DISETRONIC PEN P100 by DISETRONIC MEDICAL SYSTEMS

The Disetronic Pen P100 is a reusable device that provides a method of accurately iniecting a selected dose of insulin from an insulin cartridge supplied by other manufacturers, through a single lumen hypodermic needle. The device can be used by health professionals or for self-iniection by the patient. The device is similar in appearance and size to a ballpoint pen. It is cylindrical in shape and has a retractable dosage knob at the top that resembles the 'clicker' used to extend and retract the tip of a ballpoint pen beyond its housing.

The internal mechanisms used to set and activate the injection are the same across the product line. Each pen operates in the following manner. After the cartridge is loaded into the barrel and the needle is attached, the user pushes a button on the side of the pen opposite the digital display. This releases a spring-loaded 'knob' at the top of the pen. The knob is then rotated in a clockwise direction which increments the digital display to show the dose to be delivered. The needle cap is removed and the needle is inserted into the injection site. The knob at the top of the pen is depressed which advances the plunger to displace the chosen dose. After the injection, the needle is removed from the pen and discarded.

AI/ML Overview

The provided text is a 510(k) summary for the Disetronic Pen P100. This document focuses on demonstrating substantial equivalence to previously marketed devices and does not contain the detailed study information typically associated with acceptance criteria for a novel AI/software device. The device in question is a reusable insulin injection pen, a mechanical device, not an AI, software, or imaging device subject to the types of studies outlined in your request.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to aspects that are not relevant to a mechanical device submission like this.

However, I can extract the information that is present and indicate where the requested information is not applicable to this type of device.

Acceptance Criteria and Device Performance for Disetronic Pen P100

Based on the provided 510(k) summary, the "acceptance criteria" are not explicitly defined in a quantitative table with performance metrics as one might expect for a diagnostic or AI device. Instead, the performance is evaluated against a recognized standard for such mechanical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
General Performance	Conformance to ISO 11608 ("Pen-injectors for Medical Use") methods	"The device conforms to the requirements when tested using the methods specified in the draft ISO standard, ISO 11608, 'Pen-injectors for Medical Use.'"
Accuracy of Injection	Implicitly covered by ISO 11608 suitability for "accurately injecting a selected dose" of insulin.	The device "provides a method of accurately injecting a selected dose of insulin."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document states that the device was "tested using the methods specified in the draft ISO standard, ISO 11608," but does not detail the number of devices or injections tested.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary for a mechanical device conformance to an ISO standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a mechanical device conforming to an ISO standard, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The performance is assessed against the physical and functional specifications defined in the standard.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, which is not relevant for testing a mechanical injection pen's conformity to an ISO standard.

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

Not Applicable. This is a mechanical device, not an AI or diagnostic tool. MRMC studies are used to evaluate diagnostic accuracy and the impact of AI assistance on human reader performance, which is not relevant here.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

Standards-based Conformance: The "ground truth" in this context is the requirements and test methods specified in the draft ISO standard, ISO 11608, for "Pen-injectors for Medical Use." The device's performance is measured against these established engineering and functional benchmarks.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

Not Applicable. As there is no training set for this mechanical device.

Summary

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K93666

NOV 22 1999

510(K) SUMMARY

9.0 Summary of Safety and Effectiveness

Disetronic Pen P100 9.1 Trade/Proprietary Name:
Iniection Pen 9.2 Common/Usual Name:
Piston Svringe 9.3 Classification Name:
9.4 Substantial Equivalence: The Disetronic Pen P100 is substantially equivalent to the current Disetronic Insulin Injection Pen (K982966), the B-D 3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen Ergo (K982842) and the Owen Mumford Autopen 3ml (K983974).
9.5 The Disetronic Pen P100 is a reusable device that provides a method of accurately iniecting a selected dose of insulin from an insulin cartridge supplied by other manufacturers, through a single lumen hypodermic needle. The device can be used by health professionals or for self-iniection by the patient. The device is similar in appearance and size to a ballpoint pen. It is cylindrical in shape and has a retractable dosage knob at the top that resembles the 'clicker' used to extend and retract the tip of a ballpoint pen beyond its housing.

9.7 Technological Characteristics: The technological characteristics of the thjection Pens are the same as products currently legally marketed in the USA.
9.8 Performance Data: The device conforms to the requirements when tested using the methods specified in the draft ISO standard, ISO 11608, "Pen-injectors for Medical Use."
9.9 Conclusion: Disetronic Medical Systems concludes based on the information presented that the Injection Pens are substantially equivalent to products currently legally marketed in the USA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 22 1999

Mr. David E. Chadwick, Ph.D. Director, Requlatory Affairs Disetronic Medical Systems, Inc. 5151 Proqram Avenue St. Paul, Minnesota 55112-1014

K993666 Re : Disetronic Pen Trade Name: Requlatory Class: II Product Code: FMF October 25, 1999 Dated: November 1, 1999 Received:

Dear Dr. Chadwick:

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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Dr. Chadwick

obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA ation of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marrees problems, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriamet as (od advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to the regulacion encretica, Mibbianding by Coronover
premarket notification" (21 CFR 807.97). 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE STATEMENT

K993666 510(k) File Number:

Disetronic Pen P100 Insulin Infusion Pen Device Name:

The Disetronic Pen P100 is indicated for the injection of insulin into the Indications For Use: body

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices X 993666 510(k) Number _

Prescription Use (Per 21 CFR 801.19) OR

Over-The-Counter Use

Patricia Cacciutti

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices, 500(k) Number 1993 Colole

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).