(76 days)
The Given® Diagnostic System with the PillCam™ SB2 Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The Given® Diagnostic System is comprised of three subsystems PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software. The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include: Addition of a new model of small bowel capsule, the PillCam™ SB2 capsule. Addition of three new features to the RAPID Software: Lewis Score (optional), Study Management, Installation for End-User Computers (optional).
The provided text is a 510(k) summary for the Given® Diagnostic System with the PillCam™ SB2 Capsule. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include detailed information regarding acceptance criteria, study performance results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance evaluations.
The document primarily focuses on regulatory approval by demonstrating substantial equivalence, rather than presenting a detailed performance study against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the input:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative performance results for the device (PillCam™ SB2 Capsule or SBI feature) against such criteria are presented in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against pre-defined acceptance criteria.
2. Sample Size for the Test Set and Data Provenance:
No information regarding the sample size used for a test set, nor the provenance (country of origin, retrospective/prospective) of such data, is provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No information about experts used for ground truth establishment or their qualifications for a test set is provided.
4. Adjudication Method for the Test Set:
No information about an adjudication method for a test set is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size for human readers with vs. without AI assistance, is present in this 510(k) summary.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):
No information is provided about a standalone performance study for the device's features (such as the SBI feature).
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for any performance evaluation.
8. Sample Size for the Training Set:
No information regarding the sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established:
No information regarding how ground truth for a training set was established is provided.
Summary of Device and Intended Use from the document:
- Trade Name: Given® Diagnostic System
- Device Name: Given® Diagnostic System with PillCam™ SB2 Capsule
- Classification Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System
- Intended Use: Visualization of the small bowel mucosa. May be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up.
- Specific Feature (SBI): The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
- Modifications subject to 510(k):
- Addition of a new model of small bowel capsule: PillCam™ SB2 capsule.
- Addition of three new features to the RAPID Software: Lewis Score (optional), t Study Management, Installation for End-User Computers (optional).
Key Takeaway: This 510(k) summary asserts "substantial equivalence" to a predicate device (Given® Diagnostic System cleared under multiple previous K numbers) and refers to compliance with FDA's "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System." It does not present detailed performance data from a specific study designed to meet quantitative acceptance criteria, which is common for special 510(k)s and substantial equivalence claims where the new device is very similar in performance to an already cleared device.
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”