(178 days)
No
The description focuses on a mechanical, pneumatically powered injection system with user-controlled parameters (dosage, pressure). There is no mention of AI, ML, or any computational analysis of data to inform the device's operation or decision-making.
No
The device is described as a needle-free injection system for administering medicines and vaccines, which serves a diagnostic, prophylactic, or palliative purpose, rather than directly treating a condition itself.
No
Explanation: The device is described as a needle-free injection system for administering medicines and vaccines, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the system is comprised of a console and a single-use sterile injector kit, indicating significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of medicines and vaccines to the body. This is a therapeutic or drug delivery function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the mechanism of delivering fluid into the body via a jet. This aligns with drug delivery, not diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The Airgent™ System's function is to deliver substances into the body, which is the opposite of what an IVD does.
N/A
Intended Use / Indications for Use
The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin. The Airgent™ includes a disposable delivery kit intended for multiple injections on a single patient. The Airgent™ System is indicated for professional use only.
Product codes
KZE
Device Description
The Airgent" System is an automated, multi-use, needless injector system, intended to deliver medications and vaccines to the body by a highly accelerated pneumatically powered jet of fluid via a very small entry point in the surface of the skin The system is comprised of a console and single-use sterile injector kit.
The user may control the dosage (150ul/200ul) and system pressure for the injection via the graphical user interface on the front panel of the console The entire injector kit is replaced between patients and may be used for multiple injections per patient.
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
professional use only
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
The Argent performance and safety was tested in accordance with ISO 21649 -Needle-free Injectors for Medical Use Requirements and Test Methods. The equivalency test was performed to demonstrate that Airgent™ is as safe and effective as its predicates. Specifically, ex-vivo testing was conducted to confirm the performance of Argent. The testing results demonstrated that the Airgent is as safe and effective as its predicate devices and in all instances, the Airgent functioned as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kortisy
..
510(k) Summary
PerfAction's Airgent™
JAN 2 3 2009
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
PerfAction, Ltd 4 Pekeris Street, Rehovot 7670211 Israel Phone +972-8-9363004 Facsımıle +972-8-9471540
Contact Person. Dalia Givony, VP Regulatory & Clinical Affairs
Date Prepared July 28, 2008
Name of Device and Name/Address of Sponsor
1 Airgent™ PerfAction, Inc 4 Pekeris Street, Rehovot 7670211 Israel
Common or Usual Name Airgent™
Model Airgent™ US
Classification Name/Product Code/CFR Reference Nonelectrically powered fluid injector
Product Code KZE, 21 CFR § 880 5430
Device Class
Class II
Classification Panel
General Hospital
Predicate Devices
Brojector 2000 (Bioject Inc , K960373) Jet Syringe (Equidyne Systems, Inc , K003741)
1
Injex 30 (Equidyne Systems, Inc , K022148)
Intended Use/Indications for Use
The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin The Airgent™ includes a dısposable delivery kıt ıntended for multıple ınjections on a sıngle patient The Airgent™ System is indicated for professional use only"
Device Description
The Airgent" System is an automated, multi-use, needless injector system, intended to deliver medications and vaccines to the body by a highly accelerated pneumatically powered jet of fluid via a very small entry point in the surface of the skin The system is comprised of a console and single-use sterile injector kit
The user may control the dosage (150ul/200ul) and system pressure for the injection via the graphical user interface on the front panel of the console The entire injector kit is replaced between patients and may be used for multiple injections per patient
Performance Data
The Argent performance and safety was tested in accordance with ISO 21649 -Needle-free Injectors for Medical Use Requirements and Test Methods
Comparison Testing
The equivalency test was performed to demonstrate that Airgent™ is as safe and effective as its predicates Specifically, ex-vivo testing was conducted to confirm the performance of Argent The testing results demonstrated that the Airgent is as safe and effective as its predicate devices and in all instances, the Airgent functioned as intended
Substantial Equivalence
The Argent System is as safe and effective as the B10jector, Jet Syringe and Injex 30 It has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices The minor technological differences between the Airgent and its predicate devices rase no new issues of safety or effectiveness Performance data demonstrate that the Airgent is as safe and effective as the Injex 30 Thus, the Airgent System is substantially equivalent to the identified predicate devices
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem that resembles an abstract eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2009
PerfAction, Incorporated C/O Mr Jonathan S. Kahan Hogan & Hartson L L P 555 Thirteen Street, North West Washington, DC 20004
K082138 Re
Trade/Device Name AurgentTM Regulation Number: 21 CFR 880 5430 Regulation Name. Nonelectrically Powered Fluid Injector Regulatory Class II Product Code KZE Dated. January 16, 2009 Received January 16, 2009
Dear Mr Kahan
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 prematket 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
3
Page 2 - Mr Kahan
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 requrements, 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464. You may obtain other general unformation on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Antuan D. Matin Jr.
Ginette Y. Michaud, M. D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Indications for Use Statement | |
|---|---|
| 510(k) Number (if known) | K082138 |
| Device Name | Airgent™ |
Indications for Use:
The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin. The Airgent™ includes a disposable delivery kit intended for multiple injections on a single patient. The Airgent™ System is indicated for professional use only.
| Prescription Use X
(Part 21 C F R 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 C.F R 807 Subpart C) |
| ------------------------------------------------------ | -------- | --------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K082138 |
| Page | 1 | of | 1 |
|---|---|---|---|
| ------ | --- | ---- | --- |
\\DC 081511/000001 2848126 v1