(210 days)
Not Found
No
The document describes image processing and analysis but does not mention AI, ML, or related terms like neural networks or deep learning. The "Suspected Blood Indicator (SBI) feature" is mentioned, which could potentially use AI/ML, but the description doesn't provide enough detail to confirm this. Without explicit mention or a more detailed description of the algorithm used for the SBI feature, it's not possible to definitively say AI/ML is incorporated.
No.
The device is strictly for visualization and detection of abnormalities in the small bowel, and verification of patency, not for treating any condition.
Yes
The device is intended for "visualization of the small bowel mucosa" and "may be used as a tool in the detection of abnormalities of the small bowel," which are diagnostic purposes. The Suspected Blood Indicator (SBI) feature further aids in identifying potential diagnostic findings.
No
The device description explicitly states that the Given PillCam® Platform is comprised of three main subsystems: the ingestible PillCam capsule (hardware), the RAPID® software, and the Given® Workstation and Hardware. The Agile Patency System also includes an ingestible capsule and an external scanner (both hardware). Therefore, the device is not software-only.
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). This device, the PillCam Platform, is designed to be ingested and capture images within the body.
- The primary function is visualization and imaging. While the RAPID software processes and analyzes the images, the core purpose is to visualize the small bowel mucosa and detect abnormalities through direct observation, not through the analysis of biological samples.
- The AGILE Patency System is also ingested and its function is mechanical/physical (checking for strictures) rather than analyzing a biological sample.
The device falls under the category of medical imaging devices, specifically for endoscopic visualization of the gastrointestinal tract.
N/A
Intended Use / Indications for Use
The Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures in adults and children from two years of age.
Product codes (comma separated list FDA assigned to the subject device)
NEZ, NSI
Device Description
The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.
-
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 DataRecorder located outside the body. -
RAPID Software
The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms. -
Given Workstation and Hardware
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The SensorArray receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.
The Given Agile Patency System is designed to determine which patients with known or suspected intestinal strictures can safely ingest a PillCam video capsule. The system consists of an ingestible and dissolvable capsule that is the same size as the PillCam SB capsule, and an external scanner.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images acquired by an ingestible capsule.
Anatomical Site
Small bowel mucosa, gastrointestinal tract.
Indicated Patient Age Range
Adults and children from two 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)
Clinical data has been summarized to show safety and effectiveness for the proposed indications for use.
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.
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.”
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K090557 Page 1 of 3
Given Imaging Limited New Industrial Park PG Box 258. Yogneam
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:
Contact Person:
Fax Number:
Date Prepared:
Given Imaging Ltd. Hermon Building New Industrial Park PO Box 258 Yogneam 20692 Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9938060 Tim Thomas Global Director, Regulatory and Quality
Email: tim thomas@givenimaging.com
Phone Number:
770-662-0510
9710107
770-662-0870 ext. 1006
Given® AGILE Patency System
Establishment Registration Number:
February 23, 2009
Device Trade Name(s):
Device Common Name:
Classification:
Regulation No: 876.1300 Class: II Panel: Gastroenterology NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule NSI - System, Imaging, Esophageal, Wireless, Capsule
Ingestible telemetric gastrointestinal capsule imaging system
Given PillCam® Platform with PillCam® SB Capsules
Predicate Device(s):
Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® AGILE Patency System (K053639)
Given Imaging Ltd. Now Industrial Park, PO Box 258, Yoqueam 20692, Isract
Image /page/0/Picture/19 description: The image shows the logo for Given Imaging. The logo consists of the text "Given" in a large font, with a stylized image of a capsule endoscopy device between the words. Below the word "Given" is the word "Imaging" in a smaller font.
SEP 2 8 2009
1
K090557 Page 2 of 3
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20602 Israel Voice 972 4 909 77.77 Fax 972 4 959 2466
Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo is in black and white and features the words "Given" and "Imaging" in a sans-serif font. There is an image of a capsule between the two words. The logo is simple and modern.
General Device Description:
The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.
- 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 DataRecorder located outside the body.
RAPID Software
2
The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.
ਤੇ Given Workstation and Hardware
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The SensorArray receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.
The Given Agile Patency System is designed to determine which patients with known or suspected intestinal strictures can safely ingest a PillCam video capsule. The system consists of an ingestible and dissolvable capsule that is the same size as the PillCam SB capsule, and an external scanner.
Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqueam 20692. Israel
2
K090557 Page 3 of 3
Given Imaging Limited New Industrial Park PD Box 258, Yogneam 20602 Israel Voice 972 4 909 7777 Fax 972 ± 950 2466
Image /page/2/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "Given" in large, block letters, followed by a stylized image of a capsule. Below the word "Given" is the word "Imaging" in smaller letters. The logo is simple and professional, and it is likely used to represent the company's brand.
Intended Use:
SB Indications for Use:
The Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
AGILE Indications for Use:
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures in adults and children from two years of age.
The technology characteristics are exactly the same as the predicate devices.
The devices meet the guidance entitled "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001. Clinical data has been summarized to show safety and effectiveness for the proposed indications for use.
Based on the technological characteristics and clinical. performance of the devices, Given Imaging Ltd. believes that the Given PillCam® Platform with PillCam® SB Capsules, the Given® AGILE Patency System and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.
Technological Characteristics:
Performance Data:
Conclusion:
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim Thomas Global Director, Regulatory and Quality Given Imaging Limited New Industrial Park, PO Box 258 Yogneam, 20692 ISRAEL
SEP 2 8 2009
Re: K090557
Trade/Device Name: Given® AGILE Patency System and Given PillCam® Platform with PillCam® SB Capsules
Regulation Number: 21 CFR 876.1300
Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ, NSI Dated: September 13, 2009
Received: September 15, 2009
Dear Mr. Thomas:
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.
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. 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
4
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Device Name: Given® AGILE Patency System
Indications for Use:
AGILE Indications for Use:
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures in adults and children from two years of age.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
[K090557](https://510k.innolitics.com/search/K090557)
510(k) Number
Given Imaging Ltd. 510(k) Submission
Given PillCam® Platform with PillCam® SB Capsules
Given® AGILE Patency System
September 22, 2009
6
Proprietary to Given Imaging Ltd.
INDICATIONS FOR USE
510(k) Number (if known):
510(k) Number (if known):
Device Name: Given PillCam® Platform with PillCam® SB Capsules
Indications for Use:
SB Indications for Use:
The Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number (if known):
Given Imaging Ltd. 510(k) Submission Given PillCam® Platform with PillCam® SB Capsules Given® AGILE Patency System September 22, 2009
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number