(351 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 only.
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: MC2000-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 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 Endoscope System is intended for visualization of the small bowel mucosa and can be used to visualize and monitor lesions related to Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) not detected by upper and lower endoscopy. It can also detect other small bowel abnormalities in adults. The Suspected GI Bleeding Indicator (SGIB) marks frames suspected of containing blood or red areas.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of "acceptance criteria" with numerical targets. Instead, it describes performance testing conducted to demonstrate that modifications to the device (MC2000-B capsule and MiroView™ U 4.0 software) do not diminish the safety or effectiveness compared to its predicate (MiroCam® Capsule Endoscope System K143663 and Given® PillCam® SB3 K123864). The "reported device performance" is largely framed as equivalency or improvement over the predicate, rather than meeting specific quantitative thresholds.
However, based on the comparative effectiveness section, we can infer some performance aspects that were evaluated.
| Feature/Characteristic | Acceptance Criteria (Inferred from Predicate/Equivalency) | Reported Device Performance (Subject Device: MiroCam® MC2000-B) |
|---|---|---|
| Capsule Operation Time | At least 12 hours (K143663, K123864 predicate) | 12 Hours (Performance and Bench Test proved no problem) |
| Capsule Shelf Life | 18 months (K143663 predicate) | 12 months (Performance and Bench Test proved no problem) |
| Ingestion Ease (Capsule Size) | Comparable to or smaller than predicate | Smaller (30.1mm x Ø10.8mm) than reference device K123666 (31.5mm x Ø11.6mm), and comparable to K143663 (24.5mm x Ø10.8mm) in diameter. |
| Image Quality (Optical System) | Same as K143663 predicate | Uses the same optical system (Sensor, LED, Lens) as K143663, improved with two image sensors for bi-directional shooting. |
| Real-Time View (RTV) | Functional RTV (via USB/WiFi for K143663; LCD for K123864) | Displays RTV on LCD on the receiver (similar to K123864 predicate) |
| Software Functionality | Comparable to predicate MiroView™ U 3.0 | New features added (Compatibility with new receiver, UI for dual tip capsule, H.264 Codec, Express Play 3.0, Supplementary Play) |
| Safety (EMC, Electrical) | Compliant with relevant safety standards (implied, as stated for predicates) | Safety and EMC tests conducted to verify both devices (K143663 and subject) are safe. |
| Bite Resistance | Adequate (implied for capsule integrity) | Bite testing conducted. |
| Water Proofing | Adequate (implied for capsule integrity) | Water proof testing conducted. |
| pH Resistance | Safe in pH 2-8 (K143663, K123864 predicate) | pH resistance testing conducted; Safe in pH=2 ~ pH=8. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each performance test. It mentions tests like MTF Measurement, Minimum Distinguishable Contrast Value and Depth of Field, Geometric distortion, Field of View, Color Reproduction, Optical spectra of the light source, Intensity change during shelf life, Bite testing, Water proof testing, pH resistance testing, MR1100 and MR2000 Equivalent Performance Comparison testing, and Shelf life testing.
The data provenance is implied to be from internal lab testing and comparisons, conducted by IntroMedic Co., Ltd. The study appears to be retrospective in the sense that it compares features and performance against already cleared predicate devices. There is no information provided about prospective clinical trials or country of origin for specific data sets, except that the manufacturer is from Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
This document describes a medical device submission focusing on substantial equivalence of hardware and software features, along with physical performance tests. It does not mention any human expert review or ground truth establishment by clinical experts for the purpose of validating image-based diagnostic performance or the "Suspected GI Bleeding Indicator (SGIB)" functionality in the context of this submission. The SGIB is stated to be "intended to mark frames... suspected of containing blood or red areas," but no details are provided on its validation or ground truth.
