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The FASTI™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

The FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluid to facilitate emergency resuscitation.

The FASTITM and FASTResponder™ Sternal Intraosseous Devices were designed to provide an alternative to intravenous infusion access of the circulatory system. The devices utilize intraosseous infusion to facilitate emergency resuscitation with the use of fluids and drugs. They were designed for use on the manubrium, the upper (superior) portion of the sternum.

The provided text is a 510(k) summary for the Teleflex Medical FAST1™ Intraosseous Infusion System and FASTResponder™ Sternal Intraosseous Device. It is a submission to the FDA for a labeling change to an existing device, not for a new device requiring extensive performance data or clinical trials for substantial equivalence.

Therefore, the document explicitly states: "No performance testing was needed to support this change." (Page 7, Section VII. Performance Data).

This means the document does not contain information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance for such a test.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
6. Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
7. The type of ground truth used.
8. The sample size for a training set.
9. How the ground truth for a training set was established.

The entire submission is focused on demonstrating substantial equivalence based on the device's technological characteristics remaining unchanged, with the only modification being the addition of contraindications to the product's labeling. The "Performance Data" section explicitly confirms that no new performance testing was conducted or required for this specific 510(k) submission.

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FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

FASTRESPONDER™ Sternal Intraosseous Device has been designed to provide an alternative to intravenous infusion access of the circulatory system. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum. The FASTRESPONDER™ Sternal Intraosseous Device consists of an introducer handle with target foot which allows the user to target the recommended insertion site and place the infusion tube bone portal into the manubrium. On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids. The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

The provided text describes a 510(k) summary for the FASTResponder™ Sternal Intraosseous Device. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria, device performance, a specific study proving acceptance, sample sizes for test or training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The section "Safety & Effectiveness VII." mentions that "Bench tests, functional testing, and validation studies were conducted," and refers to compliance with various ISO standards and USP guidelines for specific aspects like risk analysis, biocompatibility, sterilization, and pyrogen studies. However, it does not provide details on the actual results of these studies or specific performance metrics that would be considered acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the provided document.

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