(60 days)
Not Found
No
The description mentions image processing and display, but there is no mention of AI, ML, or any related terms, nor is there any description of training or test data sets which are typical for AI/ML devices.
No.
The device is described for "diagnostic" purposes, such as capturing and displaying images for diagnosis, rather than for treating or alleviating a medical condition.
Yes
The device description explicitly states: "E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients" and "Captured images are viewed via the E.G. View™ Software for diagnosis of diseases related to the esophagus."
No
The device description clearly outlines hardware components (E.G. Scan™ II Esophagoscope Probe, E.G. Scan™ II Controller) that are integral to the system's function of capturing and processing images. While software is mentioned (E.G. View™ image displaying software), it is part of a larger hardware-based system.
Based on the provided information, the E.G. Scan™ II Esophagoscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body (in vitro).
- The E.G. Scan™ II Esophagoscope System is used for direct visualization of the esophagus within the human body. It captures images of the internal anatomy using an optical probe. This is an in-vivo procedure, not an in-vitro test.
The device is clearly described as an endoscopic system for examining the larynx, esophagus, and gastroesophageal junction by capturing images. This falls under the category of medical imaging and diagnostic tools used for direct examination of internal structures, which is distinct from IVD testing.
N/A
Intended Use / Indications for Use
The E.G. Scan (TM) II Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.
Product codes (comma separated list FDA assigned to the subject device)
EOX
Device Description
E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ II Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ II Controller. E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis. The E.G Scan™ II Esophagoscope Probe is disposable. E.G. Scan™ II Esophagoscope system is a transnasal 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.
Mentions image processing
E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, larynx, gastroesophageal junction
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The E.G. Scan™ II Esophagoscope System has the same device characteristics as the predicate device, E.G. Scan™ Esophagoscope System of IntroMedic Co., Ltd.; intended use, material, design and use concept are similar. The biocompatibility of the patient contact parts has been demonstrated through the cytotoxicity, sensitization and irritation testing by ISO 10993-1 Biological evaluation of medical devices. The E.G. Scan™ II Esophagoscope System conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety, IEC 60601-2-18 Medical electrical equipment-Part 2: Particular requirements for the safety of endoscopic equipment and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
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 brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
K131131
510(k) Submission - E.G. Scan™ II Esophagoscope System
Section 05_510(k) Summary
JUN 2 1 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: April 05, 2012
- 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 - JinYoung, Lee
Internet - http://www.intromedic.com
-
- Device :
| Proprietary name | : E.G. Scan™ II Esophagoscope System |
|---|---|
| Common Name | : Esophagoscope System |
| Classification Name | : Esophagoscope System |
3. Predicate Device :
| Manufacturer | : IntroMedic Co., Ltd, |
|---|---|
| Device | : E.G. Scan™ II Esophagoscope System |
| 510(k) Number | : K120702 |
-
- Classifications Names & Citations :
21CFR874.4710, EOX, Esophagoscope System, Class2
- Classifications Names & Citations :
5. Description :
5.1 Introduction
E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ II Probe takes pictures of the esophagus of human and sends
IntroMedic Co., Ltd.
1
510(k) Submission - E.G. Scan™ II Esophagoscope System .
image data to E.G. Scan™ II Controller. E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis.
The E.G Scan™ II Esophagoscope Probe is disposable.
5.2 General Technology
E.G. Scan™ II Esophagoscope system is a transnasal 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.
-
- Indication for use :
The E.G. Scan ™ II Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.
- Indication for use :
-
- Comparison with predicate device :
The E.G. Scan™ II Esophagoscope System and predicate device are substantially equivalent in the areas of design, indication for use, technological characteristics, function, application and safety and effectiveness. This was determined by reviewing the information provided in the 510(k) in comparison to the content specified in the FDA guidance documents.
- Comparison with predicate device :
-
- Safety, EMC and Performance Data :
The E.G. Scan™ II Esophagoscope System has the same device characteristics as the predicate device, E.G. Scan™ Esophagoscope System of IntroMedic Co., Ltd.; intended use, material, design and use concept are similar. The biocompatibility of the patient contact parts has been demonstrated through the cytotoxicity, sensitization and irritation testing by ISO 10993-1 Biological evaluation of medical devices. The E.G. Scan™ II Esophagoscope System conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety, IEC 60601-2-18 Medical electrical equipment-Part 2: Particular requirements for the safety of endoscopic equipment and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
- Safety, EMC and Performance Data :
2
- 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™ II Esophagoscope System is safe and effective and substantially equivalent to predicate devices as described herein.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
June 21, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
IntroMedic Company, Limited % Mr. Steve Kwon Manager IntroMedic USA Incorporated 3550 Wilshire Blvd. #738 Los Angeles, CA 90010
Re: K131131
Trade/Device Name: E.G. Scan™ II Esophagoscope System Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: April 22, 2013 Received: May 24, 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.
4
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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Deborah Falls-
S FDA
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 04.
Indications for Use
510(k) Number(if known):
Device Name: E.G. Scan™ II Esophagoscope System
Indications for Use:
E.G. Scan™ II Esophagoscope System Is Intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)