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The ComCaSet-P Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet-P Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet-P Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the shielding mechanism is activated and the needle retracts into the shielding tube.

The ComCaSet-P Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle, Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet-P Safety IV Catheter has a safety locking mechanism which enables the needle and the flash chamber to retract into a safety barrel. Disconnecting the needle assembly and catheter hub from the catheter releases the latex-free elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel.

The provided text, K070020 for the ComCaSet-P Safety IV Catheter, is a 510(k) summary. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria, sample sizes, and ground truth methodologies like those found in PMA applications or more recent AI/ML device clearances.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for the training set was established.

This 510(k) submission primarily relies on demonstrating that the ComCaSet-P Safety IV Cather is substantially equivalent to a previously cleared predicate device (ComCaSet Safety IV Catheter, K062108). The safety and effectiveness are inferred from the predicate device through direct comparison of features and intended use.

Based on the provided text, the following information can be extracted or explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria or performance metrics derived from a specific study designed to meet such criteria. The "performance" described is largely a functional description and equivalence to the predicate.

• Implied Performance: The primary "performance" characteristic highlighted is the safety locking mechanism for reducing accidental needle sticks, but no quantitative acceptance criteria or study results are presented for this.

• Functional Specifications (from Device Description): The document provides specifications for catheter gauges, dimensions, and water flow rates. These are descriptive rather than criteria for a study demonstrating efficacy or safety beyond substantial equivalence.

  Size	Color	Catheter I.D. (mm)	Catheter O.D. (mm)	Catheter Length (mm)	Water Flow Rate (ml./min.)
  14G	Orange	1.7	2.1	45	270
  16G	Grey	1.3	1.7	45	180
  17G	White	1.1	1.5	45	125
  18G	Green	0.9	1.3	45	80
  20G	Pink	0.8	1.1	32	54
  22G	Blue	0.6	0.9	25	33
  24G	Yellow	0.5	0.7	19	20

  Note: These are product specifications, not "reported device performance" in the context of a clinical study proving acceptance criteria for safety or efficacy.

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

• Not Applicable / Not Provided: This device is a traditional medical device (IV Angiocatheter), not an AI/ML device. The 510(k) submission relies on substantial equivalence to a predicate, not on a clinical "test set" in the context of an AI/ML algorithm evaluation. No specific clinical study with a defined test set sample size or data provenance is mentioned in the provided text.

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

• Not Applicable / Not Provided: See point 2. Ground truth establishment by experts is not described for this type of device submission.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: See point 2. No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size:

• No: The document does not describe an MRMC comparative effectiveness study. This type of study is generally conducted for interpretive devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The ComCaSet-P Safety IV Catheter is a physical, invasive medical device for fluid administration/blood sampling, not an interpretive device.

6. If a Standalone Performance Study Was Done:

• No: The document does not describe a standalone performance study. The evaluation primarily focuses on the device's design, materials, and functional equivalence to a predicate, particularly its safety mechanism.

7. The Type of Ground Truth Used:

• Not Applicable / Not Provided: For this type of device, ground truth as typically understood for AI/ML or diagnostic devices (e.g., pathology, outcomes data, expert consensus) is not applied. Substantial equivalence relies on comparing the new device's characteristics and intended use to a legally marketed predicate device.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: This is not an AI/ML device that requires training data.

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

• Not Applicable / Not Provided: See point 8.

Summary of the 510(k) Approach for ComCaSet-P Safety IV Catheter:

The submission demonstrates substantial equivalence by stating:

• The ComCaSet-P Safety IV Catheter has the same intended use as the predicate device (ComCaSet Safety IV Catheter, K062108).
• It has the same principle of operation.
• The main technological difference is the release element of the needle retraction element, which in the ComCaSet-P is activated by the separation of the catheter hub and needle assembly from the catheter. This modification is presented as a design change without raising new safety or effectiveness concerns, implying that the predicate's established safety and effectiveness extend to the modified device.

The FDA's decision letter (K070020) confirms that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market under general controls.

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The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube.

The ComCaSet Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle. Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet Safety IV Catheter has a safety locking mechanism which, when activated, enables the needle and the flash chamber to retract into a safety barrel. The activation element holds the needle assembly in the forward position until the user activates the device. Pulling the activator releases the latexfree elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel. In this way user maintains control of the process by determining when to activate the safety mechanism. The product is available in seven gauges identified also by specific colors.

The provided text is a 510(k) summary for the ComCaSet Safety IV Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed clinical study results with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets those criteria in the way you've outlined for performance metrics such as sensitivity, specificity, or accuracy. This submission focuses on comparing the new device against a legally marketed predicate device (Insyte™ Autoguard™ Shielded IV Catheter) to establish that it is substantially equivalent in terms of intended use, principle of operation, and safety/effectiveness.

Here's what can be extracted from the document based on your request, with an emphasis on what is not present:

1. A table of acceptance criteria and the reported device performance

• Not provided. The document does not define specific performance acceptance criteria for its safety features (e.g., minimum retraction rate, maximum force to activate) or general catheter performance (e.g., flow rate accuracy, material bio-compatibility under specific conditions). Instead, it relies on the established safety and effectiveness of the predicate device.
• The table presented in the device description section is for the physical specifications and flow rates of different gauges of the catheter, not performance data from a specific study against acceptance criteria.

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 reported. The document does not describe a performance study with a "test set" in the context of AI/diagnostic device validation. It's a medical device submission focused on substantial equivalence.

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 reported. This information is not relevant to a 510(k) submission for a non-diagnostic medical device like an IV catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Not reported. See point 3.

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

• No. This is not an AI/diagnostic device, and no MRMC study is mentioned or relevant to this 510(k) submission.

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

• No. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not reported. The "ground truth" for this type of device typically refers to engineering performance specifications and material biocompatibility, which are not detailed in this summary. The submission's "truth" is its substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable/Not reported. This is not an AI/machine learning device; there is no "training set."

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

• Not applicable/Not reported. See point 8.

Summary of Device Comparison for Substantial Equivalence:

The core of this 510(k) summary is the claim of substantial equivalence to the predicate device:

• Predicate Device: Insyte™ Autoguard™ Shielded IV Catheter from Becton-Dickinson Infusion Therapy Systems Inc (K984059).
• Intended Use: Same – "to sample blood, monitor blood pressure, or administer fluids intravenously." Also includes a shielding mechanism to reduce accidental needle sticks.
• Principle of Operation: Same, both are IV catheters with a safety locking mechanism that retracts the needle.
• Technological Difference: The main difference is the release element for the needle retraction:
  • ComCaSet Safety IV Catheter: latex-free elastic rubber band
  • Predicate Device: spring
• Conclusion: The document asserts that this technological difference "does not raise any additional concerns regarding safety and effectiveness" and therefore the device is substantially equivalent to the predicate.

In essence, the "study" mentioned implicitly is the comparison of the new device's design, materials, and intended use against the legally marketed predicate, concluding that the differences do not alter the safety or effectiveness profile significantly enough to warrant a more extensive premarket approval process.

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