(44 days)
DEN 120023
DEN 120023
No
The summary describes image processing and analysis software, but does not mention AI, ML, or any related technologies like deep learning or neural networks.
No.
The device is intended for visualization and detection, not for treating a condition or disease.
Yes
The device's intended use is to "provide visualization of the colon" and for "detection of colon polyps," which are diagnostic activities.
No
The device description clearly outlines multiple hardware components including an ingestible capsule, a recorder, a sensor array/belt, and a workstation, in addition to the software.
Based on the provided information, the PillCam COLON 2 capsule endoscopy system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro - "in glass"). This device directly visualizes the colon within the body (in vivo - "in living").
- The intended use is visualization of the colon and detection of polyps. This is a diagnostic imaging procedure, not a laboratory test performed on a biological sample.
- The device description details components for image acquisition, recording, processing, and viewing. These are characteristic of an imaging system, not an IVD.
Therefore, the PillCam COLON 2 system falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
PGD
Device Description
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.
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- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Clinical testing No clinical testing was performed or relied on for a determination of substantial equivalence.
- Performance Data: The device meets the special controls for colon capsule imaging systems, as described in 21CFR 876.1330.
- Conclusion: The device that is submitted for an expanded indication is identical to an already cleared device (DEN 120023).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEN 120023
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Given Imaging, Ltd. Hilla Debby Director, Clinical & Regulatory 2 Hacarmel St. New Industrial Park POB 258 Yoqneam, 20962 Israel
Re: K153466 Trade/Device Name: PillCam COLON 2 Capsule Endoscopy System Regulation Number: 21 CFR§ 876.1330 Regulation Name: Colon capsule imaging system Regulatory Class: II Product Code: PGD Dated: November 30, 2015 Received: December 1, 2015
Dear Hilla Debby,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153466
Device Name
PillCam COLON 2 Capsule Endoscopy Sysytem
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (21 CFR 801 Subpart D) |
|---|
| Over The Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 80
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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Image /page/3/Picture/0 description: The image shows the logo for Given Imaging. The logo is in blue and white, and it features the word "GIVEN" in large, white letters. Below the word "GIVEN" is the word "IMAGING" in smaller, white letters. To the right of the logo are several blue squares with rounded corners.
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name
and Address: | Given Imaging Ltd. (GI Solutions, Medtronic)
2 Hacarmel Street
New Industrial Park
PO Box 258
Yokneam 20692
Israel
Tel.: 011-972-4-9097774
Fax: 011-972-73-2501533 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hila Debby
Director, Clinical & Regulatory
Email: Hila.Debby@covidien.com |
| Phone Number: | 972 (4) 909-7774 |
| Fax Number: | (972) 73-2501533 |
| Establishment
Registration
Number: | 9710107 |
| Date Prepared: | January 13, 2016 |
| Device Trade
Name(s): | PillCam® COLON 2 capsule endoscopy system |
| Device Common
Name: | Colon capsule imaging system |
| Classification: | Regulation No: 876.1330, Class: II
Panel: Gastroenterology/Urology
PGD- Colon Capsule Imaging System |
| Predicate
Device(s): | PillCam COLON 2 capsule endoscopy system (DEN 120023) |
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Image /page/4/Picture/0 description: The image features the logo for Given Imaging, a medical technology company. The logo is set against a blue background and includes the company name in white, with the "V" in "Given" stylized as a green triangle pointing downwards. To the right of the logo are several blue squares of varying shades, arranged in a pattern.
General Device Description:
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.
3. 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.
4. 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.
Indications for use: 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
5
Image /page/5/Picture/0 description: The image features the logo for Given Imaging, a medical technology company. The logo is set against a blue background and consists of the company name in white lettering, with a stylized image of a capsule or pill integrated into the letter 'V'. To the right of the logo are several rounded squares in varying shades of blue, creating a visual pattern.
moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.
According to the expanded indication above, PilllCam COLON 2 capsule can be used for detection of polyps in a group of patients who may not be good candidates for colonoscopy. Pillcam COLON 2 capsule procedure would help the doctors decide whether or not they want to perform the scoping, when there is a strong clinical suspicion of a large polyp or cancer and the patient is at significant risk with colonoscopy or sedation but can tolerate colonoscopy if necessary.
- The technological characteristics of the system (Ingestible Technological Characteristics: PillCam Capsule, DR 3 PillCam Recorder, RAPID Software, Given Workstation and Accessories) are identical to the predicate device (DEN120023).
Optical Features Same as the predicate device (DEN 120023)
Bench testing: Same as the predicate device (DEN 120023)
- Clinical testing No clinical testing was performed or relied on for a determination of substantial equivalence.
- Performance Data: The device meets the special controls for colon capsule imaging systems, as described in 21CFR 876.1330.
- Conclusion: The device that is submitted for an expanded indication is identical to an already cleared device (DEN 120023).