AIO HD OTOSCOPE

K123821 · Blue Focus · ERA · May 17, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K123821
• Device Name: AIO HD OTOSCOPE
• Applicant: Blue Focus
• Product Code: ERA · Ear, Nose, Throat
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4770
• Device Class: Class 1

Intended 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.

Device Story

AIO HD Otoscope is a video otoscope system comprising a camera hand probe, main storage unit, and otoscope tip. The device captures visual images of the ear canal and tympanic membrane via the probe tip. These images are transmitted to a computer or monitor screen for physician viewing. The system utilizes an LED light source for illumination. It is intended for use by physicians in clinical settings to facilitate examination of the ear canal and tympanic membrane. The primary benefit is providing a clear, focused, magnified view of the ear anatomy to assist in clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes camera hand probe (45x60x151 mm) and main unit (235x225x58 mm). Illumination provided by LED light source (316.2 lux at 10 cm). Operates at 12V. Device temperature measured at 27.6 C. Connectivity to external monitor/computer for image display.

Indications for Use

Indicated for physicians to visualize the ear canal and tympanic membrane for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Dr.Camscope Video Otoscope (K031853)
• Welch Allyn Video Otoscope (K943916)
• Jed Med Instrument Video Otoscope (K904802)

Submission Summary (Full Text)

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K123821

## MAY 1 7 2013

## Blue Focus

615Ricci Hall Sogang University, Shinsu-Dong Mapo-Gu Seoul, Korea 121-742

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### 510K Summary

#### Applicant:

Blue Focus 615Ricci Hall Sogang University Shinsu-Dong Mapo-Gu Seoul, Korea 121-742 Phone: [phone] E-mail: [e-mail]

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.

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| LED / Halogen Light comparison | | |
|----------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------|
| | Halogen Light<br>(Dr.Camscope) | LED (AIO HD Otoscope) |
| a.Luminance measurements and<br>light intensity | minimum illumination 2 lux | 10 cm : 316.2 lux<br>15 cm : 160.2 lux<br>20 cm : 103.1 lux |
| b.Electrical specifications such as<br>operating voltage | 12v | 12v |
| c.Temperature of device | 49.9 C | 27.6 |
| d. Physical characteristics<br>including dimensions | 2mm lamp | Dimensions of camera:<br>45(w)x60(l)x151(h)mm,<br>Main unit:<br>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.

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#### 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

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#### 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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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.