(233 days)
Yes
The summary mentions an "informatics algorithm" used in the "express view mode" which significantly shortens reading time and has a high detection rate for significant images. This strongly suggests the use of an automated image analysis algorithm, which is a common application of AI/ML in medical imaging. The performance study results further support this, showing the algorithm's detection rate compared to human readers.
No.
The capsule endoscope system is used for visualization and monitoring, which are diagnostic purposes, not for treating or alleviating a disease.
Yes
The device aids in the visualization and monitoring of lesions and abnormalities of the small bowel, thereby assisting in the diagnosis of conditions like Crohn's disease, obscure bleeding, and iron deficiency anemia.
No
The device description explicitly lists hardware components (MiroCam® Capsule, MiroCam® Receiver, Data Cable / Data Belt) in addition to the software (MiroView™ Software).
Based on the provided information, the MiroCam® Capsule Endoscope System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The MiroCam® system captures images within the human body (specifically, the small bowel mucosa). It visualizes the internal anatomy directly, rather than analyzing a biological sample like blood, urine, or tissue.
- The intended use is visualization and monitoring of lesions. This is a diagnostic imaging function, not an in vitro analysis of a biological sample.
- The device description outlines image capture and processing. The system captures images, transmits them, stores them, and allows a physician to review them. This is consistent with an imaging device, not an IVD.
Therefore, the MiroCam® Capsule Endoscope System falls under the category of a medical imaging device, not an In Vitro Diagnostic.
No
The letter does not explicitly state that the FDA has reviewed and 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 in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
-
It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
-
It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for 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: MC1600-B
- MiroCam® Receiver: MR2000
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U 4.0
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 MiroCam® capsule captures imaging via a CMOS imaging sensor for at least 12 hours at the rate of 6 images per second. Twelve 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.
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 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. Using LCD display it shows icons that indicate the state of receiver, real time image view and preview. User can capture image for the real time images are displayed. Three LEDs also represent the receiver state by switching its power. And MiroCam® receiver play some sounds for notifying to user. To reduce the battery consumption of MiroCam® receiver backlight brightness is controlled. User can control MiroCam® receiver by using three buttons.
The dimensions of the receiver are 145mm in height, 82.5mm in width, and 29.8mm in length. The units weight 330 grams, 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 MiroView™ U 4.0 helps the user to upload the image data from the Receiver and review the image data with displaying.
MiroView™ U 4.0 will be deployed as three types of software: MiroView™M Server, MiroView™M Operator and MiroView™ Client.
Server PC includes two types of S/W: MiroView™ Server and Operator.
MiroView™ Server and MiroView™M Operator will be deployed on a Server PC. MiroView™ Client S/W will be deployed on reviewer's PCs. 10 Client S/Ws 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 4.0 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.
MiroView™ U 4.0 is a new version of MiroView™ U 3.0, which has new updated features from the MiroView™M U 3.0. The features are described below:
- Compatibility with New Receiver MR2000: MiroView™ U Operator 4.0
- UI Function for Reviewing Patient Data of Dual Tip Capsule: MiroView™ U Client 4.0
- Support of H.264 Codec: MiroView™ U Common 4.0
- Express Play ver 3.0: MiroView™ U Client 4.0
- Supplementary Play: MiroView™ U Client 4.0
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image capturing via a CMOS imaging sensor, video (frames)
Anatomical Site
Small bowel mucosa, GI 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 MiroCam® Capsule Endoscope System performance testing was done for the submission of predicate device but it was not included when Sensor Bench testing, MTF Measurement testing (including the predicate device, K143663), Minimum Distinguishable Contrast Value and Depth of Field testing (including the predicate device, K143663), Geometric distortion testing (including the predicate device, K143663), Field of View testing (including the predicate device, K143663), Color Reproduction testing (including the predicate device, K143663), Testing optical spectra of the light source at different time points during the battery life period (including the predicate device, K143663), Testing intensity change during the shelf life period (including the predicate device, K143663), Bite testing, Water proof testing, pH resistance testing, and Shelf life testing (Operation time, Package integrity, pH resistance and Bite) was done. 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.
