(181 days)
Not Found
Not Found
No
The summary describes a mechanical, spring-loaded injection system and does not mention any AI or ML components or functionalities.
No
The device is described as a system for delivering medicine and vaccines, not for treating a disease or condition itself. It is a delivery mechanism.
No
The device is described as a system for delivering medicines and vaccines, not for diagnosing medical conditions. It functions as an injector, not a diagnostic tool.
No
The device description explicitly states it is a "compact, spring-loaded needle-free hypodermic injector system" consisting of an injector, cocking station, and disposable vials, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering medicines and vaccines into the body (intramuscularly or subcutaneously). This is a therapeutic or drug delivery function.
- Device Description: The description confirms it's a "needle-free hypodermic injector system." This is a delivery mechanism, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
Therefore, the GMTI PharmaJet System is a drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KZE
Device Description
The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of an injector, a cocking station and single-use, sterile, disposable vials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PharmaJet System was validated through rigorous testing according to international standards and internal protocols to ensure biocompatibility, sterility assurance, functionality, and general device safety. The PharmaJet System is substantially equivalent to its predicate devices in design concepts, technologies and materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5430 Nonelectrically powered fluid injector.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
Technologies, Inc. PharmaJet Needle-free Injector System | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submission
Correspondent: | Speed To Market, Inc.
1555 East Flamingo Road, Suite 155
Las Vegas, NV 89119
Mr. Thomas Kroenke
303 956 4232
tkroenke@speedtomarket.net | |
| Manufacturer: | Genesis Medical Technologies, Inc.
24797 Foothills Drive North
Golden, CO 80401
Ms. Kathleen Callender
303 526 4278
FINNIV@aol.com | |
| Proprietary: | PharmaJet Needle-free Injector System | |
| Common: | Injector, Fluid, Non-Electrically Powered | |
| Classification: | KZE, §880.5430, Class II | |
| Device
Description: | The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector
System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic
injector system.
The PharmaJet System consists of an injector, a cocking station and single-use, sterile,
disposable vials. | |
| 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. | |
| Test
Discussion: | The PharmaJet System was validated through rigorous testing according to international
standards and internal protocols to ensure biocompatibility, sterility assurance,
functionality, and general device safety. | |
| Test
Conclusion: | The PharmaJet System is substantially equivalent to its predicate devices in design
concepts, technologies and materials. | |
1
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
3
Indications for Use
| 510(k) Number (if known): | K041239 |
|---|---|
| Device Name: | Genesis Medical Technologies, Inc. PharmaJet Needle-free |
| Injector | |
| Indications for Use: | The GMTI 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. |
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
Page 1 of 1