(90 days)
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.
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).
The provided text is a 510(k) summary for the Zetajet Needle-Free Injection Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (Biojector® 2000), rather than detailing original acceptance criteria and a study to prove meeting those criteria.
Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, and specific study types (like MRMC or standalone performance) is not present in the provided text.
The closest relevant information is about the intended use and comparison to the predicate device as part of demonstrating substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document asserts that the Zetajet "has the same intended use and operational performance as the predicate device" and that "The Zetajet is as safe and effective as the legally marketed predicate device." However, specific numerical acceptance criteria or performance metrics for either device are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document relies on demonstrating substantial equivalence to a predicate device, not on presenting a de novo performance study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. As no specific ground truth establishment for a test set is mentioned, expert involvement is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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 improvise with AI vs without AI assistance
This information is not provided and is not applicable. The device is a "Needle-free Fluid Jet Injector" for administering medications, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided and is not applicable as the device is not an algorithm, but a physical injection system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the 510(k) summary. The document focuses on showing equivalence to an existing device rather than establishing ground truth for a new performance claim.
8. The sample size for the training set
This information is not provided in the 510(k) summary. The device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary, as it's not relevant to this type of device and submission.
Summary of Available Information:
The provided document is a 510(k) summary, the purpose of which is to demonstrate substantial equivalence to an already legally marketed device (the Biojector® 2000). The core argument is that the Zetajet is as safe and effective as the predicate device because:
- It has the same intended use: "delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites."
- It has the same operational performance (asserted, but not quantified with specific metrics in this document).
- It has similar technological characteristics (e.g., use of different syringe orifice sizes to control penetration depth).
- The key technological difference (spring power vs. compressed CO2 gas) "does not raise new questions of safety or effectiveness."
To reiterate, this document does not contain details about specific acceptance criteria, a novel performance study (including sample sizes, expert qualifications, or ground truth methods), or a multi-reader comparative effectiveness study, as it is a substantial equivalence submission for a physical medical device.
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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.
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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
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Indications for Use
510(k) Number (if known): < 090003
Device Name: Zetajet Needle-free Injection Therapy System
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, Ganeral Hospital Infection Control, Dental Davides
510(k) Number: KO
Page 4-1
§ 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).