Search Results

The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site.

The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.

The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.

Acceptance Criteria and Device Performance for SOL-GUARD™ Safety Pull-Button Blood Collection Set (K213718)

This document describes the acceptance criteria and study proving the SOL-GUARD™ Safety Pull-Button Blood Collection Set meets those criteria, based on the provided FDA 510(k) summary.

It's important to note that the provided text is a 510(k) summary for a Sharps Injury Protection Device, specifically a blood collection set. The regulatory pathway for this type of device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a full-scale clinical study that establishes performance against strict, quantifiable clinical acceptance criteria (like sensitivity/specificity for a diagnostic AI). Therefore, the "acceptance criteria" here are largely related to bench testing, biocompatibility, and usability demonstrating equivalent safety and effectiveness to the predicate, particularly regarding the safety mechanism.

The documentation focuses on comparing the subject device to a predicate device (BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, K153309) and demonstrating that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from recognized international standards and a demonstration of equivalence to the predicate device. The performance data presented are primarily from bench testing, biocompatibility testing, and simulated usability studies.

2. Sample Size Used for the Test Set and Data Provenance

Given the nature of a 510(k) submission for a sharps injury protection device, formal "test sets" of patient data (as one would see for an AI/diagnostic device) are not typically used. The "test set" here refers to:

• Physical device samples used for bench testing (e.g., for force measurements, retraction tests, flow rates). The exact number of samples for each test is not specified in the summary but would be detailed in the full test reports.
• Physical device samples used for biocompatibility testing (extracted materials).
• Volunteer participants for the "Simulated Usability Study." The number of participants is not specified.

Data Provenance: The studies are prospective bench and usability studies conducted by the manufacturer (Sol-Millennium Medical, Inc.). The country of origin for the data is implicitly the location where the manufacturer's testing facilities are based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For this type of device, "ground truth" is not established by clinical experts in the sense of diagnosing a condition. Instead, the "ground truth" or "objective criteria" are defined by:

• International standards (ISO, ASTM, USP): These standards define measurable physical and chemical properties and performance benchmarks.
• Engineering specifications and regulatory requirements: Defining what constitutes "safe" and "effective" operation of the device's mechanisms.
• Predicate device performance: Used as a benchmark for equivalence.

Therefore, there wasn't a panel of "experts" (e.g., radiologists) used to establish a clinical ground truth for a test set. Rather, the "ground truth" is based on established engineering principles, validated test methods, and regulatory precedents. Individuals involved would include:

• Engineers and Quality Control personnel: Qualified to design, execute, and interpret bench tests in accordance with relevant standards.
• Toxicologists/Biocompatibility Specialists: Qualified to interpret biocompatibility test results.
• Regulatory Affairs Specialists: Qualified to interpret regulatory requirements and predicate device information.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations by multiple human readers (e.g., in medical image analysis). For this device, where "ground truth" is based on objective measurements and adherence to standards, such a medical adjudication method is not applicable.

The "adjudication" is inherent in the validation of the test methods themselves (e.g., ensuring they are robust and reproducible) and the interpretation of results against pre-defined acceptance criteria derived from standards or engineering specifications. Any discrepancies in test results would be handled through and internal quality system's investigation and retesting procedures.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or is applicable for this type of device.

MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI impacts the diagnostic performance (e.g., accuracy, sensitivity, specificity) of human readers or to compare reader performance with and without AI assistance. This device is a blood collection set with a safety mechanism, not a diagnostic tool requiring human interpretation of complex medical data.

The "human factor" component was addressed through a "Simulated Usability Study" to ensure the safety mechanism is intuitive and effective for users, but this is distinct from an MRMC study.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device, not a software algorithm. Therefore, there is no "standalone" algorithm-only performance to evaluate. The "standalone" performance for this device is its physical and mechanical performance as evaluated through bench testing.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Objective physical measurements: Forces, dimensions, flow rates, particulate counts, sterility (measured via biological indicators/analytical tests).
• Adherence to recognized industry standards: ISO, ASTM, USP, which define performance benchmarks and test methodologies.
• Biocompatibility test results: Based on standardized biological assays.
• Simulated use studies: Observing user interaction with the device under controlled, non-clinical conditions.

It does not involve expert consensus on clinical diagnoses, pathology, or patient outcomes data directly for determining the device's classification or performance in the 510(k) context. The device's safety mechanism aims to prevent adverse outcomes (needlestick injuries), and its effectiveness is demonstrated through mechanical reliability, not by analyzing patient outcome data from a clinical trial.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on training a model with data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set. The design and manufacturing processes for the device are governed by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation). Performance characteristics are verified through design validation and verification activities, not machine learning training.

Ask a specific question about this device