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510(k) Data Aggregation
(52 days)
The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.
The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.
The provided submission focuses on establishing substantial equivalence for a medical device (MPS Acacia Safeguard Huber Device) to existing predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, such as MRMC studies, effect size, standalone performance, and ground truth methodologies for training data, are not applicable here.
The document describes non-clinical testing to demonstrate safety and performance for a medical device with a sharps injury prevention feature.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility: Meets FDA requirements, method per AAMI/ANSI/ISO 11135-1994, SAL of 10⁻⁶ | Sterilized by ethylene oxide (EO). Maximum residual levels: EO 25ppm, ECH 25ppm, EG 250ppm. Labeled "Non-Pyrogenic" (LAL testing). Sterility assurance level (SAL) of 10⁻⁸ achieved during validation, exceeding minimum requirement. |
| Biocompatibility: Meets ISO 10993-1 and FDA G95-1 guidelines for external communicating devices, blood path indirect, contact duration B (>24 hours to <30 days). | All materials are identical to predicate device (K982047) for direct and indirect patient fluid contact. Tests performed: Cytotoxicity (MEM Elution), Sensitization (Guinea Pig Maximization), Irritation (Intracutaneous Reactivity), Systemic Toxicity (Acute Systemic Toxicity), and Hemocompatibility (Hemolysis Extract Method). All materials concluded to be biocompatible. No latex. |
| Safety Feature Activation/Deactivation: No failures in activating the protective sheath and no deactivation failures after activation. | "There were no safety feature activation or deactivation failures that occurred during the testing of the 3000 units." |
| Overall Simulated Clinical Performance: No other failures during simulated clinical testing. | "There were no other failures that occurred during the simulated clinical testing." |
| Bench Testing: Device meets product specifications. | Bench testing performed to ensure product specifications are met. (Specific specifications are not detailed in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 3,000 units
- Data Provenance: The study was a "simulated clinical study" performed by Registered Nurses (RNs). The context suggests this was an in-house or contracted study to simulate real-world use of the device, likely within the United States. It is a prospective and controlled study design rather than retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated as a number, but the study was "performed by Registered Nurses (RNs)." It is implied that these RNs acted as the "experts" in evaluating the functional performance and safety features of the device in a simulated clinical setting.
- Qualifications of Experts: Registered Nurses (RNs). Additional specific qualifications (e.g., years of experience with Huber devices) are not provided.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described. Given that the outcome was the absence of failures ("There were no safety feature activation or deactivation failures," "no other failures"), it suggests a pass/fail assessment per unit by the observing RNs, rather than a complex consensus or arbitration process typical of subjective diagnostic assessments.
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
Not applicable. This device is a physical medical device (Huber needle with a safety mechanism), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its performance is inherent in its mechanical design and function. While it has a safety mechanism, it doesn't operate as a "standalone algorithm."
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was its functional performance based on predetermined acceptance criteria in a simulated use environment. Specifically, the ground truth was the observation by trained Registered Nurses that the safety feature activated correctly and did not deactivate, and that no other failures occurred, aligning with the qualitative and quantitative (0 failures out of 3000 units) definitions of success.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI model that requires a training set. The "training" for the device would have been its design, engineering, and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not an AI model requiring a training set with established ground truth. The "ground truth" for the design of the device would be the product specifications and regulatory guidelines it aims to meet.
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