(55 days)
The device is indicated for the injection of insullin into the body.
The Disetronic Injection Pen is a reusable devices that provides a method of accurately injecting a selected dose of insulin from a fluid cartridge through a single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient. The device is similar in appearance and size to a ball point pen, hence the description. It is cylindrical in shape and has a retractable dosage know at the top that resembles the "clicker" used to extend and retract the tip of a ball point pen beyond its housing.
The internal mechanisms used to set and activate the injection are identical across the oroduct line. Each pen operates in the following manner. After the cartndge 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 sonng loaded 'knob' at the top of the pen The knob is then twisted in a clockwise direction which increments the digital display to show the dose to be delivered. The needle can 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.
The Pen models are differentiated in that different models of pens differ in the amount of drug represented by each incremental click of the dose setting mechanism. These differences are determined by differences in the threaded rod and nut mechanism of each model which determines the distance, and therefore the dose each click of the dosage knob represents.
The provided text describes the Disetronic Injection Pen, which is a reusable device for accurately injecting insulin. The document primarily focuses on its substantial equivalence to previously marketed devices and its conformity with an ISO standard, rather than presenting a detailed study with acceptance criteria and device performance results in the format requested.
However, based on the provided text, we can infer some information relating to the performance data and the study mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to ISO 11608-1 | The device conforms with the requirements when tested using the methods specified in ISO 11608-1, “Pen-injectors for Medical Use - Part 1. Requirements and Test Methods.” |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The statement refers to "testing using the methods specified in the ISO standard," which implies that the testing was conducted in accordance with the standard's guidelines, but specific details are not provided.
3. Number of Experts and Qualifications
The document does not mention the involvement of experts to establish ground truth for a test set. The validation primarily relies on conformance to an ISO standard.
4. Adjudication Method
There is no mention of an adjudication method as the evaluation is based on conformance to a technical standard rather than subjective assessments by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission focuses on device performance against an engineering standard, not human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done. The document states, "The device conforms with the requirements when tested using the methods specified in the ISO standard, ISO 11608-1, 'Pen-injectors for Medical Use - Part 1. Requirements and Test Methods.'" This indicates a standalone assessment of the device's functional performance against established technical specifications.
7. Type of Ground Truth Used
The ground truth used is conformance to the technical specifications and test methods outlined in ISO 11608-1, "Pen-injectors for Medical Use - Part 1. Requirements and Test Methods." This is a regulatory/standard-established ground truth for device functionality and safety.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This type of submission (510(k)) for a medical device generally focuses on validation and performance testing, not on machine learning model training.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established. The focus is on the device's compliance with established engineering standards.
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| 9.1 Trade/Proprietary Name: | Disetronic Pen |
|---|---|
| ----------------------------- | ---------------- |
Injection Pen 9.2 Common/Usual Name:
- Piston Syringe 9.3 Classification Name.
- 9.4 Substantial Equivalence: The Disetronic injection Pen product line is substantially equivalent to the NovoPen Injection Pen (K942159), the B-D Injection Pen (K941567) the standard Piston Syringe (B-D Synnge - last submission K954064) and the Disetronic H-Tron plus Insulin Infusion Pump (K973044).
- 9.5 The Disetronic Injection Pen is a reusable devices that provides a method of accurately injecting a selected dose of insulin from a fluid cartridge through a single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient. The device is similar in appearance and size to a ball point pen, hence the description. It is cylindrical in shape and has a retractable dosage know at the top that resembles the "clicker" used to extend and retract the tip of a ball point pen beyond its housing.
The internal mechanisms used to set and activate the injection are identical across the oroduct line. Each pen operates in the following manner. After the cartndge 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 sonng loaded 'knob' at the top of the pen The knob is then twisted in a clockwise direction which increments the digital display to show the dose to be delivered. The needle can 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.
The Pen models are differentiated in that different models of pens differ in the amount of drug represented by each incremental click of the dose setting mechanism. These differences are determined by differences in the threaded rod and nut mechanism of each model which determines the distance, and therefore the dose each click of the dosage knob represents.
- 9.7 Technological Characteristics The technological characteristics of the Injection Pens and their drug cartridges are the same as products currently legally marketed in the USA.
- 9 8 Performance Data. The device conforms with the requirements when rested using the methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1. Requirements and Test Methods"
- 9.9 Conclusion: Disetronic Medical Systems concludes based on the information presented that the that the Injection Pens are substantially equivalent to products currently legally marketed in the USA
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 19 1998
Disetronic Medical Systems, Incorporated C/O Mr. Lee H. Leichter Consultant P/L Biomedical 7690 Cameron Circle Fort Myers, Florida 33912
K982966 Re : Disetronic Pen Trade Name: Regulatory Class: II Product Code: FMF Dated: August 25, 1998 Auqust 25, 1998 Received:
Dear Mr. Leichter:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 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 regulations affecting your device can be found in the Code of Federal Requlations, 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Leichter
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 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 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 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
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
510(k) File Number: K982966
Disetronic Pen Device Name:
The device is indicated for the injection of insullin into the body. Indications For Use:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Palacio Cucenito
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K98 2746
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).