TACTIPEN

K083457 · Haselmeier GmbH · FMF · Feb 13, 2009 · General Hospital

Device Facts

• Record ID: K083457
• Device Name: TACTIPEN
• Applicant: Haselmeier GmbH
• Product Code: FMF · General Hospital
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.

Device Story

TactiPen is a reusable pen-injector for subcutaneous delivery of U-100 insulin. Device accepts 3-mL ISO type A cartridges and compatible pen needles. User dials desired dose manually. Operated by patients for self-injection or by healthcare professionals. Mechanical design ensures accurate dose delivery. Benefits include simplified, accurate insulin administration for diabetes management.

Clinical Evidence

Bench testing only. Device performance verified against ISO 11608-1:2000 requirements for pen-injectors.

Technological Characteristics

Reusable mechanical pen-injector. Compatible with 3-mL ISO type A cartridges (ISO 11608-3:2000) and pen needles (ISO 11608-2:2000). Manual dose dialing mechanism. No electronic or software components.

Indications for Use

Indicated for patients requiring subcutaneous injection of U-100 insulin using a 3-mL cartridge.

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

• Haselmeier Pen (K070100)
• Disetronic Pen (K982966)
• HumaPen and HumaPen Ergo (K982842)

Submission Summary (Full Text)

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510(k) Premarket Notification Haselmcier GmbH TactiPen

K083457
510(k) Summary

Page 1 of 2

# 510(k) SUMMARY

[as required by section 807.92(c)]

# FEB 1 3 7009

#### General Information

Submitted by:

Contact Person:

Haselmeier GmbH Dufourstr. 32 CH-8008 Zurich Switzerland

Robert J. Kilgore

Haselmeier USA 517 Benfield Road Suite 301 Severna Park, MD 21146-2596

Phone: [phone] Fax: --410 647-7383 Email: [e-mail]

Date Prepared:

October 2, 2008

#### Device Name

Trade Name: Common Name: Classification Number: Product Code:

TactiPen Piston syringe 880.5860 FMF

### Predicate Devices

| Haselmeier Pen | K070100 | Haselmeier GmbH |
|--------------------------|---------|---------------------------|
| Disetronic Pen | K982966 | Disetronic Medical System |
| HumaPen and HumaPen Ergo | K982842 | Eli Lilly and Company |

#### Device Description

The TactiPen is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of U-100 insulin from a single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient.

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# 510(k) Summary

The pen-injector uses 3.0-mL cartridges of U-100 insulin and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose.

The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-mL ISO type A cartridges (supplied separately), which meet ISO 11608-3: 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods.

#### Intended Use

The TactiPen is a self injection device intended to deliver a subcutaneous injection of U-100 insulin from a 3-mL cartridge.

### Technological Comparison

The TactiPen has similar indications for use and overall function and performs in a similar manner with respect to the Haselmeier Pen, Disetronic Pen, HumaPen, and HumaPen Ergo.

The technological characteristics of the TactiPen and its drug cartridge are the same as product currently legally marketed in the USA.

## Performance Data

The TactiPen has been demonstrated to perform as intended.

The TactiPen conforms to the requirements when tested using the methods specified in the ISO Standard, ISO 11608-1:2000, "Pen-injectors for Medical Use - Part 1 Requirements and Test Methods."

## Conclusion

Haselmeier concludes based on the information presented that the TactiPen is substantially equivalent to products currently, legally marketed in the USA.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 3 2009

Haselmeier GmbH C/o Mr. Stephen J. Goldner, JD, RAC President Regulatory Affairs Associates 30833 Northwestern Highway, Suite 121 Farmington Hill, Michigan 48334-2581

Re: K083457

> Trade/Device Name: TactiPen Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 20, 2008 Received: November 21, 2008

Dear Mr. Goldner:

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.

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#### Page 2 .- Mr. Goldner

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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Anthony, D., Addison for

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Haselmeier GmbH TactiPen

# Indications for Use

Page 1 of 1

# INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Sponsor Name:

Indications for Use:

K083457

TactiPen

・・

Haselmeier GmbH

The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.

Prescription Use X (21 CFR 801 Subpart D) Or

Over-The-Counter Use (21 CFR 807 Subpart C)

# Do Not Write Below This Line – Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Stil)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K683457