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K Number
K032207
Device Name
COBRA COOLED SURGICAL PROBE, MODEL M004159670
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2003-08-20

(33 days)

Product Code
GEI,OCL
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
K023291
Predicate For
K040104
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use for Cobra Cooled Surgical Probe is as follows:

The Cobra Cooled Surgical Probe is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Description

The Cobra Cooled Surgical Probe is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The text discusses a 510(k) submission for an electrosurgical probe and compares it to a predicate device, noting that "non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use." However, it does not provide details about:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts and their qualifications for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of a Special 510(k) submission, confirming substantial equivalence to a predicate device, and outlining the intended use and device characteristics. It states that non-clinical tests were conducted and met design-input criteria, but it does not elaborate on the specifics of these tests, their methodology, or the results in sufficient detail to answer your questions.

§ 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.