufactured LigaSure Exact Dissector Without Nano-coating is that the device is reprocessed an additional time. The only difference between the Remanufactured Exact Dissector Without Nano-coating and the reference device are that the device is reprocessed, and some device components are replaced with equivalent components during the reprocessing operation.
| Predicate Device | Reference Device | Subject Device | |
|---|---|---|---|
| Uses | Single Patient Use | Single Patient Use | Single Patient Use |
| Device Length | 21cm | 21cm | 21cm |
| Jaw Length | 20.6mm | 20.6mm | 20.6mm |
| Jaw Shape | Curved | Curved | Curved |
| Mechanism for Cutting | Mechanical - User | ||
| actuated blade | Mechanical - User | ||
| actuated blade | Mechanical - User | ||
| actuated blade |
Performance Data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Remanufactured LigaSure Exact Dissector Without Nano-coating. This included the following tests:
- Biocompatibility
- Validation of Reprocessing
- . Sterilization
- . Electrical Safety and Electromagnetic Compatibility
- . Functional Performance Tests
- Blade Trigger Actuation Force o
- Clamp Arm Closing and Seal Button Force O
- Clamp Arm Opening Force O
- Clamp Arm Deflection O
- Jaw Clamp Force O
- Blade Excursion O
- Jaw Opening Angle O
- Burst Pressure O
- Maximum Jaw Temperature O
- Device Reliability O
- Functional Attribute Testing O
- Generator Software Compatibility O
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, device reliability, and functional attribute tests.
Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the remanufactured device.
7
Conclusion:
The results of bench testing and preclinical laboratory evaluations demonstrate that the Remanufactured LigaSure Exact Dissector Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein.