(112 days)
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.
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.
The provided text describes the RAPID® 4 software for the Given® Diagnostic System. However, it does not include a detailed study proving the device meets specific acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to previously cleared devices.
Here's an analysis of the requested information based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the document. The submission is for a software update (RAPID® 4) to an existing diagnostic system, and the clearance is based on substantial equivalence to previous versions, not on a new set of performance acceptance criteria and a study to meet them.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present. Since no new clinical performance study is detailed, there's no mention of a test set, its sample size, or data provenance. The document only references the existing system's intended use and design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not present. Again, due to the nature of the submission (substantial equivalence for a software update), there is no mention of a new test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not present. As no test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
This information is not present. The document does not describe any MRMC study or any comparison of human readers with and without AI assistance. The RAPID® 4 is a software for processing and viewing images, not explicitly an AI-assisted detection tool with a comparative effectiveness study detailed here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
This information is not present. There is no mention of a standalone algorithm performance study.
7. The Type of Ground Truth Used:
This information is not present. Without a specific performance study outlined, the type of ground truth used is not described.
8. The Sample Size for the Training Set:
This information is not present. The document focuses on the regulatory submission for a software update and does not detail the development or training of any underlying algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not present. Similar to point 8, the document does not describe the establishment of ground truth for any training set.
Summary of what is available in the document:
- Device Name: RAPID® 4 (for Given® Diagnostic System)
- 510(k) Number: K052184
- Applicant: Given Imaging Ltd.
- Intended Use:
- With PillCam™ SB Capsule: Visualization of small bowel mucosa for detection of abnormalities in adults and children (10+). The Suspected Blood Indicator (SBI) feature marks frames with suspected blood or red areas.
- With PillCam™ ESO Capsule: Visualization of esophageal mucosa.
- Device Description: Comprised of PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation. The RAPID® 4 is a new software application for the RAPID® Workstation.
- Predicate Device: Given® Diagnostic System with previous versions of RAPID® software, and the Given® Diagnostic System with PillCam™ ESO Capsule.
- Basis for Clearance: Substantial equivalence to previously cleared devices, without raising new safety and/or efficacy issues. The system complies with "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System."
Conclusion:
The provided document is a 510(k) summary for a software update and emphasizes regulatory clearance based on substantial equivalence to existing devices. It does not present a detailed study outlining specific acceptance criteria and proving the device meets them via a new clinical performance study with associated sample sizes, expert ground truth, or comparative effectiveness studies. The assumption is that the previous versions of the software and system met these criteria, and RAPID® 4 maintains that performance.
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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
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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.
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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.
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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
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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
§ 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.”