(36 days)
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar generator in any general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps family are similar in design to the predicate devices. They have various tip lengths and configurations, and are available in insulated and non-insulated versions. They are made from a stainless steel or Titanium alloy with a proprietary non-stick coaling. The proximal end has a protective plastic insulator sheath with industry standard clectrosurgery cable connecting pins. Forceps are packaged individually, sold non-sterile, and intended for steam, and EtO sterilization.
The provided text describes the ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the format or level of detail requested in the prompt.
The document primarily focuses on:
- Device Description: Bipolar forceps with various tip lengths, configurations, insulated/non-insulated versions, made from stainless steel or Titanium alloy with a proprietary non-stick coating.
- Intended Use: Attached by cable to a standard electrosurgical bipolar generator for general surgery procedures requiring coagulation and/or tissue cauterization to achieve hemostasis.
- Technological Characteristics: Similar to predicate devices, with the main difference being the type of non-stick coating.
- Compliance with Standards: Designed to comply with ANSI/AAMI HF18-1993, FDA 510(k) Guidelines for Electrosurgical Devices, and other FDA guidance documents.
- Predicate Devices: Ethicon Inc. Non-Stick Bipolar Forceps (K973384).
- FDA Premarket Notification (510(k)) Clearance: The document includes the FDA letter granting substantial equivalence to the predicate device.
The document briefly mentions:
"Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Bipolar forceps met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended."
However, this statement does not provide the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the table or answer the specific questions about the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.
§ 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.