(233 days)
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.
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 provided text describes the MiroCam® Capsule Endoscope System and its substantial equivalence to predicate devices, including performance testing results for the MiroView™ Express 3.0 software. While it refers to "acceptance criteria" through comparison with predicate devices and mentions performance testing, explicit, quantifiable acceptance criteria are not clearly laid out in a dedicated table format with corresponding performance metrics for the AI component (Suspected GI Bleeding Indicator - SGIB).
However, the closest information to acceptance criteria for the software component's performance (specifically the MiroView™ Express 3.0 with its "informatics algorithm" for detecting significant images) can be inferred from the clinical study summary.
Here's an attempt to extract and present the information based on the provided text:
Table of Acceptance Criteria (Inferred) and Reported Device Performance
The document does not provide a formal table of acceptance criteria with "pass/fail" thresholds. Instead, it describes a clinical study to evaluate the performance of the "express view reading mode" (which includes an "informatics algorithm") for the MiroCam® Capsule Endoscope System, particularly concerning the detection of "significant lesions" and "significant images." The implicit acceptance criterion is that the new system's performance, particularly in terms of sensitivity and reading time, is comparable or improved compared to standard reading, while also demonstrating clinical utility.
| Feature / Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (MiroView™ Express 3.0 informatics algorithm) |
|---|---|---|
| Sensitivity for Significant Lesions (Express View Reading) | High sensitivity, comparable to standard reading. (The study aimed to show high sensitivity, not necessarily specific thresholds, but implicit is that it should not be significantly worse than standard reading). | 82.2% sensitivity (Standard reading had 93.3% sensitivity, noted as "NS" - not statistically significant difference, suggesting comparability was deemed acceptable). |
| Reading Time (Express View Mode) | Significant shortening of reading time compared to standard reading. | 19.7 minutes (Mean reading time) compared to 39.7 minutes for standard mode (P < 1 x 10^-). This meets the implicit criterion of significant shortening. |
| Detection of Significant Images (Informatics Algorithm) | High detection rate for significant images, comparable to or better than human readers. | 94.3% detection of significant images (66/70 images detected). For comparison, standard reading detected 82.9% (58/70) and express view reading detected 78.6% (55/70). The algorithm outperformed both standard and express view human readings in terms of image detection in this specific comparison. Note: It missed four small-bowel angiodysplasia. |
| Suspected GI Bleeding Indicator (SGIB) Functionality | The SGIB is intended to correctly mark frames suspected of containing blood or red areas (no specific performance metric like sensitivity/specificity for SGIB is provided, but its intended function is stated, implying it must perform this function reliably). The results from the "informatics algorithm" for significant image detection provide insight into this. | The "informatics algorithm" is stated to have detected 66/70 significant images (94.3%). While not explicitly stated as the SGIB, this algorithm's performance is the closest available metric related to automated detection of relevant findings like bleeding. |
Study Details Proving Device Meets Acceptance Criteria:
-
Sample Size and Data Provenance:
- Test Set Sample Size: 83 patients with obscure gastrointestinal bleeding.
- Data Provenance: Retrospective and prospective (films were read, then a second reading was performed). The study was multicenter, conducted across 10 centers in France.
-
Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Three experts.
- Qualifications of Experts: Not explicitly stated beyond "three experts." It can be inferred they are gastroenterologists or specialists in capsule endoscopy given the context of the study.
-
Adjudication Method for Ground Truth:
- Method: A "consensus reading and review" was done by the three experts. This implies a 3-expert consensus model, likely where all three agreed, or a majority vote determined the ground truth.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Yes, a comparative study was performed comparing "standard mode" reading and "express view mode" reading (which includes the AI algorithm).
- Effect Size of Human Reader Improvement with AI (Express View) vs. Without AI Assistance (Standard View):
- Reading Time: The mean reading time without AI assistance (Standard Reading) was 39.7 minutes. The mean reading time with AI assistance (Express View Mode) was 19.7 minutes. This represents a significant reduction of approximately 50.4% in reading time (39.7 - 19.7 = 20 minutes reduction) for human readers when assisted by the express view mode and its algorithm.
- Sensitivity (Clinical Lesions): Standard reading: 93.3% sensitivity. Express view reading: 82.2% sensitivity. The document states this difference was "NS" (not statistically significant). While not an "improvement" in sensitivity for the human reader due to AI, the implication is that the efficiency gain (reduced reading time) was achieved without a statistically significant compromise in sensitivity for identifying significant lesions by the human reader.
- Detection of Significant Images by Algorithm: The informatics algorithm detected 94.3% of significant images (66/70), which was higher than both standard reading (82.9%) and express view reading (78.6%) by human readers. This suggests direct algorithmic assistance in highlighting potentially crucial frames.
-
Standalone (Algorithm Only) Performance:
- Was it done? Yes, in a way. The "informatics algorithm" within the MiroView™ Express 3.0 was evaluated for its ability to detect "significant images" independently of the human review process. It is stated that "The informatics algorithm detected 66/70 images (94.3%) thus missing four small-bowel angiodysplasia." This represents a standalone performance metric for the algorithm's image detection capability compared to the ground truth.
-
Type of Ground Truth Used:
- Ground Truth: Expert consensus. Specifically, "A consensus reading and review were done by three experts, and considered to be the gold standard." This ground truth was established for identifying "significant lesions" and "significant images."
