(70 days)
Not Found
No
The device description details a microprocessor-controlled pump that administers insulin based on user-programmed settings. There is no mention of AI or ML algorithms for decision-making, prediction, or adaptation.
Yes
The device is an insulin pump designed to administer insulin for managing diabetes, which is a therapeutic intervention.
No
The device description clearly states it "administers small quantities of insulin to the patient" and describes its function for "Insulin delivery". This indicates it is a therapeutic device for delivering medication, not a diagnostic one.
No
The device description clearly details a physical, battery-operated insulin pump with mechanical components (stepper motor, piston mechanism) and an IR-Interface for data transmission, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Disetronic D-TRON Insulin Pump is an "ambulatory, battery operated pump that administers small quantities of insulin to the patient." It is a device that delivers a substance into the body, not one that tests samples from the body.
- Intended Use: The intended use describes the patient population (insulin-dependent diabetes mellitus) and the purpose of the device (insulin injection therapy). This aligns with a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electronic components involved in insulin delivery (motor, piston, reservoir, programming). There is no mention of analyzing biological samples.
Therefore, the Disetronic D-TRON Insulin Pump is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications For Use: as prescribed by a physician. as proombod by a prifortialin dependent diabetes Mellitus who do not have optimum it is indication partional insulin injection therapy. Patients for insulin pump blood gradose of the or beform self glucose monitoring on a frequent and regular therapy made be highty the a proper diet and exercise regiment. Patients must be capable of busic, as well and anot over also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
Product codes
LZG
Device Description
The Disetronic D-TRON Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump. Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U. The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.
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
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)
The Disetronic D-TRON Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24 of the International Electrotechnical Commission: Particular requirements for safety of infusion pumps and controllers. IEC 60601-2-24 incorporates the requirements of IEC 60601-1 for all general safety requirements and IEC 60601-1-2 for Electromagnetic compatibility - requirements and tests.The electronic and mechanical design is not unique an therefore the specifications fully address pump performance. The device modifications are consistent with the requirements of these standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
9 510(k) Summary
AUG 0 2 2002
9.1 Trade/Proprietary Name
Disetronic D-TRON Insulin Infusion Pump
9.2 Common/Usual Name
Infusion Pump and Accessories
9.3 Classification Name
Infusion Pump
9.4 Substantial equivalence
The modified Disetronic D-TRON Insulin Infusion Pump is substantially equivalent to the currently marketed D-TRON Pump K994186.
9.5 Device Description
The Disetronic D-TRON Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.
Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.
Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U.
The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.
9.6 Indications for Use
The Indications for Use and Intended Use have not changed.
9.7 Technological Characteristics
The technological characteristics have not been affected by these modifications.
9.8 Performance Data
The Disetronic D-TRON Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24 of the International Electrotechnical Commission: Particular requirements for safety of infusion pumps and controllers. IEC 60601-2-24 incorporates the requirements of IEC 60601-1 for all general safety requirements and IEC 60601-1-2 for Electromagnetic compatibility - requirements and tests.The electronic and mechanical design is not unique an therefore the specifications fully address pump performance. The device modifications are consistent with the requirements of these standards.
1
9.9 Conclusion
Based on the design equivalency and performance and safety testing, Disetronic Medical Systems has determined that the implementation of the DiaLog PC software for the Disetronic D-TRON Insulin Infusion Pump is substantially equivalent to the devices currently marketed in the United States.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect and promote the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sandra Soniec Manager Regulatory Affairs Disetronic Medical Systems AG Kirchbergstrasse 190, Postfach CH-3401 Burgdorf, SWITZERLAND
Re: K021725
Trade/Device Name: Distetronic D-Tron Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 9, 2002 Received: July 11, 2002
Dear Ms. Soniec:
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.
AUG 0 2 2002
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.
3
Page 2 - Ms. Soniec
. . . . .
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 (OS) 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,
and the may be any and the commended to the commended to the commended to the commended to the commended to the commended to the commended to the comments of the comments of
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
4
510(k) File Number:
Device Name: Disetronic D-TRON Insulin Infusion Pump
Indications For Use:
indications For Soc. as prescribed by a physician.
as proombod by a prifortialin dependent diabetes Mellitus who do not have optimum it is indication partional insulin injection therapy. Patients for insulin pump blood gradose of the or beform self glucose monitoring on a frequent and regular therapy made be highty the a proper diet and exercise regiment. Patients must be capable of busic, as well and anot over also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cusente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K021725
Prescription Use (Per 21 CFR 801.19) OR
Over-The-Counter Use