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510(k) Data Aggregation
(267 days)
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
For Insulin Use: The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.
For TB Use: The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.
The Sol-Guard Safety Syringe is a sterile, single use, standard hypodermic syringe with an attached Safety Shield to cover the needle. The Sol-Guard Safety Syringe will be labeled as either an Insulin Safety Syringe for U-100 insulin or as a Tuberculin Safety Syringe. The Safety Shield is extended by the user's finger or thumb. To lock the Safety Shield in place, the user turns the Safety Shield either right or left until it locks in place. Once the Safety Shield is locked in place, the Safety Shield can't be pulled back exposing the needle. The Safety Shield on the Sol-Guard Safety Syringc covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Sol-Guard Safety Syringe are sterilized by Ethylene Oxide Gas and I the Dot Gaire Saile Sare pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
Here's a breakdown of the acceptance criteria and study information for the Sol-Guard Insulin and Tuberculin Safety Syringe, based on the provided text:
Sol-Guard Insulin and Tuberculin Safety Syringe: Acceptance Criteria and Study Information
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on establishing substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding numerical performance results for the device itself. Instead, it states that the device "met the appropriate requirements contained in the following standards." The reported device performance is implicitly that it complies with these standards.
| Feature/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety Syringe Functionality | Device ensures the Safety Shield covers the needle after use and guards against accidental needle stick when activated. | Met: "The Safety Shield on the Sol-Guard Safety Syringe covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination." |
| Material Biocompatibility | Complies with ISO 10993-1. | Met: "ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing" |
| Terminal Sterilization | Complies with ISO 11135. | Met: "ISO 11135:2007, Medical Apparatus - Epoxy Ethane Sterilization Confirmation and Routine Control" |
| Packaging for Sterilized Devices | Complies with ISO 11607-1. | Met: "ISO 11607-1.- 1:2006. Packaging for terminally sterilized medical devices" |
| Sharps Injury Protection | Complies with ISO 23908. | Met: "ISO 23908:2007, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles. introducers for catheters and needles used for blood sampling" |
| Hypodermic Needles | Complies with ISO 7864. | Met: "ISO 7864:1993. Sterile Hypodermic Needles for Single Use;" |
| Hypodermic Syringes (General) | Complies with ISO 7886. | Met: "ISO 7886:1993, Sterile Hypodermic Syringes for Single Use" (for TB use) |
| Insulin Syringes | Complies with ISO 8537. | Met: "ISO 8537:2007, Sterile, Single-Use Syringes, with or without Needle, for Insulin." |
| Stainless Steel Needle Tubing | Complies with ISO 9626. | Met: "ISO 9626:1991, Stainless Steel Needle Tubing for Manufacture of Medical Devices;" |
| FDA Guidance (Needles) | Complies with FDA Guidance on hypodermic single lumen needles (April 1993). | Met: "FDA Guidance on the content of premarket notification [510(k)] submissions for hypodermic single lumen needles, April, 1993." |
| FDA Guidance (Sharps Injury Prevention) | Complies with FDA Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features (August 9, 2005). | Met: "A Simulated Use Study was conducted with the Sol-Guard Safety Syringe per the requirements of the FDA's Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features." |
| Overall Product Specifications | Meets all product specifications and requirements. | Met: "The device has been tested and found to meet all product specifications and requirements." |
| Performance over Device Life | Verified through accelerated aging. | Met: "Accelerated aging was used to verify the performance of the product over the life of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the "Simulated Use Study" or for testing adherence to the various ISO standards. It mentions a "Simulated Use Study" but does not detail its methodology, sample size, or data provenance (e.g., country of origin, retrospective or prospective nature). The other tests refer to compliance with standards, which would imply a certain number of units were tested, but these numbers are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study mentioned is a "Simulated Use Study," likely evaluating the safety feature, but no details about experts establishing ground truth or their qualifications are given. For general compliance with ISO standards, the "ground truth" is defined by the standard's specifications and test methods, not typically by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set
This information is not provided. There is no mention of an adjudication method for the "Simulated Use Study" or any other tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on substantial equivalence to a predicate device and adherence to safety and performance standards rather than comparing the device's diagnostic or therapeutic effectiveness in a clinical setting with human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable as the device is a physical medical device (safety syringe), not an algorithm or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.
7. Type of Ground Truth Used
For the various ISO and FDA guidance documents, the "ground truth" is defined by the specifications and test methods outlined within those standards and guidance documents. For example, the ground truth for "hub/needle bond strength" is achieving the strength specified in ISO 8537 (Insulin) & ISO 7886 (TB). The "Simulated Use Study" would have an implied ground truth related to the successful activation and prevention of needle sticks as per the FDA Guidance for Sharps Injury Prevention, but the specific metrics used to define this "ground truth" are not detailed.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this physical medical device.
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