Who is the manufacturer of PANOPTIC?

Welch Allyn, Inc. filed the 510(k) submission for PANOPTIC (K121405).

What is the FDA product code for PANOPTIC?

HKI. It is classified under 21 CFR 886.1120 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for PANOPTIC?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PANOPTIC?

Optomed Smartscope M5 EY3, Smartscope M5 ES (K110986); KOWA Genesis-D (K080681); EyeQuick (K102412); Welch Allyn PanOptic #11800 (K003376).

Who can help prepare an FDA 510(k) submission like PANOPTIC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PANOPTIC

K121405 · Welch Allyn, Inc. · HKI · Dec 20, 2012 · Ophthalmic

Device Facts

Record ID	K121405
Device Name	PANOPTIC
Applicant	Welch Allyn, Inc.
Product Code	HKI · Ophthalmic
Decision Date	Dec 20, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.1120
Device Class	Class 2

Intended Use

The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment.

Device Story

Device consists of plastic adapter bracket and software application; adapter aligns iPhone 4/4S camera with Welch Allyn PanOptic Ophthalmoscope optics. System captures, stores, retrieves, and transmits (via email/print) retinal images. Used by trained personnel in medical or school settings. No energy imparted to eye by iPhone; light source remains PanOptic halogen bulb. Software allows image selection, naming, and file management. Professional version enables printing/emailing; free version limits storage to ten files. Clinical utility derived from ability to document eye images for review, aiding clinical decision-making by providing visual records of retinal/eye conditions.

Clinical Evidence

Clinical trial compared electronic transfer and image quality of iExaminer against Optomed predicate. Results confirmed iExaminer images are accurate and carry sufficient detail to discern clinically important information. Bench testing verified compliance with ISO 14971, ISO 10940, ISO 15004-1/2, IEC 60601-1, and IEC 60601-1-2.

Technological Characteristics

Plastic adapter bracket for iPhone 4/4S alignment with PanOptic Ophthalmoscope. Uses PanOptic halogen bulb as light source. Connectivity via iPhone OS (email/print). Software application for image capture/management. Complies with ISO 10940 (fundus cameras), ISO 15004-1/2 (ophthalmic instruments), and IEC 60601-1/1-2 (electrical safety/EMC).

Indications for Use

Indicated for trained personnel in medical or school environments to capture, send, store, and retrieve images of the eye using an iPhone 4 or 4S attached to a Welch Allyn PanOptic Ophthalmoscope.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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

Optomed Smartscope M5 EY3, Smartscope M5 ES (K110986)
KOWA Genesis-D (K080681)
EyeQuick (K102412)
Welch Allyn PanOptic #11800 (K003376)

