LANTOS 3D EAR SCANNER

K121326 · Lantos Technologies · ERA · Jan 25, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K121326
• Device Name: LANTOS 3D EAR SCANNER
• Applicant: Lantos Technologies
• Product Code: ERA · Ear, Nose, Throat
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4770
• Device Class: Class 1

Intended Use

The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal. The Lantos 3D Ear scanner: . provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and; . includes an expanding membrane that can be inserted and conforms to the external ear canal when filled with an absorbing medium which enables the 3D scan and; . records and presents to the hearing professional in an image file a topology measurement of the external ear canal

Device Story

Hand-held scanner with LED illumination, optics, camera, and motor-driven reservoir; uses single-patient disposable with silicone membrane filled with absorbing medium to conform to ear canal. Operated by trained hearing professionals in clinical settings. Device captures visual images and 3D topographical measurements of external ear canal. Data processed and displayed on tethered laptop; images/scans stored locally and transmissible via wireless connection. Output provides magnified visualization for inspection and digital topology data for manufacturing custom hearing devices. Benefits include precise ear canal mapping for improved hearing aid fit.

Clinical Evidence

Bench testing only. Validation performed using two known models (cylindrical and anatomical) to verify topographical measurement accuracy. Scans were compared against model values to ensure mean differences met requirements for hearing device fabrication. Photobiological safety evaluated per ANSI/IESNA RP-27.3-2007, resulting in Risk Group 1 classification.

Technological Characteristics

Hand-held scanner with LED illumination, optics, camera, and motor-driven reservoir. Materials: polymers and silicone. Connectivity: tethered to docking stand/laptop. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment), ISO 14971 (risk management). Photobiological safety: ANSI/IESNA RP-27.3-2007 (Risk Group 1).

Indications for Use

Indicated for patients 18 years and older for inspection of the external ear canal and tympanic membrane, and for obtaining 3D topographical measurements of the ear canal by trained hearing professionals.

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

• Welch Allyn Video Otoscope (K943916)

Submission Summary (Full Text)

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K121326

Image /page/0/Picture/1 description: The image shows the logo for Lantos Technologies. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black square with three white concentric circles inside. The text "LANTOS" is in large, bold, sans-serif letters above the text "TECHNOLOGIES", which is in smaller, sans-serif letters.

101 Main Street, Suite 1770 Cambridge, MA 02142 · +1.617.500.9800 www.lantostechnologies.com

#### 6. 510K Summary

JAN 2 5 2013

### Applicant:

Lantos Technologies 101 Main Street, Suite 1770 Cambridge, MA 02142, USA Tel: [phone]

Date Prepared: January 17, 2013

Contact: Lora Allemeier

#### Device Identification:

Trade Name - Lantos 3D Ear Scanner Common Name - otoscope Classification Name - otoscope (21 CFR 874.4770, Product Code ERA) hearing aid, accessory (21 CFR 874.3300. Product Code ESD)

#### 510(k) Numbers and Product Codes of equivalent devices:

Welch Allyn Video Otoscope (Skaneateles Falls, NY) Welch Allyn Otoscope; K943916 - SE 08/25/1994 Code: ERA: 874.7440

## Device Description

The device consists of a hand held scanner, a single patient use disposable with a silicone conforming membrane, which when in use is filled with an absorbing medium, and a laptop computer. The hand held scanner, when not in use, is placed in a docking stand.

The hand held scanner is tethered to the docking stand with a custom cable. The laptop computer is mounted on the docking stand. The hand held scanner contains LED illumination, optics, a camera, a motor to move the probe tip, and a motor-driven reservoir.

User Interface (UI) software screens are displayed on the laptop and the user interacts with the device via the laptop keyboard and touchpad, and control buttons on the hand held scanner, as guided by the UI screens. Image data from the patient is stored in the laptop, and may be transmitted by the user via a wireless connection. No patient identifiable data is stored in the Lantos device.

A single use disposable, which includes the conforming membrane, is placed over the hand held scanner probe tip, in a manner similar to placing an ear

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speculum over the viewing tip of a conventional otoscope. The disposable includes a clear window over the probe tip. The probe can be used to inspect the ear canal, when inserted into the ear canal no closer than 4-5 mm from the tympanic membrane.

