MiroCam Capsule Endoscope System

K180732 · Intromedic Co., Ltd. · NEZ · Nov 8, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180732
• Device Name: MiroCam Capsule Endoscope System
• Applicant: Intromedic Co., Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

System captures small bowel images via ingestible capsule; CMOS sensor; 12 white LEDs; 6 frames/sec. Data transmitted via Human Body Communication (HBC) to external sensor pads (ECG-type) on patient abdomen; connected to wearable receiver (MR2000) via data cables. Physician (gastroenterologist) uploads data to PC running MiroView™ U 4.0 software for review. Software includes Suspected GI Bleeding Indicator (SGIB) to flag potential blood/red areas; assists in identifying small bowel abnormalities. Enables non-invasive visualization; reduces need for invasive procedures; aids diagnosis of obscure GI conditions.

Clinical Evidence

Literature study (Saurin JC, et al., 2018) evaluated Express View reading mode in 83 patients with obscure GI bleeding. Compared standard vs. express reading. Mean reading time: 39.7 min (standard) vs. 19.7 min (express) (p < 1x10^-). Sensitivity for significant lesions: 93.3% (standard) vs. 82.2% (express) (NS). Informatics algorithm detected 94.3% of significant images identified by consensus review.

Technological Characteristics

Capsule: 24.5mm x 10.8mm; CMOS sensor; 6 white LEDs; 170° FOV; 12-hour battery (silver oxide). Data transmission: Human Body Communication (HBC). Receiver: MR2000; Li-ion battery; LCD display. Software: MiroView™ U 4.0 (Server/Operator/Client architecture). Biocompatible plastic/COP dome. Connectivity: USB/LAN. Sterilization: Not specified.

Indications for Use

Indicated for adults and children from 2 years of age for visualization of small bowel mucosa to monitor lesions associated with Crohn's disease, obscure GI bleeding, or iron deficiency anemia not detected by upper/lower endoscopy. Includes Suspected GI Bleeding Indicator (SGIB) for marking frames with suspected blood.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• MiroCam® Capsule Endoscope System (K143663)
• MiroCam® Capsule Endoscope System (K170438)

Reference Devices

• Given PillCam SB3 Capsule endoscopy system (K123864)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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,<br>197-28 Guro-dong, Guro-gu, Seoul, 08375, Korea |
| Telephone | [phone] |
| Fax | [phone] |
| 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)<br>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.<br>- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.<br>- 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.<br>- 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.<br>- 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.<br>- 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.<br>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.<br>- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.<br>- 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.<br>- 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.<br>- It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only.<br>- 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.<br>- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.<br>- 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.<br>- 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.<br>The suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.<br>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<br>Diameter: 10.8mm | Length: 24.5mm<br>Diameter: 10.8mm | Length: 30.1mm<br>Diameter: 10.8mm | Length: 26.2mm<br>Diameter: 11.4mm |
| | Weight | $3.25g\pm0.1g$ | 3.25g | $3.5g\pm0.1g$ | $3.0\pm0.1g$ |
| | Material | Human<br>Compliance<br>Plastic | Human<br>Compliance<br>Plastic | Human<br>Compliance<br>Plastic | Biocompatible plastic |
| | Dome Material | COP (Cyclo<br>Polymers) | COP (Cyclo<br>Polymers) | COP (Cyclo<br>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)*<br>0.8mm(H) | 2.0mm(L)*1.25mm(W)*<br>0.8mm(H) | 2.0mm(L)*1.25mm(W)*<br>0.8mm(H) | |
| | LED Viewing<br>Angle | 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 |
| | Enlargement<br>Ratio | 1:8 | 1:8 | 1:8 | |
| | Detectable<br>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<br>(each 3 frames per head) | 2 or 2~6 frames per<br>second |
| | Pixel size of<br>Sensor | $6.0 \mu m*6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | $6.0 \mu m*6.0 \mu m$ | |
| | 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…