(426 days)
Not Found
Not Found
No
The summary mentions image processing but does not mention AI, DNN, or ML, nor does it describe training or test sets in a way that suggests AI/ML model development.
No
The device is indicated for visualization and detection of colon polyps, which are diagnostic purposes, not therapeutic intervention.
Yes
The device is clearly indicated for the "detection of colon polyps," which is a diagnostic purpose to identify abnormal conditions.
No
The device description explicitly lists four main subsystems, including an ingestible capsule and a recorder, which are hardware components. While software is part of the system, it is not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PillCam COLON 2 Capsule Endoscopy System is designed to visualize the colon in vivo (within the living body) using an ingestible capsule that captures video images. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide visualization of the colon for the detection of polyps, which is a diagnostic process performed directly on the patient's internal anatomy.
Therefore, the PillCam COLON 2 Capsule Endoscopy System falls under the category of a medical device used for in vivo imaging and diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PillCam COLON 2 Capsule Endoscopy System is indicated to provide visualization of the colon. It is intended to 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.
Product codes (comma separated list FDA assigned to the subject device)
PGA
Device Description
The PillCam® COLON 2 capsule endoscopy system includes a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon. The PillCam COLON 2 capsule is designed to withstand the mechanical forces and chemical environment of the digestive system.
The PillCam COLON 2 capsule endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam COLON 2 capsule, (2) the DR 3 PillCam® Recorder, (3) the RAPID® software, and (4) the Given® Workstation.
The PillCam COLON 2 video capsule is a single-patient use, ingestible capsule designed to acquire video images during natural propulsion through the digestive system. The capsule consists of the following main components:
-
- Capsule envelope (case and 2 domes)
-
- 2 optical heads
-
- 2 Complementary metal oxide semiconductor (CMOS) based Imagers
-
- 8 Light Emitting Diodes (LEDs)
-
- Application Specific Integrated Circuit (ASIC) Transmitter
-
- Full Flex Printed Circuit Board (PCB)
-
- Battery pack
The capsule is swallowed by the patient and turns off while it travels through the stomach and small bowel. It then turns on again and begins recording images of the distal small bowel and colon.
- Battery pack
The DR 3 PillCam Recorder is an external receiving/recording unit worn by the patient that receives and stores the acquired images from the capsule. The recorder supports patient/physician real time alerts for different aspects of the procedure such as the time for additional laxative intake and the time for procedure termination. The alert is done by (1) vibration on the sensor array, (2) visual indication on the LCD screen, and/or (3) audio indication. The DR 3 consists of the following main components:
-
- Dual core CPU
-
- Storage Removable Secure Digital High Capacity (SDHC) card
-
- Battery (Internal, Rechargeable, Li-Ion)
-
- LCD screen with navigation keys
-
- Sensor array to supports uplink channel
-
- Sensor loop to support down link channel
-
- Cradle with Li-Ion battery charger and status indicators
The RAPID software is proprietary software that supports the capsule endoscopy examination in all of its phases: Patient check-in, PillCam Recorder initialization, copying data from the PillCam Recorder, video creation, viewing of the RAPID video, and generation of a Capsule Endoscopy Report. The software also includes in-service training videos, and patient instruction forms that may be printed.
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 high-capacity mass storage device, and a high-capacity USB portable storage device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images
Anatomical Site
Colon, digestive system
Indicated Patient Age Range
The clinical study enrolled subjects between the ages of 50 and 75 years.
Intended User / Care Setting
Prescription use in accordance with 21 CFR 801.109. Clinicians/physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical effectiveness was evaluated in a prospective, multi-center study (MA-204) comparing CCE with optical colonoscopy (OC) for agreement on absence or presence of colon polyps (≥6 mm or ≥10 mm).
A total of 884 subjects were enrolled, meeting the inclusion criteria of being between 50 and 75 years of age and classified as average risk per AGA Guidelines on colorectal cancer (CRC) screening. 184 subjects were excluded from the effectiveness analysis, including 104 due to CCE performance issues (77 due to inadequate colon preparation or rapid transit time of less than 45 min), 63 withdrew, 2 had OC procedure violations, and 15 were from a terminated site due to protocol violations.
The study included 700 subjects who successfully completed investigations with both CCE and OC for the effectiveness analysis. The data analysis of CCE effectiveness was on a per-subject basis, comparing CCE with OC for the presence or absence of at least one polyp of size ≥6 mm or ≥10 mm identified on OC.
