(148 days)
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No
The description details a system that uses light absorption and a photodetector to detect blood, interpreting the data based on a threshold or simple algorithm to display "blood detected" or "no blood detected". There is no mention of AI, ML, or complex pattern recognition beyond basic data acquisition and interpretation.
No
The device is described as being used for the detection of blood in the upper gastrointestinal tract and as an adjunct for clinical decision-making, which indicates a diagnostic rather than a therapeutic function.
No
The document explicitly states, "Pill Sense is not a standalone diagnostic device, but an adjunct for clinical decision making."
No
The device description clearly states the system consists of both a "Pill Sense Capsule" (hardware with sensors and wireless transmission) and a "Pill Sense Receiver" (hardware that collects, interprets, and displays data). While software is involved in data interpretation and display, the system relies on significant hardware components.
Based on the provided information, the Pill Sense System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "detection of blood in the upper gastrointestinal tract". This is a diagnostic purpose, aiming to identify a specific condition (presence of blood).
- Mechanism of Action: The device works by analyzing the properties of the liquid in the sensing well within the capsule. It uses light absorption to determine the presence of blood. This analysis of a biological sample (the contents of the GI tract) is characteristic of an in vitro diagnostic.
- Output: The device provides a "blood detected" or "no blood detected" message, which is a diagnostic result based on the analysis of the sample.
- Adjunct for Clinical Decision Making: While it's stated as an adjunct and not a standalone diagnostic, this doesn't preclude it from being an IVD. Many IVDs are used in conjunction with other clinical information for diagnosis.
- Comparison to EGD: The performance study compares the Pill Sense System's results to Esophagogastroduodenoscopy (EGD), which is a diagnostic procedure. This comparison further supports its role as a diagnostic tool.
The key elements that point to it being an IVD are the analysis of a biological sample (GI tract contents) to detect a specific analyte (blood) for diagnostic purposes.
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Intended Use / Indications for Use
The Pill Sense System is a prescription only device consisting of a reusable receiver and singleuse ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB).
Pill Sense is not a standalone diagnostic device, but an adjunct for clinical decision making. A negative or normal result obtained by Pill Sense System does not exclude presence of pathology, if symptoms persist, further evaluation should be performed.
Product codes (comma separated list FDA assigned to the subject device)
QUD
Device Description
The Pill Sense system is designed to detect blood in the upper gastrointestinal tract. The overall system consists of a Pill Sense Capsule and Pill Sense Receiver. The capsule and receiver components are packaged and sold separately or as a system.
The capsule is a single-patient use, battery-powered capsule that features sensors that detect blood and wirelessly transmit data to an external receiver. The capsule makes its way through the gastrointestinal tract and is then passed naturally from the body. The reusable receiver collects and displays real-time information gathered by the capsule. The receiver interprets the data and displays a sensor output value. It plots these values on a chart using data acquisition and when completed displays a "blood detected" or "no blood detected" message. The software supports entering of the patient information, pairing of the receiver and capsule and data interpretation and display.
Within the ingestible capsule, four lights with distinct wavelengths and a photodetector are located within a sensing well in the center of the capsule. Each light is sequentially pulsed to emit light into the capsule sensing well and based on the liquid in the sensing gap, the emitted light is partially or fully absorbed. The remaining light is received by the photodetector, which converts an electrical signal proportional to the amount of light.
Once a "blood detected" message is displayed, it remains on the screen and does not change during the rest of the monitoring. If the monitoring is stopped by the user before 5 minutes has elapsed, an "Inconclusive results" message will be displayed. Only one final readout is given at the end of the 5minute monitoring period, and there is no quantification of blood detected. The overall time from capsule activation, ingestion and display of a reading takes less than 10 minutes. By design, the user is required to monitor for a minimum of 5 minutes and the monitoring automatically stops after 10 minutes. As soon as a "Blood Detected" message is received, the user can stop monitoring at any time. If deemed necessary, the user can continue monitoring for up to 40 minutes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper gastrointestinal tract
Indicated Patient Age Range
Adults, 18 and older.
Intended User / Care Setting
Trained clinicians and nurses.
Can be administered in a clinical setting that does not require the use of a specialized endoscopy suite.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The DETECT-1 study was a prospective, single-center, single-arm comparative clinical investigation designed to evaluate safety and effectiveness of the Pill Sense System when used for the detection of blood within subjects suspected to have an upper gastrointestinal bleed. The Pill Sense System performance for blood detection was compared with esophacogastroduodenoscopy (EGD) that was performed within 4 hours of the Pill Sense system reading. The investigators performing the EGD were blinded to the results provided by the Pill Sense System.
The study enrolled 131 subjects 18 and older who had symptoms of upper gastrointestinal bleeding.
Two subjects withdrew consent, one subject was withdrawn due to the need for emergent EGD before capsule ingestion. An additional two subjects were unable to swallow the capsule leaving 126 subjects for the safety population. Within the safety population, based on the EGD, there were 98 subjects without blood and 28 with blood, resulting in an overall prevalence of upper gastrointestinal bleeding of 22.6%. The Pill Sense capsule was administered by trained research staff, including non-physician health care professionals.
