The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin to drive the blood glucose level, either up or down, towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin; as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18.

The Glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.

Device Description

The Glucommander is a simple, automated, computer-based software application that, based on frequent patient glucose measurement inputs, calculates and recommends titration of intravenous and subcutaneous insulin infusion rates and intravenous qlucose infusion and oral glucose consumption rates, calculated to medicate a patient's blood glucose level towards a specified target range. The Glucommander also provides alarms and warnings, as well as alerts for subsequent blood glucose testing and monitoring.

AI/ML Overview

The provided text is a 510(k) summary for the "Glucommander Plus" device. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any details regarding test sets, training sets, ground truth establishment, or expert involvement.

The document is purely a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to previously cleared devices. It focuses on device description, intended use, and technological feature comparison, rather than clinical performance or validation studies that would outline acceptance criteria and their fulfillment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and studies from this document.

Summary

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510(k) Summary

In accordance with the requirements of SMDA 1990 and 21 CFR 807.92, this 510(k) Summary is provided:

1. Submitted by:

CollaborativeMed, LLC 14-D Pelham Ridge Dr. Greenville, SC 29615

Phone: 864-370-3297 Fax: 864-233-7828 Contact: Robert Booth

2. Date Prepared:

December 12, 2005

3. Classification of Device:

Classification Code: NDC Drug Dose Calculator, Class II Requlation Number: 868.1890 Device Class: Class II

4. Trade Name of Proposed Device:

Glucommander Plus

5. Predicate Device:

K040676, MiniMed Medtronic Paradigm Insulin Pump K042873, Animas Model IR1250 Insulin Infusion Pump K023674, Phillips Drug Calculator K043600, Medtronic MicroMed 407C K961486, IVAC MedSystem III, Infusion Pump w/ Drug Editing K051079, Hopira Gemstar Infusion Pump System

6. Proposed Device Description:

7. Statement of Intended Use:

The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and based o the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin to drive the blood glucose level, either up or down, towards a predetermined target range. Once that target blood qlucose range has been reached, the system's function is to recommend dosing of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin; as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18.

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The glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.

8. Comparison of the Technological Features of the Device Predicate Devices:

The technological features of the Glucommander do not differ from the previously cleared predicate devices.

Factor	Subject DeviceGlucommander Plus	Predicate DeviceIVAC MedSystem IIIInfusionPump w/ Drug Editing
Dose Titration	Titrates drug dosage	Same
Infusion RateCalculations	Calculates intravenous infusionRate of delivery for fluids andmedications	Same
User Input	Receives input from user toCalculate dosage	Same
Indications forUse	Indicated for use as an accessoryto an infusion pump.	Same

Factor	Subject DeviceGlucommander Plus	Predicate DeviceHopira Gemstar InfusionPumpSystem
Intended Use	Intended for use withIntravenous arterial,Subcutaneous, and parenteralAdministration of general I.V.fluid, medications, andnutritional fluids	Same
Indications foruse	Indicated for use as an accessoryTo an infusion pump andintended for use include hospitaland ambulatory environments.	Same
Operations	Provides Indications of severalfunctions including operations,alarms, program status, and theparameters of fluid flow	Same

Factor	Subject Device	Predicate Device
	Glucommander Plus	Phillips Drug Calculator

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DoseComputation	Software-based application used to compute drug dosing	Same
Operations	Utilizes alarms and alerts to notify user	Same
Algorithms	Uses a mathematical algorithm to give directions for dosing	Same

Factor	Subject DeviceGlucommander Plus	Predicate DeviceAnimas Model IR1250Insulin
Computer-Based	Computer-implemented methodOf managing the blood glucoseLevel of a patient with diabetes	Same
Interface	Provides and interface whichallows a healthcare provider toInput different types of dataused to calculate insulin,glucose, and carbohydrate intakerecommendations for the patient	Same
Data Storage	Timestamps and stores patient'sblood glucose data	Same
Nutritional Bolus	Uses a carbohydrate formula tocalculate a nutritional bolus	Same
Data Analysis	Analyzes blood glucose data,meal intake data, and trendsAssociated with the food intakeof a patient, and insulin intakedata associated with the insulinintake of the patient	Same
Alarms	Executes programmed remindersand alarms for users to checkblood glucose	Same
Corrective calculations	Recommends insulin dosing tocompensate for hyperglycemia,based on corrective calculations	Same

Factor	Subject DeviceGlucommander Plus	Predicate Device #1MiniMed MedtronicParadigmInsulin Pump
Dose Titration	Recommends appropriateamount of insulin forsubcutaneous delivery	Same
Patient Profile	Insulin delivery profile is basedon target blood glucose,carbohydrate insulin ratio, and	Same

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	insulin sensitivity
DosingComputations	Computes insulin dosing	Same
Data Storage	Tracks time period in whichinsulin is administered and storesBlood glucose and insulin historydata	Same
Warnings	Indicates warning in conditionsunder which excessive dosingwould be calculated	Same
Data Download	Ability to download trend data toA PC for physician analysis	Same

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2006

CollaborativeMed, LLC C/O Ms. Michelle S. Lee Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

Re: K061110

Trade/Device Name: Glucommander Plus Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: May 23, 2006 Received: May 25, 2006

Dear Ms. Lee:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lee

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suart Quonos

Chiu Lin, Ph.D. 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

510(k) Number (if known):

Device Name: | Glucommander Plus

Indications For Use:

X 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antony D. m

n of Anesthesiology, General Hospital, ion Control, Dental

Page 1 of

Number: K06119

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).