(14 days)
The Disetronic H-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 professional experienced in insulin pump therapy.
The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and has easy to feel buttons to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, piston rod, cartridge and adapter. The H-TRONplus Insulin Infusion 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 DC 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 his or her health care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the three 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| IEC 60601-2-24 (Safety of infusion pumps) | "The Disetronic H-TRONplus Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24" |
| IEC 60601-1 (General safety requirements) | IEC 60601-2-24 incorporates IEC 60601-1 |
| IEC 60601-1-2 (Electromagnetic compatibility) | IEC 60601-2-24 incorporates IEC 60601-1-2 |
| General requirements for pump performance | "The electronic and mechanical design is not unique and therefore the specifications fully address pump performance." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission focuses on the device's compliance with established standards rather than a clinical or performance study with a specific test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As noted above, the submission refers to design and testing against standards, not a ground truth clinical evaluation.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this document. The submission pertains to the substantial equivalence of an updated medical device to a predicate device based on technical standards, not a comparative study with human readers or AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study
A standalone performance study of an algorithm was not conducted or reported in this document. This device is a mechanical/electronic insulin infusion pump, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to compliance with international safety and performance standards (IEC 60601-2-24, IEC 60601-1, IEC 60601-1-2) rather than clinical outcomes or pathology data. The device was designed and tested to meet these established engineering and safety specifications.
8. Sample Size for the Training Set
This information is not applicable and not provided. This is an insulin pump, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
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OCT 2 9 2002
510(k) Summary H-TRONplus Insulin Infusion Pump
Image /page/0/Picture/2 description: The image shows the word "DISETRONIC" in bold, black letters. To the left of the word is a stylized letter "D" with a small plus sign in the upper right corner. The font is sans-serif and the letters are closely spaced together.
| K C23471 | |
|---|---|
| Decision Date | |
| Submitter: | Disetronic Medical Systems AGKirchbergstrasse 190, PostfachCH-3401 Burgdorf, Switzerland |
| Contact: | Sandra Soniec, Phone +41 34 424 4111 |
| Trade/Proprietary Name: | Disetronic H-TRONplus Insulin Infusion Pump |
| Common/Usual Name: | Insulin Infusion Pump and Accessories |
| Classification Name: | Infusion Pump |
Substantial Equivalence
The modified H-TRONplus Insulin Infusion Pump is substantially equivalent to H-TRONplus Insulin Infusion Pump, K973044.
Device Description
The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and has easy to feel buttons to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, piston rod, cartridge and adapter. The H-TRONplus Insulin Infusion 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 DC 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 his or her health care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the three 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.
Indications for Use
The Disetronic H-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 professional experienced in insulin pump therapy.
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Technological Characteristics
The modifications made to the H-TRONplus Insulin Infusion Pump have not affected the technological characteristics. Therefore, the modified H-TRONplus Insulin Infusion Pump has the same technological characteristics as the predicate device.
Performance Data
The Disetronic H-TRONplus 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 and therefore the specifications fully address pump performance.
Conclusion
Based on the design equivalency and performance and safety testing. Disetronic Medical Systems has determined that the modified H-TRONplus Insulin Infusion Pump is substantially equivalent to the H-TRONplus Insulin Infusion Pump, K973044.
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DEPARTMENT OF HEALTH & HUMAN SERVICE
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Disteronic Medical Systems AG C/O Mr. David E. Chadwick Director, Regulatory Affairs Disetronic Medical Systems, Incorporated 5151 Program Avenue St. Paul, Minnesota 55112-1014
Re: K023471
Trade/Device Name: H-TRONplus Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 10, 2002 Received: October 15, 2002
Dear Mr. Chadwick:
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 l'ederal agencies.
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Page 2 - Mr. Chadwick
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
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INDICATIONS FOR USE STATEMENT
510(k) File Number:
Device Name:
Disetronic H-TRONplus Insulin Infusion Pump
Indications For Use:
The Disetronic H-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 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)
Lini Naneau for Tai Cienti 11/29/96
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental Devices
510(k) Number: K023471
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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).