(13 days)
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.
Instruments 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
Caiman Seal and Cut Technology consists of the Lektrafuse RF Generator and the sterile, single use Caiman devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.
The provided text describes a 510(k) premarket notification for a medical device called "Caiman Seal and Cut Technology." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving de novo safety and effectiveness through a clinical performance study involving human subjects or AI-based image analysis.
Therefore, the information required to answer your prompt, which pertains to the acceptance criteria and study proving an AI/ML device's performance (including sample sizes, expert ground truth establishment, MRMC studies, etc.), is not present in the provided text.
The text details the following:
- Device Name: Caiman Seal and Cut Technology
- Regulatory Classification: Electrosurgical cutting and coagulation device and accessories (Class II, Product Code GEI, Regulation Number 21 CFR 878.4400)
- Purpose of Submission: K151858 – to demonstrate substantial equivalence to a previously cleared device (K140839).
- Device Description: Bipolar electrosurgical instruments (with a cutting blade) designed for vessel sealing, blunt dissection, grasping, and dividing tissue using RF energy. Used with a dedicated Lektrafuse RF Generator.
- Indications for Use: General surgery and gynecologic procedures where ligation and division of vessels up to 7mm are desired. Not for tubal sterilization.
- Performance Data: States that bench testing was performed on modified devices and found them substantially equivalent to predicate devices.
- Tests performed: Seal Burst Pressure (on three tissue types), Visual Arcing, Jaw Adhesion, Thermal Spread. This is physical device performance testing, not AI/ML model performance.
- Compliance with Standards: IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1: 3rd Edition, IEC 62304.
In summary, this document is for a traditional electrosurgical device, not an AI/ML device. Therefore, the specific criteria and study details you've requested regarding AI/ML performance are not applicable and thus not found in this regulatory submission.
§ 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.