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K Number
K990859
Device Name
DEFLECTABLE TAC ELECTROTHERMAL PROBE
Manufacturer
ORATEC INTERVENTIONS, INC.
Date Cleared
1999-06-14

(90 days)

Product Code
GEI,HRX
Regulation Number
878.4400
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K963157,K984185
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Deflectable TAC ElectroThermal probe is a disposable, monopolar electrosurgical device intended to be used for electro-coagulation of soft tissues in arthroscopic procedures. It is designed to be used with ORATEC ElectroThermal generators.

Device Description

The Deflectable TAC ElectroThermal Probe is a disposable, monopolar electrosurgical device designed to create controlled coagulative lesions in tissues. It provides minimally invasive access to the targeted tissues. The Deflectable TAC probe is used in conjunction with ORATEC ElectroThermal RF generators to deliver monopolar radiofrequency (RF) energy for electro-coagulation of soft tissues. The Deflectable TAC probe incorporates: A shaft with an RF energized tip for percutaneous or arthroscopic access to perform tissue coagulation; A thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery; A controllable, deflectable tip at the distal end of the probe to allow easier access to all tissue surfaces; A handle, with cable connector and deflecting mechanism at the proximal end.

AI/ML Overview

The provided text is a 510(k) summary for the ORATEC Interventions, Inc. Deflectable TAC ElectroThermal Probe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, or details of a clinical trial (like sample sizes, ground truth establishment, or expert involvement).

The core of the submission emphasizes:

  • Substantial Equivalence: The device is deemed substantially equivalent to the TAC-S Monopolar Cautery Probe (K963157, K984185) due to similar intended use, mechanism of action (monopolar radiofrequency energy for electro-coagulation), and basic components (insulated shaft, RF energized tip, thermocouple).
  • Minor Differences: The main differences highlighted are physical dimensions, potentially different tip/insulating materials, and the Deflectable TAC's controllable, deflectable distal tip compared to the TAC-S's malleable tip.
  • Intended Use: Electro-coagulation of soft tissues in arthroscopic procedures, used with ORATEC ElectroThermal generators.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is a regulatory submission for premarket notification, not a report of a device performance study or clinical trial.

§ 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.