4. Adjudication Method for the Test Set
As no human expert review or ground truth establishment by experts for specific diagnostic performance is mentioned, there is no adjudication method provided for an expert-based test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The device described is a capsule endoscope system with an "indicator" function (SGIB) for potential bleeding, not an AI diagnostic system designed to assist human readers in interpretation or to quantify improvement in human performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions the "Suspected GI Bleeding Indicator (SGIB)" as an "intended to mark frames... suspected of containing blood or red areas." This suggests an algorithmic function. However, the document does not provide any data on the standalone performance of this SGIB algorithm (e.g., sensitivity, specificity, accuracy) using a defined ground truth. Its presence is mentioned as a feature, not a validated diagnostic tool in this submission.
7. The Type of Ground Truth Used
For the physical and functional performance tests (e.g., bite testing, water resistance, pH resistance, optical system, operation time), the ground truth is derived from engineering specifications, physical measurements, and direct observation against established standards or predicate device performance. For the SGIB feature, no specific ground truth type (e.g., expert consensus, pathology, outcomes data) for its performance validation is described in this submission.
8. The Sample Size for the Training Set
This document concerns a capsule endoscopy system, not a machine learning model requiring a training set in the typical sense. While the SGIB feature might use some form of internal algorithm, no information on the sample size of a training set is provided.
9. How the Ground Truth for the Training Set Was Established
As no training set for an AI model is explicitly mentioned or detailed, no method for establishing ground truth for a training set is provided.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 30, 2018
Intromedic Co., Ltd. Jinyoung Lee General Manager Suite 1105, 1106, E&C Venture Dream Tower 6-Cha Guro-dong, Guro-gu Seoul. 08375 Korea
Re: K170438 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: December 7, 2017 Received: December 14, 2017
Dear Jinyoung Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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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); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold, sans-serif font. The text is black and appears to be the main subject of the image. The background is plain and does not distract from the text.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170438
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 only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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.
1. Company and Correspondent making the submission
| Name | IntroMedic Co., Ltd. |
|---|---|
| Address | Suite 1105, 1106, E&C Venture Dream Tower 6-Cha197-28 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 |
3. Predicate Device
| Manufacturer | IntroMedic Co., Ltd. |
|---|---|
| Device | MiroCam® Capsule Endoscope System |
| 510(K) Number | K143663 |
| Manufacturer | Given Imaging Ltd. |
| Device | Given PillCam SB3 Capsule endoscopy system |
| 510(K) Number | K123864 |
| Manufacturer | Given Imaging Ltd. |
| Device | Given PillCam COLON 2 Capsule endoscopy system |
| 510(K) Number | K123666 (Reference device) |
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4. Description
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- -MiroCam® Capsule: MC2000-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® 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 30.1mm 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 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.
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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™ 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 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 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.
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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