In the initial phase, colonoscopists were blinded to CCE results when evaluating OC findings. The comparison of CCE with OC was based on the presence or absence of at least one finding of a polyp of size in diameter (≥6 mm or ≥10 mm) identified on OC.
Location-based and size-based analyses of agreement were conducted. The largest estimated diameter polyp from OC was used as the 'reference' polyp. Agreement of CCE with OC was determined based on a size-matching algorithm within the same or adjacent colon segment locations of the reference OC polyp.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, multi-center clinical study entitled "Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204)".
Sample Size: 700 subjects for effectiveness analysis (out of 884 enrolled).
Key Results:
- Descriptive Analysis (non-segmental):
- Among 115 subjects with OC-identified polyps >6mm but 10mm, CCE identified a polyp ≥6mm in 55 subjects (71.4%).
- CCE failed to identify any polyp ≥6mm found on OC in 22 (28.6%) subjects, and any polyp ≥10mm in 40 (51.9%) subjects.
- Analysis of Agreement:
- For polyps ≥6 mm:
- Positive Percent Agreement (PPA) with OC: 68.8% (132/192, 95% CI 61.7-75.2%)
- Negative Percent Agreement (NPA) with OC: 81.3% (413/508, 95% CI 77.6- 84.6%)
- For polyps ≥10 mm:
- Positive Percent Agreement (PPA) with OC: 64.9% (50/77, 95% CI 53.2-75.5%)
- Negative Percent Agreement (NPA) with OC: 92.9% (579/623, 95% CI 90.6-94.8% )
- For polyps ≥6 mm:
- Unblinded Colonoscopy Results:
- For ≥6 mm threshold, results showed a 1% increase in PPA and 3% increase in NPA.
- For ≥10 mm threshold, results showed a 1% increase in both PPA and NPA.
MRMC, Standalone Performance, AUC: Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- For polyps ≥6 mm:
- Positive Percent Agreement (PPA): 68.8% (132/192, 95% CI 61.7-75.2%)
- Negative Percent Agreement (NPA): 81.3% (413/508, 95% CI 77.6- 84.6%)
- For polyps ≥10 mm:
- Positive Percent Agreement (PPA): 64.9% (50/77, 95% CI 53.2-75.5%)
- Negative Percent Agreement (NPA): 92.9% (579/623, 95% CI 90.6-94.8%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Colon Capsule Imaging System: 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.
NEW REGULATION NUMBER: 21 CFR 876.1330
CLASSIFICATION: II
PRODUCT CODE: PGA
BACKGROUND
DEVICE NAME: PillCam COLON 2 Capsule Endoscopy System
SUBMISSION NUMBER: K123666
DATE OF DE NOVO: NOVEMBER 21, 2012
- CONTACT: Tim Thomas SVP, Regulatory, Clinical & Quality Given Imaging Ltd. New Industrial Park PO BOX 258 Yoqneam, 20692 Israel
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The PillCam COLON 2 Capsule Endoscopy System is indicated to provide visualization of the colon. It is intended to 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.
1
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
Limitations on device use are also achieved through the following statements included in the Instructions for Use Manual:
Colon capsule endoscopy (CCE) is not a treatment. The device is intended to provide visualization of the colon for detection of polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. Common causes for failure to complete the colonoscopy procedure include looping and anatomic variations resulting in tortuosity, angulation, redundancy and decreased colonic mobility. The value of CCE in this limited population is not known, as the clinical trial was conducted in "normal subject" subjects who were able to undergo optical colonoscopy.
The primary risks of the Given PillCam Colon 2 Capsule Endoscopy System are the possibilities of false positive and false negative results. Patients with a false negative CCE result would not be identified as having a colon polyp or cancer, and would have possible histologic progression of the lesion or the development of a cancer would be possible during the surveillance period. In addition, patients with a false positive CCE result may be advised to undergo unnecessary additional evaluation, although it is likely that CT Colonography (CTC) would be utilized in these cases for confirmation of a lesion.
