(97 days)
Unknown
The document mentions an "Suspected GI Bleeding Indicator (SGIB)" which marks frames suspected of containing blood or red areas. While this functionality could potentially be implemented using AI/ML for image analysis, the document does not explicitly state that AI/ML is used for this purpose. It could also be based on simpler image processing techniques. Without further information or explicit mention of AI/ML, it is not possible to definitively confirm its presence.
No
The device is intended for visualization and detection of abnormalities, not for treatment or therapy. It acts as a diagnostic tool.
Yes
The device is a diagnostic device because its intended use is for visualization of the small bowel mucosa to aid in the detection of abnormalities. The description details a workflow where a physician reviews images captured by the capsule endoscope to identify suspected abnormalities, which is a diagnostic process.
No
The device description explicitly lists hardware components such as the MiroCam® Capsule, MiroCam® Receiver, and Data Cable/Belt, which are integral to the system's function of capturing and transmitting images. While software is a component, the system is not solely software.
Based on the provided information, the MiroCam® Capsule Endoscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- MiroCam® Function: The MiroCam® system is designed for visualization of the small bowel mucosa inside the patient's body. It captures images of the gastrointestinal tract as the capsule passes through.
- Specimen Type: The system does not analyze specimens taken from the body. It directly images the internal anatomy.
While the system is used for diagnostic purposes (detecting abnormalities), the method of obtaining the information (direct imaging inside the body) falls outside the definition of an In Vitro Diagnostic. It is an in vivo diagnostic imaging system.
N/A
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 and children from two years of age.
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: MC1000-B
- MiroCam® Receiver: MR1100
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl 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 Commercial PC 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 12 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 24.5mm 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, and 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 350 grams 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 uses a storage flash for storing the images. The MiroCam® Receiver has RTV (Real-Time View) function to view a capsule in the body in real time. There are the wire communication method to connect to a Commercial PC by USB cable and the wireless communication method to connect to i-Phone, i-Pad or i-Pod touch by Wifi for RTV.
MiroView™ U: The MiroView™ U helps the user to upload the image data from the Receiver and review the image data with displaying.
MiroView™ U will be deployed as three types of software: MiroView™ Server, MiroView™ Operator and MiroView™ Client. Server PC includes two types of SW: MiroView™ Server and Operator.
MiroView™ Server and MiroView™ Operator will be deployed on a Server PC. MiroView™ Client SW will be deployed on reviewer's PCs. 10 Client SWs will be able to connect to one Server PC via Network (LAN) at a time.
MiroView™ Server has functionalities: Data Storage, PACS connectivity.
MiroView™ Operator has functionalities: Receiver Management, Case Management and Account Management.
MiroView™ Client has functionalities: List Mode (Case Data Management), Review Mode (Video Display, Image Capture, Annotation Box, etc.), Report Mode (User Comment, Auto Disease Name Check, etc.), Export Mode (JPG, AVI, MiroView™ file format).
MiroView™ U provides some kinds of Modes and Views to help the user review patient video data quickly and conveniently; however, IntroMedic Co., Ltd. recommends that the doctor review the patient video in the Normal Mode / Single View to prevent from a wrong diagnosis.
The features are described below:
- Multi-Data Path (MiroView™ Server)
- Customizing Print Dialog (MiroView™ Client)
- Data Multi-Language (MiroView™ Client)
- ODF Report (MiroView™ Client)
- Data Bag (MiroView™ Client)
- Finding Setting (Custom Finding) (MiroView™ Client)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS imaging sensor
Anatomical Site
small bowel mucosa (Gl tract)
Indicated Patient Age Range
adults and children from two years of age
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)
The performance testing are exactly the same as the predicate device (K123428).
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.
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
5. 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.
