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K Number
K083415
Device Name
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2009-06-05

(199 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K073057,K070374
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

Device Description

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device consists of a handpiece with integrated controls and cable, a shaft with a suction cannula, and two interchangeable tips. The tonsil tip consists of a curved and tapered insulated blade electrode with an opening in the center to allow for the evacuation of smoke and fluids. The adenoid tip consists of a flat, straight insulated blade electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids and smoke. Both tips connect to the suction cannula of the handpiece.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for bringing a new device to market.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes and data provenance for a test set.
  3. Number of experts and qualifications for ground truth establishment.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone algorithm 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 text does mention:

  • Performance Data: "Preclinical laboratory and performance tests were executed to ensure the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide details about these tests, the specific criteria, or the results.
  • Study Type: The device's clearance is based on proving substantial equivalence to existing predicate devices (PEAK PlasmaBlade™ Tissue Dissection Device (K073057) and ArthroCare® ENT Plasma Wands™ (K070374)). This typically involves comparing technological characteristics, intended use, and safety/effectiveness profiles rather than a new clinical efficacy or performance study against predefined quantitative acceptance criteria.

§ 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.