(154 days)
Not Found
No
The device description and intended use focus solely on the mechanical delivery of a capsule. There is no mention of image processing, AI, ML, or any related terms. The performance studies described are bench testing and a clinical study focused on successful capsule placement and safety, not algorithmic performance.
No.
The device is indicated for transendoscopic delivery of a video capsule, which is a diagnostic procedure. It does not provide any therapeutic benefit or treatment.
No
The device is a delivery system for a video capsule, not the video capsule itself. It is used to place the capsule for diagnostic purposes, but it does not perform the diagnostic function.
No
The device description clearly outlines physical components (catheter, syringe, capsule holder) and mechanical actions (pneumatic release, cutting with scissors), indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a video capsule into the body (specifically the proximal duodenum). It is a mechanical device used for a procedural purpose.
- Device Description: The description details a catheter, syringe, and capsule holder used to physically place the capsule. It does not describe any components or processes for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely to facilitate the placement of another device (the PillCam capsule).
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time.
Product codes (comma separated list FDA assigned to the subject device)
NEZ, KOG
Device Description
The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts:
- Catheter
- Syringe
- Capsule holder
The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device.
The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.
The PillCam® Express Capsule Endoscopy Delivery System is a single-use, disposable and latex-free product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal duodenum
Indicated Patient Age Range
8 and above
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)
Performance data demonstrating safety and effectiveness of the PillCam® Express™ video capsule delivery device was obtained from non-clinical bench testing and from a clinical validation study. The non-clinical bench testing included strength testing of the cup to the catheter, force to release the capsule, force to maintain the capsule in the cup, and strength of the catheter. The clinical validation study included twenty five patients in the age range of 22-89 years old. All capsules were successfully placed into the duodenum and no serious adverse events were reported in the clinical study.
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.
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 3
GlEN
IMAGING
Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
510(k) Summary
SEP 30 2010
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name and Address: | Given Imaging Ltd.
Hermon Building
New Industrial Park
PO Box 258
Yoqneam 20692
Israel
Tel.: 011-972-4-9097730
Fax: 011-972-4-9938060 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas RAC
Vice President
Regulatory Affairs & Quality Assurance |
| | Email: tim.thomas@givenimaging.com. |
| Phone Number: | 770-662-0870 ext. 1006 |
| Fax Number: | 770-662-0510 |
| Establishment Registration Number: | 9710107 |
| Date Prepared: | April 27, 2010 |
| Device Trade Name(s): | PillCam® Express™ Video Capsule Delivery Device |
| Device Common Name: | Ingestible telemetric gastrointestinal capsule imaging system
& Endoscope and/or accessories |
| Classification: | Regulation No: 21 CFR 876.1300 & 876.1500
Class: II
Review panel - Gastroenterology/Urology
NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule
and KOG - Endoscope and/or accessories |
| Predicate Device(s): | Capsule endoscopy delivery device (K040494) |
Given Imaging Ltd. New Industrial Park. PO Box 258, Yoqncam 20692, I-racl
1
K101200 Page 2 of 3
Image /page/1/Picture/1 description: The image shows the logo for GI-EN Imaging. The logo is in black and white and features the words "GI-EN" in large, bold letters. Below the letters is an image of a medical device. To the right of the image is the word "IMAGING" in smaller letters.
Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Voice 972 4 909 7777 Fax 972 4 959 2466
General Device Description:
The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts:
- Catheter
- 트 Syringe
- Capsule holder
The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device.
The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.
The PillCam® Express Capsule Endoscopy Delivery System is a single-use, disposable and latex-free product.
Indications for Use: Intended Use: The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time The technology characteristics are similar as the predicate Technological device. Characteristics: Performance data demonstrating safety and effectiveness of Performance Data: the PillCam® Express™ video capsule delivery device was obtained from non-clinical bench testing and from a clinical validation study. The non-clinical bench testing included strength testing of the cup to the catheter, force to release the capsule, force to maintain the capsule in the cup, and strength of the catheter. The clinical validation study included twenty five patients in the age range of 22-89 years old. All capsules were successfully placed into the duodenum and no serious adverse events were reported in the clinical study. Based on the technological characteristics and clinical Conclusion: performance of the device, Given Imaging Ltd. believes that
Given Imaging Ltd. New Industrial Park. P() Box 258, Yoqncam 20692, Israel
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Page 3 of 3
Given Imaging Limited
New Industrial Park .PO Box 258, Yoqneam 20692 İsrael Voice 972 4 909 7777 Fax 972 4 959 2466
Given PillCam® Express™ video capsule delivery device and the predicate capsule delivery device selected are substantially equivalent and do not raise new issues of safety or effectiveness.
Image /page/2/Picture/5 description: The image shows the address of Given Imaging Ltd. The address is New Industrial Park, PO Box 258, Yoqneam 20692, Israel. The text is black and the background is white. The text is centered on the page.
Image /page/2/Picture/6 description: The image shows the logo for Glen Imaging. The logo is in black and white and features the words "Glen Imaging" in a stylized font. The word "Glen" is on the top line, and the word "Imaging" is on the bottom line. There is a graphic of a test tube between the two words.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim Thomas VP Regulatory Affairs and Quality Assurance Given Imaging Limited Hermon Building, New Industrial Park P.O. Box 258 Yoqneam 20692 ISRAEL
SEP 3 0 2010
Re: K101200
Trade/Device Name: PillCam® Express™ Video Capsule Delivery Device Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: September 20, 2010 Received: September 21, 2010
Dear Mr. Thomas:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
4
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hubert Lemire MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: PillCam® Express™ Video Capsule Delivery Device
SEP 3 0 2010
Indications for Use:
The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K10/200
Given Imaging Ltd. Traditional 510(k) Submission PillCam® Express™ Video Capsule Delivery Device
April 27, 2010