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This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.

The Fujifilm Balloon Controller PB-30 is a modified version of the legally marketed Fujifilm Balloon Controller PB-20 in K143556. Just like K143556, the proposed PB-30 is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.

PB-30 is connected to the over-tube and double balloon endoscope via a tube kit. PB-30 feeds /evacuates air to the balloon of over-tube and to the balloon at the tip of the endoscope. All of the PB-30's accessories are legally marketed in the US.

This document is a 510(k) premarket notification for the Fujifilm Balloon Controller PB-30. It states that the PB-30 is a modification of the legally marketed Fujifilm Balloon Controller PB-20. As such, the purpose of the submission is to demonstrate that the modified device performs equivalently to the predicate.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance testing described relates to EMC and electrical safety, likely involving single units or a small sample of the device, rather than a large patient-based test set.

• Sample Size: Not explicitly stated, but typically involves a limited number of devices (e.g., 1-3) for electrical and EMC testing.
• Data Provenance: Not specified, but likely from laboratory testing conducted by Fujifilm or a certified testing facility. It is not clinical data, so country of origin or retrospective/prospective does not apply in the usual sense.

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

This information is not applicable. The performance testing for this device (EMC and electrical safety) does not involve human expert interpretation or ground truth establishment in the way a diagnostic imaging device might. The "ground truth" for these tests would be the established international standards themselves.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations in clinical studies. The testing performed here (EMC and electrical safety) does not involve such a process.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical performance testing (EMC and electrical safety) and functional equivalence to the predicate device (PB-20), not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable to the device described. The Balloon Controller PB-30 is a hardware device (a balloon pump apparatus) and does not involve an AI algorithm or human-in-the-loop performance testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described (EMC and electrical safety) is defined by established international consensus standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). Compliance with these standards serves as the ground truth for safety and performance in these specific areas.

8. The Sample Size for the Training Set

This information is not applicable. The device is a hardware product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this hardware device.

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