(307 days)
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.
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 provided document K101250 is a 510(k) summary for the Given PillCam Platform with PillCam SB Capsules. It primarily focuses on demonstrating substantial equivalence to a predicate device (Given Diagnostic System with PillCam SB2 Capsule, K090557) and does not contain detailed information about a de novo study with specific acceptance criteria and performance metrics for the device itself beyond its "Suspected Blood Indicator (SBI) feature".
However, the document states: "The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas." And later: "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."
Based on the limited information, here's what can be extracted and inferred, focusing on the SBI feature as the most "AI-like" component described in terms of its function:
Description of Acceptance Criteria and Study for Given PillCam® Platform with PillCam® SB Capsules (with emphasis on SBI feature)
The provided submission primarily focuses on the substantial equivalence of the Given PillCam® Platform with PillCam® SB Capsules to a predicate device (Given® Diagnostic System with PillCam® SB2 Capsule, K090557). It does not outline specific, quantitative acceptance criteria for the overall device's performance (e.g., diagnostic accuracy for specific conditions) in the way one might expect for a de novo device with novel algorithms.
However, the document mentions a "Suspected Blood Indicator (SBI) feature" and states that "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.'"
Given the lack of explicit quantitative acceptance criteria or detailed study results for the SBI feature within this 510(k) summary, specific numerical performance metrics cannot be provided directly from this document. The "Performance Data" section broadly states that clinical data was summarized to show safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
Since the document does not provide specific acceptance criteria or reported performance metrics for the SBI feature (or the overall device's diagnostic ability) in a quantitative format, this table cannot be fully populated as requested. The "acceptance criteria" here implicitly refers to meeting the "Special Controls Guidance Document" and demonstrating safety and effectiveness for the intended use through clinical data summarization.
| Feature/Metric | Acceptance Criteria (Not explicitly stated numerically in this document) | Reported Device Performance (Not explicitly stated numerically in this document) |
|---|---|---|
| Suspected Blood Indicator (SBI) Functionality | The SBI feature is intended to accurately mark frames of video suspected of containing blood or red areas, aiding in the visualization of lesions that may be a source of obscure bleeding or IDA. (Implicitly, the performance should be clinically acceptable and comparable to the predicate device, although specific thresholds are not provided.) | The document states: "The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas." It further mentions that "Clinical data has been summarized to show safety and effectiveness for the proposed indication for use" which includes visualizing lesions that may be a source of obscure bleeding or IDA. However, no specific metrics like sensitivity, specificity, or predictive values for the SBI feature are reported. The basis for approval relies on substantial equivalence and the general claim of safety and effectiveness as supported by the clinical data summary (which is not detailed here). |
| General Device Safety and Effectiveness | Device meets the guidance document "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001." Demonstrates safety and effectiveness for its intended uses. | The conclusion states: "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." No specific performance numbers (e.g., for detection rates of Crohn's, obscure bleeding, or IDA) are provided in this summary. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in this 510(k) summary. The document mentions "Clinical data has been summarized to show safety and effectiveness," implying a study was conducted, but details regarding the size of the test set (number of patients or cases) are absent.
- Data Provenance: Not specified. Standard clinical studies for such devices often involve multiple clinical sites, potentially across different countries. The document does not indicate if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in this 510(k) summary.
4. Adjudication method for the test set:
- Not specified in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- Not explicitly stated that an MRMC comparative effectiveness study was done specifically to quantify how much human readers improve with AI vs. without AI assistance for the SBI feature. The primary focus of this 510(k) is substantial equivalence based on overall device performance and safety, not on the comparative effectiveness of a specific AI assist feature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- It is not explicitly stated whether a standalone performance study of the SBI algorithm was conducted, divorced from human review. The SBI is described as "intended to mark frames... suspected of containing blood or red areas," suggesting it's an assist feature for human review.
7. The type of ground truth used:
- Not explicitly stated. For a device visualizing the small bowel mucosa and detecting lesions, the ground truth would typically be established through consensus of expert gastroenterologists interpreting the capsule endoscopy video, possibly supplemented by findings from conventional endoscopy, biopsy (pathology), or subsequent clinical outcomes if those were part of the study design.
8. The sample size for the training set:
- Not applicable/Not specified. The 510(k) submission primarily relies on substantial equivalence to a predicate device and summarizes clinical data rather than describing the development and training of a novel algorithm from scratch. If the SBI feature involved machine learning, details of its training set would typically be provided in a more detailed technical report, which is not part of this summary.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as information on a specific training set for a novel algorithm within this context is not provided.
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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 andAddress: | Given Imaging Ltd.Hermon BuildingNew Industrial ParkPO Box 258Yokneam 20692IsraelTel.: 011-972-4-9097936Fax: 011-972-4-9938060 |
|---|---|
| Contact Person: | Tim ThomasVice President,Regulatory Affairs and Quality AssuranceEmail: tim.thomas@givenimaging.com |
| Phone Number: | 770-662-0870 ext. 1006 |
| Fax Number: | 770-662-0510 |
| EstablishmentRegistration 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: 876.1300Class: IIPanel: GastroenterologyNEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Predicate Device(s): | Given® Diagnostic System with PillCam® SB2 Capsule(K090557) |
| General DeviceDescription: | The Given PillCam® Platform is comprised of three mainsubsystems; (1) the ingestible PillCam capsule, (2) theRAPID® software, and (3) the Given® Workstation andHardware. |
Given Imaging Ltd. New Industrial Park, PO Box 258, Yokneam 20692, Israel
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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
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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.
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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
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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
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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
§ 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.”