E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM

K111030 · Intromedic Co., Ltd. · EOX · Oct 21, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111030
• Device Name: E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
• Applicant: Intromedic Co., Ltd.
• Product Code: EOX · Ear, Nose, Throat
• Decision Date: Oct 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4710
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

E.G. Scan™ Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus.

Device Story

E.G. Scan™ Esophagoscope System is a transnasal esophagoscope for esophageal visualization. System comprises a disposable probe and a controller. Probe captures esophageal images; controller processes and converts image data for display via E.G. View™ software. Device includes a balloon to expand the esophagus, facilitating lumen observation and centering the probe. Used by clinicians in a clinical setting for diagnostic purposes. Output is a visual image displayed on a monitor, assisting the physician in diagnosing esophageal diseases. Benefits include improved visualization of the esophagus through balloon-assisted expansion and disposable probe design.

Clinical Evidence

Bench testing only. Performance data included electrical, mechanical, and environmental safety testing according to EN/IEC 60601-1 and EN/IEC 60601-2-18, as well as EMC testing per EN/IEC 60601-1-2(2001). Transportation and disinfection performance tests were also conducted. All test results were reported as satisfactory.

Technological Characteristics

Transnasal esophagoscope system. Components: disposable probe, controller, and E.G. View™ software. Features an integrated balloon for esophageal expansion. Connectivity: image data transmission from probe to controller. Standards: EN/IEC 60601-1 (general safety), EN/IEC 60601-2-18 (endoscopic equipment), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for endoscopic access and examination of the larynx and esophagus in patients requiring visualization of these structures.

Regulatory Classification

Identification

An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• EndoSheath® Systems for use with VSI Flexible Scope (K071903)
• Modified Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems (K072088)

Reference Devices

• Maxforce TTS Single-Use Balloon Dilator (K061787)
• Fujinon Double Balloon Enterscopy System (K040048)

Submission Summary (Full Text)

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K/// 030

## 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.

Date: _Aug. 20, 2010

- 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 - [phone] Fax - [phone] Contact - JinYoung, Lee Internet - http://www.intromedic.com

- 2. Device :

| Proprietary name | : E.G. Scan™ Esophagoscope System |
|---------------------|-----------------------------------|
| Common Name | : Esophagoscope System |
| Classification Name | : Esophagoscope System |

- 3. Predicate Device :

| Manufacturer | : Vision-Sciences, Inc. |
|---------------|-------------------------------------------------------|
| Device | : EndoSheath® Systems for use with VSI Flexible Scope |
| 510(k) Number | : K071903 |

: Vision-Science, Inc. Manufacturer Device : Modified Flexible Trans-Nasal Esophagoscope with , )
, ' Digital Video Processor and Disposable EndoSheath® Systems 510(k) Number : K072088

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| Manufacturer | : Boston Scientific Corporation |
|---------------|--------------------------------------------|
| Device | : Maxforce TTS Single-Use Balloon Dilator |
| 510(k) Number | : K061787 |
| Manufacturer | : Fujion, Inc. |
| Device | : Fujinon Double Balloon Enterscopy System |
| 510(k) Number | : K040048 |

4 . Classifications Names & Citations :

21CFR874.4710, EOX, Esophagoscope System, Class2

- 5. Description :
- 5.1 Introduction

E.G. Scan™ Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ Controller. E.G. Scan™ Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis.

The E.G. Scan™ Esophagoscope Probe is disposable.

- 5.2 General Technology
E.G. Scan™ esophagoscope system is a fransnasal esophagoscope designed to capture images of the esophagus. Captured images are viewed via the E.G. View™ Software for diagnosis of diseases related to the esophagus.

- 6. Indication for use :
The E.G. Scan™ Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus.

- 7. Comparison with predicate device :
IntroMedic Co., Ltd., believes that the Esophagoscope System (E.G. Scan) is substantially equivalent to EndoSheath® Systems for use with VSI Flexible TNE Scope of Vision-Sciences, Inc. and Modified Flexible Trans-Nasal Esophagoscope

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with Digital Video Processor and Disposable EndoSheath® Systems of Vision-Sciences, Inc., Fujinon double balloon enteroscope of Fujinon, Inc..

Esophagus is always strongly contracted making it difficult to observe the lumen during the insertion. A balloon is needed in order to expand the size of the esophagus. Due to the small diameter of the probe and to avoid it leaning to one side in the esophagus, expansion of the balloon will allow the probe to be maintained in the center. As well as predicate device the Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

- 8. Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-18 and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). And Transportation and disinfection performance test were conducted. All test results were satisfactory.

- 9. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification IntroMedic Co., Ltd. concludes that The E.G. Scan is safe and effective and substantially equivalent to predicate devices as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

Intromedic Co., LTD c/o Mr. Marc Mouser Engineering Leader, and Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607-9526

0CT 2 1 2011

Re: K111030

Trade/Device Name: Esophagoscope System Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOX Dated: September 21, 2011 Received: October 3, 2011

Dear Mr. Mouser:

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. Marc Mouser

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Acker m. f.

Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number(if known):

Device Name: E.G. Scan™ Esophagoscope System

Indications for Use:

E.G. Scan™ Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus.

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)

Sim March

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111030

Page 1

Prescription Use (Per 21 CFR 801.109)