(28 days)
No
The summary describes image processing on a workstation but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as being for "visualization of esophageal mucosa" and the "PillCam™ ESO Capsule" transmits "digital data" to be stored and viewed by a physician. This indicates a diagnostic purpose rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Given® Diagnostic System...is intended for the visualization of esophageal mucosa," which is a diagnostic purpose.
No
The device description clearly states that the system is comprised of three subsystems: a capsule (hardware), a data recorder (hardware), and a workstation (which includes software but is part of a larger hardware system). This is not a software-only device.
Based on the provided information, the Given® Diagnostic System with the PillCam™ ESO Capsule 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™ ESO Capsule is a system for visualizing the esophageal mucosa. It involves a capsule that is swallowed and transmits images from inside the body. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use is for "visualization of esophageal mucosa," which is a direct observation of the internal anatomy, not a test performed on a sample.
Therefore, this device falls under the category of medical devices used for imaging or visualization within the body, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
Product codes
78 NSI
Device Description
The Given® Diagnostic System with the PillCam™ ESO Capsule is comprised of three subsystems: PillCam™ ESO Capsule, Data Recorder Set, and RAPID® Workstation.
The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. 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.
The reason for this submission is the implementation of two modifications in the system: (1) improved capsule model that transmits images at a rate of 14 frames per second (fps); and (2) release of an improved version of the RAPID Software application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal mucosa
Indicated Patient Age Range
Not Found
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)
Given® Diagnostic System with PillCam™ (M2A®) ESO Capsule (K041149)
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.”
0
510(K) SUMMARY
Given® Diagnostic System with PillCam™ ESO Capsule
510(k) Number K042960
Applicant's Name:
Given Imaging Ltd. 13 HaYetzira St. P.O. Box 258 New Industrial Zone Yokneam 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:
Given® Diagnostic System
Classification Name:
Ingestible Telemetric Gastrointestinal Capsule Imaging System
Classification:
FDA has classified Ingestible Telemetric Esophageal Capsule Imaging System as class II devices (product code 78 NSI) and they are reviewed by the Gastroenterology Panel.
Predicate Device:
Given® Diagnostic System with PillCam™ (M2A®) ESO Capsule (K041149)
1
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™ ESO Capsule is intended for the visualization of esophageal mucosa.
Device Description:
The Given® Diagnostic System with the PillCam™ ESO Capsule is comprised of three subsystems: PillCam™ ESO Capsule, Data Recorder Set, and RAPID® Workstation.
The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. 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.
The reason for this submission is the implementation of two modifications in the system: (1) improved capsule model that transmits images at a rate of 14 frames per second (fps); and (2) release of an improved version of the RAPID Software application.
Substantial Equivalence:
Given Imaging Ltd. believes that, based on the information provided in this submission, the Given® Diagnostic System with PillCam™ ESO Capsule is substantially equivalent to the market-cleared Given® Diagnostic System with the PillCam™ ESO Capsule without raising any new safety and/or efficacy issue.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or a symbol representing health and human services, depicted with flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Shosh Friedman, RAC Corporate V.P. Regulatory & Medical Affairs Given Imaging Ltd. 13 HaYetzira Street, P.O. Box 258 New Industrial Zone Yoqneam 20692 ISRAEL
K042960 Re:
Trade/Device Name: Given® Diagnostic System with PillCam™ ESO Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NSI Dated: October 10, 2004 Received: October 27, 2004
Dear Ms. Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave tevitwed your becared by equivalent (for the indications for use stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the cherosale) to regary maneloa procession Medical Device Amendments, or to devices that have been May 20, 1770, the chaemient acts of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a prematet approval application (PMA). You may, therefore, market the do not require approval of a promance appesions of the Act. The general controls provisions of the Act de nec, subject to the general 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 device is othssilled (000 additional controls. Existing major regulations affecting your Apploval), it may be subject to satir aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban of round mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I case oe acternination that your device complies with other requirements of the Act or any FDA has made a accertifications administered by other Federal agencies. You must comply with all the I caraf statues and regulating, 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) (2) Cr F r art 80 75 good may applicable, 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) 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.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/dsma/dsmamain.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 (if known): _ Ko4 2960
Device Name:
Given® Diagnostic System with PillCam™ ESO Capsule
Indications for Use:
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 K042960
Prescription Use $\checkmark$
(Per 21 CFR 801.109)
Division of Reproductive, Abd and Radiological Devices
(Division Sign
510(k) Number
OR
Over the Counter Use_