(61 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention image processing in a way that suggests AI/ML is used for analysis. The SBI feature is mentioned, but its description doesn't indicate AI/ML is used for the marking process.
No
The device is described as a "Diagnostic System" intended for "visualization" of the small bowel and esophageal mucosa to "mark frames of the video suspected of containing blood or red areas," indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Given® Diagnostic System" is "intended for visualization of the small bowel mucosa" and "may be used as a tool in the detection of abnormalities." It is also called a "Diagnostic System" multiple times throughout the document.
No
The device description explicitly states that the Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule, Data Recorder Set, and RAPID® Workstation. While the RAPID Access SW is a software application accessory, the overall system includes hardware components (capsule, data recorder, workstation).
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for "visualization of the small bowel mucosa" and "visualization of esophageal mucosa." It is used as a "tool in the lor vivalies abnormalities of the small bowel." This clearly indicates that the device is used to examine internal bodily tissues to aid in diagnosis.
- Device Description: The system includes a "PillCam™ Capsule" which is ingested by the patient. This capsule captures images from within the body.
- Input Imaging Modality: The "Ingestible Telemetric Gastrointestinal/Esophageal Capsule Imaging System" confirms that the device is collecting data from within the patient's body.
- Anatomical Site: The device targets the "small bowel" and "esophageal," which are internal anatomical sites.
While the device doesn't process samples outside the body in the traditional sense of a lab test, the FDA's definition of an IVD includes devices used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. In this case, the "specimen" is the internal lining of the small bowel and esophagus, and the device is used to visualize and assess this "specimen" for abnormalities.
The fact that it's an imaging system that captures data from within the body for diagnostic purposes aligns with the scope of IVDs.
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 lor vivalies 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® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
Product codes (comma separated list FDA assigned to the subject device)
78NZE, 78 NSI, NEZ, NSI
Device Description
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The RAPIDAccess optional accessory system, which is the subject of this Special 510(k) application, is designed to facilitate access to PillCam Capsule Endoscopy by allowing the performance of CE procedure without requiring the use of a full Given® Diagnostic System. It comes in two versions: RAPIDAccess RT (Real-Time), which is a standalone accessory that also allows monitoring the advancement of the capsule through the GI tract, and RAPID Access SW (software application).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bowel, Esophageal mucosa, GI tract
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
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.
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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K608005 Page 1 of 2
ATTACHMENT 6-1
510(K) SUMMARY
MAY 2 4 2006
RAPID® 4 (for Given® Diagnostic System)
510(k) Number K_
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:
RAPIDAccess (for Given® Diagnostic System)
Classification Name:
Ingestible Telemetric Gastrointestinal/Esophageal Capsule Imaging System
Classification:
FDA has classified Ingestible Telemetric Gastrointestinal/Esophageal Capsule Imaging System as class II devices (product code 78NZE for small bowel and 78 NSI for esophageal capsule, regulation no. 876.1300 ) and they are reviewed by the Gastroenterology Panel.
Predicate Device:
- Given® Diagnostic System (with M2A®/PillCam™ SB Capsule) cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184.
- Given® Diagnostic System with PillCam™ ESO Capsule cleared under K041149 and K042960
1
K060805 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; Telemetric Gastrointestinal Capsule Imaging System; Ingestible Final Guidance for Industry and FDA" issued on November 28, 2001
Intended Use:
There is no change in the intended used of the Given® Diagnostic System as a result of including the RAPIDAccess optional accessory system
Device Description:
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The RAPIDAccess optional accessory system, which is the subject of this Special 510(k) application, is designed to facilitate access to PillCam Capsule Endoscopy by allowing the performance of CE procedure without requiring the use of a full Given® Diagnostic System. It comes in two versions: RAPIDAccess RT (Real-Time), which is a standalone accessory that also allows monitoring the advancement of the capsule through the GI tract, and RAPID Access SW (software application).
Substantial Equivalence:
Given Imaging Ltd. believes that the Given® Diagnostic System with RAPIDAccess optional accessory system is substantially the 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 the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is on a white background. The text is likely part of a document or sign.
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 entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The text and symbol are both in black and are set against a white background.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
3
MAY 2 4 2006
Shoshana Friedman, R.A.C. Senior Vice President Regulatory and Clinical Affairs Given® Imaging Limited New Industrial Park P.O. Box 258, Yoqneam ISRAEL 20692
K060805 Re:
Trade/Device Name: Given® Diagnostic System - RAPID Access Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ and NSI Dated: April 26, 2006 Received: April 28, 2006
Dear Ms. Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rove 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 prof to thay 20, 1976, and cordance 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 If your do rever to such additional controls. Existing major regulations affecting your I tppto rary, it ifely 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 is a black and white logo or emblem. It features the letters "PA" in a bold, stylized font, with the text "Centennial" written below. Above the letters, the years "1906-2006" are displayed, indicating a centennial celebration. The entire design is encircled by a border with text, and there are three stars located beneath the word "Centennial".
Protecting and Promoting Public Health
3
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 promation no licate 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (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
1
Enclosure
机
4
ATTACHMENT 6-3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_KO6 © OOOS
Device Name:
Given® Diagnostic System
Indications for Use:
with PillCam™ SB Capsule
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 lor vivalies 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
with PillCam™ ESO Capsule
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use___
Nancy C Brogdon
(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Numbe
6-6