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OSPREY PERIPHERAL IV catheter 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.

The OPREY IV Catheter System is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood pressure, or administer fluids intravenously. The device has a usable length catheter of 1.67 inches in a 20 Gauge size for short-term (

The provided text describes the OSPREY PERIPHERAL IV Catheter System, its intended use, technological characteristics, and comparison to a predicate device (BD Angiocath & Insyte Autoguard Catheters) to demonstrate substantial equivalence, rather than detailing a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity commonly associated with AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

However, based on the provided text, I can infer the acceptance criteria relate to meeting established medical device standards for performance, biocompatibility, sterilization, and packaging, as well as demonstrating that the device's characteristics do not raise new or different questions of safety or effectiveness compared to the predicate device.

Here's a breakdown of the available information structured as requested, with details that are not applicable or unavailable marked as such:

1. Table of Acceptance Criteria and Reported Device Performance

• Conformance to ISO 10555-1 (General requirements for sterile, single-use intravascular catheters).
• Conformance to ISO 10555-5 (Over-needle Peripheral catheters).
• Conformance to ISO 80369-7 (Luer connectors).
• Conformance to ISO 80369-20 (Common test methods for small-bore connectors).
• Conformance to ISO 7864 (Sterile hypodermic needles).
• Conformance to ISO 9626 (Stainless steel needle tubing).
• Conformance to ISO 8536-4 (Infusion sets for gravity feed).
• Conformance to USP (Particulate Matter for Injections).
• Functionality of Sharps Prevention Feature per ISO 23908. | Bench tests were conducted to verify that the proposed device met all design specifications. (Specific quantitative results for each standard are not provided, but the conclusion states "Bench tests were conducted to verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device.")

Key Performance Aspects Mentioned:

• Sharps Prevention Feature: "performs as intended" (per ISO 23908:2011).
• Flow Rate: 30 mL/min (Applicant states this is "adequate to support its referenced Indications for Use, as the flow rate is significantly greater than sizing parameters of clinically prescribed flow rates for both gravity infusion and legally marketed volumetric pumps... substantially greater than the maximum programable flow rate for legally marketed volumetric pumps (999 ml./hr).")
• Dimensions: Catheter OD: 0.041 - 0.043 in., Catheter ID: 0.025 - 0.031 in., Catheter Length: 1.67 in. (Stated to be "appropriate for a 20GA catheter per ISO 10555-5").
• Design Characteristics (e.g., Catheter-Needle Interface, Tip, Needle Retraction): Differences compared to predicate device were found not to "alter or raise different questions of safety and effectiveness" (Notes 2 & 3). |
  | Biocompatibility| Conformance to ISO 10993-1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) and FDA guidance for:
• Genotoxicity, Carcinogenicity, Reproductive Toxicity (ISO 10993-3).
• Interactions with Blood, Hemolytic Properties (ISO 10993-4, ASTM F756-17).
• Cytotoxicity (ISO 10993-5).
• Local Effects after Implantation (ISO 10993-6).
• Irritation and Skin Sensitization (ISO 10993-10).
• Systemic Toxicity (ISO 10993-11).
• Sample preparation and reference materials (ISO 10993-12).
• Pyrogenicity (USP-NF ). | "Tested per ISO 10993-1: PASS" (for Externally communicating, Circulation blood path, Prolonged contact (> 24 hours to 30 days)). The document confirms testing for all listed biological endpoints. |
  | Sterilization & Packaging| Conformance to:
• ISO 14937 (Sterilization process characterization and validation).
• AAMI TIR56 (Guidance for EtO sterilization).
• ISO 10993-7 (Ethylene oxide sterilization residuals).
• ASTM F1980-16 (Accelerated Aging).
• ASTM D4332-14 (Conditioning Containers).
• ASTM D4169-16 (Performance Testing of Shipping Containers).
• ASTM F1886-16 (Integrity of Seals by Visual Inspection).
• ASTM F2096-11 (Detecting Gross Leaks).
• ASTM F1929-15 (Detecting Seal Leaks by Dye Penetration).
• ASTM F88-15 (Seal Strength). | "EtO Sterilized" and "Sterile Barrier: Individual Tyvek and PET Pouches." (The document implies successful validation against these standards as part of the substantially equivalent determination; specific results are not detailed beyond listing the standards.) |

Regarding AI/ML specific information (not applicable to this medical device filing):

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (catheter) 510(k) filing, not an AI/ML device. The "test set" in this context refers to physical units of the catheter system subjected to bench and biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images) is not relevant here. The ground truth for device performance is based on established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device testing against standards does not typically involve adjudication in this manner.
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 is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective measurements against harmonized engineering and biological standards (e.g., ISO, ASTM, USP) and the demonstration that the device's intended use and technological characteristics are substantially equivalent to a predicate device whose safety and efficacy have been established.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study (Bench and Biocompatibility Testing):

The "study" referenced in the document consists of various bench tests and biocompatibility evaluations performed on the OSPREY PERIPHERAL IV Catheter System.

• Objective: To verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device (BD Angiocath & Insyte Autoguard Catheters).
• Methodology: The device was tested in accordance with a comprehensive list of international and national standards covering:
  • Performance: General requirements for intravascular catheters, specific requirements for over-needle peripheral catheters, small-bore connectors (Luer taper), common test methods for connectors, sterile hypodermic needles, stainless steel needle tubing, infusion equipment, particulate matter, and sharps injury protection.
  • Biocompatibility: Evaluation based on ISO 10993-1, covering aspects like genotoxicity, blood interactions, cytotoxicity, local effects, irritation, systemic toxicity, and pyrogenicity.
  • Sterilization and Packaging: Validation of the Ethylene Oxide (EtO) sterilization process and sterile barrier packaging against relevant ISO and ASTM standards.
• Results: The document concludes that "Bench tests were conducted to verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device." Specifically, it states the biocompatibility testing "Tested per ISO 10993-1: PASS" and that the sharps prevention feature "performs as intended" per ISO 23908:2011. Differences in certain characteristics (materials, design, flow rate) were deemed not to raise "new or different questions of safety or effectiveness."
• Conclusion: The tests demonstrated that the OSPREY PERIPHERAL IV Catheter System is substantially equivalent to the predicate device with respect to indications for use and technological characteristics, and therefore meets the regulatory requirements for market clearance.

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