Related Devices

K223381 — iExaminer System with Panoptic Plus · Welch Allyn, Inc. · Mar 15, 2023
K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 · Optomed OY · Dec 18, 2013
K122572 — ICAM FUNDUS CAMERA · Optovue, Inc. · Jan 11, 2013
K093071 — FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 · Fundus Photo, LLC · Nov 17, 2010
K092056 — OPTOMED SMARTSCOPE, MODEL M3-1 EY1 · Optomed OY · Oct 1, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ K12/405 DEC 2 0 2012 : 510(k) Summary [As described in 21 CFR 807.92] | Submitted by: | Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kevin Crossen, Director Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: Kevin.Crossen@welchallyn.com | | Date Prepared: | December 11, 2012 | | Trade Name: | Welch Allyn iExaminer | | Common Name: | iExaminer | | Device Classification: | Class II | | Classification Reference: | 886.1120, Ophthalmic Camera | | Classification Product Code: | HKI | | Predicate Devices: | Optomed Smartscope M5 EY3, Smartscope M5 ES Optomed Oy 510(k) K110986 KOWA Genesis-D KOWA CO.LTD 510(k) K080681 EyeQuick EyeQuick, LLC 510(k) K102412 Welch Allyn PanOptic #11800 Welch Allyn, Inc. 510(k) K003376 | {1}------------------------------------------------ ### Description of Device: The Welch Allyn iExaminer is comprised of the adapter, the iPhone and the software application. The adapter is specifically designed to hold the iPhone 4 and iPhone 4S in a fixed position in order to align the camera in the iPhone with the optics of the Welch Allyn PanOptic. The software application allows the user to capture, store, send, and retrieve images of the eye as seen through the PanOptic. With the Retinal image application, iExaminer Professional Version, the user has the ability to capture images of the patient's eye by activating the camera icon at the iPhone tool bar. Additional icons, buttons and pages allow the user to save images, transfer images and retrieve previously saved images. ### Indications for Use: The iExaminer is an attachment and software used only with the iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment. ### Technological Characteristics: The PanOptic is not being changed. None of the technological characteristics and indications for use of the PanOptic are being changed. The Welch Allyn iExaminer is composed of two components that are used in combination and in conjunction with the PanOptic. The adapter is a plastic bracket that aligns the optics of PanOptic with the camera of the iPhone 4 and iPhone 4S. The software that can be purchased along with the adapter allows the user to document images of the patient's eyes. The software allows the user to capture images of the Retinal Image button. Next the user can view these images and select the ones to save. The user can name the images for later retrieval. Also, if the iPhone is configured and the user is using the Professional version of the iExaminer software application they can print or email saved images. The software Application itself has two version and a Professional version. The Free version only allows the user to save ten patient files and does not allow them print or Email the images. These are the only differences between the Free and Professional versions of the iExaminer software. ### Non-Clinical Tests: Verification and validation were conducted to ensure expected performance of the Welch Allyn iExaminer, compliance to applicable standards, and to demonstrate that it does not affect the functionality or performance of the PanOptic. The Welch Allyn iExaminer is an ophthalmic camera that allows the user to document images of the eye as seen through the PanOptic. The following FDA Guidance and standards were applied to the modified device. - ISO 14971 Application of Risk Management to Medical Devices - . Off the Shelf Software guidance. - Guidance for the Content of Premarket Submission for software contained in Medical Devices. . - . ISO 10940 2009 Ophthalmic instruments- Fundus cameras - ISO 15004-1: 2006 Ophthalmic instruments-Fundamental requirements and test methods- Part 1: . General requirements applicable to all ophthalmic instruments. - ISO 15004-2 2:2007 Ophthalmic Instruments- Fundamental Requirements and Test Methods-Part 2: ● Light Hazard Protection - IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; . Amendment 1, 1991-11, Amendment 2, 1995. - . IEC 60601-1-2 : 2007 Medical Electrical Equipment -Part 1-2 General Requirements for Safety -Collateral standard: Electromagnetic Compatibility. {2}------------------------------------------------ 11121405 ### Device Comparison Tables ### Overall Comparison. The 510(k) consists of using the Welch Allyn iExaminer in conjunction with the PanOptic. The Welch Allyn iExaminer compares favorably to the predicate devices listed above in terms of technology, Intended use and Indications for use. The information in the tables below were obtained from 510(k) summaries found on the FDA database along with information obtained from the respective device websites. ### Substantial Equivalence Discussion The Welch Allyn iExaminer is substantially equivalent in intended use and technology. Like the predicate devices classified in product code HKI, the Welch Allyn iExaminer has a camera with the ability to digitally capture images of the eye along with the ability to store images on the device itself. Also, as with the predicates classified as HKI, the Welch Allyn iExaminer has the ability to electronically