(181 days)
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.
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.
The provided document, a 510(k) Premarket Notification for the Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector System, is a summary of safety and effectiveness, and the FDA's acceptance letter. It does not contain the detailed study information required to answer many of the questions regarding acceptance criteria and device performance. The document only states that the device was validated through "rigorous testing according to international standards and internal protocols to ensure biocompatibility, sterility assurance, functionality, and general device safety." However, it does not provide the specifics of these tests, their acceptance criteria, or the reported performance data.
Therefore, the following answers are based only on the information available in the provided text and indicate where information is not present.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (Specific criteria not provided) | "Validation through rigorous testing according to international standards and internal protocols to ensure biocompatibility." (Specific results not provided) |
| Sterility Assurance (Specific criteria not provided) | "Validation through rigorous testing according to international standards and internal protocols to ensure ... sterility assurance." (Specific results not provided) |
| Functionality (Specific criteria not provided for e.g. jet penetration, accurate dose delivery, etc.) | "Validation through rigorous testing according to international standards and internal protocols to ensure ... functionality." (Specific results not provided) |
| General Device Safety (Specific criteria not provided) | "Validation through rigorous testing according to international standards and internal protocols to ensure ... general device safety." (Specific results not provided) |
| Equivalence to predicate devices in design concepts, technologies and materials | "The PharmaJet System is substantially equivalent to its predicate devices in design concepts, technologies and materials." (Specific comparison data not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The document describes a medical device, not an AI or diagnostic tool where expert ground truth would typically be established for a test set. The validation seems to be based on engineering and functional performance testing rather than human expert interpretation data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of the device validation described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI or diagnostic device. It's a needle-free injector system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a physical medical device, not an algorithm. Performance testing would inherently be "standalone" in the sense that the device performs its function independently, but this question is generally applied to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies ground truth was established through adherence to "international standards and internal protocols" for metrics like biocompatibility, sterility assurance, functionality, and general device safety. The specific "types" of ground truth (e.g., specific chemical analyses for biocompatibility, sterility testing methodology, physical measurements for functionality) are not detailed in this summary.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
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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 MedicalTechnologies, Inc. PharmaJet Needle-free Injector System | |
|---|---|---|
| SubmissionCorrespondent: | Speed To Market, Inc.1555 East Flamingo Road, Suite 155Las Vegas, NV 89119Mr. Thomas Kroenke303 956 4232tkroenke@speedtomarket.net | |
| Manufacturer: | Genesis Medical Technologies, Inc.24797 Foothills Drive NorthGolden, CO 80401Ms. Kathleen Callender303 526 4278FINNIV@aol.com | |
| Proprietary: | PharmaJet Needle-free Injector System | |
| Common: | Injector, Fluid, Non-Electrically Powered | |
| Classification: | KZE, §880.5430, Class II | |
| DeviceDescription: | The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free InjectorSystem (PharmaJet System) is a compact, spring-loaded needle-free hypodermicinjector 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 andvaccines either intramuscularly or subcutaneously by means of a narrow, high velocityfluid jet which penetrates the surface of the skin and delivers the medicine or vaccine tothe body. | |
| TestDiscussion: | The PharmaJet System was validated through rigorous testing according to internationalstandards and internal protocols to ensure biocompatibility, sterility assurance,functionality, and general device safety. | |
| TestConclusion: | The PharmaJet System is substantially equivalent to its predicate devices in designconcepts, 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 (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
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Indications for Use
| 510(k) Number (if known): | K041239 |
|---|---|
| Device Name: | Genesis Medical Technologies, Inc. PharmaJet Needle-freeInjector |
| Indications for Use: | The GMTI PharmaJet System is intended to deliver variouspredetermined medicines and vaccines either intramuscularly orsubcutaneously by means of a narrow, high velocity fluid jet whichpenetrates the surface of the skin and delivers the medicine or vaccine tothe 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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§ 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).