(316 days)
Not Found
No
The summary describes image processing and analysis but does not mention AI, ML, or any related technologies like deep learning or neural networks. The performance studies focus on bench testing related to the capsule's physical properties and image quality, not algorithmic performance.
No.
The device is intended for visualization and diagnostic purposes, not for treating a condition or disease.
Yes
The device is intended for visualization of the upper gastrointestinal tract to identify conditions like blood presence, which is a diagnostic function.
No
The device description clearly outlines multiple hardware components including the ingestible capsule, the recorder, the workstation, and accessories, in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The PillCam system works by the patient ingesting a capsule that captures images inside the body.
- The primary function is visualization. The system is designed to provide visual information about the upper GI tract. While it can be used to visualize blood, this is still a visual assessment, not a laboratory analysis of a sample.
- The device description focuses on imaging and recording. The components are related to capturing, transmitting, storing, and viewing images. There is no mention of analyzing biological samples.
Therefore, the PillCam UGI capsule endoscopy system falls under the category of a medical device used for diagnostic imaging, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 least18 years of age.
Product codes (comma separated list FDA assigned to the subject device)
NEZ
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
DR 3 PillCam Recorder is an external The receiving/recording unit that receives and stores the acquired images from the capsule. -
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. RAPID 8.0 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules. In addition, RAPID 8.0 supports PillCam Recorder DR 2C and PillCam Recorder DR 3. -
Given Workstation and Accessories
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The PillCam Recorder is an external receiving/recording unit that receives acquired images from the capsule. The Sensor Array receives data from the PillCam capsule and transfers the data to the PillCam Recorder. 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
Video images
Anatomical Site
upper gastrointestinal tract (esophagus, stomach, duodenum)
Indicated Patient Age Range
at least 18 years of age
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)
Bench testing: Since PillCam UGI capsule and the COLON 2 capsule predicate device are identical in terms of external components and technology, the biting test and pH resistance test for the predicate device are applicable for PillCam UGI capsules as well. In addition optical resolution test results demonstrate that different pH environments do not affect the optical performance of the PillCam capsule, specifically the image quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K071153, K103025, K123864, K123666
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
§ 876.1300 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.”
0
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 stylized caduceus symbol, which features three abstract human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2014
Given Imaging, Ltd. Hila Debby Director, Clinical & Regulatory 2 Hacarmel Street New Industrial Park, PO Box 258 Yogneam 20692 Israel
Re: K140284
Trade/Device Name: Given PillCam UGI capsule endoscopy system Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: November 11, 2014 Received: December 15, 2014
Dear Hila 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.
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Benjamin R. Fisher -A
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
2
INDICATIONS FOR USE
K140284 510(k) Number (if known):
Device Name: Given PillCam UGI capsule endoscopy system
Indications for Use:
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 least18 years of age.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box with the word "GIVEN" in white, with the "I" in "GIVEN" being a stylized image of a pill. Below the word "GIVEN" is the word "IMAGING" in white. To the right of the logo are several blue squares.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
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.
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@givenimaging.com |
| Phone Number: | 972 (4) 909-7774 |
| Fax Number: | (972) 73-2501533 |
| Establishment
Registration
Number: | 9710107 |
| Date Prepared: | January 30, 2014 |
| Device Trade
Name(s): | Given® PillCam® UGI capsule endoscopy system |
| Device Common
Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| Classification: | Regulation No: 876.1300, Class: II
Panel: Gastroenterology/Urology
NSI- System, Imaging, Esophageal, Wireless, Capsule
NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Predicate
Device(s): | · Given Diagnostic System with PillCam ESO 2 capsule
(K071153)
● Given PillCam Platform System with RAPID 6.5 and Given
PillCam Platform with ESO 3 capsule (K103025)
· Given PillCam® SB 3 capsule endoscopy system (K123864)
• Given PillCam® COLON 2 capsule endoscopy system
(K123666) |
4
Image /page/4/Picture/0 description: The image contains the logo for Given Imaging. The logo is in a blue box and contains the text "Given" in white, with a green triangle below the text. Below the triangle is the text "Imaging" in white. To the right of the logo are several blue squares of varying shades.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
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.
- Ingestible PillCam Capsule
-
- DR 3 PillCam Recorder
DR 3 PillCam Recorder is an external The receiving/recording unit that receives and stores the acquired images from the capsule.
- DR 3 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. RAPID 8.0 supports PillCam capsule endoscopy of the GI
- RAPID Software
tract with all PillCam video capsules. In addition, RAPID 8.0 supports PillCam Recorder DR 2C and PillCam Recorder DR 3.
-
- Given Workstation and Accessories
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The PillCam Recorder is an external receiving/recording unit that receives acquired images from the capsule. The Sensor Array receives data from the PillCam capsule and transfers the data to the PillCam Recorder. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.
- Given Workstation and Accessories
-
Indication for use: 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 the upper gastrointestinal tract (esophagus, stomach, in duodenum) in patients who are hemodynamically stable and at least18 years of age.
5
Image /page/5/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box with the words "Given" and "Imaging" in white. The "i" in Given is replaced with a green triangle. To the right of the logo are several blue squares in different shades.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
The technological characteristics are similar to the predicate Technological Characteristics: devices (ESO 2, ESO 3 and COLON 2 capsules). There are two modifications compared to the ESO 2 and ESO 3 capsules that are listed in Section 12 of this submission. However, it may be concluded from the Substantial Equivalence Summary that none of the presented changes raise any new safety issues. These two modifications have been made in order to achieve better coverage of the upper GI tissue. The first modification is the prolonged operation time. The second modification is the adaptive frame rate [35 frames per second (fps) in the first 10 minutes and 18 frames per second (fps) in the remaining 80 minutes]. No new safety issues were raised due to the proposed design. Optical Features 4 white LEDs per optical head are used as the UGI capsule illumination source. The Field of view is 172° (ISO 9600-3) and the Effective Visibility distance is set to 0-30mm. Bench testing: Since PillCam UGI capsule and the COLON 2 capsule predicate device are identical in terms of external components and technology, the biting test and pH resistance test for the predicate device are applicable for PillCam UGI capsules as well. In addition optical resolution test results demonstrate that different pH environments do not affect the optical performance of the PillCam capsule, specifically the image quality.
The device meets the guidance entitled "Class II Special Performance Data: Controls Guidance Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001. The proposed changes in this submission do not raise new performance or safety issues.
Conclusion: Based on the technological characteristics of the devices, Given Imaging Ltd. believes that the PillCam UGI capsule endoscopy system and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.