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.

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.

AI/ML Overview

The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system to calculate an individual patient's dose for a given agent based on their weight.

Here's an analysis of its acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the Picis Weight Based Dose Converter. However, it indicates the general performance goal and the successful outcome of testing.

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Software performs as intended (calculates drug doses based on weight).	"The results of the testing confirmed that the Picis Weight Based Dose Converter software performs as intended."	This is a general statement. Specific metrics (e.g., accuracy, precision) are not provided in the summary.
Functionality and reliability are established.	"Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability of the Picis Weight Based Dose Converter software."	This indicates that these aspects were evaluated and found acceptable.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: Not specified. The document only mentions "Software verification and validation testing activities were conducted." There is no information about the number of test cases or the specific data points used in these tests.
Data Provenance: Not specified. It's unclear whether the testing involved real patient data, simulated data, or a combination. The country of origin is also not mentioned.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a dose calculator, it's highly likely that ground truth would be established by comparing the software's output against manually calculated doses (e.g., by pharmacists or clinicians using standard formulas and calculators), but the method (e.g., 2+1, 3+1, none) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported. This device is a software calculator, not an AI-assisted diagnostic tool that human readers would use to improve their performance on diagnostic tasks.
Effect Size of Human Improvement with AI: Not applicable, as no MRMC study was conducted.

6. Standalone Performance Study

Standalone Study: Yes, implicitly. The "Software verification and validation testing activities" described are for the algorithm itself ("the Picis Weight Based Dose Converter software"). The stated intended use is "to calculate any individual patient's dose," implying a standalone function for calculation. The document also states, "The Picis Weight Based Dose Converter is not a substitute for clinical reasoning," which further clarifies its role as a tool rather than an integrated human-AI system for decision-making. No results of human-in-the-loop performance are provided.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated, but for a dose calculator, the ground truth would almost certainly be derived from mathematically correct calculations based on standard drug dosing formulas, patient weight, and the specified dose per unit weight. This would typically involve manual calculation by qualified personnel or comparison against another validated calculator.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The Picis Weight Based Dose Converter uses "simple mathematical equation[s] to calculate dosing based on patient weight and numerical dose and units." This implies a deterministic, rule-based algorithm rather than a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a rule-based mathematical calculator. Ground truth is inherent in the mathematical formulas themselves.

Summary

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K121542

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.

Technological Characteristics

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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	PredicateTRxF Intelligent Dosing System(K011571)
Intended Use/Indications forUse	The Picis Weight Based DoseConverter is designed for use by trainedclinicians to calculate any individualpatient's dose for a given agent basedon a weight based determination by theclinician. Drug dosing for a patient mustbe made only after careful considerationof the full clinical status of the patient bythe ordering clinician and the softwareprovides no validation as to theappropriateness of the entered weightbased dose. The Picis Weight BasedDose Converter is not a substitute forclinical reasoning. The Picis WeightBased Dose Converter is aconvenience feature for trainedclinicians based upon accuratelyentered data. No medical decisionshould be based solely upon the resultsprovided by this software program.	The Intelligent Dosing System ("IDS")is a three-part software suitecomprised of DoseRxTM,InterchangeRxTM andPracticePrescribeRxTM. TheDoseRxTM is designed for use bytrained clinicians to calculate anyindividual patient's optimal next dosefor any given agent. TheInterchangeRxTM is designed toswitch a patient from one brand ofagent to another while maintaining thetherapeutic effect of the originalagent. The PracticePrescribeRxTM isa dosing simulator that offers gradedprescriber training of the next dosecalculation scenarios with scalablepatient response and surrogatemarker inputs that allows thehealthcare provider to gain guidedand measured experience incalculating the next dose for a new orinfrequently used drug. TheIntelligent Dosing System is not asubstitute for clinical reasoning. TheIDS is an aid for trained cliniciansbased upon significant and properlyentered data. Final drug doserecommendations for a patient mustbe made only after carefulconsideration of the fully clinical

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	Weight Based Dose Converter	PredicateTRxF Intelligent Dosing System(K011571)
TargetPopulation	In-hospital patients	In-hospital patients
UserPopulation	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, surrogatemarker response information, thecurrent dose and the desiredsurrogate marker response
Dosecomputation	Software-based application used tocompute total drug dose	Software-based application used tocompute next optimal drug dose
Algorithms	Uses simple mathematical equation tocalculate dosing based on patientweight and numerical dose and units	Uses mathematical clinical algorithmto give proposal for dosing based onscalable patient response andsurrogate marker inputs
Testing	Software validation and verification	Software validation and verification

and the control control control of the control of

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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.

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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

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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.

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

Page 1 of 1

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).