(438 days)
• The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering.
• The FROG removable filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover.
• The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.
The FROG device is a prescription device intended for use by healthcare professionals in a healthcare or outpatient setting. The FROG device incorporates a removable filter, which surrounds the hypodermic needle and allows the filtered aspiration of glass-contaminated drug into the syringe. After aspiration, the filter is removed from the device, permitting injection with the hypodermic needle which is already attached to the syringe. Each package will include an assembled FROG device. The device is intended for single use and provided sterile.
The provided FDA 510(k) clearance letter and documentation for the FROG (Filter Removal of Glass) device focuses on demonstrating substantial equivalence to a predicate device, the BD Precision Glide Needle (K021475). The documentation outlines detailed testing performed to support this claim, especially concerning the unique filter feature of the FROG device.
Here's an analysis of the acceptance criteria and study data based on the provided text, structured as requested:
Acceptance Criteria and Reported Device Performance
The documentation does not explicitly provide a table of quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical study assessing diagnostic accuracy (e.g., sensitivity, specificity). Instead, the performance evaluations are designed to demonstrate the device meets established engineering, biocompatibility, and sterilization standards, and that its unique filtering functionality is effective and comparable to a reference device.
The "Assessment of Equivalence" column in Table 5-1 implicitly serves as a form of "reported device performance" against the predicate and reference devices, indicating whether the FROG device met the functional and safety expectations.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Form/Fit/Function Equivalence | Device Class: Class II | Equivalent |
| Device Classification Name: Hypodermic single lumen needle | Equivalent | |
| Regulation Number: 880.5570 | Equivalent | |
| Product Code: FMI | Equivalent | |
| Intended Users: Licensed healthcare practitioners (Rx only) | Equivalent | |
| Needle Gauge and Length | Same as predicate device (18G 1.5in needle) | |
| Aspiration and Injection Method | Same manner as predicate device | |
| Filter Performance | Filtration capability of 5-micron particles | Confirmed the FROG is able to filter 5-micron particles, similar to the reference device |
| Residual volume remaining in ampoule | Comparable to the reference device | |
| Materials/Biocompatibility | Safety in accordance with ISO10993-1 | Acceptable biological risk established, meets ISO 10993-1:2018 |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) | All tests performed and device meets requirements | |
| Sterilization | Sterility Assurance Level (SAL) 10⁻⁶ | Sterile SAL 10⁻⁶ |
| Performance after sterilization | Potential difference in sterilization does not raise new questions of safety and effectiveness | |
| Shelf-Life | 6 months (based on accelerated aging) | |
| Device Design/Technology | Device incorporates removable filter | Device incorporates removable filter; testing confirmed filtering capability |
| Filter should not alter indications for use | Filter function does not alter indications for use for hypodermic needle | |
| Unique technological filter feature does not raise new questions of safety and efficacy | Performance testing demonstrated equivalence to reference device for filtration, and other testing confirmed safety. | |
| Human Factors | Application of risk management, usability engineering principles | Testing conducted according to ANSI/AAMI/ISO 14971, ANSI/AAMI/IEC 62366-1/2, and FDA guidance documents. |
Study Details
The provided document primarily details design verification and validation testing, not a traditional clinical study with patient data.
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for individual performance tests (e.g., filtration efficiency, residual volume, needle penetration, biocompatibility). It generally states "Performance Data" and lists categories of tests performed.
- Data Provenance: The nature of the tests (e.g., ISO standard testing, biocompatibility) implies lab-based testing rather than patient data. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable as the studies described are engineering and bench testing rather than clinical or diagnostic studies requiring expert review for ground truth establishment. The ground truth for these tests is defined by international standards (e.g., ISO 7864, ISO 10993-1) and objective measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. This is not relevant to the engineering and bench testing described in this 510(k) summary.
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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 study or any study involving human readers/AI assistance was conducted or described. The device is a physical medical device (hypodermic needle with a filter), not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and performance tests, the "ground truth" is based on:
- Defined specifications and standards: Adherence to ISO standards (e.g., ISO 7864 for needle requirements, ISO 10993-1 for biocompatibility).
- Physical measurements: For parameters like filtration efficiency (e.g., 5-micron particle filtration) and residual volume, these are direct, objective measurements against defined targets.
- Comparison to a reference device: The BBraun Filter Straw serves as a performance benchmark for the filtering capability and residual volume.
- For the engineering and performance tests, the "ground truth" is based on:
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).