Capsule Endoscope System is intended for visualization of the small The MiroCam® 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 mav 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.
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
- Given® PillCam® SB3 Capsule endoscopy system by Given Imaging Ltd. K123864
- Given PillCam® COLON 2 capsule endoscopy system by Given Imaging Ltd. K123666 (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®Endoscope SystemSubject device | MiroCam®Endoscope SystemK143663 | Given® PillCam® SB3Capsule systemK123864 | Given PillCam®COLON 2 capsuleendoscopy systemK123666(Reference device) |
|---|---|---|---|---|---|
| Indications for Use | The MiroCam® CapsuleEndoscope System isintended for visualizationof the small bowelmucosa.- It may be used in thevisualization andmonitoring oflesions that mayindicate Crohn'sdisease not detectedby upper and lowerendoscopy.- It may be used in thevisualization andmonitoring oflesions that may be asource of obscurebleeding (eitherovert or occult) notdetected by upperand lowerendoscopy.- It may be used in thevisualization andmonitoring oflesions that may bepotential causes ofiron deficiencyanemia (IDA) notdetected by upperand lowerendoscopy.- It may be used as a tool inthe detection ofabnormalities of the smallbowel and this device isindicated for adults only.- The Suspected GIBleeding Indicator(SGIB) is intended tomark frames of the videosuspected of containingblood or red areas. | MiroCam® CapsuleEndoscope System isintended for visualizationof the small bowelmucosa. It may be used asa tool in the detection ofabnormalities of the smallbowel in adults andchildren from two yearsof age.- The Suspected GIBleeding Indicator(SGIB) is intended tomark frames of the videoof suspected of containingblood or red areas. | The PillCam SB capsuleis intended forvisualization of the smallbowel mucosa.- It may be used in thevisualization andmonitoring oflesions that mayindicate Crohn'sdisease not detectedby upper and lowerendoscopy.- It may be used in thevisualization andmonitoring oflesions that may bea source of obscurebleeding (eitherovert or occult) notdetected by upperand lowerendoscopy.- It may be used in thevisualization andmonitoring oflesions that may bepotential causes ofiron deficiencyanemia (IDA) notdetected by upperand lowerendoscopy.- The suspected BloodIndicator (SBI) feature isintended to mark framesof the video suspected ofcontaining blood or redareas.- The PillCam SB capsulemay be used as a tool inthe detection ofabnormalities of the smallbowel and is intended foruse in adults and childrenfrom two years of age. | The PillCam COLON 2System is indicated toprovide visualization ofthe colon. It is intended tobe used for detection ofcolon polyps in patientsthat may after an incompleteoptical colonoscopy withadequate preparation, anda complete evaluation ofthe colon was nottechnically possible.(※The Indications forUse of the device do notapply to the subjectdevice.) | |
| Manufacturer | IntroMedic Co., Ltd.MC2000-B | IntroMedic Co., Ltd.MC1200-B | Given Imaging Ltd.PillCam SB3 | Given Imaging Ltd.PillCam COLON 2 | |
| ule | Size | Length: 30.1mmDiameter: 10.8mm | Length: 24.5mmDiameter: 10.8mm | Length: 26.2mmDiameter: 11.4mm | Length: 31.5mmDiameter: 11.6mm |
| Weight | $3.5g\pm0.1g$ | 3.25g | $3.0\pm0.1g$ | $2.9\pm0.03g$ | |
| Material | Human CompliancePlastic | Human CompliancePlastic | Biocompatible plastic | Biocompatible plastic | |
| Dome Material | COP (Cyclo OlefinPolymers) | COP (Cyclo OlefinPolymers) | Polycarbonate | Polycarbonate | |
| Light | 12 White LEDs (eachWhite LEDs) | 6 White LEDs | 4 White LEDs | 8 White LEDs (eachWhite LEDs) | |
| LED Size | 2.0mm(L)1.25mm(W)0.8mm(H) | 2.0mm(L)1.25mm(W)0.8mm(H) | |||
| LED ViewingAngle | 130° | 130° | |||
| Exposure Time | 0.5 ~ 24 ms | 0.5~24 ms | |||
| Field of View | 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 | |||
| DetectableRange | Under 0.1mm | Under 0.1mm | At least 0.07mm | ||
| Sampling Ratio | 6 frames per second (each3 frames per head) | 3 frames per second | 2 or 2~6 frames persecond | Up to 35 Frames perSecond per head | |
| Pixel size ofSensor | $6.0 \mu m*6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | |||
