MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

Device Description

The MiroCam® Capsule Endoscope System is comprised of the following core components:

MiroCam® Capsule: MC1000-B
MiroCam® Receiver: MR1100
Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i

The 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.

AI/ML Overview

The provided text describes a 510(k) submission for the MiroCam® Capsule Endoscope System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone clinical study with specific acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, and MRMC studies are not explicitly stated in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics as would be found in a standalone clinical study. Instead, it relies on substantial equivalence to a legally marketed predicate device (MiroCam® Capsule Endoscope System K111450). The performance testing mentioned is primarily for safety and functional characteristics, not clinical efficacy metrics like sensitivity or specificity.

Aspect of Performance/Criteria	Reported Device Performance (Summary from text)
Biocompatibility	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Electrical Safety	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Software Life Cycle Validation	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Mechanical Structural Integrity	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Field of View	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Depth of Field	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Battery Life	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Battery Short-Circuit Temp.	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Shelf Life	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
pH Resistance	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Biting Resistance	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Sensor Bench Testing	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Optical Performance	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Wireless Coexistence	Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate.
Overall Safety & Effectiveness	Demonstrated substantial equivalence to listed predicate devices; differences do not affect product's safety or effectiveness.
Suspected GI Bleeding Indicator (SGIB) Functionality	Intended to mark frames of the video suspected of containing blood or red areas (functionality described, no performance metrics stated).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set with a specific sample size. The performance testing mentioned are "bench testing" and "non-clinical performance testing," which typically refers to laboratory or engineering tests rather than patient studies. Therefore, details regarding country of origin or retrospective/prospective nature of a clinical test set are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the submission relies on substantial equivalence and does not detail a clinical study with expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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

A MRMC comparative effectiveness study is not mentioned. The submission is for a medical device that assists physicians (Gastroenterologists) in reviewing images, but it does not detail a study comparing human performance with and without the device's assistance. The document mentions the "Suspected GI Bleeding Indicator (SGIB)" as a feature to "mark frames of the video suspected of containing blood or red areas," which implies an assistive function, but no study measuring its impact on reader performance is presented.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance study for an algorithm like the SGIB is not explicitly detailed. The SGIB is described as an "indicator" intended to "mark frames," implying it's a feature within the system. The submission mainly focuses on the physical and functional aspects of the capsule endoscopy system itself, establishing substantial equivalence to a previous version.

7. The Type of Ground Truth Used

For the bench testing described, the "ground truth" would be established through engineering specifications, known physical properties, and controlled experimental conditions (e.g., specific field of view measurements, battery discharge curves, pH levels). For the SGIB, the nature of its "ground truth" for marking frames is not specified but would likely be based on visual characteristics of blood or redness. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth in this submission.

8. The Sample Size for the Training Set

No training set is mentioned. This submission is for a device, not a machine learning algorithm requiring a distinct training phase documented here for its efficacy claims. While the SGIB feature might be algorithm-based, no details of its development or training are provided.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is mentioned in the document.

Summary

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K123428

page 1 of 5

5. 510(k) Summary

MAY 2 0 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Company and Correspondent making the submission

Name	IntroMedic Co., Ltd.
Address	Suite 1104, E&C Venture Dream Tower 6-Cha, 197-28 Guro-Dong, Guro-Gu, Seoul, 152-719 Korea
Telephone	+82-2-801-9300
Fax	+82-2-801-9330
Contact	Steve Kwon
Internet	http://www.intromedic.com

2. Device

Proprietary Name	MiroCam® Capsule Endoscope System
Common Name	Capsule Imaging System
Classification Name	21 CFR 876.1300 (Product Code NEZ)

3. Predicate Device

Manufacturer	IntroMedic Co., Ltd.
Device	MiroCam® Capsule Endoscope System
510(K) Number	K111450

4. Description

The MiroCam® Capsule Endoscope System is comprised of the following core components:

MiroCam® Capsule: MC1000-B -
MiroCam® Receiver: MR1100 -
Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L) -
MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i -

IntroMedic Co., Ltd.
MiroCam® Capsule Endoscope System, Traditional 510(k)

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The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel. The key system components are explained in detail below.

MiroCam® Capsule

Functionally, the MiroCam® capsule captures imaging via a CMOS imaging sensor for at least 12 hours at the rate of 3 images per second. Six white LEDs flash in concert with the imaging sensor. A sensor PCB links the imaging sensor to the two gold electrodes of the capsule, from which a weak current is emitted containing the image data via Human Body Communication technology. The weak current is then passed through the bodily tissue and fluid to be picked up by the sensor pads. Human Body Communications is uni-directional from the capsule to the sensor pads.

Physically, the capsule is 24.5mm in length, and 10.8mm in diameter. The exterior of the capsule is composed of biocompatible materials, capable of withstanding potential bite forces and exposure to fluids in the GI tract.

