(44 days)
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 Gl 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.
The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories.
- Ingestible PillCam Capsule The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body.
- DR 3 PillCam Recorder Recorder is an external The DR 3 PillCam receiving/recording unit that receives and stores the acquired images from the capsule. The Sensor Array/belt receives data from the PillCam capsule and transfers the data to the PillCam Recorder.
- RAPID Software The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms.
- Given Workstation and Accessories The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.
This document is a 510(k) summary for the PillCam COLON 2 Capsule Endoscopy System. It requests an expanded indication for use for detection of colon polyps.
Based on the provided text, the device itself (PillCam COLON 2 Capsule Endoscopy System) is identical to a previously cleared device (DEN 120023). No new clinical testing was performed or relied upon for this specific 510(k) submission for the expanded indication. The submission relies on the substantial equivalence of the existing device and its performance against "special controls for colon capsule imaging systems, as described in 21CFR 876.1330."
Therefore, the input does not provide information about a new study directly demonstrating the device meets specific acceptance criteria for this expanded indication. Instead, it states that the device's technological characteristics and optical features are the same as the predicate device (DEN 120023).
In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, because the submission claims substantial equivalence without new clinical testing.
However, given the constraint to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, I will extract what is explicitly stated in the document about general performance data and and the basis for the approval.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria and reported device performance for this expanded indication. It only states that the "device meets the special controls for colon capsule imaging systems, as described in 21CFR 876.1330."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states: "No clinical testing was performed or relied on for a determination of substantial equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical testing was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical testing was performed for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as no new clinical testing was performed for this submission. This device is not an AI-assisted device in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This would not apply to a capsule endoscopy system. The system provides visualization, and a human (physician) interprets the images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical testing was performed for this submission.
8. The sample size for the training set
Not applicable, as no new clinical testing was performed for this submission, and the device is not described as involving a machine learning algorithm that undergoes a "training set" in the context of this approval.
9. How the ground truth for the training set was established
Not applicable.
Conclusion based on the provided text:
The submission for the expanded indication of the PillCam COLON 2 Capsule Endoscopy System relies on the substantial equivalence to a predicate device (DEN 120023). The document explicitly states: "No clinical testing was performed or relied on for a determination of substantial equivalence." The acceptance criteria are broadly described as meeting "the special controls for colon capsule imaging systems, as described in 21CFR 876.1330," rather than specific performance metrics from a new clinical study.
§ 876.1330 Colon capsule endoscopy system.
(a)
Identification. A prescription, single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The capsule must be demonstrated to be biocompatible.
(2) Non-clinical testing data must demonstrate the mechanical and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested and detailed protocols must be provided for each test:
(i) Bite test to ensure that the capsule can withstand extreme cases of biting.
(ii) pH resistance test to evaluate integrity of the capsule when exposed to a range of pH values.
(iii) Battery life test to demonstrate that the capsule's operating time is not constrained by the battery capacity.
(iv) Shelf-life testing to demonstrate that the device performs as intended at the proposed shelf-life date.
(v) Optical testing to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, distortion, signal-to-noise ratio, uniformity, and image artifacts. A test must be performed to evaluate the potential of scratches, caused by travelling through the gastrointestinal tract, on the transparent window of the capsule and their impact on the optical and color performance.
(vi) An optical safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided.
(vii) A color performance test must be provided to compare the color differences between the input scene and output image.
(viii) The video viewer must clearly present the temporal or spatial relationship between any two frames as a real-time lapse or a travel distance. The video viewer must alert the user when the specific video interval is captured at a frame rate lower than the nominal one due to communication errors.
(ix) A performance test evaluating the latency caused by any adaptive algorithm such as adjustable frame rate must be provided.
(x) If the capsule includes a localization module, a localization performance test must be performed to verify the accuracy and precision of locating the capsule position within the colon.
(xi) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the recorder. Controlled signal attenuation should be included for simulating a non-ideal environment.
(xii) Software validation, verification, and hazards analysis must be provided.
(xiii) Electrical equipment safety, including thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. If the environments of intended use include locations outside of hospitals and clinics, appropriate higher immunity test levels must be used. Labeling must include appropriate EMC information.
(xiv) Information demonstrating immunity from wireless hazards.
(3) The clinical performance characteristics of the device for the detection of colon polyps must be established. Demonstration of the performance characteristics must include assessment of positive percent agreement and negative percent agreement compared to a clinically acceptable alternative structural imaging method.
(4) Clinician labeling must include:
(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device.
(ii) A detailed summary of the clinical testing pertinent to use of the device, including the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.
(iii) The colon cleansing procedure.
(iv) A detailed summary of the device technical parameters.
(v) A detailed summary of the device- and procedure-related complications pertinent to use of the device.
(vi) An expiration date/shelf life.
(5) Patient labeling must include:
(i) An explanation of the device and the mechanism of operation.
(ii) Patient preparation procedure.
(iii) A brief summary of the clinical study. The summary should not only include the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.
(iv) A summary of the device- and procedure-related complications pertinent to use of the device.