The Disetronic H-TRON V 100 Plus 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, as well as adhere to a proper diet and exercise regiment. 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.

Device Description

The physical dimensions and specifications, pumping method, safety systems, accuracy and basic design and operation of the device have not been changed by the modifications.

AI/ML Overview

The provided text describes a 510(k) submission for the Disetronic H-TRON Plus V 100 Insulin Infusion Pump, asserting its substantial equivalence to a predicate device (Disetronic H-TRON V 100 Insulin Infusion Pump, K905693). This type of submission focuses on demonstrating equivalence rather than conducting a full clinical study with acceptance criteria in the typical sense of a novel device.

Therefore, the information you've requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or explicitly stated in this 510(k) summary.

Here's why and what information can be extracted:

510(k) Submissions Focus: 510(k)s are premarket submissions made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). They typically rely on demonstrating technological characteristics, performance data, and intended use are substantially equivalent, rather than proving performance against specific clinical acceptance criteria in a de novo study.
Performance Data Mentioned: The summary mentions "Performance Data" (Section 9.8) but describes it in terms of compliance with standards (IEC 601-2-24, IEC 601-1, IEC 801-2, 801-3) and internal testing to ensure specifications and functional requirements are met. This is about engineering and safety compliance, not clinical performance against specific patient outcomes.

Let's address each point based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as clinical performance metrics. The stated "acceptance criteria" are adherence to international standards and internal system specifications/functional requirements. These are engineering and safety standards, not clinical performance metrics like accuracy of glucose control or specific adverse event rates in a clinical population.
Reported Device Performance:
- Compliance with IEC 601-2-24 (infusion pump safety): Met.
- Compliance with IEC 601-1 (general safety, including EMI/ESD): Met.
- System specifications and functional requirements: Met.
- Physical dimensions, specifications, pumping method, safety systems, accuracy, basic design, and operation: Unchanged by modifications, implying they perform equivalently to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable/not specified. The testing described is likely bench testing for engineering and safety compliance, not a clinical test set with human subjects.
Data Provenance: Not applicable/not specified. The testing is internal to the manufacturer for design validation and compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable/not specified. Ground truth as typically defined for medical AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant to this type of device submission. The "ground truth" here would be objective measurements against engineering specifications and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is an insulin infusion pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable/not specified. The device operates as intended by delivering insulin based on programming, but there's no "algorithm only" performance reported in the context of clinical decision-making or diagnostic tasks. The device itself is "standalone" in its operation once programmed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For engineering and safety, the "ground truth" would be objective measurements and adherence to established industry standards (e.g., flow rate accuracy measured by calibrated equipment, electrical safety parameters measured against limits). No clinical ground truth (like pathology or outcomes data) is mentioned for a specific clinical study for this 510(k).

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not specified. This is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable/not specified.

In summary, this 510(k) submission demonstrates substantial equivalence through:

Asserting that physical dimensions, pumping method, and safety systems are unchanged from the predicate device.
Indicating that the intended use has not changed.
Stating that technological characteristics have not been affected.
Confirming compliance with international standards for infusion pump safety (IEC 601-2-24, IEC 601-1 incorporating IEC 801-2 and 801-3 for EMI/ESD).
Stating adherence to software development and Good Quality Assurance procedures, with test results demonstrating system specifications and functional requirements were met.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits. The digits are '1473044'. The numbers are written in black ink on a white background. The numbers are slightly distorted, but still legible.

SEP 1 5 1997 510(K) SUMMARY

9.0 Summary of Safetv and Effectiveness

9.1 Trade/Probrietarv Name: Disetronic H-TRON Plus Insulin Infusion Pump
Insulin Infusion Pump and Accessories 9.2 Common/Usual Name:
Infusion Pump 9.3 Classification Name:
9.4 Substantial Equivalence: The Disetronic H-TRON Plus V 100 Insulin Infusion Pump is substantially equivalent to the Disetronic H-TRON V 100 Insulin Infusion Pump (K905693).

9.5 Device Description

The physical dimensions and specifications, pumping method, safety systems, accuracy and basic design and operation of the device have not been changed by the modifications.

9.6 Intended Use

The Indications for use and intended use have not changed.

9.7 Technological Characteristics

The technological characteristics of the device have not been affected by these modifications.

9.8 Performance Data

ﻤﺴﻌ

The Disetronic H-TRON Plus V 100 Insulin Infusion Pump has been designed and tested in accordance with IEC 601-2-24 of the International Electrotechnical Commission Technical Committee No. 62: Electrical Equipment in Medical Practice Sub-Committee 62D: Electromedical Equipment - Draft Date: August 29, 1994 - Part 2: Particular requirements for safety of infusion pumps and controllers. IEC 601-2-24 incorporates the requirements of IEC 601-1 for all general safety requirements including IEC 801-2 and 801-3 for Electromagnetic Interference (EMI)) and Electrostatic Discharge (ESD).

The electronic and mechanical design is not unique and therefore the specifications fully address pump performance. Disetronic has adhered to all software development procedures and Good Quality Assurance procedures. All test results demonstrate that the system specifications and functional requirements were met.

9.9 Conclusion

Based on the functional comparison, design equivalency and the functional and safety testing, Disetronic has determined that the H-TRON Plus V 100 Insulin Infusion Pump is substantially equivalent to the un-modified device.

{1}------------------------------------------------

Image /page/1/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 image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1997

Mr. Jim Myers Vice President Disetronic Medical Systems 5201 East River Road, #312 Minneapolis, Minnesota 55421-1014

K973044 Re : Trade Name: Disetronic H-Tron Plus V 100 Insulin Infusion Pump Regulatory Class : II Product Code: LZG Dated: August 12, 1997 Received: August 15, 1997

Dear Mr. Myers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Druq Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your

{2}------------------------------------------------

Page 2 - Mr. Myers

premarket notification submission does not affect any obligation you might have under section 531 through 542 of the for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires Because the device is subject to tracking, you are tracking. required to adopt a method of tracking that follows the devices throuqh the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling requlation (21 CFR part 801 and additionally 809.10 for in vitro diaqnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 688-2041 or at (301) 443-6597.

Sincerely yours,

Clurist

Timoty A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{3}------------------------------------------------

INDICATIONS FOR USE

510(k) File Number:

Disetronic H-Tron Plus V 100 Insulin Infusion Pump Device Name:

Indications For Use: The Disetronic H-TRON V 100 Plus 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, as well as adhere to a proper diet and exercise regiment. 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.

Patricio Cisternas

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita

Regulation Number and Section

§ 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).