Search Results

Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly" style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe.

Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Unistik® ShieldLock is a sterile, single use, multi-sample blood collection set for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik Shield Lock is a 'butterfly needle' with wings, the color of the wings is unique for each needle gauge to assist with identification. The Unistik ShieldLock is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

The Unistik® VacuFlip is a sterile, single use, multi-sample blood collection vacuum needle for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik VacuFlip is a 'vacuum needle' and is designed with a user activated integral sharps injury prevention feature, the safety shield, which can be activated after the needle is removed from the vein to help prevent needlestick injuries. The safety shield features a textured surface to help improve grip during activation. An audible click signals that the safety shield is activated and is locked in place, covering the needle, and preventing reuse. The color of the safety shield is unique for each needle gauge to assist with identification. The Unistik VacuFlip is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

This FDA 510(k) summary describes the acceptance criteria and study results for two medical devices: Unistik® ShieldLock Blood Collection Set and Unistik® VacuFlip Safety Blood Collection Needle.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document explicitly states that "Design verification testing has been performed on the Unistik® ShieldLock and Unistik VacuFlip lancets to demonstrate that the devices operate safely and effectively. Testing has been conducted to evaluate the performance of the devices against defined acceptance criteria." The tables show a comprehensive list of bench tests and corresponding ISO/ASTM standards.

• Sample Size for Test Set: The document does not specify the exact sample size for each individual test. It generally states that "samples" were tested. However, the mention of "samples that were accelerated aged to the 5 year shelf life" for Unistik® ShieldLock's shelf life confirmation implies multiple units were subjected to these tests. Given the nature of medical device testing for regulatory submission, these samples would have been representative of the production.
• Data Provenance (Country of Origin and Retrospective/Prospective): The data provenance is not explicitly stated in terms of country of origin. The submitting company, Owen Mumford Ltd, is located in the United Kingdom. The testing appears to be prospective as it's verification testing for a new device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The studies described are bench testing (laboratory-based performance and safety evaluations against recognized industry standards and internal specifications) and biocompatibility testing. These types of studies do not involve human expert interpretation of results to establish a "ground truth" in the way clinical studies or AI diagnostic studies do. The "ground truth" is typically defined by the objective metrics and criteria within the specified standards.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human observers or readers to resolve discrepancies in diagnoses or assessments, which is not the nature of the bench and biocompatibility testing performed here.

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 improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." These devices are blood collection devices and do not involve AI assistance or diagnostic interpretation by human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No standalone algorithm (AI) performance study was done. These are physical medical devices (blood collection sets and needles), not AI algorithms.

7. The type of ground truth used

The "ground truth" for the performance criteria is established by the requirements and specifications within the referenced international and national standards (ISO, ASTM, USP), as well as the manufacturer's own validated specifications. For example, for "Fluid Leakage Test," the ground truth is "Meets specification" based on the criteria outlined in ISO 80369-7:2016. For biocompatibility, the ground truth is adherence to the requirements of the ISO 10993 series and FDA guidance.

8. The sample size for the training set

This section is not applicable. There is no AI component mentioned in the device description or testing. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable, as there is no training set.

Ask a specific question about this device