GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000

K041239 · Genesis Medical Technology, Inc. · KZE · Nov 8, 2004 · General Hospital

Device Facts

• Record ID: K041239
• Device Name: GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
• Applicant: Genesis Medical Technology, Inc.
• Product Code: KZE · General Hospital
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

Device Story

PharmaJet Needle-free Injector System is a compact, spring-loaded, non-electrically powered device for hypodermic injection. System components include an injector, a cocking station, and single-use, sterile, disposable vials. Operation involves loading the device via the cocking station, filling the disposable vial with the medication or vaccine, and triggering the spring mechanism. This releases a narrow, high-velocity fluid jet that penetrates the skin surface to deliver the substance intramuscularly or subcutaneously. The device is intended for use by healthcare providers or patients to administer predetermined medications without the use of a traditional needle, potentially reducing needle-stick injuries and patient anxiety associated with needles.

Clinical Evidence

Bench testing only. The device was validated through rigorous testing according to international standards and internal protocols to ensure biocompatibility, sterility assurance, functionality, and general device safety.

Technological Characteristics

Spring-loaded, non-electrically powered fluid injector. System includes injector, cocking station, and single-use sterile disposable vials. Operates via high-velocity fluid jet mechanism. Materials and design are consistent with established predicate devices for needle-free injection.

Indications for Use

Indicated for the intramuscular or subcutaneous delivery of predetermined medicines and vaccines via a high-velocity fluid jet that penetrates the skin. No specific patient population, age, or disease state restrictions are provided.

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.

Submission Summary (Full Text)

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## NOV = 8 2004

## 510(k) Premarket Notification Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector System Summary of Safety and Effectiveness

10 May 2004

The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Genesis Medical<br>Technologies, Inc. PharmaJet Needle-free Injector System | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submission<br>Correspondent: | Speed To Market, Inc.<br>1555 East Flamingo Road, Suite 155<br>Las Vegas, NV 89119<br><br>Mr. Thomas Kroenke<br>303 956 4232<br>[e-mail] | |
| Manufacturer: | Genesis Medical Technologies, Inc.<br>24797 Foothills Drive North<br>Golden, CO 80401<br><br>Ms. Kathleen Callender<br>303 526 4278<br>[e-mail] | |
| Proprietary: | PharmaJet Needle-free Injector System | |
| Common: | Injector, Fluid, Non-Electrically Powered | |
| Classification: | KZE, §880.5430, Class II | |
| Device<br>Description: | The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector<br>System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic<br>injector system.<br><br>The PharmaJet System consists of an injector, a cocking station and single-use, sterile,<br>disposable vials. | |
| Intended Use: | The PharmaJet System is intended to deliver various predetermined medicines and<br>vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity<br>fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to<br>the body. | |
| Test<br>Discussion: | The PharmaJet System was validated through rigorous testing according to international<br>standards and internal protocols to ensure biocompatibility, sterility assurance,<br>functionality, and general device safety. | |
| Test<br>Conclusion: | The PharmaJet System is substantially equivalent to its predicate devices in design<br>concepts, technologies and materials. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Genesis Medical Technologies, Incorporated C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated 1555 East Flamingo Road, Suite 155 Las Vegas, Nevada 89119

Re: K041239

Trade/Device Name: Genesis Medical Technologies, Incorporated PharmaJet Needle-Free Injector Regulation Number: 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: October 28, 2004 Received: October 29, 2004

Dear Mr. Kroenke:

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 interstate commerce prior to they's ,
Amendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act rood alle metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 Wry, it hay of such of Federal Regulations, Title 21, Parts 800 to 898. In your device announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Kroenke

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 mean that IDA has made a december and regulations administered by other Federal agencies. of the Act of ally I ederal bates and systements, including, but not limited to: registration 1 ou must comply with an all the Piece brog (21 CFR Part 801); good manufacturing practice alle listing (21 CFR Part 807), laoling systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality sign 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) ITIIS letter will anow you to began finding of substantial equivalence of your device to a premiarket notification: - The PD Fresults 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), If you desire speofile at no to pliance at [phone]. Also, please note the regulation picase contact the Office or other in premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Chiu Lin, Ph.D.

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): | K041239 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Genesis Medical Technologies, Inc. PharmaJet Needle-free<br>Injector |
| Indications for Use: | The GMTI PharmaJet System is intended to deliver various<br>predetermined medicines and vaccines either intramuscularly or<br>subcutaneously by means of a narrow, high velocity fluid jet which<br>penetrates the surface of the skin and delivers the medicine or vaccine to<br>the body. |

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chán Dinh

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

510(k) Number: Koy) 239

000008
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