(95 days)
Not Found
No
The device description and intended use clearly state that it is a simple dose conversion tool based on clinician-entered data and weight, with no mention of learning, adaptation, or complex algorithms characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a dose calculation tool, not a therapeutic device. It assists clinicians in determining drug doses but does not directly administer therapy or provide therapeutic effects to the patient.
No
The device aids clinicians in calculating drug doses based on weight but explicitly states it is "not a substitute for clinical reasoning" and "provides no validation as to the appropriateness of the entered weight based dose," indicating it does not diagnose patient conditions.
Yes
The device description explicitly states it is a "drug dose conversion feature designed for use with an electronic medical record system," and the performance studies focus solely on "software verification and validation testing activities." There is no mention of any hardware component being part of the device itself.
Based on the provided information, the Picis Weight Based Dose Converter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Picis Weight Based Dose Converter is a software tool that performs calculations based on patient weight and a clinician-provided weight-based dose. It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use is to assist trained clinicians in calculating drug doses, not to diagnose or monitor a disease or condition through the analysis of in vitro samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the Picis Weight Based Dose Converter falls outside the scope of an In Vitro Diagnostic device. It is a clinical decision support tool focused on drug dosage calculation.
N/A
Intended Use / Indications for Use
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient's dose for a given agent based on a weight based determination by the clinician. Druq dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.
The Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system. The feature allows a user to convert a drug dose in units per body weight to a total dose. For example, the Weight Based Dose Converter provides for a conversion of an agent dose in milligrams per kilogram of body weight to an agent dose in total milligrams according to the patient's weight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals / In-hospital patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability of the Picis Weight Based Dose Converter software. The results of the testing confirmed that the Picis Weight Based Dose Converter software performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) SUMMARY
Picis, Inc.'s Weight Based Dose Converter
AUG 27 2012
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Picis, Inc. 100 Quannapowitt Parkway Wakefield, MA 01880 Phone: (781) 557-3034 Facsimile: (781) 557-3118
Contact Person: Karen A. Iorio
Date Prepared: May 24, 2012
Device Trade Name
Picis Weight Based Dose Converter
Common or Usual Name / Classification Name
Drug Dose Calculator (Product Code: NDC; 21 C.F.R. 868.1890)
Predicate Devices
The Rx Files Corp., TRxF Intelligent Dosing System (K011571)
Intended Use / Indications for Use
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient's dose for a given agent based on a weight based determination by the clinician. Druq dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.
The Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program.
Technological Characteristics
The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system. The feature allows a user to convert a drug dose in units per body weight to a total dose. For example, the Weight Based Dose Converter provides for a conversion of an agent dose in milligrams per kilogram of body weight to an agent dose in total milligrams according to the patient's weight.
1
Performance Data
Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability of the Picis Weight Based Dose Converter software. The results of the testing confirmed that the Picis Weight Based Dose Converter software performs as intended.
Substantial Equivalence
The Picis Weight Based Dose Converter software is substantially equivalent to the identified predicate device listed above. The Weight Based Dose Converter software has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the subject Weight Based Dose Converter software and its predicate device raise no new issues of safety or effectiveness. Thus, the Picis Weight Based Dose Converter software is substantially equivalent.
Predicate Device Comparison Table
| | Weight Based Dose Converter | Predicate
TRxF Intelligent Dosing System
(K011571) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The Picis Weight Based Dose
Converter is designed for use by trained
clinicians to calculate any individual
patient's dose for a given agent based
on a weight based determination by the
clinician. Drug dosing for a patient must
be made only after careful consideration
of the full clinical status of the patient by
the ordering clinician and the software
provides no validation as to the
appropriateness of the entered weight
based dose. The Picis Weight Based
Dose Converter is not a substitute for
clinical reasoning. The Picis Weight
Based Dose Converter is a
convenience feature for trained
clinicians based upon accurately
entered data. No medical decision
should be based solely upon the results
provided by this software program. | The Intelligent Dosing System ("IDS")
is a three-part software suite
comprised of DoseRxTM,
InterchangeRxTM and
PracticePrescribeRxTM. The
DoseRxTM is designed for use by
trained clinicians to calculate any
individual patient's optimal next dose
for any given agent. The
InterchangeRxTM is designed to
switch a patient from one brand of
agent to another while maintaining the
therapeutic effect of the original
agent. The PracticePrescribeRxTM is
a dosing simulator that offers graded
prescriber training of the 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
Intelligent Dosing System 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 fully clinical |
2
| | Weight Based Dose Converter | Predicate
TRxF Intelligent Dosing System
(K011571) |
|----------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Target
Population | In-hospital patients | In-hospital patients |
| User
Population | Trained healthcare professionals | Trained healthcare professionals |
| User Input | Patient weight, numerical dose and unit,
agent form and route of administration | Patient's last agent dose, surrogate
marker response information, the
current dose and the desired
surrogate marker response |
| Dose
computation | Software-based application used to
compute total drug dose | Software-based application used to
compute next optimal drug dose |
| Algorithms | Uses simple mathematical equation to
calculate dosing based on patient
weight and numerical dose and units | Uses mathematical clinical algorithm
to give proposal for dosing based on
scalable patient response and
surrogate marker inputs |
| Testing | Software validation and verification | Software validation and verification |
and the control control control of the control of
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing service to the people. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 27 2012
Picis Incorporated C/O Ms. Janice Hogan Hogan Lovells US, Limited Liability Partnership 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K121542
Trade/Device Name: Picis Weight Based Dose Converter Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: August 8, 2012 Received: August 8, 2012
Dear Ms. Hogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Ms. Hogan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For Alex
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Picis Weight Based Dose Converter
Indications for Use:
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient's dose for a given agent based on a weight based dose determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.
The Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rill C. Chyz
(Division Sign-Off) Ivision of Anesthesiology, General Hospital tion Control. Dental I
510(k) Number: K121542
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