Undergoing an MRI while the PillCam video capsule is inside the patient's body may cause damage to the intestinal tract or abdominal cavity. If the patient did not positively verify the excretion of the PillCam capsule from the body, contact the physician for evaluation and possible abdominal X-ray before undergoing an MRI examination.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The PillCam® COLON 2 capsule endoscopy system includes a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon. The PillCam COLON 2 capsule is designed to withstand the mechanical forces and chemical environment of the digestive system.
2
Technological Characteristics
The PillCam® COLON 2 capsule endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam COLON 2 capsule, (2) the DR 3 PillCam® Recorder, (3) the RAPID® software, and (4) the Given® Workstation.
1. Ingestible PillCam COLON 2 Capsule
The PillCam COLON 2 video capsule (Figure 1 and Table 1) is a single-patient use, ingestible capsule designed to acquire video images during natural propulsion through the digestive system. The basic characteristics and components of the PillCam COLON 2 capsule are similar to the Small Bowel (PillCam SB) and Esophagus (PillCam ESO) capsules. However the software of the PillCam Colon 2 Capsule Endoscopy System is designed for the detection of polyps. The software also adjusts the time the capsule is on to preserve battery life during the transit through the small bowel.
The capsule consists of the following main components:
-
- Capsule envelope (case and 2 domes)
-
- 2 optical heads
-
- 2 Complementary metal oxide semiconductor (CMOS) based Imagers
-
- 8 Light Emitting Diodes (LEDs)
-
- Application Specific Integrated Circuit (ASIC) Transmitter
-
- Full Flex Printed Circuit Board (PCB)
-
- Battery pack
The capsule is swallowed by the patient and turns off while it travels through the stomach and small bowel. It then turns on again and begins recording images of the distal small bowel and colon. This action is accomplished by an image processing algorithm which is designed to detect the capsule transit to small bowel. The frame rate increases with more rapid movement and slows while movement is slower.
Image /page/2/Figure/13 description: The image shows a PillCam with measurements labeled. The length of the PillCam is 31.5 mm, and the width is 11.6 mm. The weight of the PillCam is 2.9 +- 0.03 g.
Figure 1: PillCam Colon 2 capsule
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| PillCam COLON 2 Capsules | |||
|---|---|---|---|
| Physical | Dimensions: | Length: | 31.5 mm ±5% |
| Diameter: | 11.6 mm ±5% | ||
| Weight: | 2.9 gr ±5% | ||
| Material: | Biocompatible plastic | ||
| Optical | Illumination: | 4 white light emitting diodes for each head | |
| # of imaging heads | 2 | ||
| Effective Visibility Distance: | 0-30 mm | ||
| Operational | Frame Rate: | Up to 35 Frames per Second per head | |
| Operating Time: | 10 hours | ||
| Chemical Safety: | Resistant to dissolution in pH=2 to pH=8 | ||
| Battery Type: | Silver Oxide batteries | ||
| Operating Temperature: | 20-40°C | ||
| Storage Temperature: | 0-30°C |
Table 1: PillCam Colon 2 Capsule, Basic Specifications
2. Data Recorder 3 (DR3) PillCam Recorder
The DR 3 PillCam Recorder (Figure 2) is an external receiving/recording unit worn by the patient that receives and stores the acquired images from the capsule. The recorder supports patient/physician real time alerts for different aspects of the procedure such as the time for additional laxative intake and the time for procedure termination. The alert is done by (1) vibration on the sensor array, (2) visual indication on the LCD screen, and/or (3) audio indication. The DR 3 consists of the following main components:
-
- Dual core CPU
-
- Storage Removable Secure Digital High Capacity (SDHC) card
-
- Battery (Internal, Rechargeable, Li-Ion)
-
- LCD screen with navigation keys
-
- Sensor array to supports uplink channel
-
- Sensor loop to support down link channel
-
- Cradle with Li-Ion battery charger and status indicators
Image /page/3/Picture/11 description: The image shows a medical device with a screen displaying information. The screen shows the date as November 25, 2026, and the number 25 is prominently displayed. The device has a white and gray color scheme with an orange button on the side.
Figure 2: DR 3 PillCam Recorder
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3. RAPID Software
The RAPID software is proprietary software that supports the capsule endoscopy examination in all of its phases: Patient check-in, PillCam Recorder initialization, copying data from the PillCam Recorder, video creation, viewing of the RAPID video, and generation of a Capsule Endoscopy Report. The software also includes in-service training videos, and patient instruction forms that may be printed.
