(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML-specific performance metrics or training/test data. The "Suspected Blood Indicator (SBI) feature" is mentioned, which could potentially use image processing, but the document does not indicate it uses AI/ML for this function.
No.
The device's intended use is "for visualization of the small bowel mucosa" and "as a tool in the detection of abnormalities," which are diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Given® Diagnostic System...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..." which indicates its purpose is to aid in diagnosis.
No
The device description explicitly states the system is comprised of three subsystems: PillCam™ Capsule, Data Recorder Set, and RAPID® Workstation, indicating hardware components are integral to the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization of the small bowel mucosa" and "detection of abnormalities of the small bowel." This describes a diagnostic imaging system used to directly observe the internal anatomy.
- Device Description: The components listed (PillCam™ Capsule, Data Recorder Set, RAPID® Workstation) are consistent with an imaging system, not a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples like blood, urine, tissue, etc., which is the defining characteristic of an IVD. The device captures images from within the body.
Therefore, the Given® Diagnostic System with the PillCam™ SB Capsule is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Given® Diagnostic System with the PillCam™ SB Capsule 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.
Product codes
78NZE, NEZ
Device Description
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bowel mucosa, small bowel
Indicated Patient Age Range
adults and children from 10 years of age and up
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805
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.”
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page 1 of 2
ATTACHMENT 6-1
0C1 1 8 2006
GI EN
IMAGING
510(K) SUMMARY Given® Diagnostic System 510(k) Number KQ6 2786
Expanding the scope of
Applicant's Name:
Given Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Zone P.O. Box 258 Yogneam 20692, Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9592466
Contact Person:
Shosh Friedman, RAC Senior V.P. Regulatory & Clinical Affairs Tel: 011-972-4- 9097784 Fax: 011-972-4-9938060 Email: shosh@givenimaging.com
Trade Name:
Given® Diagnostic System
Classification Name:
Ingestible Telemetric Gastrointestinal Capsule Imaging System
Classification:
FDA has classified Ingestible Telemetric Gastrointestinal Capsule Imaging System as class II devices (product code 78NZE, regulation number CFR 876.1300) and they 21 are reviewed by the Gastroenterology Panel.
Predicate Device:
Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, and K060805
Performance Standards and Special Controls:
The Given® Diagnostic System complies with the requirements presented in "Class II Special Controls Guidance Document.
1
K062706 Page 2 of 2
Ingestible Telemetric Gastrointestinal Capsule Imaging System Final Guidance for Industry and FDA" issued on November 28, 2001
Intended Use:
The Given® Diagnostic System with the PillCam™ SB Capsule 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
Device Description:
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.
Substantial Equivalence:
Given Imaging Ltd. believes that the modified Given® Diagnostic System is substantially equivalent to the market cleared Given® Diagnostic System without raising any new safety and/or efficacy issue.
Image /page/1/Picture/10 description: The image shows the logo for Given Imaging. The logo has the word "GI" in large, bold letters, followed by an image of what appears to be a capsule with waves emanating from the bottom. To the right of the capsule is the word "IMAGING" in smaller, bold letters. Below the logo is the phrase "Expanding the scope of GI" in a smaller, italicized font.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 8 2006
Shoshana Friedman, R.A.C. Senior V.P. Regulatory and Clinical Affairs Given® Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Park P.O. Box 258 Yoqneam 20692 ISRAEL
Re: K062786
Trade/Device Name: Given® Diagnostic System い
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: September 15, 2006 Received: September 18, 2006
Dear Ms. Friedman:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The logo is circular with the letters FDA in a stylized font at the center. Below the logo, the words "Promoting Public" are visible, suggesting a public service or health-related context.
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Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT 6-3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO6 2786
Device Name:
Given® Diagnostic System
Indications for Use:
The Given® Diagnostic System with the PillCam™ SB Capsule 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
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use_
David b. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
6-6