(154 days)
The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time.
The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts:
- Catheter
- Syringe
- Capsule holder
The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device.
The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.
The PillCam® Express Capsule Endoscopy Delivery System is a single-use, disposable and latex-free product.
The provided 510(k) summary (K101200) describes the PillCam® Express™ Video Capsule Delivery Device. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a typical "pass/fail" format for the clinical study. Instead, it describes the outcome that serves as proof of acceptable performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Successful transendoscopic delivery of the PillCam® SB capsule | All capsules were successfully placed into the duodenum (100% success rate). |
| Device safety (absence of serious adverse events) | No serious adverse events were reported in the clinical study. |
| Strength of mechanical components | Non-clinical bench testing included strength testing of the cup to the catheter, force to release the capsule, force to maintain the capsule in the cup, and strength of the catheter. (Implied successful completion, no specific metrics provided.) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Twenty-five (25) patients.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data, nor does it explicitly classify it as retrospective or prospective. However, the nature of a clinical validation study typically implies a prospective design for gathering new data. Given the submitter's location (Israel), the study likely originated there or in a collaborating country.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The study focuses on the mechanical delivery of the capsule and patient safety, not on diagnostic accuracy requiring expert interpretation of images to establish ground truth for algorithm performance.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study evaluates successful delivery and adverse events, not diagnostic findings that typically require adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation of a delivery device, not an imaging device that requires human interpretation or comparison of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) study was not done. The device is a mechanical delivery system for a capsule endoscope, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical validation study was based on:
- Direct observation of successful capsule placement: Clinicians would confirm the capsule's release into the duodenum during the procedure.
- Clinical assessment of adverse events: Monitoring patients for any complications related to the device.
- Bench testing results: Measurements of mechanical strength and forces for various components.
8. The Sample Size for the Training Set
This information is not applicable/provided. As the device is a mechanical delivery system and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above.
§ 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.”