(30 days)
K#022831
Not Found
No
The summary describes a standard insulin pump with programmable basal and bolus rates, without mentioning any AI/ML capabilities for automated insulin delivery or glucose prediction.
Yes
The device is described as an "Insulin Infusion Pump" intended for the "controlled delivery of insulin as prescribed by a physician" for patients with "insulin dependent Diabetes Mellitus," which is a medical condition. This directly indicates its use in treating a disease.
No
The device is described as an insulin infusion pump intended for the "controlled delivery of insulin." It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it is an "external, portable insulin pump," which is a hardware device designed for continuous delivery of insulin.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "controlled delivery of insulin" to patients with diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of delivering insulin (basal rates, bolus amounts).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on samples taken from the body to diagnose or monitor diseases.
This device is an insulin infusion pump, which is a therapeutic medical device used to manage diabetes by delivering insulin.
N/A
Intended Use / Indications for Use
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.
It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
Product codes
LZG
Device Description
The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows settings of 0.0 to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit increments.
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)
Testing of the D-TRONplus demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the D-TRONplus is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Disetronic D-TRONplus Insulin Infusion Pump (K#022831)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2004
Disetronic Medical Systems AG C/O Mr. Scott Thiel Regulatory Affairs Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250
Re: K043000
Trade/Device Name: D-TRONplus Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 29, 2004 Received: November 1, 2004
Dear Mr. Thiel:
This letter corrects our substantially equivalent letter of December 1, 2004 regarding the incorrect Indications for Use statement that was sent to you.
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 (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 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.
1
Page 2 - Mr. Thiel
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 continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
कुछ
Sincerely yours,
Sura Russo
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
2
Page 3 - Mr. Thiel
Indications for Use -
510 (k) Number (if known) : K043000
Device Name: D-TRONplus insulin infusion pump
Indications For Use:
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.
It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
3
Ko43000
DEC - 1 2004
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Submitted by:
Disetronic Medical Systems AG
Kirchbergstrasse 190, Postfach
CH-3401 Burgdorf, Switzerland
United States Contact Person:
Scott Thiel
Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana 46250
317-521-3362
scott.thiel@roche.com
Date Prepared: October 29, 2004 |
| 2) Device name | Proprietary name: D-TRONplus
Common name: Insulin infusion pump and accessories
Classification name: Pump, infusion, insulin
Product Code: LZG |
| 3) Predicate
device | We claim substantial equivalence to the following legally marketed insulin
infusion pumps:
Disetronic D-TRONplus Insulin Infusion Pump (K#022831) |
| 4) Device
Description | The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump
designed for continuous delivery of insulin. The design allows settings of 0.0
to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and
up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit
increments. |
| | Continued on next page |
4
510(k) Summary, Continued
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the 5) Intended use controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
| 6) Data
demonstrating
substantial
equivalence | Testing of the D-TRONplus demonstrated that the device meets the
requirements for its intended use. The data also demonstrates that the D-
TRONplus is substantially equivalent to the predicate device. |
| -------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|