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The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously.

The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.

This document is a 510(k) summary for an I.V. Catheter (K142797) submitted by Jiangxi Sanxin Medtec Co., Ltd. It declares substantial equivalence (SE) to a predicate device (K083429).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international and ASTM standards. The reported device performance is that it complies with these standards.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for each non-clinical test. The data provenance is indicated as "Non clinical tests were conducted to verify that the proposed device met all design specifications" (Page 5), suggesting these were performed by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd. The country of origin for the device itself is China, and the tests were likely conducted there or by affiliated entities. The tests are prospective with respect to the submission, performed specifically to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a 510(k) submission for a medical device (I.V. Catheter). The "tests" here are primarily engineering and biocompatibility evaluations against recognized standards, not diagnostic performance assessments requiring expert ground truth establishment in a clinical sense. Therefore, this information is not applicable and not provided in the document. The standards themselves represent expert consensus on performance requirements.

4. Adjudication method for the test set

Similarly to point 3, adjudication methods like 2+1 or 3+1 are typically for diagnostic studies where there's variability in interpretation or a need to resolve discrepancies. For the non-clinical tests listed (e.g., seal strength, sterilization, biocompatibility), the results are generally objective measurements against predefined criteria in the standards. Therefore, an adjudication method is not applicable and not provided.

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

This document is for an I.V. Catheter, which is a physical medical device, not an AI software or a diagnostic imaging system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

As this is a physical medical device and not an algorithm, a standalone performance study in the context of an algorithm is not applicable and not discussed in the document. The non-clinical tests represent the standalone performance of the physical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and limits set forth in the referenced ASTM and ISO international standards. For example, for sterility, the ground truth is "achieve a SAL of 10^-6". For biocompatibility, it's "conforms to the requirement of ISO 10993 series Standards." This is based on established scientific and engineering principles for medical device safety and performance.

8. The sample size for the training set

This document describes non-clinical testing of a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable and no information is provided.

9. How the ground truth for the training set was established

As there is no training set for a machine learning algorithm, this question is not applicable.

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I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

The proposed device, I.V. Catheter for Single Use including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. It is provided EO sterilized, latex free, prygon-free and DEHP-free. All types are available in four sized, which are 18G, 20G, 22G and 24G.

Type Straight Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and straight connector. Type Y I.V. Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and Y connector. And Type I I.V. Catheter for single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle handle and vent fitting, Type Straight and Type Y are closed system while Type I is open system.

The provided text describes a 510(k) summary for an I.V. Catheter for Single Use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies for AI/software devices.

Therefore, much of the requested information, specifically related to acceptance criteria for device performance with specific metrics, study design for proving performance (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance), and training set details, is not present in the provided document. The device is a physical medical device (I.V. catheter), not a software or AI device, which explains the absence of these types of details.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for device performance in the manner of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the statement that the device "met all design specifications" and was "substantially equivalent to the predicate device." The performance reported is that these design specifications were met during laboratory testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions "Laboratory testing was conducted." No specific number of units tested is provided.
• Data Provenance: Not specified. The testing was described as "Laboratory testing," implying internal testing by the manufacturer. The manufacturer is Weihai Jierui Medical Products Co., Ltd. in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Not specified. This information is typically relevant for studies validating diagnostic accuracy, often in AI or imaging devices, where human expert consensus forms the ground truth. Since this is a physical medical device (I.V. catheter), the "ground truth" would be objective measurements against design specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, which is not relevant for the type of testing described for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical medical device, not a diagnostic or AI-powered system that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment would be the objective measurements against its physical and material design specifications (e.g., strength, flow rate, biocompatibility, sterilization efficacy) as confirmed through laboratory tests. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As described above, there is no training set for this type of device.

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The I.V. Catheter System is designed to gain access to and deliver a short term (<30 days) intravascular catheter into the patient's vascular system to sample blood, monitor blood pressure, or administer fluids.
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel.

The I.V. Catheter System contains a short term intravascular catheter and a catheter introducer. The intravascular catheter consists of a slender catheter tube and a catheter hub. The catheter introducer consists of a housing that contains a flash chamber, a flash plug, a stainless steel needle and a needle safety mechanism. The I.V. Catheter System is designed to reduce the risk of accidental needlesticks.

The provided 510(k) submission for the I.V. Catheter System focuses on demonstrating substantial equivalence to predicate devices and the effectiveness of its sharps injury prevention feature.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as quantitative thresholds in the usual sense of a performance study for a diagnostic AI device. Instead, the submission focuses on meeting safety and performance aspects, particularly regarding the needlestick prevention feature, and demonstrating equivalence to existing products.

Below is a table summarizing the implicit acceptance criteria derived from the study and the reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • 50 participants were involved in the simulated use study.
  • A total of 500 I.V. Catheter Systems were successfully inserted and evaluated.
• Data Provenance: The document does not explicitly state the country of origin for the simulated use study. It is a prospective study designed to assess the device's performance in a controlled, simulated environment. The manufacturer, Johnson & Johnson Medical, is located in Arlington, Texas, USA, suggesting the study likely took place in the USA or under their direct oversight.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission for a physical medical device (I.V. catheter) typically does not involve "ground truth" in the same way as an AI diagnostic device (e.g., pathology, expert consensus on images).

For this device:

• Ground Truth Establishment: The primary ground truth for the device's main claim (reducing needlestick injuries and functional performance) was established through direct observation and reporting of sharps injuries and failures of the protective feature during the simulated use study by the study participants and/or observers.
• "Experts": The "50 participants" acted as the evaluators of the device's usability and whether it met customer requirements. Their qualifications are not specified beyond being "participants" in a simulated use study, implying they are likely healthcare professionals or trained individuals who would use such a device. There is no mention of external adjudicating experts (e.g., radiologists) in the context of this device.

4. Adjudication Method for the Test Set

The reported simulated use study assessed the occurrence of sharps injuries and failures of the protective feature, and gathered feedback on usability.

• Sharps Injury/Protective Feature Failure: The criteria for these events would presumably be objective observations. There is no mention of a formal adjudication method (e.g., 2+1, 3+1 consensus) in the document. It's implied that these were directly observed and recorded events (or non-events).
• User Feedback: "Positive responses" from participants regarding insertion and use characteristics suggest qualitative feedback that was summarized. The method of collating or adjudicating this feedback (e.g., specific survey questions, interview analysis) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of AI algorithms on human reader performance, which is not applicable to this physical I.V. Catheter System. The study conducted was a simulated use study to evaluate safety and usability of the physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an algorithm or AI was not done. This product is a physical I.V. Catheter System, not an AI or software-only device. The "standalone" performance here refers to the device's inherent ability to prevent needlestick injuries and its functional operation, which was tested in the simulated use study.

7. Type of Ground Truth Used

For the key claims:

• Sharps Injury Prevention & Protective Feature Functionality: The ground truth was based on direct observation of events (or non-events) during simulated use. The absence of sharps injuries and failures of the protective feature served as the ground truth for its effectiveness in this regard.
• Biocompatibility & Material Standards: The ground truth was established by compliance with recognized international standards (ISO 10993-1, ISO 10555-5) through material testing.
• Usability/Customer Requirements: The ground truth was gathered through participant feedback indicating satisfaction and ease of use.

8. Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" that occurs is the manufacturing process and quality control to ensure all devices meet specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or "training set," this question does not apply.

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