TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE

• K Number: K011571
• Device Name: TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
• Manufacturer: THE RX FILES CORP.
• Date Cleared: 2001-08-09 ( 80 days)
• Product Code: NDC
• Regulation Number: 868.1890
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx1M, InterchangeRx™ and PracticePrescribeRxTM. The DoseRx™ is designed for use by trained clinicians to calculate any individual patient's optimal next dose for any given agent. The InterchangeRx™ is designed to switch a patient from one brand of agent to another while maintaining the therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator that offers graded prescriber training of next dose calculation scenarios with scalable patient response and surrogate marker inputs that allows the healthcare provider to gain guided and measured experience in calculating the next dose for a new or infrequently used drug.

The IDS™ is not a substitute for clinical reasoning. The IDS™ is an aid for trained clinicians based upon significant and properly entered data. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

Device Description

The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx1M, InterchangeRx™ and PracticePrescribeRxTM.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document is an FDA 510(k) clearance letter for the TRxF Intelligent Dosing System™, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device. It defines the device's indications for use but does not present the results of any performance studies against specific acceptance criteria.

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).