SHL DISPOSABLE AUTOINJECTOR

K050434 · Shl Medical, USA · KZH · Jun 24, 2005 · General Hospital

Device Facts

• Record ID: K050434
• Device Name: SHL DISPOSABLE AUTOINJECTOR
• Applicant: Shl Medical, USA
• Product Code: KZH · General Hospital
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended Use of DAI™ is for the automatic self-administration of FDA-approved drugs and biologics from standard 1.0mL Long Syringes with Needle that have been prefilled prior to use with DAI™.

Device Story

DAI™ is a spring-powered, single-use, disposable auto-injector for subcutaneous drug delivery. It accepts standard 1.0mL long glass syringes with staked needles (25g-27g, 12.7mm). Operation involves loading a prefilled syringe into the two-part tubular plastic/metal housing; pressing an activation button triggers a pre-compressed stainless steel spring. This mechanism automatically inserts the needle to a predetermined depth and delivers the syringe contents. Used in home environments by patients for self-injection. Features include a safety mechanism to prevent inadvertent activation, automatic needle recovery, a viewing window for syringe inspection, and self-disabling functionality post-injection. The device has no fluid path and does not contact the drug product.

Clinical Evidence

Bench testing only. The device was assessed using methods specified in ISO 11608:2000 for pen injectors. Testing confirmed performance specifications for activation force, needle extension, injection time, completeness of injection, functionality, and robustness.

Technological Characteristics

Plastic and metal construction; pre-compressed stainless steel spring actuation; tubular form factor for 1.0mL long glass syringes; manual activation; safety lock and self-disabling mechanism. Evaluated per ISO 11608:2000.

Indications for Use

Indicated for patients requiring subcutaneous self-administration of FDA-approved drugs and biologics using standard 1.0mL long prefilled syringes. Intended for home use to support prescribed treatment.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• Owen Mumford Autoject Mini (K000482)

Submission Summary (Full Text)

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KOS-0934

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JUN 2 4 2005

## 510(k) SUMMARY

1. Submitter

SHL Medical, USA 23 Vreeland Road, Suite 104 Florham Park, New Jersey 07932 Office Telephone: [phone]

Contact Person Lucio Giambattista Telephone: [phone]

Date of Preparation: February 17, 2005

- 2. Device Information
Device Trade Name: DAI™ Device Common Name: Auto-injector Classification Name: Introducer, Syringe Needle

- 3. Device to which substantial equivalence is claimed Device Name: Owen Mumford Autoject Mini 510(k) Clearance Number: K000482 Device Common Name: Syringe needle introducer Classification Name: Introducer, Syringe Needle
- 4. Device Description

DAI™ is an automatic drug delivery device that is used for the subcutaneous administration of drugs and biologics from standard 1.0mL long glass syringes with staked needle from 25g to 27g and 12.7mm in length that are prefilled prior to use in DAI™ is a single-use, disposable, syringe needle introducer device that is spring-powered and designed to administer the entire contents of the prefilled syringe during one injection. A DAI™ injection consists of the automatic insertion of the syringe needle to a predetermined depth into the skin, followed by the automatic delivery of the syringe contents.

DAT™ consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self injection. The assembled DAI™ has a tubular design with a needle end and a power assembly with activation button end. DAI™ components and subassemblies are made of plastic and metal. DAI™ does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.

Page 1 of 2

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K050434

JUN 2 4 2005

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510(k) Summary - page 2

5. Intended Use

The Intended Use of DAI™ is for the automatic self-administration of FDA-approved drugs and biologics from standard 1.0mL Long Syringes with Needle that have been prefilled prior to use with DAI™.

6. Technological Characteristics

The technological characteristics of DAI™ are the same as other introducer products that are currently marketed in the U.S.

DAT™ is made of materials that have been evaluated for use in manufacturing medical devices, including syringe needle introducers. DAI™ uses a pre-compressed stainless steel spring that when released by the activation of the device, drives a plunger rod onto the stopper of the svringe to expel the contents and effect the injection.

Design and performance features of DAI™ include a safety mechanism to prevent inadvertent activation, automatic recovering of the used needle, cutout window on the front assembly to permit inspection of the syringe, locking tabs to prevent disassembly of DAI™ once the two subassemblies have been connected, and self-disabling after use.

No performance standards have been established for Introducer, Syringe Needle. DAI™ was assessed using the sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods" as they apply to injection devices with non-replaceable prefilled cartridges. Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; DAI™ met all requirements and specifications.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

JUN 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lucio Giambattista Managing Director SHL Medical, USA 23 Vreeland Road, Suite 104 Florham Park, New Jersey 07932

Re: K050434

Trade/Device Name: SHL DAI™ Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: June 20, 2005 Received: June 22, 2005

Dear Mr. Giambattista:

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. Giambattista

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,

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):

K050434

Device Name: SHL DAI™

Indications for Use:

DAI™ is a hand-held mechanical device intended for the automated, subcutaneous, selfadministration of FDA-approved drugs and biologics. DAI™ is designed to be used with the standard 1.0mL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAI™ is for use in the home environment to aid and support prescribed treatment and therapy.

Prescription Use _ XX (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chis un

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: __ cus 5 44