5.1 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 | JinYoung Lee |
| Internet | http://www.intromedic.com |
5.2 Device
| Proprietary Name | MiroCam® Capsule Endoscope System |
|---|---|
| Common Name | Capsule Imaging System |
| Classification Name | 21 CFR 876.1300 (Product Code NEZ) |
5.3 Predicate Device
| Manufacturer | IntroMedic Co., Ltd. |
|---|---|
| Device | MiroCam® Capsule Endoscope System |
| 510(k) Number | K123428 |
1
| Manufacturer | Given Imaging Ltd. |
|---|---|
| Device | Given PillCam® Platform with PillCam® SB Capsules |
| with PillCam® SensorBelt | |
| 510(k) Number | K103088 |
5.4 Description
·
(※ The device description is exactly the same as the predicate device (K123428).)
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- -MiroCam® Capsule: MC1000-B
- MiroCam® Receiver: MR1100 ।
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L) -
- MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i -
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl 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 Commercial PC 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 12 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 24.5mm in length, and 10.8mm in diameter. The exterior of the
2
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, and 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 350 grams 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 uses a storage flash for storing the images.
The MiroCam® Receiver has RTV (Real-Time View) function to view a capsule in the body in real time. There are the wire communication method to connect to a Commercial PC by USB cable and the wireless communication method to connect to i-Phone, i-Pad or i-Pod touch by Wifi for RTV.
MiroView™ U
The MiroView™ U helps the user to upload the image data from the Receiver and review the image data with displaying.
MiroView™ U will be deployed as three types of software: MiroView™ Server, MiroView™™ Operator and MiroView™ Client Server PC includes two types of SW: MiroView™ Server and Operator
MiroView™ Server and MiroView™ Operator will be deployed on a Server PC. MiroView™ Client SW will be deployed on reviewer's PCs. 10 Client SWs will be able to connect to one
MiroCam® Capsule Endoscope System, Traditional 510(k)
3
Server PC via Network (LAN) at a time.
MiroView™ Server has functionalities: Data Storage, PACS connectivity
MiroView™ Operator has functionalities: Receiver Management, Case Management and Account Management
MiroView™ Client has functionalities: List Mode (Case Data Management), Review Mode (Video Display, Image Capture, Annotation Box, etc.), Report Mode (User Comment, Auto Disease Name Check, etc.), Export Mode (JPG, AVI, MiroView™ file format)
MiroView™ U provides some kinds of Modes and Views to help the user review patient video data quickly and conveniently; however, IntroMedic Co., Ltd. recommends that the doctor review the patient video in the Normal Mode / Single View to prevent from a wrong diagnosis.
The features are described below:
- Multi-Data Path (MiroView™ Server) -
- Customizing Print Dialog (MiroView™ Client)
- Data Multi-Language (MiroView™ Client) -
- ODF Report (MiroView™ Client) -
- Data Bag (MiroView™ Client) -
- Finding Setting (Custom Finding) (MiroView™M Client) -
5.5 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 and children from two years of age.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
5.6 Technological Characteristics
The technology characteristics are exactly the same as the predicate device (K123428).
MiroCam® Capsule Endoscope System, Traditional 510(k)
4
- 5.7 Performance Testing
The performance testing are exactly the same as the predicate device (K123428).
5.8 Conclusion
Based on the 510k submission data IntroMedic Co., Ltd. believes that MiroCam® Capsule Endoscope System and the predicate devices selected are substantially equivalent and do not change the fundamental scientific technology and indications for use of the market-cleared devices.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Intromedic Co., Ltd. % Jinyoung Lee General Manager Suite 1104 E&C Venture Dream Tower 6-cha 197-28 Guro-dong, Guro-gu Seoul 152-719 Korea
Re: K140751
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 2, 2014 Received: May 5, 2014
Dear Jinyoung Lee,
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.
6
Page 2 - Jinyoung Lee
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 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/ReportalProblem/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,
Image /page/6/Picture/6 description: The image shows the name "Benjamin Fisher-S" in a bold, sans-serif font. The letters "FDA" are stacked on top of each other in the middle of the name. The letters "FDA" are outlined and have a textured fill.
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
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4. Indications for Use
510(k) Number (if known): K140751
Device Name: MiroCam® Capsule Endoscope System
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 and children from two years of age.
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 Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTUNUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benian 2014.06.30
IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System, Traditional 510(k)