Summary of Clinical Information (MiroView™ Express 3.0)
Saurin JC, er al. Endoscopy International Open 2018; 06: E616-621 "Multicenter prospective evaluation of the express view reading mode for small-bowel capsule endoscopy studies"
- Patients: 83 patients with obscure gastrointestinal bleeding
- Center: 10 in France
- Method: Films were read in standard mode, then a second reading was performed in express view mode at a second center. For each lesion, the precise location, nature, and relevance were collected. A consensus reading and review were done by three experts, and considered to be the gold standard.
- Results: The mean reading time of capsule films was 39.7 minutes (11-180 minutes) and 19.7 minutes (4-40 minutes) by standard and express view mode, respectively (P
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
November 8, 2018
IntroMedic Co., Ltd. Jinyoung Lee Director Suite 1105, 1106 E&C Venture Dream Tower 6-Cha, Guro-dong, Guro-gu Seoul. 08375 Korea
Re: K180732
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: September 19, 2018 Received: September 24, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jeffrey W. Cooper -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
2
Indications for Use
510(k) Number (if known) K180732
Device Name
MiroCam® Capsule Endoscope System
Indications for Use (Describe)
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa.
-
It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
-
It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
-
It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
And the subject device had no prior submissions.
1. Company and Correspondent making the submission
| Date prepared | November 6th, 2018th |
|---|---|
| Name | IntroMedic Co., Ltd. |
| Address | Suite 1105, 1106, E&C Venture Dream Tower 6-Cha, |
| 197-28 Guro-dong, Guro-gu, Seoul, 08375, Korea | |
| Telephone | +82-2-801-9300 |
| Fax | +82-2-801-9330 |
| Contact | Jinyoung Lee |
| 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) |
| Ingestible telemetric gastrointestinal capsule imaging system | |
| Regulatory Class | II |
3. Predicate Device
| Manufacturer | IntroMedic Co., Ltd. |
|---|---|
| Device | MiroCam® Capsule Endoscope System |
| 510(K) Number | K143663 |
| Manufacturer | IntroMedic Co., Ltd. |
| Device | MiroCam® Capsule Endoscope System |
| 510(K) Number | K170438 |
4
| Manufacturer | Given Imaging Ltd. |
|---|---|
| Device | Given PillCam SB3 Capsule endoscopy system |
| 510(K) Number | K123864 (Reference device) |
4. Description
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule: MC1600-B -
- MiroCam® Receiver: MR2000 -
- -Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U 4.0 -
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 6 images per second. Twelve 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,
5
and the data cable is subsequently attached to 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. Using LCD display it shows icons that indicate the state of receiver, real time image view and preview. User can capture image for the real time images are displayed. Three LEDs also represent the receiver state by switching its power. And MiroCam® receiver play some sounds for notifying to user. To reduce the battery consumption of MiroCam® receiver backlight brightness is controlled. User can control MiroCam® receiver by using three buttons.
The dimensions of the receiver are 145mm in height, 82.5mm in width, and 29.8mm in length. The units weight 330 grams, 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.
MiroView™ U 4.0
The MiroView™ U 4.0 helps the user to upload the image data from the Receiver and review the image data with displaying.
MiroView™ U 4.0 will be deployed as three types of software: MiroView™M Server, MiroView™M Operator and MiroView™ Client.
Server PC includes two types of S/W: MiroView™ Server and Operator.
MiroView™ Server and MiroView™M Operator will be deployed on a Server PC. MiroView™ Client S/W will be deployed on reviewer's PCs. 10 Client S/Ws 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 4.0 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
6
video in the Normal Mode / Single View to prevent from a wrong diagnosis.
MiroView™ U 4.0 is a new version of MiroView™ U 3.0, which has new updated features from the MiroView™M U 3.0. The features are described below:
- Compatibility with New Receiver MR2000: MiroView™ U Operator 4.0 -
- UI Function for Reviewing Patient Data of Dual Tip Capsule: MiroView™ U Client 4.0 -
- Support of H.264 Codec: MiroView™ U Common 4.0 -
- Express Play ver 3.0: MiroView™ U Client 4.0 -
- Supplementary Play: MiroView™ U Client 4.0 -
5. Indications for Use
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease । not detected by upper and lower endoscopy.
