DISENTRONIC PENFINE INJECTION PEN NEEDLE

K994197 · Disetronic Medical Systems · FMI · Dec 29, 1999 · General Hospital

Device Facts

• Record ID: K994197
• Device Name: DISENTRONIC PENFINE INJECTION PEN NEEDLE
• Applicant: Disetronic Medical Systems
• Product Code: FMI · General Hospital
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Special
• 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 injector pen.

Device Story

Disetronic Penfine® Injection Pen Needle is a sterile, non-pyrogenic, single-use hypodermic needle. Device attaches to commercially available injection pens to facilitate fluid delivery into the body. Used in clinical or home settings by patients or healthcare providers. Device serves as a mechanical conduit for medication administration; no electronic or software components involved.

Clinical Evidence

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

Technological Characteristics

Sterile, non-pyrogenic, single-use hypodermic needle. Mechanical device; no energy source, connectivity, or software. Materials and design identical to predicate devices (K982399), differing only in cannula length.

Indications for Use

Indicated for hypodermic injection of fluids into the body via attachment to an injector pen. No specific patient population, age, or disease state contraindications 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 (8, 10 and 12 mm) (K982399)

Submission Summary (Full Text)

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1994197

# "510(k) SUMMARY"

Disetronic Penfine® Injection Pen Needle 8.1 Trade/Proprietary Name:

Iniection Pen Needle 8.2 Common/Usual Name:

8.3 Classification Name: Hypodermic Single Lumen Needle --

### 8.4 Comparison to Currently Marketed Devices

The 6 mm Disetronic Penfine® Injection Pen Needles are substantially equivalent to the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles (K982399).

#### 8.5 Device Description

The 6 mm 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 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles. The only difference is in the length 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 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® Iniection 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

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

Re : K994197

> Trade Name: Disetronic Penfine® Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: December 7, 1999 December 13, 1999 Received:

Dear Mr. 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, 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 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 Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Chadwick

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 regulations.

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 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 compriation as (advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Eleanor W Shippen

Timothy A. Ulatowski 1 197 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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# !NDICATIONS FOR USE STATEMENT

1499 41977

510(k) File Number:

Device Name:

Indications For Use:

Disetronic Penfine® Injection Pen Needle

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)

Prescription Use
(Per 21 CFR 801.19)

OR

Over-The-Counter Use

Healed in Shunum

(Division Sign-Off) ·vision of Dental, Infection Control, · General Hospital Dev Nomber _______________________________________________________________________________________________________________________________________________________________________