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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.

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:

1. 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.

2. 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.

3. 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.

4. 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.

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/Not available in document: This is entirely for AI-assisted diagnostic devices. This is a standalone physical medical device.

6. 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.

7. 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).

8. The sample size for the training set

   • Not applicable/Not available in document: This applies to AI models.

9. 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.

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OSPREY Closed IV Catheter System (OspreyV2) is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion 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 Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.

The OPREY Closed IV Catheter System (OspreyV2) 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 text describes the regulatory clearance (510(k)) for the OSPREY Closed IV Catheter System (OspreyV2) and includes a comparison to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

Instead, the document details:

• Device Description and Intended Use: The OspreyV2 is an intravascular catheter for short-term use, blood sampling, pressure monitoring, and fluid administration, including compatibility with power injectors up to 325 psi.
• Comparison to Predicate Devices: It highlights similarities and differences with two predicate devices (OSPREY PERIPHERAL IV Catheter System and Nexiva Closed IV Catheter System) in terms of classification, indications for use, critical procedural steps, materials of construction, design characteristics, and performance attributes like flow rate.
• Performance Data (Bench Tests): The document states that bench tests were conducted to verify the device met design specifications and supported substantial equivalence, referencing a list of ISO and ASTM standards (e.g., ISO 10555-1, ISO 23908 for sharps injury protection, ISO 8536-4 for infusion equipment).
• Biocompatibility Testing: It confirms biocompatibility evaluation per ISO 10993 series standards.
• Sterilization and Packaging Validation: It outlines validation per ISO and ASTM standards.
• Absence of Clinical Testing: Explicitly states that no clinical testing was performed as it was not required to demonstrate substantial equivalence to the predicate device.

Therefore, I cannot populate the requested table and provide details about acceptance criteria or a study with AI/ML performance data because this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through non-clinical (bench) testing and material/design comparisons, not on validating an AI/ML algorithm's diagnostic or predictive performance against specific acceptance criteria.

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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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