- -It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for 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.
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. K143663 ● MiroCam® Capsule Endoscope System by IntroMedic Co., Ltd.
- K170438 ● Given PillCam® SB3 Capsule endoscopy system by Given Imaging Ltd. K123864 (Reference device)
7
Table 5-1. Side-by-Side Comparison of the MiroCam® Capsule Endoscope System with the Predicate Device
| Type | Characteristics | MiroCam® Capsule Endoscope System Subject device | MiroCam® Capsule Endoscope System K143663 | Capsule MiroCam® Endoscope System K170438 | Capsule Given® PillCam® SB3 capsule endoscopy system K123864 (Reference device) |
|---|---|---|---|---|---|
| Indications for Use | The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. |
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
- It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for 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. | 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. | The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
- It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only.
- The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas. | The PillCam SB capsule is intended for visualization of the small bowel mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam SB capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. |
| Manufacturer | | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | Given Imaging Ltd. |
| e | Size | Length: 24.5mm
Diameter: 10.8mm | Length: 24.5mm
Diameter: 10.8mm | Length: 30.1mm
Diameter: 10.8mm | Length: 26.2mm
Diameter: 11.4mm |
| | Weight | $3.25g\pm0.1g$ | 3.25g | $3.5g\pm0.1g$ | $3.0\pm0.1g$ |
| | Material | Human
Compliance
Plastic | Human
Compliance
Plastic | Human
Compliance
Plastic | Biocompatible plastic |
| | Dome Material | COP (Cyclo
Polymers) | COP (Cyclo
Polymers) | COP (Cyclo
Polymers) | Polycarbonate |
| | Light | 6 White LEDs | 6 White LEDs | 12 White LEDs (each 6 White LEDs) | 4 White LEDs |
| | LED Size | 2.0mm(L)1.25mm(W)
0.8mm(H) | 2.0mm(L)1.25mm(W)
0.8mm(H) | 2.0mm(L)1.25mm(W)
0.8mm(H) | |
| | LED Viewing
Angle | 130° | 130° | 130° | |
| | Exposure Time | 0.5 ~ 24 ms | 0.524 ms | 0.5 ~ 24 ms | |6 frames per
| | Field of View | 170° | 170° | 170° | 156° |
| | Image Sensor | CMOS | CMOS | CMOS | CMOS |
| | Depth of Field | Length: 3cm | Length: 3cm | Length: 3cm | Length: 3cm |
| | Enlargement
Ratio | 1:8 | 1:8 | 1:8 | |
| | Detectable
Range | Under 0.1mm | Under 0.1mm | Under 0.1mm | At least 0.07mm |
| | Sampling Ratio | 6 frames per second | 3 frames per second | 6 frames per second
(each 3 frames per head) | 2 or 2
second |
| | Pixel size of
Sensor | $6.0 \mu m6.0 \mu m$ | $6.0 \mu m6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | |
| | Working Time | 12 Hours | 12 Hours | 12 Hours | Over 8 Hours |
| | Chemical Safety | Safe in pH=2 ~ pH=8 | Safe in pH=2~ pH=8 | Safe in pH=2~ pH=8 | Safe in pH=2 ~ pH=8 |
| | Battery Type | Silver Oxide Cell | Silver Oxide Cell | Silver Oxide Cell | Silver Oxide Cell |
| | Optimum
working
distance | 0mm | 0mm | 0mm | |
| | Direction
of View | 0° | 0° | 0° | |
| | Resolution | 320x320 | 320x320 | 320x320 | |
| | Distortion (%) | -14.5 | -14.5 | -14.5 | |
| | Lens Uniformity
(%) | 79.39 | 79.39 | 79.39 | |
| | Shelf life | 18 months from date
manufacture | 18 months from date
manufacture | 12 months from date
manufacture | |
| | Operation Temp. | 20 ~ 40°C | 20 ~ 40 °C | 20 ~ 40 °C | 20 ~ 40 °C |
