(80 days)
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Unknown
The device name "Intelligent Dosing System" and the description of calculating "optimal next dose" suggest potential use of AI/ML, but the summary lacks explicit mention of AI, ML, or related terms, and no details about training or test data are provided.
No.
The software provides calculations and simulations for healthcare providers to determine optimal drug doses and gain experience; it does not directly treat or diagnose a medical condition.
No
The device is described as a software suite designed to calculate optimal drug doses, switch between drug brands, and simulate dosing scenarios for training. It explicitly states it is an "aid for trained clinicians" and "not a substitute for clinical reasoning," rather than a tool for identifying or characterizing diseases or medical conditions.
Yes
The device description explicitly states it is a "three-part software suite" and there is no mention of any associated hardware components or dependencies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the Intelligent Dosing System (IDS)™ is a software suite designed to calculate drug doses for patients based on clinical data. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The function of the IDS is to aid in clinical decision-making regarding drug dosing. While it uses patient data, its purpose is to assist clinicians in determining appropriate drug dosages, not to diagnose, monitor, or screen for diseases or conditions through the analysis of in vitro specimens.
The IDS is a clinical decision support software tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NDC
Device Description
The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx1M, InterchangeRx™ and PracticePrescribeRxTM.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Trained clinicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, featuring three curved lines that suggest a flowing or dynamic form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2001
The RxFiles Corporation c/o Ms. Yolanda Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
Re: K011571
Trade/Device Name: TRxF Intelligent Dosing System™ Regulation Number: 868.1890 Regulatory Class: II Product Code: NDC Dated: May 11, 2001 Received: May 21, 2001
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Yolanda Smith
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: TRxF Intelligent Dosing System™
Classification Panel: 868.1890
Indications for 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Over the Counter Use |
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K011571 |
|---|---|
| --------------- | --------- |