(112 days)
No
The document describes image processing and a "Suspected Blood Indicator (SBI) feature," but there is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms in medical devices. The description of the system is based on image capture, transmission, storage, and processing for physician review, which is standard for capsule endoscopy systems and does not inherently imply AI/ML.
No.
The device is used for visualization and detection of abnormalities, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for visualization of the small bowel mucosa" and "may be used as a tool in the detection of abnormalities of the small bowel." The term "Diagnostic System" is also part of its name.
No
The device description clearly states the system is comprised of three subsystems: PillCam™ Capsule, Data Recorder Set, and RAPID® Workstation. While the submission focuses on new software for the workstation, the overall system includes hardware components (capsule, recorder, antennas).
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Given® Diagnostic System with the PillCam™ capsules is designed for visualization of the small bowel and esophageal mucosa within the body. It captures images as the capsule passes through the GI tract.
- No Sample Analysis: The system does not analyze samples taken from the body. It is a direct imaging system.
Therefore, while it is a diagnostic tool, it falls under the category of in vivo diagnostic devices rather than in vitro diagnostics.
N/A
Intended Use / 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 detection of abnormalities of the small bowel in adults and children from 10 years of age and up
With PillCam™ ESO Capsule: The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
Product codes
78NZE, 78NSI, NSI, NEZ
Device Description
The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The PillCam™ Capsules are wireless, disposable capsules designed to glide smoothly through the GI tract. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician. A new RAPID® software application, RAPID® 4, for the RAPID® Workstation is the subject of this submission.
Mentions image processing
The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bowel mucosa, esophageal mucosa
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, K041149, K042960
Reference Device(s)
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.”
0
Page 1 of 2
DEC I 2005
ATTACHMENT 6-1
510(K) SUMMARY
RAPID® 4 (for Given® Diagnostic System) 510(k) Number K_052184
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 Corporate V.P. Regulatory & Medical Affairs Tel: 011-972-4- 9097784 Fax: 011-972-4-9938060 Email: shosh@givenimaging.com
Trade Name:
RAPID® 4 (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, and K040248.
- Given® Diagnostic System with PillCam™ ESO Capsule cleared under K041149 and K042960
1
K052184 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:
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 detection of abnormalities of the small bowel in adults and children from 10 years of age and up
With PillCam™ ESO Capsule: The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
Device Description:
The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The PillCam™ Capsules are wireless, disposable capsules designed to glide smoothly through the GI tract. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician. A new RAPID® software application, RAPID® 4, for the RAPID® Workstation is the subject of this submission.
Substantial Equivalence:
Given Imaging Ltd. believes that, based on the information provided in this submission, the Given® Diagnostic System with RAPID® 4 is substantially equivalent to the market cleared Given® Diagnostic System with previous versions of the RAPID® software application without raising any new safety and/or efficacy issue.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2005
Shosh Friedman, RAC Corporate V.P. Regulatory & Medical Affairs Given Imaging Limited Herman Building (Shaar Yokneam) New Industrial Park P.O. Box 258 Yogneam 20692 ISRAEL
Re: K052184
KUS2184
Trade/Device Name: RAPID® 4 for the Given® Diagnostic System with PillCam™ ESO and SB Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NSI and NEZ Dated: October 7, 2005 Received: October 11, 2005
Dear Ms. Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becared by equivalent (for the indications for use stated in above and nave occerimined the as redicate devices marketed in interstate commerce prior to the enclosure) to regally marketse predicate deal Device Amendments, or to devices that have been May 26, 1770, the clacultions dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the proval application (PMA). You may, therefore, market the do not require approval or a premation approvisions of the Act. The general controls provisions of the Act device, subject to the general oomons priors, 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 device is classified (386 able) into major regulations affecting major regulations affecting your Approval), It may oc subject to subject to successions, Title 21, Parts 800 to 898. In addition, FDA device can be round in nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that 1 DA 3 issualled of a vith other requirements of the Act or any FDA has made a decemination and Joan BS House Federal agencies. You must comply with all the Federal statues and regulations administed to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, medium, but hot mixted to requirements as set forth in the quality systems (QS) (21 CFR 1 at 801); good manufacturing prades the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notheation: "The I DA midmig of backnown
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 11 you desire specific advice tor your ac restled to 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 notifications" (21 CFR Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). I ou may outer genoral missal 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. Hogdon
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): __K052184
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 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
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
K05-2184
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number _
6-6