(359 days)
Not Found
Yes
The device description mentions a "Suspected GI Bleeding Indicator (SGIB)" which is intended to "mark frames of the video suspected of containing blood or red areas." This functionality, while not explicitly labeled as AI/ML, strongly suggests an automated image analysis algorithm is being used to identify specific visual features (blood/red areas) within the video stream. This type of automated feature detection and marking is a common application of machine learning in medical imaging.
No.
The device is intended for visualization and detection of abnormalities, which are diagnostic purposes, not therapeutic (treatment) purposes.
Yes
The device is intended for "visualization of the small bowel mucosa" to "detect abnormalities." It also includes a "Suspected GI Bleeding Indicator (SGIB)" which "marks frames of the video suspected of containing blood or red areas." This function directly supports the identification of medical conditions or diseases, which is the definition of a diagnostic device. The "physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel" to make a diagnosis.
No
The device description clearly lists hardware components (MiroCam® Capsule, Data Cables, MiroCam® Receiver, MiroView™ Workstation) in addition to the software.
Based on the provided information, the MiroCam® Capsule Endoscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- MiroCam® Function: The MiroCam® system is designed to visualize the small bowel mucosa inside the patient's body using a swallowed capsule with a camera. It captures images of the internal anatomy.
- Lack of Sample Testing: The system does not involve collecting samples from the patient and performing tests on them outside the body.
The MiroCam® is an in vivo diagnostic device, meaning it is used to diagnose conditions within the living body.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The MiroCam® Capsule Endoscope System 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.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
Product codes (comma separated list FDA assigned to the subject device)
NEZ
Device Description
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule
- Data Cables
- MiroCam® Receiver
- MiroView™ Software and Workstation
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the MiroView™ workstation and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
MiroCam® Capsule: Functionally, the MiroCam® captures imaging via a CMOS imaging sensor for at least 11 hours at the rate of 3 images per second. Six white LEDs flash in concert with the imaging sensor. A sensor PCB links the imaging sensor to the two gold electrodes of the capsule, from which a weak current is emitted containing the image data via Human Body Communication technology. The weak current is then passed through the bodily tissue and fluid to be picked up by the sensor pads. Human Body Communications is uni-directional from the capsule to the sensor pads. Physically, the capsule is 24mm in length, and 10.8mm in diameter. The exterior of the capsule is composed of biocompatible materials, capable of withstanding potential bite forces and exposure to fluids in the GI tract.
MiroCam® Receiver: The image data from the capsule is saved to the MiroCam® Receiver via the sensor pads and data cables. The sensor pads are standard ECG type sensor pads (3M Red Dot), which are affixed to the patient's abdomen according to the location guide. The 9 sensor pads are attached to the 9 leads of the data cable is subsequently attached to the Receiver. The Receiver sits in a shoulder pouch, which is put on the patient for the duration of the procedure. A waist pouch is used to organize the data cables. The Receiver can store images for up to 12 hours. The three indicators on the Receiver are for battery status, initialization status of the receiver, and status of signal receipt from the capsule. The dimensions of the receiver are 140mm in height, 85mm in width, and 40mm in length. The units weight 350grams with the battery, which is data cable. The battery is lithium ion, and is unique to the Receiver. The battery is rechargeable, and can be charged by placing in the battery charger provided with the Receiver. The receiver uses a storage flash for storing the images.
