DISETRONIC PEN

K982966 · Disetronic Medical Systems · FMF · Oct 19, 1998 · General Hospital

Device Facts

• Record ID: K982966
• Device Name: DISETRONIC PEN
• Applicant: Disetronic Medical Systems
• Product Code: FMF · General Hospital
• Decision Date: Oct 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for the injection of insullin into the body.

Device Story

Reusable injection pen for insulin delivery; cylindrical, ball-point pen-like form factor. User loads insulin cartridge into barrel, attaches single-lumen hypodermic needle, and sets dose via digital display by twisting spring-loaded knob. Depressing knob advances plunger to displace selected dose. Used by healthcare professionals or patients for self-injection. Models differentiated by threaded rod/nut mechanism determining dose per incremental click. Facilitates accurate insulin administration; improves patient convenience compared to traditional syringes.

Clinical Evidence

Bench testing only. Device conforms to ISO 11608-1, 'Pen-injectors for Medical Use - Part 1. Requirements and Test Methods'. No clinical data presented.

Technological Characteristics

Reusable mechanical pen-injector. Materials are consistent with currently marketed devices. Sensing/actuation: manual spring-loaded knob, threaded rod, and nut mechanism for dose setting and plunger advancement. Form factor: cylindrical, pen-like. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for the injection of insulin into the body for patients requiring insulin therapy.

Regulatory Classification

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.

Predicate Devices

• NovoPen Injection Pen (K942159)
• B-D Injection Pen (K941567)
• B-D Syringe (K954064)
• Disetronic H-Tron plus Insulin Infusion Pump (K973044)

Submission Summary (Full Text)

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

K982966

| 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

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

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.

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

## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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

## 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)