(194 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the description of the device and its performance testing does not indicate the use of such technologies. The "Suspected GI Bleeding Indicator" is mentioned, but its mechanism is not described as AI/ML.
No
The device is intended for visualization and detection of abnormalities, not for treatment or therapy.
Yes
The device is intended for "visualization of the small bowel mucosa" to "detect abnormalities of the small bowel," which is a diagnostic purpose. The output, images of the small bowel, is reviewed by a physician to identify suspected abnormalities.
No
The device description explicitly lists hardware components (MiroCam® Capsule, MiroCam® Receiver, Data Cable / Data Belt) that are integral to the system's function of capturing and transmitting images. While software is part of the system, it is not the sole component.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- MiroCam® Function: The MiroCam® Capsule Endoscope System is a device that is swallowed by the patient and captures images inside the body (in vivo) of the small bowel mucosa. It is a visualization tool, not a test performed on a sample.
- Intended Use: The intended use is for visualization of the small bowel mucosa and detection of abnormalities, which is a diagnostic process performed by a physician reviewing images, not an in vitro test.
Therefore, the MiroCam® Capsule Endoscope System falls under the category of a medical device used for in vivo imaging and diagnosis, not an in vitro diagnostic device.
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.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
Product codes
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 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 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.
MiroCam® Capsule: Functionally, the MiroCam® capsule 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). 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 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. 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 S/W: MiroView™ Server and Operator. MiroView™ Server and MiroView™ Operator will be deployed on a Server PC. MiroView™ Client SMV will be deployed on reviewer's PCs. 10 Client SMs 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, MiroVlew™ 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)
- Drag Bag (MiroView™ Client)
- Finding Setting (Custom Finding) (MiroView TM Client)
Mentions image processing
Yes, "Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel." and "The MiroView™ U helps the user to upload the image data from the Receiver and review the image data with displaying."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS imaging sensor (capsule endoscopy)
Anatomical Site
Small bowel
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician (Gastroenterologist) / Not Specified but likely clinical setting
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 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, field of view and depth of field testing, battery life testing, and battery short-circuit temperature testing, shelf life testing, pH resistance testing, biting testing, sensor bench testing, optical performance testing, wireless coexistence 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 5
5. 510(k) Summary
MAY 2 0 2013
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 | IntroMedic Co., Ltd. |
|---|---|
| Device | MiroCam® Capsule Endoscope System |
| 510(K) Number | K111450 |
4. 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 -
| IntroMedic Co., Ltd. | |
|---|---|
| MiroCam® Capsule Endoscope System, Traditional 510(k) |
1
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 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® capsule 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 350grams with the battery, which is data cable. The battery is lithium ion,
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.
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 S/W: MiroView™ Server and Operator.
MiroView™ Server and MiroView™ Operator will be deployed on a Server PC. MiroView™ Client SMV will be deployed on reviewer's PCs. 10 Client SMs 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, MiroVlew™ 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.
3
The features are described below:
- Multi-Data Path (MiroView™ Server)
- Customizing Print Dialog (MiroView™ Client) -
- Data Multi-Language (MiroView™ Client) -
- ODF Report (MiroView™ Client) -
- Drag Bag (MiroView™ Client)
- Finding Setting (Custom Finding) (MiroView TM Client)
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.
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
MiroCam® Capsule Endoscope System by IntroMedic Co., Ltd. K111450 .
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
4
integrity testing, field of view and depth of field testing, battery life testing, and battery shortcircuit temperature testing, shelf life testing, pH resistance testing, biting testing, sensor bench testing, optical performance testing, wireless coexistence 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.
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 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 symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2013
IntroMedic Co., Ltd. % Mr. Steve Kwon Manager Suite 1104, E&C Venture Dream Tower, 6 Cha 197-28 Guro-Dong, Guro-Gu SEOUL 152-719 REPUBLIC OF KOREA
K123428 Re:
Trade/Device Name: MiroCam® Capsule Endoscope System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible Telemetric Gastro-intestinal Capsule Imaging System Regulatory Class: Class II Product Code: NEZ Dated: May 15, 2013 Received: May 17, 2013
Dear Mr. Kwon:
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.
6
Page 2 - Mr. Steve Kwon
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 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.goy/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,
Herber - Daterner -S
for
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
4. Indications for Use
510(k) Number (if known): K123428
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
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)
Herbert P. Derner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number
IntroMedic Co., Ltd.
MiroCam® Capsule Endoscope System, Traditional 510(k)
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