(91 days)
OSPREY Midline Closed IV Catheter System (OspreyEDC) is an intravascular catheter intended to be inserted into the patient’s vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The OSPREY Midline Closed IV Catheter System (OspreyEDC) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.
The OSPREY Midline Closed IV Catheter System (OspreyEDC) has a usable (deployed) catheter length of 3.25 inches. The device is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (
The provided FDA 510(k) clearance letter and summary discuss a medical device, the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20), and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing detailed acceptance criteria and a study proving those criteria are met for an AI/software-as-a-medical-device (SaMD).
Here's an analysis based on the provided text, highlighting what information is available and what is not available regarding the specific questions about acceptance criteria and a study proving device performance in the context of AI/SaMD:
Summary of Acceptance Criteria and Device Performance (Based on provided document):
The document does not present explicit "acceptance criteria" in the format one might expect for a software or AI product's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence by comparing the new device's technological characteristics and performance outcomes against a predicate device and relevant industry standards. The implicit "acceptance criteria" are that the new device performs at least as well as the predicate and meets established safety and performance standards.
| Acceptance Criteria Category (Derived) | Stated Device Performance (OSPREY Midline Closed IV Catheter System) | Substantial Equivalence to Predicate |
|---|---|---|
| Indications for Use | Short-term IV catheter for blood sampling, pressure monitoring, fluid administration; aids in blood exposure prevention; suitable for all patient populations (with considerations); Power Injector compatible (max 325 psi). | Identical |
| Classification | 21 CFR §880.5200, Class II, FOZ - Intravascular Catheter | Identical |
| Critical Procedural Steps | Expanded IFU to include removal of pink wire slider, wire slider track, and guidewire components. | Different, but does not raise new safety/effectiveness questions. |
| Materials of Construction | Polycarbonate, Stainless Steel, Polyurethane w/ radiopaque barium sulfate, Loctite, Polypropylene, Tygon®, Porous Polyethylene w/ CMC, Silicone. Additional components: Wire Slider Track, Wire Slider Cap, Guidewire (Stainless Steel). | Different, but materials are identical for common components and new materials passed biocompatibility. Does not raise new safety/effectiveness questions. |
| Design Characteristics | Catheter-Needle Interface: Catheter through needle; Beveled Needle Tip; Rounded Catheter Tip; Spring-loaded needle retraction; Female Locking Luer Hub; Flashback Visualization. Catheter OD: 0.0435 – 0.0445 in. Catheter ID: 0.0275 – 0.0325 in. Catheter Length: 3.25 in. Integrated extension tube, pinch clamp, female luer with porous plug. Guidewire slider/track interface. Power Injector compatible (325 psi). | Different (catheter OD/ID/length slightly different, new guidewire mechanism). Does not alter or raise different questions of safety and effectiveness. |
| Performance (Functional) | Flashback Chamber / Technology: Yes; Sharps Prevention Feature: Yes; Radiopaque: Yes; Flow Rate: 30 mL/min | Identical |
| Biocompatibility | Passed ISO 10993-1 testing | Identical (PASSED) |
| Sterilization | EtO Sterilized | Identical |
| Packaging | Sterile Barrier: Individual Tyvek and PET Pouches | Identical |
| Shelf Life | 6 Months | Identical |
Since this is a filing for a physical medical device (an IV catheter system) and not an AI/SaMD, many of the requested items related to AI model validation, such as test sets, ground truth establishment, expert adjudication, and training set details, are not applicable and therefore not present in the document.
Here's a breakdown of the specific points from your request:
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A table of acceptance criteria and the reported device performance
- Available in document: Yes, a comparison table (Table VII - I) is provided on pages 7-11, outlining attributes of the subject device (OSPREY Midline Closed IV Catheter System) against the predicate device. This indirectly serves as acceptance criteria in the context of substantial equivalence for a physical medical device. The "Performance" section on page 12 also lists standards adhered to via bench testing.
- Not explicitly stated as AI/SaMD performance metrics (e.g., sensitivity, specificity): This is a hardware device, so these metrics are not relevant or provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not available in document: This information is typically for AI/SaMD. For a physical device, testing involves bench tests and biocompatibility, not data sets in the AI sense. No specific "sample sizes" for clinical data or data provenance are mentioned, as clinical studies in the AI context were not conducted or required for this type of device and submission. The document mentions "bench tests," but doesn't specify sample sizes for those tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available in document: "Ground truth" in this context refers to clinical data labeling for AI. For a physical device like a catheter, "ground truth" is established through engineering and biocompatibility standards, and performance against those standards is evaluated by engineers and lab personnel, not necessarily "experts" in the clinical decision-making sense with specific experience levels for data labeling.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in document: This is relevant for clinical data labeling for AI performance evaluation.
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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
- Not applicable/Not available in document: This is entirely for AI-assisted diagnostic devices. This is a standalone physical medical device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available in document: This pertains to AI algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not available in document: As mentioned, for this physical device, "ground truth" is based on adherence to recognized industry standards (ISO, ASTM, USP) and established engineering principles and test methods (e.g., flow rate measurement, physical dimensions, material properties, biocompatibility assays).
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The sample size for the training set
- Not applicable/Not available in document: This applies to AI models.
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How the ground truth for the training set was established
- Not applicable/Not available in document: This applies to AI models.
In conclusion, the provided document is a standard 510(k) submission for a physical medical device. It successfully demonstrates substantial equivalence to a predicate device by comparing design, materials, indications for use, and performance based on engineering bench tests and adherence to recognized international standards for medical devices. The specific questions you asked are geared towards the evaluation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), which is not the subject of this 510(k) clearance letter.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).