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The TEGO™ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an intravascular Administration Set for the administration or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The TEGO™ is a needle-free capping device which close the end of the catheter. The TEGO™ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

The TEGO is a one piece, swab-able, needle-free catheter patency device. The TEGO is intended for the capping of venous and arterial access devices. The TEGO has a low deadspace, a straight fluid path, high flow rate and straight hale purchant and ergonomically pleasing profile. When a fluid adminstration device is removed from the TEGO an automatic positive displacement of fluid will exit the device and provent blood reflux. The TEGO will permit the use of normal saline for what is known as a rountine flush and patency rodintenance of the venous or arterial access device. The materials include polycarbonate, silicone rubber, polyethlene and trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.

The provided document K040710 describes a 510(k) premarket notification for the TEGO Needle-Free Access Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria, statistical analyses, or comprehensive performance metrics that would be typical for a novel device or a device requiring a PMA.

Therefore, the document does not contain the detailed information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document does state the following:

1. Acceptance Criteria and Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance data from a clinical study for the TEGO device. The basis for clearance is demonstrating substantial equivalence to a predicate device.

2. Study Description:
The submission is a 510(k) premarket notification, which establishes substantial equivalence. It describes the device and its intended use, and compares its technical characteristics to a predicate device. There is no mention of a specific clinical study conducted by the applicant to prove detailed performance against novel acceptance criteria.

Key statements from the document that indicate the nature of the submission:

• "SUMMARY OF SAFETY AND EFFECTIVENESS TEGO (NEEDLE- FREE ACCESS DEVICE)"
• "The TEGO is similar to legally marketed devices with the same intended use and design."
• The FDA letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

This means the "study" demonstrating the device meets "acceptance criteria" here is the 510(k) process itself, where the device is shown to be substantially equivalent to an already approved predicate device (CLC 2000 Ultra-Site Valve). The "acceptance criteria" are therefore implicit in the regulatory requirements for substantial equivalence, which primarily involve demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate. Detailed performance metrics and associated studies are typically not required for 510(k) if substantial equivalence can be demonstrated through other means (e.g., comparative testing, material safety, design similarities).

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