Workstation: Image data 'is uploaded to the MiroView™ workstation from the MiroCam® Receiver via a USB cable connection. The MiroView™ workstation is a PC with the MiroView™ software installed. The workstation also includes a printer and LCD monitor. The MiroView™ software enables the following key operator tasks: receiver management and upload of image data; diagnostic review of images by the physician; creation of capsule endoscopy procedure patient reports; user administration; and export of image data and reports. Included in the diagnostic review interface is a number of features to optimize the efficiency of the diagnostic review, including variable viewing speed (1 to 40 frames per second), suspected GI bleeding indicator (SGIB), and Quick mode. Images of suspected disease pathology or transit points in the GI tract are readily captured for inclusion in the report. Included with the MiroView™ workstation is a copy of MiroView™ Express. MiroView™ Express is a scaled down version of the MiroView™ software; only supporting the diagnostic review and reporting functionality detailed above. The receiver cannot be connected to the MiroView™ Express software. This software can be installed on remote PCs, notebooks or laptops to enable review of patient files at the convenience of the reviewer. Patient files are transferred from MiroView™ workstation to the MiroView™ Express via DVD or USB.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image capture via CMOS imaging sensor
Anatomical Site
Small bowel mucosa / GI tract
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician (Gastroenterologist)
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)
A multi-center, prospective, randomized, open-label clinical trial was performed on the MiroCam® Capsule Endoscope System. The effectiveness endpoint was to compare the agreement between MiroCam® and predicate device with respect to the detection and identification of sources of small bowel bleeding. The concordance rate and corresponding 95% confidence interval were estimated. The 89 of the 105 subjects were evaluable for the effectiveness analysis, having at least 2 hours of small bowel imaging time successfully. The overall agreement on the identification (cause) of small bowel bleeding between MiroCam® and predicate device was 74.16% (66 of 79). The results of this clinical testing conclude that the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System is safe, performs as intended, and meets the user needs.
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.”
0
11450 Page 1 of 5
MAY 1 8 2012
510(k) Summary
·This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Company and Correspondent making the submission
| Name | IntroMedic Co., Ltd. |
|---|---|
| Address | Suite 1104, E&C Venture Dream Tower 6-Cha, 197-28 Guro- |
| Dong, Guro-Gu, Seoul, 152-719 Korea | |
| Telephone | +82-2-801-9300 |
| Fax | +82-2-801-9330 |
| Contact | Steve Kwon |
| Internet | http://www.intromedic.com |
2. Device
| Proprietary Name | MiroCam® Capsule Endoscope System |
|---|---|
| Common Name | Capsule Imaging System |
| Classification Name | 21 CFR 876.1300 (Product Code NEZ) |
3. Predicate Device
| Manufacturer | Given Imaging Ltd. |
|---|---|
| Device | Given Diagnostic Imaging System |
| 510(K) Number | K070475 |
4. Description
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule -
- Data Cables -
- MiroCam® Receiver -
- MiroView™ Software and Workstation -
IntroMedic Co., Ltd.
MiroCam® Capsule Endoscope System, Traditional 510(k)
1
K111450 Page 2 of 5
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the MiroView™ workstation and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel. The key system components are explained in detail below.
MiroCam® Capsule
Functionally, the MiroCam® captures imaging via a CMOS imaging sensor for at least 11 hours at the rate of 3 images per second. Six white LEDs flash in concert with the imaging sensor. A sensor PCB links the imaging sensor to the two gold electrodes of the capsule, from which a weak current is emitted containing the image data via Human Body Communication technology. The weak current is then passed through the bodily tissue and fluid to be picked up by the sensor pads. Human Body Communications is uni-directional from the capsule to the sensor pads.
Physically, the capsule is 24mm in length, and 10.8mm in diameter. The exterior of the capsule is composed of biocompatible materials, capable of withstanding potential bite forces and exposure to fluids in the GI tract.
MiroCam® Receiver
The image data from the capsule is saved to the MiroCam® Receiver via the sensor pads and data cables. The sensor pads are standard ECG type sensor pads (3M Red Dot), which are affixed to the patient's abdomen according to the location guide. The 9 sensor pads are attached to the 9 leads of the data cable is subsequently attached to the Receiver. The Receiver sits in a shoulder pouch, which is put on the patient for the duration of the procedure. A waist pouch is used to organize the data cables. The Receiver can store images for up to 12 hours. The three indicators on the Receiver are for battery status, initialization status of the receiver, and status of signal receipt from the capsule.
