(40 days)
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure™ Vessel Sealing System 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™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.
This document is a 510(k) premarket notification for the LigaSure™ Vessel Sealing System. The primary purpose of this notification is to advise the FDA of a change in the intended use and resulting labeling for the device, not to introduce a new device or demonstrate a new level of performance. As such, the information you're requesting regarding acceptance criteria and performance studies for a new device or algorithm development is largely not present in this submission.
The document confirms the safety and effectiveness of the device for its expanded indications based on pre-clinical studies and its substantial equivalence to a legally marketed predicate device.
Here's an attempt to answer your questions based on the provided text, highlighting what is explicitly stated and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., target accuracy, sensitivity, specificity) are defined or reported in this document. The document states that pre-clinical studies were conducted.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (from Pre-clinical studies) |
|---|---|
| Effectiveness in sealing lymphatic vessels | Produces seals with burst pressures substantially greater than the physiologic pressures in the vessels. |
| Seals vessels up to 7mm and tissue bundles as large as can fit in the jaws of each instrument | Confirmed operation for vessels up to 7mm and bundles as large as will fit in the jaws of the instruments. |
| Substantial Equivalence to Predicate Device (K981916) | The device is considered substantially equivalent to the predicate device for its stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "pre-clinical studies" but does not specify the sample size, the type of test set (e.g., animal models, cadaveric tissue), or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The pre-clinical studies likely involved laboratory measurements and potentially histological analysis by trained personnel, but no details on expert consensus for ground truth are given.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This is a medical device for surgical procedures, not an AI diagnostic tool, so such a study would not be typically performed in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the LigaSure™ Vessel Sealing System is a physical medical device operated by a surgeon, not an AI algorithm.
7. Type of Ground Truth Used
Based on the "pre-clinical studies," the ground truth likely involved:
- Measurement of burst pressures: This is a direct physical measurement.
- Visual and/or histological examination of sealed vessels: To confirm complete and effective sealing.
- Functional tests: To ensure the seals withstand physiological pressures.
8. Sample Size for the Training Set
This information is not provided, nor is it directly relevant in the context of this type of device where "training set" for an algorithm is not applicable. The device's "training" refers to its design and engineering iterations.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, and the concept of a "training set ground truth" in the AI sense does not apply to this device. The design and validation of this medical device would have relied on engineering principles, material science, and pre-clinical testing to establish its performance and safety characteristics.
§ 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.