| | Storage Temp. | 0 ~ 50°C | 0 ~ 50°C | 0 ~ 50°C | 0 ~ 25 °C |
| | Transmission
Methods | HBC (Human
Communication) | HBC (Human
Communication) | HBC (Human
Communication) | RF |
| | Receiver Model Name | MR2000 | MR1100 | MR2000 | DR3 |
| | Recording Time | 12 Hours | 12 Hours | 12 Hours | Up to 15 hours at LCD
off |
| | Weight | 330g (Include Battery) | 350g (Include Battery) | 330g (Include Battery) | 500g (Include Battery
Pack) |
| | Operation
Voltage | 3.65Vdc, 0.45A | 3.7Vdc, 0.45A | 3.65Vdc, 0.45A | 3.54.2Vdc, 0.150.5A |
| | Battery Type | Lithium Ion Battery,
3.65V, 10,500mA | Lithium Ion Battery,
3.7V, 10,400mA | Lithium Ion Battery,
3.65V, 10,500mA | Lithium Ion Battery,
3.8V, 8,800mAh |
| | Operation Temp. | 0 ~ 40°C | 0 ~ 40°C | 0 ~ 40°C | 0 ~ 40 °C |
| | Storage Temp. | 0 ~ 55°C | 0 ~ 55°C | 0 ~ 55°C | 0 ~ 55 °C |
| | Category | Internal power supply,
Type BF | Internal power supply,
Type BF | Internal power supply,
Type BF | Internal power supply,
Type BF |
| | Real Time View | LCD | USB, Wifi | LCD | LCD |
| | Method of Data
Communication | Data Cable or Data Belt
(Optional) | Data Cable or Data Belt
(Optional) | Data Cable or Data Belt
(Optional) | Sensor Array or Sensor
Belt |
| | Characteristics | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | Given Imaging Ltd. |
| Softw
are | Software | MiroView TM U 4.0 | MiroViewTM U 3.0
MiroViewTM RTV (Real
Time Viewer
Application-only USB)
MiroViewTM RTV-I
(Real Time Viewer
Application-only Wifi) | MiroViewTM U 4.0 | RAPID 8.0 |
| | Language | English,
Portuguese,
Chinese, French, Italian,
Korean, Dutch, Russian,
Swedish | Spanish, English,
Danish, Portuguese,
Chinese, French, Italian,
Korean, Dutch, Russian,
Swedish | Spanish, English,
Danish, Portuguese,
Chinese, French, Italian,
Korean, Dutch, Russian,
Swedish | French
Danish, German, Italian, Spanish,
Portuguese, Dutch
Swedish, Finish, Danish
Chinese-Mandarin,
Korean, Russian, Greek |
| | Data Export | JPEG Image, AVI Video
Clip, PDF Report Data,
ODF (Open Data
Format), EXMIF
(Exchangeable Medical
Information Format) | JPEG Image, AVI Video
Clip, PDF Report Data,
ODF (Open Data
Format), EXMIF
(Exchangeable Medical
Information Format) | JPEG Image, AVI Video
Clip, PDF Report Data,
ODF (Open Data
Format), EXMIF
(Exchangeable Medical
Information Format) | JPEG Images, (MPEG
Video clips, grml (Given
proprietary) files, PDF
Reports, generic XML
format, Capsule
Endoscopy report data |
| | Data Display | Single and Multi Image,
Time Bar, Diagnosis
Data, Dual Bar | Single and Multi Image,
Time Bar, Diagnosis
Data | Single and Multi Image,
Time Bar, Diagnosis
Data, Dual Bar | Single and Multi Image,
Time Bar, Colorbar with
region specific color and
other diagnostic data |
| | Event Marker | Small Image with
Explanation | Small Image with
Explanation | Small Image with
Explanation | Annotated thumbnails |
| | Display Ratio | 310,000fps | 310,000fps | 310,000fps | 580fps |
| | Display Mode | Single View, Dual View,
Quad View, Range View,
Map View | Single View, Dual View,
Quad View, Range View,
Map View | Single View, Dual View,
Quad View, Range View,
Map View | Single View, Dual View,
Quad View, Mosaic
View, Dual Head View |
| | Running Mode | Normal Mode, Express,
SGIB | Normal Mode, Express,
SGIB | Normal Mode, Express,
SGIB | Normal, Auto, Quick
View, SBI |
8
9
For the predicate device and the subject device, this has all the same performances except Receiver and Software.
