(76 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or components that would typically indicate the use of AI/ML. The described features are related to image capture, data recording, and software for review and scoring.
No
The device is described as a "Diagnostic System" for "visualization of the small bowel mucosa" and "detection of abnormalities," which are diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "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." Detection of abnormalities for medical purposes is a diagnostic function.
No
The device description explicitly states the system is comprised of three subsystems: PillCam™ Capsule, Data Recorder Set, and RAPID® Workstation or RAPID® Software. This includes hardware components (capsule and data recorder) in addition to the software.
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® Diagnostic System with the PillCam™ SB2 Capsule is used for visualization of the small bowel mucosa. It involves a capsule that is swallowed and captures images internally. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples or the detection of substances within those samples, which are hallmarks of IVDs.
Therefore, the device's function and the information provided clearly indicate it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Given® Diagnostic System with the PillCam™ SB2 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 (comma separated list FDA assigned to the subject device)
78NZE, NEZ
Device Description
The Given® Diagnostic System is comprised of three subsystems PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include:
- Addition of a new model of small bowel capsule, the PillCam™ (1) SB2 capsule.
- (2) Addition of three new features to the RAPID Software
- Lewis Score (optional) .
- t Study Management
- Installation for End-User Computers (optional) .
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): 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.
K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805, K062786
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.”
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Page 1 of 2
ATTACHMENT 6-1
510(K) SUMMARY
MAY -- 7 2007
Expanding the scope of C++
Given® Diagnostic System with PillCam™ SB2 Capsule
510(k) Number K070475
Applicant's Name:
Given Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Zone P.O. Box 258 Yoqneam 20692, Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9592466
Contact Person:
Shosh Friedman, RAC Senior Consultant 91 Rokyspring Cir. NW Calgary, AB T3G 6A1, Canada Tel: (403) 208-4916 Fax: (403) 208-4953 Email: Shosh.Friedman@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 CFR 876.1300) and they are reviewed number 21 bv the Gastroenterology Panel.
Predicate Device:
Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786
1
K070475 Page 2 of 2
Performance Standards and Special Controls:
The Given® Diagnostic System complies with the requirements presented in "Class II Special Controls Guidance Document; 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™ SB2 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 (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include:
- Addition of a new model of small bowel capsule, the PillCam™ (1) SB2 capsule.
- (2) Addition of three new features to the RAPID Software
- Lewis Score (optional) .
- t Study Management
- Installation for End-User Computers (optional) .
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.
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. To the left of the bird, there is text arranged vertically along a curved path, likely the name of an organization or department. The text is somewhat blurry, making it difficult to read the exact words.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Shoshana Friedman, RAC V.P. Regulatory and Medical Affairs Given® Imaging Ltd. 91 Rockyspring Cir. N.W. Calgary, Alberta T3G6A1 CANADA
- 7 2007 MAY
Re: K070475
KU/0475
Trade/Device Name: Given® Diagnostic System with PillCam™ SB2 Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: April 3, 2007 Received: April 6, 2007
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 circular stamp with the text "1906-2006" at the top. Inside the circle, the letters "FDA" are prominently displayed in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. At the bottom of the circle, there are three stars.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I least of advisou mail 1221 i issumines 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) I this lotter will and in your finding of substantial equivalence of your device to a legally promation from the 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 11 you done if compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, picase note the regulation 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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: K0 70475
Device Name:
Given® Diagnostic System
Indications for Use:
The Given® Diagnostic System with the PillCam™ SB2 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)
510(k) Number K070475
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use_
Ruta Phillips
Division Sign Off
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number