Two subjects were excluded from the mITT analysis due to devices not providing valid readings as intended and therefore there was no data to be compared with the EGD results. Among the 124 patients included in the mITT cohort, 28 had bleeds and 96 were without bleeds based on EGD evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, single-center, single-arm comparative clinical investigation (DETECT-1 study)
Sample Size: 124 subjects in the mITT cohort. (28 with blood, 96 without blood, as determined by EGD).
Key Results:
The sensitivity of the Pill Sense System was 92.9% (95%C1. 76.5%, 99.1%) and for specificity it was 90.6% (95%CI, 82.9%, 95.6%). The alternative hypotheses that the true values for Pill Sense sensitivity and specificity would exceed the performance goals of 75% and 60% were satisfied with respective p values of 0.0248 and
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DE NOVO CLASSIFICATION REQUEST FOR PILL SENSE SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Ingestible gastrointestinal blood detection capsule. An ingestible gastrointestinal blood detection capsule is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.
NEW REGULATION NUMBER: 21 CFR 876.1390
CLASSIFICATION: Class II
PRODUCT CODE: QUD
BACKGROUND
DEVICE NAME: Pill Sense System
SUBMISSION NUMBER: DEN220065
DATE DE NOVO RECEIVED: September 29, 2022
SPONSOR INFORMATION:
EnteraSense Ltd. % MedDRA Assistance, Inc. 55 Peaceful Way Tiverton, Rhode Island 02878
INDICATIONS FOR USE
The Pill Sense System is indicated as follows:
The Pill Sense System is a prescription only device consisting of a reusable receiver and singleuse ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB).
Pill Sense is not a standalone diagnostic device, but an adjunct for clinical decision making. A negative or normal result obtained by Pill Sense System does not exclude presence of pathology, if symptoms persist, further evaluation should be performed.
LIMITATIONS
The sale, distribution, and use of the Pill Sense System is restricted to prescription use in accordance with 21 CFR 801.109.
1
The device is not intended to be used as a stand-alone diagnostic device.
A negative or normal result obtained by the Pill Sense System does not exclude presence of pathology, if symptoms persist, further evaluation should be performed.
The device is contraindicated for patients with known gastrointestinal obstructions or strictures.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Pill Sense system is designed to detect blood in the upper gastrointestinal tract. The overall system consists of a Pill Sense Capsule and Pill Sense Receiver. The capsule and receiver components are packaged and sold separately or as a system.
The capsule is a single-patient use, battery-powered capsule that features sensors that detect blood and wirelessly transmit data to an external receiver. The capsule makes its way through the gastrointestinal tract and is then passed naturally from the body. The reusable receiver collects and displays real-time information gathered by the capsule. The receiver interprets the data and displays a sensor output value. It plots these values on a chart using data acquisition and when completed displays a "blood detected" or "no blood detected" message. The software supports entering of the patient information, pairing of the receiver and capsule and data interpretation and display.
Figure 1. Pill Sense Capsule and Pill Sense Receiver
Image /page/1/Picture/8 description: The image shows two capsule endoscopy devices and a data recorder. The capsule endoscopy devices are small, disposable cameras that are swallowed by the patient. As the capsule travels through the digestive tract, it takes pictures that are transmitted to the data recorder. The data recorder is a small, portable device that is worn by the patient. After the procedure, the data recorder is returned to the doctor, who can then review the images.
Within the ingestible capsule, four lights with distinct wavelengths and a photodetector are located within a sensing well in the center of the capsule. Each light is sequentially pulsed to emit light into the capsule sensing well and based on the liquid in the sensing gap, the emitted light is partially or fully absorbed. The remaining light is received by the photodetector, which converts an electrical signal proportional to the amount of light.
Once a "blood detected" message is displayed, it remains on the screen and does not change during the rest of the monitoring. If the monitoring is stopped by the user before 5 minutes has elapsed, an "Inconclusive results" message will be displayed. Only one final readout is given at the end of the 5minute monitoring period, and there is no quantification of blood detected. The overall time from capsule activation, ingestion and display of a reading takes less than 10 minutes. By design, the user is required to
2
monitor for a minimum of 5 minutes and the monitoring automatically stops after 10 minutes. As soon as a "Blood Detected" message is received, the user can stop monitoring at any time. If deemed necessary, the user can continue monitoring for up to 40 minutes.
Image /page/2/Figure/1 description: The image shows two different medical device screens. The screen on the left shows a sensor output of 1121, a monitoring time of 01:46, and the text "No Blood Detected". The screen on the right shows a sensor output of 3742, a monitoring time of 02:46, and the text "Blood Detected".
Image /page/2/Figure/2 description: The image is a title for a figure. The title reads, "Figure 2. Schematic of Pill Sense Receiver display". The title is written in a clear, legible font. The title is centered and easy to read.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Pill Sense capsule is classified as mucosal membrane contacting with a cumulative duration of exposure of