DISETRONIC PENFINE INJECTION PEN NEEDLE

K982399 · Disetronic Medical Systems · FMI · Aug 6, 1998 · General Hospital

Device Facts

• Record ID: K982399
• Device Name: DISETRONIC PENFINE INJECTION PEN NEEDLE
• Applicant: Disetronic Medical Systems
• Product Code: FMI · General Hospital
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.

Device Story

Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single-use hypodermic needles. Designed for attachment to commercially available automatic injector pens; used for fluid delivery into the body. Device functions as a mechanical conduit for medication administration. Operation involves manual attachment to an injector pen by the user or clinician. Benefit includes providing a 31-gauge needle option for fluid injection, consistent with established needle technology.

Clinical Evidence

Bench testing only. Performance data generated in compliance with international standards and protocols demonstrated equivalence to predicate devices.

Technological Characteristics

Sterile, non-pyrogenic, single-use hypodermic needle. 31-gauge cannula. Mechanical design identical to predicate devices. No software or electronic components.

Indications for Use

Indicated for hypodermic injection of fluids into the body via attachment to an automatic injector pen. No specific patient population, age, or disease state restrictions provided.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Disetronic PenFine® Injection Pen Needles (29 and 30 gauge) (K973339)
• Becton Dickinson B-D Ultra-Fine II Injection Pen Needles (K970737)

Submission Summary (Full Text)

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K982399

AUG 6 1998

#### 8.0 SUMMARY OF SAFETY AND EFFECTIVENESS

### "510(k) SUMMARY"

8.1 Trade/Proprietary Name: 31 Gauge Disetronic PenFine® injection Pen Needle

8.2 Common/Usual Name: Injection Pen Needle

8.3 Classification Name: Hypodermic Single Lumen Needle

. .

# 8.4 Comparison to Currently Marketed Devices

The 31 gauge Disetronic PenFine® Injection Pen Needles are substantially equivalent to the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles (K973339) and the Becton Dickinson B-D Ultra-Fine II Injection Pen Needles (K970737).

# 8.5 Device Description

The 31 gauge Disetronic PenFine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness of the cannula.

### 8.6 indications for Use

The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.

### 8.7 Technological Characteristics

The technological characteristics are the same as the predicate devices.

### 8.8 Performance Data

Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.

#### 8.9 Conclusion

Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the PenFine® Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Mr. Patrik De Haes ·President and CEO Disetronic Medical Systems, Incorporated 5201 East River Road, Suite 312 Minneapolis, Minnesota 55421-1014

K982399 Re : Disetronic PenFine® Injection Pen Needle Trade Name: Requlatory Class: II Product Code: FMI Dated: July 2, 1998 July 10, 1998 Received:

Dear Mr. De Haes:

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 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). 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 (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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. De Haes

through 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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 premarket notification" (21CFR 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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Olin S. L/or
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:

,Device Name:

Disetronic PenFine® Injection Pen Needle

Indications For Use:

The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuccenti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)