| Working Time | 12 Hours | 12 Hours | Over 8 Hours | 10 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 | |||
| Direction ofView | 0° | 0° | |||
| Resolution | 320x320 | 320x320 | |||
| Distortion (%) | -14.5 | -14.5 | |||
| Lens Uniformity(%) | 79.39 | 79.39 | |||
| Shelf life | 12 months from datemanufacture | 18 months from datemanufacture | 12 months from datemanufacture | ||
| Operation Temp. | 20 ~ 40 ℃ | 20 ~ 40 ℃ | 20 ~ 40℃ | 20 ~ 40 ℃ | |
| Storage Temp. | 0 ~ 50 ℃ | 0~50℃ | 0 ~ 25℃ | 0~30℃ | |
| TransmissionMethods | HBC (HumanCommunication) | HBC (Human BodyCommunication) | RF | RF | |
| Receiver | Model Name | MR2000 | MR1100 | DR3 | DR3 |
| Recording Time | 12 Hours | 12 Hours | Up to 15 hours at LCD off | Up to 15 hours at LCD off | |
| Weight | 330g (Include Battery) | 350g (Include Battery) | 500g (Include BatteryPack) | 500g (Include BatteryPack) | |
| OperationVoltage | 3.65Vdc, 0.45A | 3.7Vdc, 0.45A | 3.5 | 3.5 | |
| Battery Type | Lithium Ion Battery,3.65V, 10,500mA | Lithium Ion Battery,3.7V, 10,400mA | Lithium Ion Battery,3.8V, 8,800mAh | Lithium Ion Battery,3.8V, 8,800mAh | |
| Operation Temp. | 0 ~ 40 ℃ | 0~40℃ | 0 ~ 40℃ | 0 ~ 40 ℃ | |
| Storage Temp. | 0~55℃ | 0 ~ 55 ℃ | 0 ~ 55 ℃ | 0 ~ 55 ℃ | |
| 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) | Sensor Array or SensorBelt | Sensor Array or SensorBelt | |
| Characteristics | IntroMedic Co., Ltd. | IntroMedic Co., Ltd. | Given Imaging Ltd. | Given Imaging Ltd. | |
| Software | Software | MiroView™ U 4.0 | MiroView™ U 3.0MiroView™ RTV (RealTime ViewerApplication-only USB)MiroView™ RTV-I(Real Time ViewerApplication-only Wifi) | RAPID 8.0 | |
| Language | English,Portuguese, | Spanish, English,Danish, Portuguese,Chinese, French, Italian, Korean, Dutch, Russian,Swedish | English, French, German,Italian, Spanish,Portuguese, Dutch,Swedish, Finish, Danish,Chinese-Mandarin,Korean, Russian, Greek | ||
| Data Export | JPEG Image, AVI VideoClip, PDF Report Data,ODF (Open DataFormat),(Exchangeable MedicalInformation Format) | JPEG Image, AVI VideoClip, PDF Report Data,ODF (Open DataEXMIF Format),(Exchangeable MedicalInformation Format) | JPEG Images, (MPEG)Video clips, grml (GivenData proprietary) files, PDFEXMIF Reports, generic XML-format, CapsuleEndoscopy report data | ||
| Data Display | Single and Multi Image,Time Bar, DiagnosisData, Dual Bar | Single and Multi Image,Time Bar, Diagnosis Data | Single and Multi Image,Time Bar, Colorbar withregion specific color andother diagnostic data | ||
| Event Marker | Small Image withExplanation | Small Image withExplanation | Annotated thumbnails with | ||
| Display Ratio | 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, MosaicView, Dual Head View | ||
| Running Mode | 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]
Subject device uses the same optical system as Capsule of Predicate device K143663. It means that this optical system uses the same parts as those of K143663 such as Sensor, LED, and Lens. However, the K143663 Capsule can only shoot in one direction, but the subject device can shoot in both directions. Two-way Capsule has the advantage of eliminating blind spots by two-way shooting because it has two identical optical systems compared to one-way Capsule. This is comparable to that of the Predicate device in terms of effectiveness. And this two-way Capsule endoscope system has the reference device, COLON 2, K123666. The COLON 2 is able to expand indications for use from diagnosis of colon to diagnosis of small bowel due to the advantages of bi-directional photography and increased frame number. The frame number of this submitted the subject device is smaller than that of the reference device and because it cannot prove the effectiveness of colon diagnosis, the reference device is limited to small bowel diagnosis. In addition, the subject device is smaller in size than the COLON 2 of the
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reference device K123666, which makes ease of ingestion easier.
And because two optical systems are used compared to K143663, Operating Time and Shelf Life can be different, and it is proved that there is no problem in operating time when using within the given period through Performance and Bench Test.
