(48 days)
Not Found
No
The description mentions "programmed logic" and "automated, computer-based software application" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a system that learns or adapts from data.
Yes
The device is intended to calculate and recommend doses of saline, glucose, and insulin to drive and maintain a patient's blood glucose level within a target range, which constitutes a therapeutic intervention.
No
The device is described as calculating and recommending dosing strategies based on glucose measurements to achieve and maintain a target blood glucose range. It does not diagnose a condition but rather assists in managing an existing one.
Yes
The device description explicitly states that the Glucommander is a "simple, automated, computer-based software application" and does not mention any associated hardware components that are part of the device itself.
Based on the provided information, the Glucommander is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Glucommander's intended use and device description clearly state that it evaluates patient blood glucose values and calculates and recommends doses based on those values. While it uses blood glucose measurements as input, it does not perform the actual testing or analysis of the blood specimen itself. The blood glucose measurement is an input to the device, not something the device does.
- The device's function is to recommend treatment (dosing of saline, glucose, and insulin). This is a therapeutic function, not a diagnostic one. IVD devices are used to provide information for diagnosis, monitoring, or screening, not to directly recommend treatment.
- The device description focuses on software calculations and recommendations for infusion rates. This aligns with a treatment management system, not an in vitro diagnostic test.
In summary, the Glucommander is a software-based system that uses blood glucose data to assist medical professionals in managing a patient's blood glucose levels through recommended dosing. It does not perform the in vitro diagnostic testing of the blood itself.
N/A
Intended Use / 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.
Product codes
NDC
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.
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
The device is not intended for use with patients under the age of 18.
Intended User / Care Setting
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040676, K042873, K023674, K043600, K961486, K051079
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
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.
1
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
Glucommander Plus | Predicate Device
IVAC MedSystem III
Infusion
Pump w/ Drug Editing |
|-------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Dose Titration | Titrates drug dosage | Same |
| Infusion Rate
Calculations | Calculates intravenous infusion
Rate of delivery for fluids and
medications | Same |
| User Input | Receives input from user to
Calculate dosage | Same |
| Indications for
Use | Indicated for use as an accessory
to an infusion pump. | Same |
| Factor | Subject Device
Glucommander Plus | Predicate Device
Hopira Gemstar Infusion
Pump
System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | Intended for use with
Intravenous arterial,
Subcutaneous, and parenteral
Administration of general I.V.
fluid, medications, and
nutritional fluids | Same |
| Indications for
use | Indicated for use as an accessory
To an infusion pump and
intended for use include hospital
and ambulatory environments. | Same |
| Operations | Provides Indications of several
functions including operations,
alarms, program status, and the
parameters of fluid flow | Same |
| Factor | Subject Device | Predicate Device |
|---|---|---|
| Glucommander Plus | Phillips Drug Calculator |
2
| Dose
| 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
Glucommander Plus | Predicate Device
Animas Model IR1250
Insulin |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Computer-Based | Computer-implemented method
Of managing the blood glucose
Level of a patient with diabetes | Same |
| Interface | Provides and interface which
allows a healthcare provider to
Input different types of data
used to calculate insulin,
glucose, and carbohydrate intake
recommendations for the patient | Same |
| Data Storage | Timestamps and stores patient's
blood glucose data | Same |
| Nutritional Bolus | Uses a carbohydrate formula to
calculate a nutritional bolus | Same |
| Data Analysis | Analyzes blood glucose data,
meal intake data, and trends
Associated with the food intake
of a patient, and insulin intake
data associated with the insulin
intake of the patient | Same |
| Alarms | Executes programmed reminders
and alarms for users to check
blood glucose | Same |
| Corrective calculations | Recommends insulin dosing to
compensate for hyperglycemia,
based on corrective calculations | Same |
| Factor | Subject Device
Glucommander Plus | Predicate Device #1
MiniMed Medtronic
Paradigm
Insulin Pump |
|-----------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Dose Titration | Recommends appropriate
amount of insulin for
subcutaneous delivery | Same |
| Patient Profile | Insulin delivery profile is based
on target blood glucose,
carbohydrate insulin ratio, and | Same |
3
| insulin sensitivity | ||
|---|---|---|
| Dosing | ||
| Computations | Computes insulin dosing | Same |
| Data Storage | Tracks time period in which | |
| insulin is administered and stores | ||
| Blood glucose and insulin history | ||
| data | Same | |
| Warnings | Indicates warning in conditions | |
| under which excessive dosing | ||
| would be calculated | Same | |
| Data Download | Ability to download trend data to | |
| A PC for physician analysis | Same |
4
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.
5
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
6
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
Page 1 of
Number: K06119