(220 days)
The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa.
• It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn's disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn's disease.
• It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy.
• The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults.
PillCam Desktop Software 9.0 indications for use:
With PillCam SB 2/ SB 3 Capsule
The PillCam SB 2/ SB 3 capsule is intended for visualization of the small bowel mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam SB 2/ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
With PillCam UGI Capsule
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.
With PillCam COLON 2 Capsule
The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.
With PillCam SBC Capsule
The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa.
- It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn's disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn's disease.
- It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy.
- The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults.
The PillCam SBC capsule endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam SBC capsule, (2) the PillCam Recorder DR3, (3) the PillCam Software (a new version of the formerly branded "RAPID" software), and (4) the Workstation and/or accessories.
- Ingestible PillCam SBC Capsule
The disposable, ingestible PillCam SBC Capsule is designed to acquire images during the natural propulsion through the digestive system. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body. - PillCam Recorder DR3
The PillCam Recorder DR3 is an external receiving/recording unit that receives and stores the acquired images from the capsule. - PillCam Software
The PillCam Software (previously branded as "RAPID" Software) 9.0 is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms. PillCam Desktop Software 9.0 supports PillCam capsule endoscopy of the gastrointestinal (GI) tract with all PillCam video capsules (SB, COLON, UGI and SBC). - Workstation and Accessories
The Workstation is a modified standard personal computer that is the operational platform for the PillCam software. The Sensor array or sensor belt receive data from the PillCam capsule and transfer the data to the PillCam Recorder DR3.
The provided text describes a 510(k) premarket notification for the PillCam SBC capsule endoscopy system and PillCam Desktop Software 9.0. It asserts substantial equivalence to predicate devices but does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The document states that the device "meets the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA' dated November 28, 2001." and that "The proposed changes in this submission do not raise new performance or safety issues." However, it does not provide specific quantitative acceptance criteria or detailed reported performance against those criteria. It lists some "Bench Testing" but without numerical results or criteria.
- Sample sizes used for the test set and the data provenance: No information is provided regarding the sample size of any test sets or whether data was retrospective or prospective, or its country of origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: This information is not present.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: No mention of an MRMC study or AI assistance is made. The software's features focus on improving user viewing experience and providing tools for analysis.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document does not describe standalone algorithm performance studies.
- The type of ground truth used: The document does not specify the type of ground truth used for performance evaluation, beyond implying that the device's visualization capabilities are compared to existing diagnostic methods (e.g., endoscopy) as part of its intended use.
- The sample size for the training set: No information about training sets is provided.
- How the ground truth for the training set was established: No information about training sets is provided.
However, the document does contain information about performance data in a general sense:
Relevant Performance Data Mentioned:
The document mentions that the device "meets the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA' dated November 28, 2001." This is the general regulatory standard the device aims to meet.
It also highlights that "The proposed changes in this submission do not raise new performance or safety issues."
Bench Testing:
The following bench tests were conducted or deemed applicable due to similarity with the predicate device (PillCam COLON 2 capsule):
- Biting test
- pH resistance test
- Optical resolution
- Optical verification including Field of View and depth of focus
- Verification of frame rate (PillCam SBC capsule, PillCam Desktop Software 9.0)
- Shelf life and battery evaluation (PillCam SBC capsule, PillCam Desktop Software 9.0)
- Color reproducibility (PillCam SBC capsule, PillCam Desktop Software 9.0)
- Image quality (PillCam SBC capsule, PillCam Desktop Software 9.0)
Software Validation:
PillCam Desktop Software 9.0 was validated and documented per FDA's software guidance document.
Optical Features:
- 4 white LEDs per optical head are used as the SBC capsule illumination source.
- The optical Field of view from the entrance pupil is 168°.
- The Effective Visibility distance is set to 30mm. (These features are identical to the PillCam COLON 2 capsule).
In summary, while the document confirms that performance testing and validation were conducted to demonstrate substantial equivalence and adherence to regulatory guidance, it does not provide the detailed, quantitative breakdown of acceptance criteria and study results requested.
§ 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.”