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K Number
K971328
Device Name
OLYMPUS CD-6C-1 COAGULATION ELECTRODE
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-07-01

(82 days)

Product Code
FFE
Regulation Number
876.4650
Type
Traditional
Panel
GU
Reference & Predicate Devices
K955247
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

Device Description

Olympus CD-6C-1 Coagulation Electrode.

AI/ML Overview

I apologize, but the provided text from the 510(k) summary for the Olympus CD-6C-1 Coagulation Electrode does not contain the information needed to answer your request about acceptance criteria and a study demonstrating device performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's technical performance against specific acceptance criteria.

Here's what the document does provide:

  • Device Name: Olympus CD-6C-1 Coagulation Electrode
  • Intended Use: For electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree when used with the Olympus BF-240 Bronchovideoscopes.
  • Classification: Class II, Endoscopic Coagulation Electrode and Accessories (21 CFR 876.4300)
  • Predicate Devices: Olympus CD-1L/U Coagulation Electrode (Preamendment) and Olympus KD Series Sphinctertomes (K955247)
  • Regulatory Determination: Substantially Equivalent

It does not include any sections describing:

  • Specific acceptance criteria for performance metrics (e.g., coagulation time, temperature thresholds, tissue effect size).
  • Details of a study conducted to test these criteria.
  • Sample sizes for test sets or training sets.
  • Data provenance, expert qualifications, or adjudication methods for ground truth because these are typically found in detailed performance studies, not in a 510(k) summary emphasizing substantial equivalence.
  • Any mention of AI, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

§ 876.4650 Water jet renal stone dislodger system.

(a)
Identification. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.