send/transfer these images to other Information Technology Equipment (e.g., personal computer). The Welch Allyn iExaminer transfers these images via email. The predicate devices transfer the images via a USB. As with the predicate devices, images on the Welch Allyn iExaminer can be retrieved for viewing at a later time. As part of the clinical study, the electronic transfer of images by the Welch Allyn iExaminer and the subsequent downloading to a Personal computer were compared to the Optomed images that were electronically transferred and downloaded to the same personal computer. The transferred images were determined to be at least as accurate and adequate (carry sufficient imaging details) to discern important clinical information as the predicate Optomed device, and thus substantially equivalent. The iPhone does not impart any energy into the eye as part of the iExaminer. The energy released into the eye by the Welch Allyn iExaminer is the same as the Welch Allyn PanOptic. The light source for the iExaminer is the Halogen bulb used by the PanOptic, i.e., no additional light source beyond the PanOptic's halogen bulb is utilized by the iExaminer. In addition, the Welch Allyn iExaminer has been tested and found to be in compliance to applicable industry standards. ### Summary of Device Performance Confirmed by Bench Testing Several bench tests were completed to confirm the device is substantially equivalent, based on standards, to the predicate device. ### Summary of Device Performance Confirmed by Clinical Testing As noted above, testing was conducted to confirm that the Welch Allyn iExaminer performed as intended to capture images that have sufficient detail to allow a trained professional to discern clinically important information. | Point of comparison | iPhone 4 | iPhone 4S | Optomed Smartscope M5 EY3 | EyeQuick EDOC-1000 | KOWA Genesis D | |---------------------|----------------|-------------|------------------------------|-----------------------|---------------------------| | Resolution | 5.00 megapixel | 8 megapixel | 5.0 megapixel | Less than I megapixel | 2 megapixel | | Image type | JPEG | JPEG | JPEG | JPEG | JPEG / BMP | | Focus type | Autofocus | Autofocus | Autofocus | Manual diopter | Information not available | ### Camera System Technical Specifications {3}------------------------------------------------ K121405 | Point of comparison | iPhone 4 | iPhone 4S | Optomed Smartscope M5 EY3 | EyeQuick EDOC-1000 | KOWA Genesis D | |--------------------------------------------------------------|------------------------|------------------------|---------------------------------------|---------------------------------------|---------------------------| | Image size / Resolution | 2592 x 1936 (5.0MP) | 3264 x 2448 (8.0MP) | 2560 x 1920 (5.0 MP) | 480 x 672 (< 1 MP) | 2 megapixel | | Sensor Type | CMOS | CMOS | CMOS | Information not available | CCD | | Sensor Size | 1/3.2 | 1/3.2 | Information not available | Information not available | Information not available | | Focal Length multiplier | 7.62 | 8.20 | Information not available | Information not available | Information not available | | Aspect Ratio | 16:9 / 4:3 | 16:9 / 4:3 | Information not available | Information not available | Information not available | | Lens focal length | 29mm | 35mm | Information not available | Information not available | Information not available | | Zoom ratio | 1.00x | 1.00x | Information not available | Information not available | Information not available | | Auto Focus | Yes | Yes | Yes | No | Information not available | | Aperture Range | Fixed f/2.8 | Fixed f/2.4 | Information not available | Information not available | Information not available | | ISO | Auto | Auto | Information not available | Information not available | Information not available | | White Balance | Auto | Auto | Information not available | Auto | Information not available | | Shutter Speed | 1/15 - 1/10055 | 1/15 - 1/300002 | Information not available | Information not available | Information not available | | First 3 categories reference Apple technical specs. | | | Technical information | Technical information | Technical information | | http://www.apple.com/iphone/iphone-4/specs.html | | | was gathered from | was gathered from | was gathered from | | http://www.apple.com/iphone/specs.html | | | manufacturer product | manufacturer product | manufacturer product | | The remaining categories reference www.imaging-resource.com. | | | literature and labeling of devices | literature and labeling of devices | literature | | www.ephotozine.com. | | | | | | Summary of Pupil diameter size, working distance and magnification. . • | Point of Comparison | iExaminer | Optomed Smartscope M5 with EY3 | EyeQuick - EDOC- 1000 | KOWA Genesis D | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------|-----------------------------------| | Minimal Pupil Diameter Size | 2 mm (Per PanOptic Ophthalmoscope) | 3.5 mm | Information not available | 8 mm recommended | | Working Distance | 25.4mm (Pupil to first optical surface on the objective lens. Per PanOptic Ophthalmoscope) | 1 – 2 cm (from the surface of the eye) | 5mm (between top of cornea and ophthalmoscope front) | 5mm (between eye and prism) | | Pixel Pitch (Per ISO 10940, Magnification of image is only applicable for fundus cameras recording on film. Pixel pitch is the applicable measurement for fundus cameras recording on a digital sensor) | Measured 5.37 um/pixel for iPhone 4 High res. 4.25 um/pixel for