(165 days)
Not Found
No
The document describes a standard insulin pump and communication software without any mention of AI or ML capabilities for data analysis, prediction, or automated decision-making beyond basic programming and data transfer.
Yes.
The device is used for "Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes," which indicates a therapeutic purpose.
No
The device is described as an "Insulin Infusion Pump" for "Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes." Its primary function is to deliver insulin, not to diagnose a condition. While it has a "Treatment Assistant™ PC Communications System" that allows accessing data and programming, this is for "optimizing diabetes management" and not for making a diagnosis.
No
The submission describes an insulin infusion pump and its accessories, which are hardware devices. While it includes a software component (Treatment Assistant™ PC Communications System), the overall device being cleared is a combination of hardware and software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "Insulin Infusion Pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes." This describes a device used to deliver medication in vivo (within the body), not to perform tests on samples in vitro (outside the body).
- Device Description: The description details a pump, cartridge, and communication system for delivering insulin subcutaneously. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, calibrators, controls, or methods for analyzing biological fluids or tissues.
- Performance Studies: The performance studies focus on functional testing of the pump and cartridge, and clinical studies were not deemed necessary. This aligns with the evaluation of a drug delivery device, not a diagnostic test.
- Predicate Devices: The predicate devices listed are other insulin pumps and related communication systems, further reinforcing that this device falls under the category of drug delivery, not diagnostics.
In summary, the Deltec Cozmo™ Insulin Infusion Pump and its accessories are designed for the delivery of insulin to a patient, which is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
"The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes."
"The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).
"The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump."
Product codes (comma separated list FDA assigned to the subject device)
LZG
Device Description
The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.
The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A. Functional Testing
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified for the Deltec Cozmo™ Insulin Infusion Pump and the Deltec Cozmo™ Treatment Assistant™ Communications System.
In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the use of the Deltec Cozmo™ Insulin Infusion Pump and Accessories.
C. Conclusions Drawn from Studies
Based upon the information provided above, the Deltec Cozmo™ Insulin Infusion Pump and Accessories are substantially equivalent to other commercially available devices.
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.
K990801, K991936, K973917, K993012
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
AUG 1 3 2002
KO28655
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Deltec Cozmo™ Insulin Infusion Pump (Model 1700) and Accessories
June 3, 2002
I. GENERAL INFORMATION
| Applicant's Name and Address: | Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa J. Stone
Manager, Regulatory Affairs |
| Common/Usual Name: | Insulin Infusion Pump and Accessories |
| Proprietary Name: | Deltec Cozmo™ Insulin Infusion Pump (Model
1700) and Accessories |
| Equivalence Device Comparison: | MiniMed Model 508 Insulin Pump, MiniMed 3.0 ml Reservoir, Deltec CADD-Diplomat® System,
and MiniMed Com-Station™ Communication
System |
DEVICE DESCRIPTION II.
The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.
The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump
1
and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.
III. INTENDED USE OF THE DEVICE
The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.
The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Pump for Continuous Subcutaneous Insulin Infusion (CSII).
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with the Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming of the pump.
IV. DEVICE COMPARISON
The Deltec Cozmo™ Insulin Infusion Pump is similar in design, function, and intended use to the MiniMed Model 508 Insulin Pump (K990801). The pumps are small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump delivery systems. Each device is indicated for the delivery of insulin and includes the following features: backlit liquid crystal display (LCD), 4-key keypad, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading capability, IR windows, and 3-ml medication cartridge.
The Deltec Cozmo™ 3-ml Cartridge is similar in design, function, and intended use to the MiniMed 3-ml Reservoir (K991936). Each device is a syringe style reservoir with a capacity of 3 ml. They are made of the same materials and both are provided with a 22-gauge needle. Each device is indicated for use in the infusion of insulin with an external infusion pump.
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is similar in design, function, and intended use to the Deltec CADD-Diplomat® System (K973917). The products allow communications between a personal computer (PC) and an infusion pump. The software programs allow for downloading of information from the pump to a PC and for programming of the pump via a PC. The Deltec Cozmo™ Treatment Assistant™ PC Communications System is also similar to the MiniMed Com-Station™ Communication System (K993012), which uses IR communication.
2
510(k) Summary of Safety and Effectiveness Page 3 of 3
V. SUMMARY OF STUDIES
A. Functional Testing
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified for the Deltec Cozmo™ Insulin Infusion Pump and the Deltec Cozmo™ Treatment Assistant™ Communications System.
In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the use of the Deltec Cozmo™ Insulin Infusion Pump and Accessories.
C. Conclusions Drawn from Studies
Based upon the information provided above, the Deltec Cozmo™ Insulin Infusion Pump and Accessories are substantially equivalent to other commercially available devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three curved lines that resemble a bird or a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. The text is in all capital letters and is evenly spaced around the circle.
AUG 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Stone Managing, Regulatory Affairs Deltec, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112
Re: K020655
Trade/Device Name: Deltec Cozmo™ Insulin Infusion Pump (Model 1700), Deltec Cozmo™ 3-ml Cartridge, and Deltec Cozmo™ Treatment Assistant™ PC Communications System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: June 3, 2002 Received: June 4, 2002
Dear Ms. Stone
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.
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.
4
Page 2 - Ms. Stone
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
JAWithdmer for,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Deltec Cozmo™ Insulin Infusion Pump (Model 1700), Deltec Cozmo™ 3-ml Cartridge, and Deltec Cozmo™ Treatment Assistant™ PC Communications System
Indications for Use:
"The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes."
"The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).
"The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The Coun
Over-The Counter Use
ion Sianivision of Anesthesiology General Hosnital Infection Control, Dental
510(k) Number: K020655