INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM

K020786 · Rosch AG Medizintechnic · KZE · Sep 25, 2002 · General Hospital

Device Facts

• Record ID: K020786
• Device Name: INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
• Applicant: Rosch AG Medizintechnic
• Product Code: KZE · General Hospital
• Decision Date: Sep 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The INJEX™ - and ROJEX™ needle- free injection systems Extra are designed for the delivery of medicines which are administrated subcutaneously by jet injection. Because of the absence of a needle, the fluid is transferred from an ampoule via its mirco- orifice through the aid of a capillary, high velocity, to the body. The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure. This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.

Device Story

Needle-free injection systems (INJEX/ROJEX) deliver liquid medication subcutaneously using high-velocity fluid jets. INJEX is a multi-use device requiring a reset box to tension an internal spring; ROJEX is a single-use, pre-tensed disposable device. Both utilize spring-loaded energy to accelerate fluid through a micro-orifice ampoule, penetrating skin without needles. Accessories include transporters for cartridge-to-ampoule transfer and sterile adapters. Used in clinical or home settings under physician order; patients self-administer or receive injections. Device eliminates needle-stick risks and facilitates subcutaneous drug delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Non-clinical testing included raw material analysis and biological safety testing (cytotoxicity, tissue irritation, systemic toxicity, and sensitization) for ampoule components.

Technological Characteristics

Non-electrically powered fluid injector. Energy source: internal spring. Components: injector, reset box (INJEX), ampoule, adapter, transporter. Materials: plastic (ROJEX). Mechanism: high-velocity jet through micro-orifice. Sterilization: sterile ampoules/adapters. Connectivity: none.

Indications for Use

Indicated for patients requiring subcutaneous delivery of liquid pharmaceuticals via jet injection. Prescription use only.

Regulatory Classification

Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

Predicate Devices

• Hypex Jet Injector (K945873)
• Medi-Jector Choice (K962956)
• INJEX 50 System (K003864)
• Jet Syringe (K003741)

Submission Summary (Full Text)

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| 004 | | PRE- MARKET NOTIFICATION | | |
|----------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Dr. Zalewski<br>05.09.2002 | | 510(k) Summary<br>(As required by 21 CFR 880.5430) | | |
| | | | | Page 1 / 1 |
| A | Submitter Information | Rösch AG Medizintechnik<br>Buckower Damm 114<br>D - 12349 Berlin | | K02078 |
| | | Phone: [phone]<br>Fax: [phone]-939<br>Email: [e-mail]<br>Contact: Dr.-Eng. Kerstin Zalewski<br>Head of Regulatory Affairs<br>Date: July, 22nd, 2002 | | SEP 2 5 2002 |
| B | Device Information<br>Trade/ Proprietary Name: | INJEX ™ needle- free injection system Extra<br>ROJEX ™ needle- free injection system Extra | | |
| | Common Name of device: | Jet Injector | | |
| | Classification Name: | Fluid Injector, non- electrically powered | | |
| C | Predicate Device(s): | Hypex Jet Injector, Medi-Jector Choice, INJEX 50 System,<br>Jet Syringe | | |
| | Predicate 510(k) #: | K945873; K962956, K003864, K003741 | | |
| D | Device Description: | The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free through<br>the skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jet<br>of fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source to<br>accelerate the fluid within the ampoule is an internal spring.<br><br>The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector for<br>injection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. The<br>automatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting | | |

The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.

To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.

The INJEX™ Systems Extra consist of two main components which are re- usable:

- . INJEX™ Injector
- . Reset Box

The ROJEX™ Systems Extra represent the disposable medical device:

- · ROJEX™ Injector, pre- tensed

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| 004 | |
|--------------|--|
| Dr. Zalewski | |
| 05.09.2002 | |

| PRE- MARKET NOTIFICATION | |
|----------------------------------|--|
| 510(k) Summary | |
| (As required by 21 CFR 880.5430) | |

RÖSCH
Rösch AG MedizintechnikPage 2 / 2

The three accessories for INJEX™ needle- free Injection systems Extra are:

- Transporter, re- usable .
- Adapter, sterile, usable for one medicine repository .
- Ampoule, sterile, for single- use .
- E Intended Use:

The INJEX™ - and ROJEX™ needle- free injection systems Extra are designed for the delivery of medicines which are administrated subcutaneously by jet injection. Because of the absence of a needle, the fluid is transferred from an ampoule via its mirco- orifice through the aid of a capillary, high velocity, to the body.

F Comparison of Required Technological Characteristics: The INJEX™ - and ROJEX™ needle-free injection systems Extra picture the same technological characteristics as the predicated devices. The key difference of the ROJEX™ injector is its mainly plastic composition and single- use mode. Both devices, INJEX™ - and ROJEX™ injectors, are suitable to deliver liquid pharmaceuticals into the subcutaneous tissue of the body. Due to the technological identity and the same indications for use, no additional safety items had to be investigated.

- G Summary and Conclusions of non- clinical Tests
In addition to the supplier's raw material testing reqarding the ampoule, biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation were analysed.

The body contact of the ampoule is classified as short term (< 10 min) indirect contact (drug- mediated) to skin.

Conclusion

The investigation present that the INJEX ™ - and ROJEX™ needle-free injections systems Extra are safe and effective for the intended use and substantially equivalent to the legally market predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 5 2002

Mr. Mark Job Responsible Third Party TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K020786

Trade/Device Name: INJEX™/ROJEX ™ Needle-free Injection System Extra Regulation Number: 880.5430 Regulation Name: Non-electrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: September 9, 2002 Received: September 10, 2002

Dear Mr. Job:

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Job

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,

Timothy A. Ulatowski

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

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## Indications for Use Statement

Verl 3 - 4/24/96

Applicant: Rösch AG Medizintechnik, Buckower Damm 114, 12349 Berlin, Germany

510(k) Number (if known): _

Device Name: INJEX ™/ ROJEX ™ Needle- free Injection System Extra

Indications For Use:

The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.

This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.

Target Population: Patients who have to be injected with liquid pharmaceuticals.

Patricia Cuceniti

510(k) Number: K020786

**Prescription Use**
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)