(90 days)
No
The description focuses on the mechanical aspects of a needle-free injection system and does not mention any AI or ML components or functionalities.
Yes
The device is called a "Needle-free Injection Therapy System" and is used to deliver medications, which is a therapeutic function.
No
The device is described as a needle-free injection system intended for delivering vaccines and other injectable medications. Its purpose is therapeutic delivery, not diagnosis.
No
The device description clearly outlines physical components like an injector body, syringe assembly, and piston, indicating it is a hardware device for delivering injections.
Based on the provided information, the Zetajet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of the Zetajet is for the delivery of vaccines and injectable drugs into the body (subcutaneously or intramuscularly). This is a therapeutic or drug delivery function.
- Device Description: The description details a mechanical system for injecting substances into tissue. It does not describe any components or processes for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Zetajet is a device for administering medication, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
Product codes
KZE
Device Description
The Zetajet Needle-free Injection Therapy System is a compact, spring-powered, needlefree delivery system. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet system consists of the injector body and the single-use, sterile syringe assembly with a pre-inserted piston in the syringe. The Zetajet uses jet force to propel a finely dispersed stream of the injectable medication into the subcutaneous or intramuscular tissue.
The disposable assembly consists of a single-use, sterile, disposable syringe designed to contain a volume between 0.05 and 0.5 ml and a plunger to discharge the medicine or vaccine through a syringe orifice size based on the type of injection to be given (either subcutaneous or intramuscular).
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
The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
B||OJECT
BIOJECT INC.
20245 SW 95th AVENUE
TUALATIN, OR 97062
PH: 503.692.8001
FAX: 503.692.6698
WWW.BIOJECT.COM
510(k) Summary as required by section 807.92(c)
Submitter Identification:
APR - 2 2009
| Bioject Inc. | 20245 SW 95th Avenue |
|---|---|
| Tualatin, OR 97062 USA | |
| 503-692-8001 | |
| 503-692-6698 (Fax) | |
| Contact Person: | Kris Richard |
| Quality Assurance/Regulatory Affairs | |
| Email: krichard@bioject.com | |
| Date Prepared: | December 30, 2008 |
| Trade name: | Zetajet Needle-Free Injection Therapy System |
| Common name: | Needle-free Fluid Jet Injector |
| Classification name: | Injector, Fluid, Non-Electrically Powered (Class II, KZE, 880.5430) |
| Predicate Device: | Biojector® 2000 (B2000) Jet Injection System (K960373) |
Device Description:
The Zetajet Needle-free Injection Therapy System is a compact, spring-powered, needlefree delivery system. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet system consists of the injector body and the single-use, sterile syringe assembly with a pre-inserted piston in the syringe. The Zetajet uses jet force to propel a finely dispersed stream of the injectable medication into the subcutaneous or intramuscular tissue.
The disposable assembly consists of a single-use, sterile, disposable syringe designed to contain a volume between 0.05 and 0.5 ml and a plunger to discharge the medicine or vaccine through a syringe orifice size based on the type of injection to be given (either subcutaneous or intramuscular).
Intended Use:
The Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
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Substantial Equivalence:
The Zetajet is as safe and effective as the B2000, the device upon which this 510k demonstrates substantial equivalence. The Zetajet has the same intended use and operational performance as the predicate device. The Zetajet also has many of the same or similar technological characteristics as the predicate device, including the use of different syringe orifice sizes to control the depth of penetration. The technological difference between the Zetajet and its predicate device, namely the use of a spring instead of compressed CO2 gas as the power source, does not raise new questions of safety or effectiveness.
સારી ગાનના
09000 3
PAGE 2 of 2
Page 5-2
Substantial equivalence is based upon equivalence in intended use, labeling, design, and operational performance to the B2000. The Zetajet is as safe and effective as the legally marketed predicate device, and does not raise questions of safety and efficacy different than that of the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kris Richard BIOJECT, Incorporated 20245 South West 95th Avenue Tualatin, Oregon 97062
APR - 2 2009
K090003 Re:
Trade/Device Name: Zetajet Needle-free Injection Therapy System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: February 24, 2009 Received: February 25, 2009
Dear Ms. Richard:
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.
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Page 2 - Ms. Richard
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 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. 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 information 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.
Antrum V, Watson for
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
510(k) Number (if known):