-
Training Set Sample Size:
- The document does not specify the sample size used for the training set of the "informatics algorithm" or the MiroView™ Express 3.0 software. The clinical study described appears to be a validation study for an already developed algorithm.
-
How Ground Truth for Training Set Was Established:
- The document does not provide information on how the ground truth for the training set was established. The clinical study details describe the ground truth establishment for the test set used in this specific performance evaluation.
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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.
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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
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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 |
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| 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,
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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
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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)
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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: 24.5mmDiameter: 10.8mm | Length: 24.5mmDiameter: 10.8mm | Length: 30.1mmDiameter: 10.8mm | Length: 26.2mmDiameter: 11.4mm |
| Weight | $3.25g\pm0.1g$ | 3.25g | $3.5g\pm0.1g$ | $3.0\pm0.1g$ | |
| Material | HumanCompliancePlastic | HumanCompliancePlastic | HumanCompliancePlastic | Biocompatible plastic | |
| Dome Material | COP (CycloPolymers) | COP (CycloPolymers) | COP (CycloPolymers) | 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 ViewingAngle | 130° | 130° | 130° | ||
| Exposure Time | 0.5 ~ 24 ms | 0.5~24 ms | 0.5 ~ 24 ms | ||
| Field of View | 170° | 170° | 170° | 156° | |
| Image Sensor | CMOS | CMOS | CMOS | CMOS | |
| Depth of Field | Length: 3cm | Length: 3cm | Length: 3cm | Length: 3cm | |
| EnlargementRatio | 1:8 | 1:8 | 1:8 | ||
| DetectableRange | 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 2~6 frames persecond | |
| Pixel size ofSensor | $6.0 \mu m*6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | ||
| 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 | |
| Optimumworkingdistance | 0mm | 0mm | 0mm | ||
| Directionof 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 datemanufacture | 18 months from datemanufacture | 12 months from datemanufacture | ||
| 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 | |
| TransmissionMethods | HBC (HumanCommunication) | HBC (HumanCommunication) | HBC (HumanCommunication) | RF | |
| Receiver Model Name | MR2000 | MR1100 | MR2000 | DR3 | |
| Recording Time | 12 Hours | 12 Hours | 12 Hours | Up to 15 hours at LCDoff | |
| Weight | 330g (Include Battery) | 350g (Include Battery) | 330g (Include Battery) | 500g (Include BatteryPack) | |
| OperationVoltage | 3.65Vdc, 0.45A | 3.7Vdc, 0.45A | 3.65Vdc, 0.45A | 3.5 | |
| 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 DataCommunication | Data Cable or Data Belt(Optional) | Data Cable or Data Belt(Optional) | Data Cable or Data Belt(Optional) | Sensor Array or SensorBelt | |
| Characteristics | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | Given Imaging Ltd. | |
| Software | Software | MiroView TM U 4.0 | MiroViewTM U 3.0MiroViewTM RTV (RealTime ViewerApplication-only USB)MiroViewTM RTV-I(Real Time ViewerApplication-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 | FrenchDanish, German, Italian, Spanish,Portuguese, DutchSwedish, Finish, DanishChinese-Mandarin,Korean, Russian, Greek | |
| Data Export | JPEG Image, AVI VideoClip, PDF Report Data,ODF (Open DataFormat), EXMIF(Exchangeable MedicalInformation Format) | JPEG Image, AVI VideoClip, PDF Report Data,ODF (Open DataFormat), EXMIF(Exchangeable MedicalInformation Format) | JPEG Image, AVI VideoClip, PDF Report Data,ODF (Open DataFormat), EXMIF(Exchangeable MedicalInformation Format) | JPEG Images, (MPEGVideo clips, grml (Givenproprietary) files, PDFReports, generic XMLformat, CapsuleEndoscopy report data | |
| Data Display | Single and Multi Image,Time Bar, DiagnosisData, Dual Bar | Single and Multi Image,Time Bar, DiagnosisData | Single and Multi Image,Time Bar, DiagnosisData, Dual Bar | Single and Multi Image,Time Bar, Colorbar withregion specific color andother diagnostic data | |
| Event Marker | Small Image withExplanation | Small Image withExplanation | Small Image withExplanation | Annotated thumbnails | |
| Display Ratio | 3~10,000fps | 3~10,000fps | 3~10,000fps | 5~80fps | |
| 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, MosaicView, Dual Head View | |
| Running Mode | Normal Mode, Express,SGIB | Normal Mode, Express,SGIB | Normal Mode, Express,SGIB | Normal, Auto, QuickView, SBI |
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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.
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| 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 mode00 -> Direct01 -> BPSK10 -> 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).
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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.
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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
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- Center: 10 in France
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- 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.
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- 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 < 1 x 10-). The consensus review identified a significant lesion in 44/83 patients (53.0%). Standard reading and express view reading had a 93.3% and 82.2% sensitivity, respectively (NS). Consensus review identified 70 significant images from which standard reading and express view reading detected 58 (82.9%) and 55 (78.6%), respectively. The informatics algorithm detected 66/70 images (94.3%) thus missing four small-bowel angiodysplasia.
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- Conclusion: The express view algorithm allows an important shortening of Intromedic capsule film reading time with a high sensitivity.
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8. Conclusion
Based on Indications for Use, Substantial Equivalence, Performance testing of the devices, IntroMedic Co., Ltd. believes that the MiroCam® Capsule Endoscope System and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.
§ 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.”