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K Number
K012236
Device Name
STARS2000 POWER CANNULA
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2001-11-19

(125 days)

Product Code
QPB,MUU
Regulation Number
878.5040
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Stars2000 Power Cannula," a suction lipoplasty system. It does not contain information about acceptance criteria, study details, or device performance metrics.

The letter primarily focuses on:

  • Notifying the applicant of an administrative change (new product code).
  • Confirming the substantial equivalence determination made in 2001.
  • Outlining the regulatory requirements for marketing the device.
  • Stating the intended use of the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, or standalone performance) from the provided text. This type of information would typically be found in the 510(k) submission itself, not in the clearance letter.

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.