(156 days)
Not Found
No
The 510(k) summary describes a standard video otoscope for imaging the ear canal and tympanic membrane. There is no mention of AI, ML, image processing beyond basic visualization, or any performance studies related to algorithmic analysis of images. The predicate devices are also standard video otoscopes.
No
The device is used for imaging and viewing purposes, not for treating or curing a medical condition.
Yes
Explanation: The device is an otoscope used to provide images of the ear canal and tympanic membrane, allowing a physician a clear view for examination, which is a diagnostic activity.
No
The device description explicitly mentions hardware components: a camera hand probe, main storage unit, and otoscope tip.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The AIO HD otoscope is used to directly visualize the ear canal and tympanic membrane inside the body. It provides images for a physician to view.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or laboratory testing, which are hallmarks of IVD devices.
The AIO HD otoscope is a medical device used for direct visualization and examination, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
AIO HD otoscope is used to provide images of the ear canal and tympanic membrane. The AIO HD otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.
Product codes
ERA
Device Description
AIO camera system consists of the camera hand probe, main storage unit and otoscope tip.
The camera hand probe dimensions are 45 mm (w) x 60 mm (l) x 151 mm (h).
The main unit dimensions are 235 mm (w) x 225 mm (l) x 58 mm (h). The otoscope tip is carefully inserted into the external ear to view the ear canal and ear drum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear canal and tympanic membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4770 Otoscope.
(a)
Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.
0
MAY 1 7 2013
Blue Focus
615Ricci Hall Sogang University, Shinsu-Dong Mapo-Gu Seoul, Korea 121-742
#############################################################################################################################################################################
510K Summary
Applicant:
Blue Focus 615Ricci Hall Sogang University Shinsu-Dong Mapo-Gu Seoul, Korea 121-742 Phone: 1-770-825-0100 E-mail: Keithh@sometechcorp.com
Date Prepared: May 17, 2013
Contact: Keith Han
Device Identification:
Trade name - AIO HD Otoscope Common Name - Otoscope Classification Name - otoscope (21 GFR 874.4770. Product Code ERA)
510 (k) Numbers and Product Codes of equivalent devices:
Dr.Camscope Video Otoscope: K031853 / Code: ERA 874.4770
Welch Allyn Video Otoscope: K943916 / Code: ERA 874.4770
Jed Med Instrument Video Otoscope: K904802 / Code: ERA 874.4770
Device Description
AIO camera system consists of the camera hand probe, main storage unit and otoscope tip.
The camera hand probe dimensions are 45 mm (w) x 60 mm (l) x 151 mm (h).
The main unit dimensions are 235 mm (w) x 225 mm (l) x 58 mm (h). The otoscope tip is carefully inserted into the external ear to view the ear canal and ear drum.
1
| LED / Halogen Light comparison | ||
|---|---|---|
| Halogen Light | ||
| (Dr.Camscope) | LED (AIO HD Otoscope) | |
| a.Luminance measurements and | ||
| light intensity | minimum illumination 2 lux | 10 cm : 316.2 lux |
| 15 cm : 160.2 lux | ||
| 20 cm : 103.1 lux | ||
| b.Electrical specifications such as | ||
| operating voltage | 12v | 12v |
| c.Temperature of device | 49.9 C | 27.6 |
| d. Physical characteristics | ||
| including dimensions | 2mm lamp | Dimensions of camera: |
| 45(w)x60(l)x151(h)mm, | ||
| Main unit: | ||
| 235(w)x225(l)x58(h)mm |
The AIO HD scope and the Dr.Camscope have the same intended usage although they have different light sources. Both otoscopes fall under the same product code(ERA).
The following chart provides a comparison of the subject device and the predicate device, Dr. Camscope, listing relevant technological characteristics and other critical performance specifications, including:
a. Luminance measurements and light intensity
b. Electrical specifications such as operating voltage
c. Temperature of device
d. Physical characteristics, including dimensions.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
May 17, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Blue Focus Co. Ltd. Mr. Keith Han President % Sometech Corporation 965 Oakland Rd Suite 2B Lawrenceville, Georgia 30044
Re: K123821
Trade/Device Name: AIO HD Otoscope Regulation Number: 21 CFR 874.4770 Regulation Name: Otoscope Regulatory Class: Class I Product Code: ERA Dated: April 1, 2013 Received: April 9, 2013
Dear Mr. Han:
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
3
Page 2 - Mr. Keith Han
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/ResourcesforYou/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.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric AMMann -S
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
4
Indications for Use
510(k) Number (if known): K123821
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
AIO HD otoscope is used to provide images of the ear canal and tympanic membrane. The AIO HD otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/10 description: The image shows the name "Sageev-George-S" at the top. Below the name is the date and time "2013:05:15 16:36:53". The time zone "-04'00'" is at the bottom left. The FDA logo is in the background.