MiroCam® Receiver

The image data from the capsule is saved to the MiroCam® Receiver via the sensor pads and data cables. The sensor pads are standard ECG type sensor pads (3M Red Dot), which are affixed to the patient's abdomen according to the location guide. The 9 sensor pads are attached to the 9 leads of the data cable, and the data cable is subsequently attached to the Receiver. The Receiver sits in a shoulder pouch, which is put on the patient for the duration of the procedure. A waist pouch is used to organize the data cables. The Receiver can store images for up to 12 hours. The three indicators on the Receiver are for battery status, initialization status of the receiver, and status of signal receipt from the capsule.

The dimensions of the receiver are 140mm in height, 85mm in width, and 40mm in length. The units weight 350grams with the battery, which is data cable. The battery is lithium ion,

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and is unique to the Receiver. The battery is rechargeable, and can be charged by placing in the battery charger provided with the Receiver. The receiver uses a storage flash for storing the images.

The MiroCam® Receiver has RTV (Real-Time View) function to view a capsule in the body in real time. There are the wire communication method to connect to a Commercial PC by USB cable and the wireless communication method to connect to i-Phone, i-Pad or i-Pod touch by Wifi.for RTV.

MiroView™ U

The MiroView™ U helps the user to upload the image data from the Receiver and review the image data with displaying.

MiroView™ U will be deployed as three types of software: MiroView™ Server, MiroView™™ Operator and MiroView™ Client.

Server PC includes two types of S/W: MiroView™ Server and Operator.

MiroView™ Server and MiroView™ Operator will be deployed on a Server PC. MiroView™ Client SMV will be deployed on reviewer's PCs. 10 Client SMs will be able to connect to one Server PC via Network (LAN) at a time.

MiroView™ Server has functionalities: Data Storage, PACS connectivity.

MiroView™ Operator has functionalities: Receiver Management, Case Management and Account Management.

MiroView™ Client has functionalities: List Mode (Case Data Management), Review Mode (Video Display, Image Capture, Annotation Box, etc.), Report Mode (User Comment, Auto Disease Name Check, etc), Export Mode (JPG, AVI, MiroVlew™ file format)

MiroView™ U provides some kinds of Modes and Views to help the user review patient video data quickly and conveniently; however, IntroMedic, Co., Ltd. recommends that the doctor review the patient video in the Normal Mode / Single View to prevent from a wrong diagnosis.

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The features are described below:

Multi-Data Path (MiroView™ Server)
Customizing Print Dialog (MiroView™ Client) -
Data Multi-Language (MiroView™ Client) -
ODF Report (MiroView™ Client) -
Drag Bag (MiroView™ Client)
Finding Setting (Custom Finding) (MiroView TM Client)

5. Indications for Use

The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

6. Technological Characteristics and Substantial Equivalence

The characteristics of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System are substantially equivalent to the following current legally marketed predicate devices based on indications for use, typical clinical use, and operational and fundamental technological characteristics

MiroCam® Capsule Endoscope System by IntroMedic Co., Ltd. K111450 .

A detailed side-by-side comparison of the MiroCam® Capsule Endoscope System with the identified predicate device is provided in the substantial equivalence discussion in this premarket notification.

7. Performance Testing

The MiroCam® Capsule Endoscope System performance testing includes biocompatibility testing, electrical safety testing, and software life cycle validation to the appropriate FDA Recognized Consensus Standards and bench testing which includes mechanical structural

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integrity testing, field of view and depth of field testing, battery life testing, and battery shortcircuit temperature testing, shelf life testing, pH resistance testing, biting testing, sensor bench testing, optical performance testing, wireless coexistence testing. The results of this performance testing conclude that the material and technological characteristics have not diminished the safety and effectiveness of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System device when compared to the predicate device.

8. Conclusion

Based on the similarities in indications for use, design, functional, and operational features as evaluated through clinical and non-clinical performance testing the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System has demonstrated substantial equivalence to the listed legally marketed predicate devices and any differences do not affect the product's safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2013

IntroMedic Co., Ltd. % Mr. Steve Kwon Manager Suite 1104, E&C Venture Dream Tower, 6 Cha 197-28 Guro-Dong, Guro-Gu SEOUL 152-719 REPUBLIC OF KOREA

K123428 Re:

Trade/Device Name: MiroCam® Capsule Endoscope System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible Telemetric Gastro-intestinal Capsule Imaging System Regulatory Class: Class II Product Code: NEZ Dated: May 15, 2013 Received: May 17, 2013

Dear Mr. Kwon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Steve Kwon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must. comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herber - Daterner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

510(k) Number (if known): K123428

Device Name: MiroCam® Capsule Endoscope System

Indications for Use:

MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

K123428

Herbert P. Derner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

IntroMedic Co., Ltd.

MiroCam® Capsule Endoscope System, Traditional 510(k)

Page 4-1

Regulation Number and Section

§ 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.”