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The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for vempuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen.

The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy.

After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury.

The device is not used for a diagnostic or treatment purpose.

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This FDA clearance letter for the UltraFlo-R Push Button Blood Collection Set (K220458) does not contain the information you've requested regarding acceptance criteria or the study that proves the device meets those criteria.

The provided document is a 510(k) clearance letter, which means the device has been determined to be substantially equivalent to a legally marketed predicate device. This determination is typically based on a comparison of technological characteristics and safety/effectiveness data to a predicate device, rather than a detailed presentation of novel clinical study results against specific performance acceptance criteria.

Here's why the requested information is absent:

• Type of device: The UltraFlo-R is a blood specimen collection device, which is a relatively low-risk device (Class II). For such devices, the FDA often relies on performance testing and comparison to predicate devices, rather than large-scale clinical trials with extensive ground truthing by experts.
• Nature of the document: This is a clearance letter, a summary of the FDA's decision, not the full 510(k) submission which would contain the detailed testing reports.
• Focus of the letter: The letter primarily focuses on the administrative details of the clearance, regulatory class, and general controls applicable to the device. The "Indications for Use" section (page 4) describes how the device is intended to be used but does not specify performance metrics or acceptance criteria for a study.

Therefore, I cannot extract the following from the provided text:

1. Table of acceptance criteria and reported device performance: This is not present in the clearance letter.
2. Sample size, data provenance, number of experts, qualifications, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, or how training ground truth was established: None of this information regarding specific studies or expert reviews is included in this document.

For this type of information, one would typically need to review the actual 510(k) submission, which is a much more detailed document submitted by the manufacturer to the FDA.

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Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non- patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.

The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter. The Improsafe Blood Collection Set includes an attached safety shield.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Improve Blood Collection Set and Improsafe Blood Collection Set," specifically an administrative change letter and the original clearance letter with indications for use. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory information but does not detail performance acceptance criteria or a study proving their achievement.

Therefore, I cannot provide the requested information based on the given input.

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The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Quick-Draw Capillary Whole Blood Collection System." This document primarily focuses on regulatory approval and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Information on standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document confirms regulatory clearance based on substantial equivalence to a predicate device, but it does not detail the specific performance studies that would typically be conducted to demonstrate the device meets acceptance criteria. Those details would normally be found in the 510(k) submission itself, not in the clearance letter.

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