(307 days)
Not Found
No
The document describes image processing and analysis, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The "Suspected Blood Indicator (SBI) feature" is described as marking frames, which could be a rule-based algorithm rather than an AI/ML model.
No
The device is described for visualization and monitoring of conditions, not for treating them.
Yes
The device's intended use clearly states it is for "visualization of the small bowel mucosa" to "monitoring of lesions," "visualization of lesions that may be a source of obscure bleeding," and "visualization of lesions that may be potential causes of iron deficiency anemia (IDA)," explicitly functioning as a diagnostic tool for identifying abnormalities.
No
The device description clearly states that the system is comprised of three main subsystems: the ingestible PillCam capsule (hardware), the RAPID software, and the Given Workstation and Hardware (including a DataRecorder, SensorArray, and other accessories). This indicates the device is a system with significant hardware components, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The PillCam system acquires images inside the body during its passage through the GI tract. It does not analyze biological samples like blood, urine, or tissue in vitro (outside the body).
- The primary function is visualization. The intended use and device description clearly state that the system is for "visualization of the small bowel mucosa" and acquiring "video images." While the software processes and analyzes these images, the core function is image capture and display, not the analysis of biological specimens.
- The Suspected Blood Indicator (SBI) feature is based on image characteristics. The SBI feature marks frames "suspected of containing blood or red areas," which is an analysis of the visual data, not a biochemical or cellular analysis of a specimen.
In summary, the PillCam Platform with PillCam SB capsules is an in vivo imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa.
- The PillCam Platform with PillCam SB capsules may be used in the visualization and . monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of . lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of ● lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
Product codes (comma separated list FDA assigned to the subject device)
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 1.
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.
2 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.
3 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bowel mucosa, small bowel, 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)
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 indication 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.
Given® Diagnostic System with PillCam® SB2 Capsule (K090557)
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/0 description: The image shows the logo for ULTEN IMAGING. The logo consists of the word "ULTEN" in large, bold, sans-serif font, with a stylized image of a camera lens or optical device between the "L" and "T". Below the word "ULTEN" is the word "IMAGING" in a smaller, sans-serif font. The logo is black and white.
K101250 Pgz/
MAR - 7 2011
New Industrial Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
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.
Hermon Building
New Industrial Park
PO Box 258
Yokneam 20692
Israel
Tel.: 011-972-4-9097936
Fax: 011-972-4-9938060 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas
Vice President,
Regulatory Affairs and 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: | May 3, 2010 |
| Device Trade Name(s): | Given PillCam® Platform with PillCam® SB Capsules |
| 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® Diagnostic System with PillCam® SB2 Capsule
(K090557) |
| 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. |
Given Imaging Ltd. New Industrial Park, PO Box 258, Yokneam 20692, Israel
1
Image /page/1/Picture/0 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 goblet or chalice in between the "I" and the "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters. The logo is simple and modern, and the use of the goblet or chalice suggests a connection to medicine or health.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
Ingestible PillCam Capsule 1.
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.
2 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.
3 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.
Given Imaging Ltd. New Industrial Park, PO Box 258, Yokneam 20692, Israel
2
Image /page/2/Picture/0 description: The image shows the logo for "ULTEN IMAGING". The logo features the word "ULTEN" in bold, sans-serif font, with a stylized image of a lightbulb or lamp between the letters "L" and "T". Below "ULTEN", the word "IMAGING" is printed in a similar font, but slightly smaller in size.
K101250 Page 39
uren maging limited
Intended Use: SB Indications for Use: The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa. The PillCam Platform with PillCam SB capsules may . be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may . be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may . be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. Technological The technology characteristics are exactly the same as the Characteristics: predicate devices. Performance Data: 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 indication for use. Conclusion: Based on the technological characteristics and clinical performance of the devices, Given Imaging Ltd. believes that the Given PillCam® Platform with PillCam® SB Capsules and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.
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 stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines, representing health and human services. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 Ltd. New Industrial Park, Hermon Building P.O. Box 258 Yogneam 20692 ISRAEL
MAR - 7 2011
Re: K101250
Trade/Device Name: Given PillCam® Platform with PillCam® SB Capsules Regulation Number: 21 CFR 8876.1300 Regulation Name: Ingestible telemetric gastro-intestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: February 26, 2011 Received: March 1, 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/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,
Stubert Lemmer 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
INDICATIONS FOR USE
| 510(k) Number (if known): | K101250 |
|---|---|
| --------------------------- | --------- |
Device Name: Given PillCam® Platform with PillCam® SB Capsules
Indications for Use:
The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa.
- The PillCam Platform with PillCam SB capsules may be used in the visualization and . monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of . lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of ● lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
Prescription Use AND/OR × (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101250
Given Imaging Ltd. 510(k) Submission Given PillCam® Platform with PillCam® SB Capsules February 26, 2011