PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE

K141638 · Propper Manufacturing Co., Inc. · HLI · Sep 17, 2014 · Ophthalmic

Device Facts

• Record ID: K141638
• Device Name: PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
• Applicant: Propper Manufacturing Co., Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

Device Story

Propper Insight™ Binocular Indirect Ophthalmoscope (BIO) is a head-worn optical instrument for eye examinations. Device consists of illumination and viewing optics housed in a metal module attached to an adjustable headband via a pivot bracket. Illumination system utilizes an LED source, lenses, filters (red-free, amber, cobalt blue), light apertures, and a diffuser. Illumination intensity is adjusted via two polarizer filters. Viewing system uses adjustable lenses and mirrors to visualize the patient's fundus. Magnetic securement mechanism allows pivoting between in-use and out-of-use positions; magnetic contact automatically toggles power to the LED. Powered by AC adapter or rechargeable battery. Operated by physicians or eye care professionals in clinical settings. Provides direct visualization of ocular structures to assist in diagnosis and clinical decision-making regarding eye health.

Clinical Evidence

Bench testing only. Device complies with ISO 10943:2012 (Ophthalmic Instruments - Indirect Ophthalmoscopes). No clinical data provided.

Technological Characteristics

Head-worn binocular indirect ophthalmoscope. LED light source. Optomechanical illumination control via dual polarizers. Metal housing (BIO module) with magnetic pivot/power-switching mechanism. Powered by AC adapter or rechargeable battery. Complies with ISO 10943:2012. No software or digital connectivity.

Indications for Use

Indicated for medical professionals to examine the ocular media (cornea, aqueous, lens, vitreous) and the retina of the eye in patients.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Heine OMEGA 500 binocular Indirect ophthalmoscope, LED version (K123316)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by a flowing line that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 17, 2014

Propper Manufacturing Co., Inc. Andrew Sharavara, Ph.D. Chief Technical Officer 36-04 Skillman Avenue Long Island City, NY 11101

Re: K141638

Trade/Device Name: Propper Insight" Binocular Indirect Ophthalmoscope (BIO) Kits (Models 199185 and 199285) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HLI Dated: June 12, 2104 Received: June 19, 2014

Dear Dr. Sharavara:

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. Isting 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander - 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): ____________________

Device Name: Insight™ Binocular Indirect Ophthalmoscope.

Indications for Use:

Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

Submitted by Propper Manufacturing Company, Inc. 36-04 Skillman Avenue, Address: Long Island City, New York 11101 Telephone: [phone] or [phone] Facsimile: [phone] Contact Name: Andrew Sharavara

## Date Submitted: June 12, 2014

| Trade Name: | Insight™ Binocular Indirect Ophthalmoscope |
|--------------|--------------------------------------------|
| Common Name: | Binocular Indirect ophthalmoscope |

Product Code / Regulation: HLI (AC), HLJ (DC) / 21 C.F.R. 866.1570

Description: The Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes.

The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens.

The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters.

The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus.

The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position.

The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.

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- Indication: Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
The Insight™ Binocular Indirect Ophthalmoscope is similar in Substantial Equivalence: intended use, design and operating principles to the following device:

| Predicate device | 510k number |
|-------------------------------------------------------------------|-------------|
| Heine OMEGA 500 binocular Indirect<br>ophthalmoscope, LED version | K123316 |

Substantial equivalence to the predicate device was evaluated according to the FDA guidance document "guidance for Industry. Ophthalmoscope guidance (Direct and Indirect)" issued on July 8, 1998.

Propper Insight™ Binocular Indirect Ophthalmoscope is equivalent to the predicate device Heine Omega-500 Binocular Indirect Ophthalmoscope because both devices are designed for the same purpose, use similar light sources (LED), have the same indications for use, very similar operational principles and design, and the new device does not introduce new potential hazard or safety risks.