[Capsule]
The Subject device and the predicate device which is MC1200-B is identical in every aspect such optical system, raw material, mechanical design, working principle, usage and etc. except the frame rates. For the frame rates of MC1200-B and MC1600-B, it is 3 frames per second and 6 frames per second respectively. What the frame rates is different is that this is not the hardware change, only the frame rate can be adjusted by changing the [0] bit value of address 0x04 in the EEPROM of the capsule as shown in the table below during the manufacturing process.
10
| ADDRESS
(HEX) | REGISTER NAME | R/W | DEFAULT
(HEX) | DESCRIPTION |
|------------------|---------------|-----|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0x00 | PRODUCT ID0 | R | 0x52 | Product ID0 |
| 0x01 | PRODUCT ID1 | R | 0x01 | Product ID1 |
| 0x02 | PRODUCT ID2 | R | 0x01 | Product ID2 |
| 0x03 | PRODUCT ID3 | R | 0x01 | Product ID3 |
| 0x04 | CONTROL_FLAG | R/W | 0x40 | [7] : convolution mode
[6:5] : tx mode
00 -> Direct
01 -> BPSK
10 -> DBPSK
[4] : sel_tx
[3] : Dual
[2] : AE disable
[1] : EFIC enable
[0] : 2X mode |
How to change the value is as follows;
0100 0000 0 4
For 3 frames per second that means MC1200-B, set the [0] bit value indicated in red to "0" as above.
0100 0001 4 0
For 6 frames per second that means MC1600-B, set the [0] bit value indicated in red to "1" as above.
And, MC1200-B and MC1600-B are indicated for adults and children from two years of age since the two products is identical in size, which it means that the ease of device ingestion is proven. In addition, for the other predicate device which is MC2000-B, it is identical to MC1600-B in "Indication for Use" because two products have the same frame rates as 6 frames for second.
[Receiver]
The subject device same as the predicate device MR2000 (K170438).
[Software]
The subject device same as the predicate device MiroView U 4.0 (K170438).
11
7. Performance Testing
The MiroCam® Capsule Endoscope System performance testing was done for the submission of predicate device but it was not included when Sensor Bench testing, MTF Measurement testing (including the predicate device, K143663), Minimum Distinguishable Contrast Value and Depth of Field testing (including the predicate device, K143663), Geometric distortion testing (including the predicate device, K143663), Field of View testing (including the predicate device, K143663), Color Reproduction testing (including the predicate device, K143663), Testing optical spectra of the light source at different time points during the battery life period (including the predicate device, K143663), Testing intensity change during the shelf life period (including the predicate device, K143663), Bite testing, Water proof testing, pH resistance testing, and Shelf life testing (Operation time, Package integrity, pH resistance and Bite) was done. 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.
-
Summary of Clinical Information (MiroView™ Express 3.0)
Saurin JC, er al. Endoscopy International Open 2018; 06: E616-621 "Multicenter prospective evaluation of the express view reading mode for small-bowel capsule endoscopy studies" -
- Patients: 83 patients with obscure gastrointestinal bleeding
-
- Center: 10 in France
-
- Method: Films were read in standard mode, then a second reading was performed in express view mode at a second center. For each lesion, the precise location, nature, and relevance were collected. A consensus reading and review were done by three experts, and considered to be the gold standard.
-
- Results: The mean reading time of capsule films was 39.7 minutes (11-180 minutes) and 19.7 minutes (4-40 minutes) by standard and express view mode, respectively (P