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The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.

Acceptance Criteria and Study Details for Injectra Injection Needle

This submission (K061222) pertains to the Injectra Injection Needle and demonstrates its substantial equivalence to a predicate device. The performance data focuses on verification that the new device meets established requirements and maintains safety, rather than providing complex clinical trial outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical or analytical study with a defined dataset. The performance data section refers to "Design verification data" and "Biological testing," which are typically internal engineering and laboratory tests.

• Test Set Sample Size: Not explicitly stated as a defined "sample size" for a dataset. Design verification and biological testing are usually conducted on a set number of manufactured devices or materials.
• Data Provenance: The nature of "Design verification data" and "Biological testing" suggests these are results from internal testing conducted by the manufacturer, Medi-Globe Corporation. The country of origin and whether it is retrospective or prospective are not specified, but such tests are generally prospective (performed on new designs or materials).

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

This submission does not involve expert-established ground truth for a test set in the context of diagnostic accuracy. The "ground truth" for this type of device (an injection needle) is largely based on engineering specifications, material properties, and established biological safety standards. There is no mention of external experts being used to establish a ground truth for performance.

4. Adjudication Method for the Test Set

Not applicable. The performance data described are based on objective engineering and laboratory tests, not subjective interpretations requiring an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Injectra Injection Needle is an interventional accessory device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not conducted. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Engineering Specifications and Performance Requirements: Measured against pre-defined functional parameters (e.g., fluid delivery capability, structural integrity, compatibility with endoscopes).
• Predetermined Safety Standards: Biological testing confirms the device meets accepted biocompatibility standards.
• Equivalence to Predicate Device: The primary ground truth is established by demonstrating that the new device performs identically or equally well to the legally marketed predicate device (K955558) in terms of its intended function and safety profile.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a training set.

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

Not applicable, as there is no training set for this device.

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