DAI-R

K060141 · Shl Medical, USA · KZH · Jun 12, 2006 · General Hospital

Device Facts

• Record ID: K060141
• Device Name: DAI-R
• Applicant: Shl Medical, USA
• Product Code: KZH · General Hospital
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended Use of the DAI-R is for the automatic self-administration of FDA-approved drugs and biologics from standard Glass Barrel 1mL Long Syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R.

Device Story

DAI-R is a single-use, spring-powered, disposable autoinjector for 1mL prefilled glass syringes. Device consists of main body and syringe carrier assembly; constructed of plastic and steel. Operation involves three steps: automatic needle insertion to predetermined depth, automatic drug delivery, and needle withdrawal. Used in home environment by patients for self-administration of prescribed medications. Features include safety mechanism to prevent inadvertent activation, automatic needle sheathing, cutout window, locking tabs to prevent disassembly, and self-disabling mechanism to prevent reuse. Device has no fluid path and no contact with drug/biologic. Healthcare providers prescribe the therapy; device facilitates patient adherence and safe administration.

Clinical Evidence

Bench testing only. Device assessed using ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods." Evaluated parameters included activation force, needle extension, injection time, completeness of injection, functionality, and robustness. Device met all specified requirements.

Technological Characteristics

Spring-powered mechanical autoinjector. Materials: plastic and steel. Dimensions: designed for 1mL long glass syringes with Luer Lock tip. Features: safety mechanism, automatic needle sheathing, locking tabs, self-disabling mechanism. Standards: ISO 11608:2000. No fluid path; no drug contact.

Indications for Use

Indicated for automatic self-administration of FDA-approved drugs and biologics using prefilled 1mL long glass syringes with Luer Lock tips. Intended for home use by patients to support prescribed treatment and therapy.

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

• SHL Medical, USA Disposable Autoinjector "DAI" (K050434)

Submission Summary (Full Text)

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Kobo 141

רייני ביינונג

## 510(k) SUMMARY

- 1. Submitter
JUN 1 2 2006

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: January 18, 2006

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

- 3. Device to which substantial equivalence is claimed
Device Name: SHL Medical, USA Disposable Autoinjector "DAI" 510(k) Clearance Number: K050434 Device Common Name: Syringe needle introducer Classification Name: Syringe Needle Introducer

- 4. Device Description
The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.

The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.

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Image /page/1/Picture/0 description: The image shows the logo for SHL Medical. The logo consists of the text "SHL MEDICAL" in a bold, sans-serif font. To the left of the text is a stylized graphic element that appears to be a combination of lines and shapes, possibly representing a medical device or a stylized "S" and "H".

Image /page/1/Picture/1 description: The image shows the text "K060111" on the top line and "2 of 2" on the second line. The text appears to be handwritten and slightly distorted. The numbers "060111" could be a date or a code, while "2 of 2" suggests that this is the second page of a two-page document.

510(k) Summary - page 2

- 5. Intended Use
The Intended Use of the DAI-R is for the automatic self-administration of FDA-approved drugs and biologics from standard Glass Barrel 1mL Long Syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R.

- 6. Technological Characteristics
The technological characteristics of the DAI-R are the same as other introducer products that are currently marketed in the U.S.

The DAI-R is made of the same materials as the identified predicate device.

Design and performance features of the DAI-R include a safety mechanism to prevent inadvertent activation. automatic sheathing of the used needle, cutout window on the front assembly, locking tabs to prevent disassembly of the DAI-R once the two subassemblies have been connected, and self-disabling to prevent reuse.

There are no current performance standards for a Syringe Needle Introducer. The DAI-R 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; the DAI-R met these requirements and specifications as identified in the ISO standard.

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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 features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

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

Re: K060141

Trade/Device Name: DAI-RTM Autoinjector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: April 18, 2006 Received: April 24, 2006

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 (OS) 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,

Syndite Y. Michau Omd

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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KOLON 14

510(k) Number (if known):

Device Name: DAI-R™ Autoinjector

Indications for Use:

The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector 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)

Anthey V. nxt

nesthesiology, General Hospital. Control. Dental Devices

Number: KY60141