HASELMEIER PEN

K070100 · Haselmeier Sarl · FMF · Mar 21, 2007 · General Hospital

Device Facts

• Record ID: K070100
• Device Name: HASELMEIER PEN
• Applicant: Haselmeier Sarl
• Product Code: FMF · General Hospital
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.

Device Story

Haselmeier Pen is a reusable, hand-held mechanical autoinjector for subcutaneous delivery of FDA-approved drugs and biologics. User loads 3.0 mL cartridge into barrel, attaches needle, sets dose, and presses button to deliver medication. Device intended for home use by patients to support prescribed therapy. Output is controlled delivery of medication; device does not contain electronics or software. Benefits include simplified self-administration of injectable treatments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical hand-held autoinjector; compatible with 3.0 mL ISO type A cartridges and needles compliant with ISO 11608-2:2000 and ISO 11608-3:2000. No energy source, software, or electronic components.

Indications for Use

Indicated for subcutaneous self-administration of FDA-approved drugs and biologics in a home environment using 3.0 mL prefilled cartridges.

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

• DAI-RTM Autoinjector (K060141)
• Disetronic Pen (K982966)
• HumaPen and HumaPen Ergo (K982842)

Submission Summary (Full Text)

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Haselmeier Sàrl Haselmeier Pen Hasemiary 510(k) Premarket Notification

Page 1 of 2

Ko 7 0/00

# 510(k) SUMMARY

# General Information

Submitted by:

Contact Person:

Haselmeier Sàrl 5 route de St Cergue CH-1295 Mies Switzerland

Robert J. Kilgore Haselmeier USA 517 Benfield Road Suite 301 Severna Park, MD 21146-2596

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

Date Prepared:

March 5, 2007

## Device Name

| Trade Name: | Haselmeier Pen |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Autoinjector, Pen Injector |
| Classification Name: | Syringe Needle Introducer, Piston syringe<br>21 CFR 880 6920 21 CFR 880 5860 |

## Predicate Device

| Manufacturer | Product Name | 510(k) No |
|---------------------------|--------------------------|-----------|
| SHL Medical, USA | DAI-RTM Autoinjector | K060141 |
| Disetronic Medical System | Disetronic Pen | K982966 |
| Eli Lilly and Company | HumaPen and HumaPen Ergo | K982842 |

A

MAR 2 1 2007

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Page 2 of 2

## evice Description

K070100

The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.

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, with the following dimensions:

Overall cartridge length including aluminum cap: Outside Cartridge Diameter: Inner Cartridge Diameter:

Maximum eccentricity of aluminum cap:

63.9 mm ± 0.3 mm 11.94 mm MAX. 9.65 mm ± 0.1 mm measured at open end. 0.33 mm

#### Intended Use

The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.

### Technological Comparison

The Haselmeier Pen has similar indications for use to the DAI-R™ Autoinjector and is similar in design and operating principle to the Disetronic Pen, HumaPen, and HumaPen Ergo.

## Testing

The Haselmeier Pen has been demonstrated to perform as intended.

#### Conclusions

The Haselmeier Pen is substantially equivalent to legally marketed devices (autoinjectors and pen injectors).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert J. Kilgore Director Haselmeier USA 517 Benfield Road, Suite 301 Severna Park, Maryland 21146-2596

MAR 2 1 2007

Re: K070100

Trade/Device Name: Haselmeier Pen Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: March 5, 2007 Received: March 5, 2007

Dear Mr. Kilgore:

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 in ture 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. Kilgore

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Clare

Chiu Lin, Ph.D. 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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# INDICATIONS FOR USE

510(k) Number (if known):

K070100

Device Name:

Haselmeier Pen

Sponsor Name:

Haselmeier Sàrl

Indications for Use:

The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.

Prescription Use (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)

Richard C. Chapman for ADw 3/21/07

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