GLUCOMMANDER PLUS

K061110 · Collaborativemed, LLC · NDC · Jun 7, 2006 · Anesthesiology

Device Facts

• Record ID: K061110
• Device Name: GLUCOMMANDER PLUS
• Applicant: Collaborativemed, LLC
• Product Code: NDC · Anesthesiology
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Glucommander Plus is a computer-based software application for clinical management of patient blood glucose. Input: frequent patient blood glucose measurements, meal intake data, and insulin intake history. Operation: software processes inputs using mathematical algorithms to calculate and recommend titration of intravenous/subcutaneous insulin, glucose, and saline to reach/maintain target glucose ranges. Output: dosing recommendations, alarms, and alerts for monitoring. Used in hospital and ambulatory settings by qualified medical personnel. The system provides decision support; clinicians review recommendations alongside patient history and clinical judgment before acting. Benefits include automated, data-driven titration to achieve glycemic control.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and functional equivalence to predicate devices.

Technological Characteristics

Computer-based software application. Features include data storage, timestamping, and interface for healthcare provider input. Implements mathematical algorithms for dose titration based on target blood glucose, carbohydrate-insulin ratios, and insulin sensitivity. Connectivity includes data download to PC for physician analysis. Operates as an accessory to infusion pumps.

Indications for Use

Indicated for patients aged 18 and older requiring management of blood glucose levels via intravenous or subcutaneous insulin, glucose, and saline titration. Contraindicated in patients with known insulin allergies.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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:

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.

## 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 Device<br>Glucommander Plus | Predicate Device<br>IVAC MedSystem III<br>Infusion<br>Pump w/ Drug Editing |
|-------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Dose Titration | Titrates drug dosage | Same |
| Infusion Rate<br>Calculations | Calculates intravenous infusion<br>Rate of delivery for fluids and<br>medications | Same |
| User Input | Receives input from user to<br>Calculate dosage | Same |
| Indications for<br>Use | Indicated for use as an accessory<br>to an infusion pump. | Same |

| Factor | Subject Device<br>Glucommander Plus | Predicate Device<br>Hopira Gemstar Infusion<br>Pump<br>System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | Intended for use with<br>Intravenous arterial,<br>Subcutaneous, and parenteral<br>Administration of general I.V.<br>fluid, medications, and<br>nutritional fluids | Same |
| Indications for<br>use | Indicated for use as an accessory<br>To an infusion pump and<br>intended for use include hospital<br>and ambulatory environments. | Same |
| Operations | Provides Indications of several<br>functions including operations,<br>alarms, program status, and the<br>parameters of fluid flow | Same |

| Factor | Subject Device | Predicate Device |
|--------|-------------------|--------------------------|
| | Glucommander Plus | Phillips Drug Calculator |

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| Dose<br>Computation | 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 Device<br>Glucommander Plus | Predicate Device<br>Animas Model IR1250<br>Insulin |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Computer-Based | Computer-implemented method<br>Of managing the blood glucose<br>Level of a patient with diabetes | Same |
| Interface | Provides and interface which<br>allows a healthcare provider to<br>Input different types of data<br>used to calculate insulin,<br>glucose, and carbohydrate intake<br>recommendations for the patient | Same |
| Data Storage | Timestamps and stores patient's<br>blood glucose data | Same |
| Nutritional Bolus | Uses a carbohydrate formula to<br>calculate a nutritional bolus | Same |
| Data Analysis | Analyzes blood glucose data,<br>meal intake data, and trends<br>Associated with the food intake<br>of a patient, and insulin intake<br>data associated with the insulin<br>intake of the patient | Same |
| Alarms | Executes programmed reminders<br>and alarms for users to check<br>blood glucose | Same |
| Corrective calculations | Recommends insulin dosing to<br>compensate for hyperglycemia,<br>based on corrective calculations | Same |

| Factor | Subject Device<br>Glucommander Plus | Predicate Device #1<br>MiniMed Medtronic<br>Paradigm<br>Insulin Pump |
|-----------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Dose Titration | Recommends appropriate<br>amount of insulin for<br>subcutaneous delivery | Same |
| Patient Profile | Insulin delivery profile is based<br>on target blood glucose,<br>carbohydrate insulin ratio, and | Same |

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| | insulin sensitivity | |
|------------------------|----------------------------------------------------------------------------------------------------------------|------|
| Dosing<br>Computations | Computes insulin dosing | Same |
| Data Storage | Tracks time period in which<br>insulin is administered and stores<br>Blood glucose and insulin history<br>data | Same |
| Warnings | Indicates warning in conditions<br>under which excessive dosing<br>would be calculated | Same |
| Data Download | Ability to download trend data to<br>A 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 [phone]. 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 [phone] or [phone] 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:

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.

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

- Off

n of Anesthesiology, General Hospital, ion Control, Dental

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Number: K06119