(78 days)
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 10 years of age and up.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
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.
l. 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.
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 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.
The provided text focuses on the 510(k) summary for the Given PillCam® Platform and does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. The document 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." However, it does not provide the specific metrics or outcomes from any study demonstrating this compliance.
Therefore, most of the requested information cannot be extracted from the given text.
Here's an attempt to answer the questions based only on the provided snippet, acknowledging the lack of detailed performance data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from guidance document) | Reported Device Performance (from guidance document compliance) |
|---|---|
| (Not specified in this document, but referred to as "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001") | "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." |
2. Sample size used for the test set and the data provenance
Not provided in the document. The document only mentions "design control (verification and validation) activities" without detailing specific studies, sample sizes, or data provenance for any test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not provided in the document.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not mentioned or indicated in the document. The "Suspected Blood Indicator (SBI) feature" is described as intended to "mark frames of the video suspected of containing blood or red areas," but no study on reader improvement with this feature is presented.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not specifically stated in the document. The SBI feature is an algorithm, but its standalone performance metrics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
Summary of what is known:
The filing states that the device's technological characteristics are "exactly the same as the predicate device" and 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." The submission concludes that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable and acceptable under the existing regulatory framework for such devices. However, the specific data, metrics, and study details that demonstrate this compliance are not included in the provided 510(k) summary.
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K091405 Page 1 of 3
Image /page/0/Picture/1 description: The image shows the logo for Given Imaging. The logo is black and white and features the company name in a bold, sans-serif font. The word "GIVEN" is on the top line, and the word "IMAGING" is on the bottom line. There is a graphic of a capsule between the two words.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20602 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
510(k) Summary
JUL 2 9 2009
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 Yogneam 20692 Israel Tel .: 011-972-4-9097730 Fax: 011-972-4-9938060 Tim Thomas
Contact Person:
Phone Number:
Date Prepared:
Contact Person.
Email: tim.thomas@givenimaging.com
Global Director, Regulatory and Quality
770-662-0870 ext. 1006
770-662-0510
Fax Number:
Establishment Registration Number:
9710107
May 7, 2009
Device Trade Name(s):
Device Common Name:
Classification:
May 7, 2009
Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt
Ingestible telemetric gastrointestinal capsule imaging system
Regulation No: 876.1300 Class: II Panel: Gastroenterology NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule
Predicate Device(s):
Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® Diagnostic System (K062786)
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K091405 Page 2 of 3
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
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.
l. 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.
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 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.
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 10 years of age and up.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
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K091405 Page-353
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 or pill below the letters. To the right of the word "GIVEN" is the word "IMAGING" in smaller letters. The logo is simple and modern, and it is likely used to promote the company's products or services in the medical imaging field.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Volce 972 4 909 777 Fax 972 4 959 2466
Technological Characteristics:
Performance Data:
Conclusion:
The technology characteristics are exactly the same as the predicate device.
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.
Based on the design control (verification and validation) activities, Given Imaging Ltd. believes that the Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt and the predicate device selected are substantially equivalent and do not change the fundamental scientific technology and intended use of the market-cleared device.
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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 features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim Thomas Global Director Regulatory and Quality Given Imaging Limited New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL
1111 9 8 2009
Re: K091405
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: June 26, 2009
Received: July 1, 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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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
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INDICATIONS FOR USE
510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Given PillCam® Platform with PillCam® 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 10 years of age and up.
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)
| (Division Sign Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Division of Reproductive, Abdominal,and Radiological Devices | |
| 510(k) Number | K091405 |
Given Imaging Ltd. Special 510(k) Submission
Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt
May 7, 2009
§ 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.”