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510(k) Data Aggregation
(67 days)
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.
The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a regulatory approval summary for the "VACUETTE® PREMIUM Safety Needle System Tube-Touch." It establishes substantial equivalence to a predicate device (VACUETTE® PREMIUM Safety Needle System, K072602) for its intended use and materials. This type of submission typically relies on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring a detailed clinical study with specific acceptance criteria and performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the regulatory process for clearance, not on a detailed performance study of the device against specific acceptance criteria.
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(278 days)
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
The provided text is a 510(k) summary for the VACUETTE® PREMIUM Safety Needle System. This document focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot provide the requested information from the given text. The document acts as a regulatory submission for market clearance, not a clinical or performance study report.
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