Additionally, the disposable can be filled with an absorbing medium so the membrane conforms to the ear, to enable the 3D scanning functionality of the device. After scanning is complete, the absorbing medium drains from the disposable so that the probe and disposable can be removed from the ear canal. The topographical measurement (scan) of the ear may be transmitted and may be used in the same manner as a desktop scan of a silicone earmold impression.

#### Indications for Use

The Lantos 3D Ear Scanner is intended for use bv a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

- . provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
- . includes an expanding membrane that can be inserted and conforms to the external ear canal when filled with an absorbing medium which enables the 3D scan and;
- . records and presents to the hearing professional in an image file a topology measurement of the external ear canal

#### Intended Use Population

The Lantos 3D Ear Scanner is indicated for use by trained hearing professionals on patients 18 years of age and older presenting for inspection of the external ear canal.

January 17, 2013 Proprietary ~ Page 2 of 4

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#### Technological Characteristics

The Lantos 3D Ear Scanner is not a change or modification to the predicate device that could significantly affect safety or effectiveness. In other words, there is no change in the intended use (otoscope and hearing aid accessory), design (hand-held with illuminating LED probe tip covered by silicone cover), materials (polymers and silicone), and power source that could raise new issues of safety or effectiveness.

The Lantos 3D Ear Scanner followed ACGIH American Conference of Governmental Industrial Hygienists Threshold Limit Values for chemical substances and physical agents and Biological Exposure Indices. 2011. For both intended use and reasonably foreseeable misuse, the Scanner falls within ACGIH Threshold Limit Values for retinal thermal exposure within 10 seconds, blue light exposure within 10000 seconds, actinic ultraviolet radiation within 8 hours of operation and near UV exposure. In addition, the illumination subsystem was evaluated according to ANSI/IESNA RP-27.3-2007 Recommended Practice for Photobiological Safety for Lamps-Risk Group Classification & Labeling to provide a photobiological hazard evaluation (including blue light hazard exposure limits). This evaluation resulted in a "Risk Group 1" classification for the blueviolet LED. The exposure time limit for Risk Group 1 was 15 minutes of direct, continuous exposure to the scanner tip without the membrane attached. Package labeling includes a caution: "Do not stare at the scanner tip, or direct scanner tip toward patient's face, while illumination is active. Staring at scanner tip for more than 15 minutes with no membrane attached under fault conditions may exceed photobiological exposure. May be harmful to the eves."

The output of the Lantos 3D Ear Scanner was validated using two known models (cylindrical and anatomical) with given values and obtaining multiple scans on each using multiple Scanner units. All scans were required to have a mean difference between the model and the scan consistent with manufacturer's requirements for fabrication of devices inserted in the ear.

#### Performance Standards

The Lantos 3D Ear Scanner meets the following Recognized Performance Standards:

- ISO 10993 Parts 1-13 as applicable
January 17, 2013 Proprietary

Page 3 of 4

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- IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2 General requirements for basic safety and essential performance -Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- · IEC 60601-2-18 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- ISO 14971: Medical devices—Application of risk management to medical devices

### Conclusion

Based on the comparison of the technological characteristics (including the intended use) and verification tests of the Lantos 3D Ear Scanner, there are no significant new issues of safety and effectiveness that are raised when compared to the predicate device. The Lantos 3D Ear Scanner provides for inspection of the ear canal comparable to the predicate otoscope device and also allows for ear canal measurements, which may be used for the manufacture of hearing devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

January 25, 2013

Public Health Service

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

Lantos Technologies % Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Southwest Ranches, FL 33332

Re: K121326

Trade/Device Name: Lantos 3D Ear Scanner Regulation Number: 21 CFR 874.4770 Regulation Name: Otoscope Regulatory Class: Class I Product Code: ERA, ESD Dated: December 18, 2012 Received: December 19, 2012

Dear Mr. Greenbaum:

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 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

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#### Page 2 - Mr. John Greenbaum

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/CDRH0ffices/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,

**Eric A. Mann** 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

#### K121326 510(k) Number (If Known):

Device Name: Lantos 3D Ear Scanner

Indications for Use:

The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

- . provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
- includes an expanding membrane that can be inserted and conforms to the external ear . canal when filled with an absorbing medium which enables the 3D scan and;
- records and presents to the hearing professional in an image file a topology measurement . of the external ear canal

Prescription Use _ X

AND/OR

Over-the Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of Ophthalmic and Ear, Nose and Throat Devices | |
| 510(k) Number | K121326 |