DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE

K013782 · Disetronic Medical Systems · FMI · Nov 20, 2001 · General Hospital

Device Facts

• Record ID: K013782
• Device Name: DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
• Applicant: Disetronic Medical Systems
• Product Code: FMI · General Hospital
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Disetronic Penfine® Insulin Injection Pen Needles are sterile, nonpyrogenic, single-use needles; available in 6, 8, 10, and 12 mm lengths. Designed for attachment to commercially available insulin injector pens. Used by patients for self-administration of insulin or by healthcare providers in clinical settings. Device facilitates subcutaneous delivery of insulin; enables precise dosing via pen mechanism. Benefits include ease of use and reliable insulin delivery for diabetes management.

Clinical Evidence

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

Technological Characteristics

Sterile, nonpyrogenic, single-use hypodermic needles. Available in 6, 8, 10, and 12 mm lengths. Designed for compatibility with standard insulin injector pens. No software or electronic components.

Indications for Use

Indicated for hypodermic injection of insulin into the body via an injector pen for patients requiring insulin therapy.

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 (K982399)
• Disetronic Penfine® Injection Pen Needles (K994197)
• Disetronic Penfine® Injection Pen Needles (K992399)

Submission Summary (Full Text)

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Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use

#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

NOV 2 0 2001

#### "510(k) SUMMARY"

| Trade/Proprietary Name: | Disetronic Penfine® Insulin Injection Pen<br>Needle |
|-------------------------|-----------------------------------------------------|
| Common/Usual Name: | Insulin Injection Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle |

Comparison to Currently Marketed Devices

The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399).

#### Device Description

The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.

#### Indications for Use

The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hyoodermic injection of insulin into the body when attached to an injector pen.

### Technological Characteristics

The technological characteristics are the same as the predicate devices.

#### Performance Data

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

#### Conclusion

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 0 2001

Mr. David E. Chadwick Director, Regulatory Affairs/Quality Assurance Disetronic Medical Systems 5151 Program Avenue Saint Paul. Minnesota 55112-1014

Re: K013782

Trade/Device Name: Disetronic Penfine Insulin Injection Pen Needle Regulation Number: 880.5570 Regulation Name: Insulin Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: November 12, 2001 Received: November 14, 2001

Dear Mr. Chadwick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kj Wlatust

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

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Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use

K013782

# NOV 2 0 2001

## INDICATIONS FOR USE STATEMENT

510(k) File Number:

Device Name:

Insulin Injection Pen Disetronic Penfine® Needle

Indications For Use:

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|---------|
| 'Division Sign-Off | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| Number | K013782 |

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_ OR