- . Ease of device ingestion
The size of MC2000-B is 30.1mm x Ø10.8mm. This is smaller than the 31.5mm x Ø11.6mm of the previously FDA clearance device COLON 2 (K123666). So ease of device ingestion of subject device is smaller than COLON 2 (K123666) and can be claimed to be easier to ingest.
The predicate device K143663 and the subject device are using the same sensor (ASPIN), LED and battery. However, the subject device has two image sensors in each head of the capsule and two sensors capture images alternately, so that the total current can be minimized. (See "Hand Shaking Mode for
Dual camera")
Hand Shaking Mode for Dual camera
ASPIN supports dual camera mode. One of the two chips is set to operate in Master mode by setting the SEL SAVE pin to "LOW" while another chip must be set to operate in Slave mode by setting the SEL SLAVE pin to "High". In Dual mode, the hand shaking operation is implemented using HAND1 pins. In Master mode, HAND0 operates as output and HAND1 operates as input. In slave mode the situation is opposite. Timing diagram is shown below.
-
- Master device EEPROM data read: time interval (1)
-
- Slave device EEPROM data read: time interval (2)
- time interval (3) 3) Master dummy tx period:
-
- Slave dummy tx period:
- time interval 4
- time interval 5, 7 5) Master tx. Slave idle:
-
- Slave tx. Master idle: time interval 6, 8
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Image /page/11/Figure/1 description: The image shows a timing diagram with several signals, including HAND0, HAND1, SCL, SDA, LED0, SEL_SLAVE, TX, and pd. The diagram is divided into two sections, labeled "Master" and "Slave", each with its own set of signals. The HAND0 signal has numbered sections 1 through 8. The diagram illustrates the timing relationships between these signals in a master-slave communication scenario.
Figure 12-1_Hand Shaking Mode operation
Changing of battery voltage caused by LED connected with control resistance than entire battery voltage changes due to increase of LED resistance has no affect on image quality.
Image /page/11/Figure/4 description: The image shows two different LED module schematics. The first schematic is labeled "LED Module of MC1200-B" and shows a module with two current control resistors labeled R1 and R2, each with a value of 100. The second schematic is labeled "LED Module of MC2000-B" and shows two modules labeled "Master" and "Slave", each with two current control resistors labeled R2 and R3, each with a value of 150.
Figure 12-2_Comparison LED Module
For the MC1200-B, Auto Exposure time is used to adjust the LED turn-on time depending on the target brightness, which applies equally to the MC2000-B.
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AE (Auto Expose Control)
Depending on the sensor's incident light intensity, the AE function optimally adjusts the exposure time, thus preventing the over-exposure and low exposure situations. Namely, it calculates an average brightness of the image and, after checking the present state of the exposure, adjusts the exposure doze to make sure that the current average brightness converges to target brightness value by means of P-control. ASPIN adjusts the exposure time by adjusting the pixel control timing as well as LED ON-time. The unit step of exposure time adjustment is 1 PCLOCK period.
[Receiver]
The Human Body Communication (HBC) method is used on both Subject device and Predicate device (K143663). Even if. Subject device and Predicate device share same communication method, they have different way to display real time view (RTV). Predicate device displays RTV using another device such as laptop and tablet PC via USB or wifi connection, abd Subject device displays these RTV on LCD on the receiver, similar way to Predicate device (K123864).
Another difference, electro-mechanically can be found between K143663 and Subject device but we conducted Safety and EMC test to verifie both devices are safe.
[Software]
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 4.0 Operator -
- UI Function for Receiving Patient Data of Dual Tip Capsule MC2000 Series: MiroView™ -U Client 4.0
- -Support of H.264 Codec: MiroView™ U 4.0
- Express Play 3.0: MiroView™ U Client 4.0 -
- Supplementary Play: MiroView™ U Client 4.0 -
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
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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, MR1100 (predicate device, K143663) and MR2000 (subject device) Equivalent Performance Comparison 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.
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.”