The dimensions of the receiver are 140mm in height, 85mm in width, and 40mm in length. The units weight 350grams with the battery, which is data cable. The battery is lithium ion,
MiroCam® Capsule Endoscope System, Traditional 510(k)
2
and is unique to the Receiver. The battery is rechargeable, and can be charged by placing in the battery charger provided with the Receiver. The receiver uses a storage flash for storing the images.
Workstation
Image data 'is uploaded to the MiroView™ workstation from the MiroCam® Receiver via a USB cable connection. The MiroView™ workstation is a PC with the MiroView™ software installed. The workstation also includes a printer and LCD monitor.
The MiroView™ software enables the following key operator tasks: receiver management and upload of image data; diagnostic review of images by the physician; creation of capsule endoscopy procedure patient reports; user administration; and export of image data and reports. Included in the diagnostic review interface is a number of features to optimize the efficiency of the diagnostic review, including variable viewing speed (1 to 40 frames per second), suspected GI bleeding indicator (SGIB), and Quick mode. Images of suspected disease pathology or transit points in the GI tract are readily captured for inclusion in the report.
Included with the MiroView™ workstation is a copy of MiroView™ Express. MiroView™ Express is a scaled down version of the MiroView™ software; only supporting the diagnostic review and reporting functionality detailed above. The receiver cannot be connected to the MiroView™ Express software. This software can be installed on remote PCs, notebooks or laptops to enable review of patient files at the convenience of the reviewer. Patient files are transferred from MiroView™ workstation to the MiroView™ Express via DVD or USB.
5. Indications for Use
The MiroCam® Capsule Endoscope System 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.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
MiroCam® Capsule Endoscope System, Traditional 510(k)
3
6. Technological Characteristics and Substantial Equivalence
The characteristics of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System are substantially equivalent to the following current legally marketed predicate devices based on indications for use, typical clinical use, and operational and fundamental technological characteristics
● Given Diagnostic Imaging Systems marketed by Given Imaging Ltd., K070475
A detailed side-by-side comparison of the MiroCam® Capsule Endoscope System with the identified predicate device is provided in the substantial equivalence discussion in this premarket notification.
7. Performance Testing
The MiroCam® Capsule Endoscope System performance testing includes biocompatibility testing, electrical safety testing, and software life cycle validation to the appropriate FDA Recognized Consensus Standards and bench testing which includes mechanical structural integrity testing, pH resistance testing, field of view and depth of view testing, battery life testing, and battery short-circuit temperature testing. The results of this performance testing conclude that the material and technological characteristics have not diminished the safety and effectiveness of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System device when compared to the predicate device.
A multi-center, prospective, randomized, open-label clinical trial was performed on the MiroCam® Capsule Endoscope System. The effectiveness endpoint was to compare the agreement between MiroCam® and predicate device with respect to the detection and identification of sources of small bowel bleeding. The concordance rate and corresponding 95% confidence interval were estimated. The 89 of the 105 subjects were evaluable for the effectiveness analysis, having at least 2 hours of small bowel imaging time successfully. The overall agreement on the identification (cause) of small bowel bleeding between MiroCam® and predicate device was 74.16% (66 of 79). The results of this clinical testing conclude that the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System is safe, performs as intended, and meets the user needs.
4
K111450 Page 5/5
8. Conclusion
Based on the similarities in indications for use, design, functional, and operational features as evaluated through clinical and non-clinical performance testing the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System has demonstrated substantial equivalence to the listed legally marketed predicate devices and any differences do not affect the product's safety or effectiveness.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
IntroMedic Co., Ltd. % Mr. Jeffrev Roberts Regulatory Consultant Medical Device Consultants, Inc. 40 Plain Street NORTH ATTLEBORO MA 02760
Re: K11450
Trade/Device Name: MiroCam® Capsule Endoscope System Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: May 14, 2012 Received: May 16, 2012
Dear Mr. Roberts:
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 (reporting of medical
6
Page 2 -
device-related 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,
Sincerely yours,
Benjamin K. Fisher
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K111450
Device Name: MiroCam® Capsule Endoscope System
Indications for Use:
MiroCam® Capsule Endoscope System 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.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
t 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Dorothy M. White
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111450