(87 days)
Not Found
No
The document mentions image processing and analysis but does not explicitly state the use of AI or ML algorithms. The "Suspected Blood Indicator (SBI) feature" is mentioned, which could potentially use rule-based image analysis rather than AI/ML. There is no mention of training or test sets for AI/ML models.
No
The device is used for visualization and detection of abnormalities, not for treatment.
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 abnormalities.
No
The device description explicitly states that the Given PillCam® Platform is comprised of three main subsystems, including the ingestible PillCam capsule and the Given® Workstation and Hardware, in addition to the RAPID® software. This indicates the device includes significant hardware components.
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 Given PillCam® Platform with the PillCam® SB Capsules is designed to visualize the small bowel mucosa inside the body using an ingestible capsule that captures video images.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly captures images of the internal anatomy.
Therefore, while it is a medical device used for diagnostic purposes, it does not fit the definition of an In Vitro Diagnostic.
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.
Product codes
NEZ
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 PillCam® SensorBelt 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video images
Anatomical Site
small bowel mucosa, GI 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 validation test has been conducted in order to utilize PillCam® SensorBelt in overweight population with BMI greater than 30 kg/m2, and supporting exclusion of overweight population warning statement in Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt labeling. The validation clinical test was conducted with twenty five healthy volunteers who underwent the SB procedure using PillCam®SB2 capsule, a DR2 DataRecorder, and a PillCam® SensorBelt. There had no multiple ingestions, and each of the twenty five healthy volunteers ingested a separate PillCam® SB2 capsule. There are no new risks raised by utilizing PillCam® SensorBelt in overweight population of BMI >= 30kg/m2. The performance of the SensorBelt has not been studied in patients with BMI greater than 43.3.The clinical validation data presented in details in Section 20 -Performance Testing Clinical of this Traditional 510(k) Notification has shown substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt ,(K091405), Given PillCam Platform with PillCam SB Capsules and Given AGILE Patency System (K090557)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K103088 Pgz 1 of 3
Image /page/0/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GIVEN" in large, bold letters, with a stylized image of a capsule between the "I" and "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters.
Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 77777 Fax 972 4 959 2466
510(k) Summary
JAN 1 4 2011
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.
Hermon Building
New Industrial Park
PO Box 258
Yoqneam 20692
Israel
Tel.: 011-972-4-9097730
Fax: 011-972-4-9938060 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas
Vice President
Regulatory Affairs & Quality Assurance
Email: tim.thomas@givenimaging.com |
| Phone Number: | 770-662-0870 ext. 1006 |
| Fax Number: | 770-662-0510 |
| Establishment
Registration Number: | 9710107 |
| Date Prepared: | October 14, 2010 |
| Device Trade Name(s): | Given PillCam® Platform with PillCam® SB Capsules with
PillCam® SensorBelt |
| Device Common Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| Classification: | Regulation No: 876.1300
Class: II
Panel: Gastroenterology
NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Predicate Device(s): | Given PillCam® Platform with PillCam® SB Capsules with
PillCam® SensorBelt ,(K091405)
Given PillCam Platform with PillCam SB Capsules and Given
AGILE Patency System (K090557) |
| | |
Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel
1
Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GI-EN" in large, bold letters, with a stylized image of a capsule between the "I" and "E". Below the capsule image is the word "IMAGING" in smaller, bold letters. The logo is simple and modern, and it is likely used to represent a medical imaging company.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel
General Device Description:
Intended Use:
The Given PillCam® Platform is comprised of three main subsystems; { } } 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 ನ
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 3
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 PillCam® SensorBelt 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.
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.
Given Imaging Ltd. New Industrial Park, PO Box 258, Yogneam 20692, Israel
2
Image /page/2/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GIVEN" in large, bold letters, with a stylized image of a capsule between the "I" and the "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters. The logo is black and white.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 972 6 000 7777
Technological The technology characteristics are exactly the same as the Characteristics: predicate device. Performance Data: The device meets 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 validation test has been conducted in order to utilize PillCam® SensorBelt in overweight population with BMI greater than 30 kg/m2, and supporting exclusion of overweight population warning statement in Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt labeling. The validation clinical test was conducted with twenty five healthy volunteers who underwent the SB procedure using PillCam®SB2 capsule, a DR2 DataRecorder, and a PillCam® SensorBelt. There had no multiple ingestions, and each of the twenty five healthy volunteers ingested a separate PillCam® SB2 capsule There are no new risks raised by utilizing PillCam® SensorBelt in overweight population of BMI ≥ 30kg/m2. The performance of the SensorBelt has not been studied in patients with BMI greater than 43.3.The clinical validation data presented in details in Section 20 -Performance Testing Clinical of this Traditional 510(k) Notification has shown substantial equivalence to the predicate device.
Conclusion:
Based on the clinical validation data Given Imaging believes that Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt and the predicate devices selected are substantially equivalent and do not change the fundamental scientific technology and intended use of the market-cleared devices.
Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim Thomas Vice President, Regulatory Affairs & Quality Assurance Given® Imaging Limited New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL
JAN 1 4 201
Re: K103088
Trade/Device Name: Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt
Regulation Number: 21 CFR §876.1300
Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II
Product Code: NEZ
Dated: January 4, 2011
Received: January 7, 2011
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. 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. 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 of medical device-related
4
Page 2 .
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/CDRH0fffices/ucm11 1 1 800 1, plass 1 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 Para 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 tollofire number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Richard Lemon MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Proprietary to Given Imaging Ltd.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Given PillCam® Platform with PillCem® SB Capsules with
PillCam® SensorBelt
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)
Given Imaging Ltd. 510(k) Submission
Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt
October 14, 2010
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
| 510(k) Number | K103088 |
|---|---|
| --------------- | --------- |