4. Given Workstation and other 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 high-capacity mass storage device, and a high-capacity USB portable storage device.
Principles of operation
The PillCam COLON 2 capsule endoscopy system acquires video images of the colon during natural propulsion through the digestive system. Figure 3 illustrates the data flow from the PillCam COLON 2 capsule through the antennas of the Sensor Array and PillCam Recorder to the workstation that utilizes the RAPID software to output an image of the colon.
Image /page/4/Picture/6 description: This image shows the components of the PillCam system. The PillCam itself is a small capsule with the word "PillCam" printed on it. The PillCam connects to a sensor array that is attached to the patient's body. The sensor array then connects to a data recorder, which stores the images captured by the PillCam. Finally, the images are downloaded to a computer for analysis.
Figure 3: Data flow of Given PillCam endoscopy system
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The patient-contacting components of the PillCam COLON 2 capsule were evaluated with respect to their intended use per ISO 10993-1:2003. Testing was performed on finished devices. Below is a table of all patient contacting and non-contacting materials (Table 2), as well as a summary of the biocompatibility tests conducted, and the results.
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| No. | Name | Raw material | Body contact |
|---|---|---|---|
| 1 | Optical dome | Polycarbonate | |
| material | Surface device | ||
| contacting the | |||
| mucosal | |||
| 2 | Capsule case | Polycarbonate material | membrane for |
| prolonged | |||
| duration (>24 | |||
| hours to 30 days) | |||
| 3 | Optical head | General electric | |
| component | No body contact | ||
| 4 | LED | General electric | |
| component | |||
| 6 | CMOS image sensor | General electric | |
| component | |||
| 7 | Printed circuit | General electric | |
| component | |||
| 8 | MEMS magnetic switch | General electric | |
| component | |||
| 9 | Battery | General electric | |
| component | |||
| 10 | ASIC/receiver |
- transmitter | General electric
component | |
| 11 | Receiving antenna
(inductor) | General electric
component | |
TABLE 2: PILLCAM COLON 2 CAPSULE MATERIAL LIST
The PillCam COLON 2 capsule was evaluated for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation or intracutaneous reactivity (ISO 10993-11). The device was shown to be biocompatible per ISO 10993-1:2003.
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. Cytotoxicity
Cytotoxicity testing was performed in L-929, mouse fibroblast cells and 5% serum supplemented media with 2% antibiotics. The three samples tested all demonstrated a cytotoxicity grade of zero.
Sensitization .
Tests performed in mice (strain CBA/J). The test substance was regarded as a skin sensitizer if the Stimulation Index (SI) for the test group was greater than 3.0. The saline and DMSO test extracts had an SI of 1 AGA Guidelines: Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline From the American Cancer Society, the US Multi-Society Task Force on Colorectal and the American College of Radiology; Gastroenterology 2008;134:1570-1595
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Descriptive Analysis
Sizes of the largest colon polyp identified in a subject by OC and CCE were compared regardless of segmental location. The non-segmental analysis was performed to provide an 'all-or-none' per subject view of the data, which is clinically valuable information for clinicians to consider in discussing the pros and cons of undergoing this study with a patient. The results outlined in Table 4 below show that among 115 subjects with a polyp identified on OC that was greater than 6 mm but less than 10 mm in diameter, CCE also identified 55 (47.8%) subjects with a polyp greater than 6 mm but less than 10 mm in diameter anywhere in the colon, and 19 (16.5%) subjects with a 10 mm in diameter sized polyp, for a total of 74 subjects (64.3%) with a CCE detected polyp of 6 mm or greater.
Among 77 subjects with a polyp identified on OC that was greater than 10 mm in diameter, CCE identified a polyp anywhere in the colon less than 6 mm in diameter in 12 (15.6%) subjects, a polyp greater than 6 mm but less than 10 mm in diameter in 18 (23.4%) subjects, and a polyp measuring at least 10 mm in diameter in 37 (48.1%) subjects. Thus, CCE identified a total of 55 subjects (71.4%) with a polyp of 6 mm or greater. CCE failed to identify any polyp that was found on colonoscopy of 6 mm or greater in 22 (28.6%) subjects and any polyp of 10 mm or greater in 40 (51.9%) subjects.
| Max OC (mm) | |||||
|---|---|---|---|---|---|
| Max CCE (mm) | 0 | 0 |