iPhone 4S High Res | Measured 8.77 um/pixel | Information not available | Information not available | | Optical Magnification | 1.183 (Per PanOptic Ophthalmoscope, Magnification: M=h'/h The Optical magnification (M) is defined by the ratio between the image size (h') and the object size (h). (h) = the object size of retinal detail (such as a blood vessel) (h') = the image size of the retinal detail (such as the image of that blood vessel)) | Information not available | Information not available | Information not available | {4}------------------------------------------------ # VelchAllyn # Summary of ISO 10940 performance (Predicate device comparison | | Requirement | | iPhone 4 Standard res | iPhone 4 High res | iPhone 4S Standard res | iPhone 4S High res | Optomed Smartscope M5 EY3 | |-------------------------------------------------------------------------------------------------|---------------------------------------------|------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------| | Resolving power on fundus camera | Centre | ≥ 80 lp/mm | 82.94 lp/mm | | | | Not possible to observe | | Fundus camera Field of view | Middle (r/2) | ≥ 60 lp/mm | 74.12 lp/mm | | | | Not possible to observe | | | Periphery (r) | ≥ 40 lp/mm | 58.82 lp/mm | | | | Not possible to observe | | Tolerance of angular field of view | +/- 5% | | -1.16 % (Measured 24.71° against 25° claim) | -1.16 % (Measured 24.71° against 25° claim) | -1.16 % (Measured 24.71° against 25° claim) | -1.16 % (Measured 24.71° against 25° claim) | +10.5% (Measured 44.23° against 40°claim by manufacturer) | | Tolerance of magnification of image | N.A. (Fundus camera on a digital sensor) | | NA | NA | NA | NA | NA | | Tolerance of pixel pitch on fundus | +/- 7% | | Measured 16.25 um/pixel | Measured 5.37 um/pixel | Measured 16.25 um/pixel | Measured 4.25 um/pixel | Measured 8.77 um/pixel | | Range of diopter adjustment of the optical finder (when optical finder is attached) | -5D to +5D | | -20D to +20D | | | | At least -20D to +20D | | Range of focus adjustment for compensation of patient's refractive | -15D to +15D | | -20D to +20D | | | | At least -20D to +20D | echnical information was gathered from via engineer product literature, labeling of devices and by side-by-side comparison K121405 Page 5 of 9 2012-12-11 {5}------------------------------------------------ VelchAllyn 1 evice Comparison Tabl | Point of comparison | iExaminer (K121405) | Optomed Smartscope M5 with EY3(K110986) | KOWA Genesis- D (K080681) | EyeQuick EDOC- 1000 (HKI, K102412) | Welch Allyn 11800 Ophthalmoscope (K003376) | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment. | Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area. | To capture and save fundus images with mydriatic | The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately 8 degrees narrow angle field of view images of the eyelids, retina and anterior segment of the eye. | The Welch Allyn model #11800 Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment. | | Data output / Output terminals | iExaminer App: Ability to Transfer images via email or print (Performed by the iPhone 4 / 4S operating system) | Image data can be transferred to the PC by using USB connection. USB 1.1 terminal. Compatible with Windows XP/Vista/7. | Image data can be transferred to the PC by using USB connection. USB 1.1 terminal. Compatible with Windows ME/2000/XP. | Image data can be transferred to a PC via a USB memory drive. USB 2.0 terminal | NA | | Usage | Prescription Use. Trained personnel within medical or school environment. | Prescription Use | Prescription Use | Prescription Use | Prescription Use. Trained personnel within medical or school environment. | Page 6 of 9 2012-12-11 K121405 {6}------------------------------------------------ | Point of comparison | iExaminer (K121405) | Optomed Smartscope M5 with EY3(K110986) | KOWA Genesis- D (K080681) | EyeQuick EDOC- 1000 (HKI, K102412) | Welch Allyn 11800 Ophthalmoscope (K003376) | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------| | Use Conditions | school environment. With or without mydriatic | Intended to use without mydriatic but can be used also with mydriatic | With or without mydriatic | With or without mydriatic | With or without mydriatic | | Observation light source | As per PanOptic: Halogen lamp, visible light | Visible and infrared LED | Visible LED | Welch Allyn Halogen lamp, visible light | Halogen lamp, visible light. Visible LED | | Observation and display system | As per iPhone 4 or 4S: 3.5" widescreen display. 960 x 640 pixel resolution at 326 ppi, 800:1 contract ratio, 500cd/m2 max brightness | 2.4" active matrix color TFT LCD | Visual observation | 1.75" LCD screen | Visual observation | | Photographic light source | As per PanOptic observation light source: Halogen lamp visible light | Visible and infrared LED | Xenon flash lamp | As per observation light source: Welch Allyn Halogen lamp, visible light | NA | | Camera spec | 5 megapixel / 8 megapixel | 5 megapixel | 2 megapixel | Less than 1 megapixel | NA | | Diopter compensation | As per PanOptic: - 20D to +20D | At least -20D to +20D | -15D to +35D | -25D to +40D | -20D to +20D | | Apertures | As per Panoptic: Multiple | -- | Multiple | Multiple | Multiple | | Picture angle | 25 degrees | Over 40 degrees | Horizontal 30 degree Vertical 25 degree | 8 degrees | 25 degrees | 2012-12-11 Page 7 of 9 K12/405 {7}------------------------------------------------ | Point of comparison | iExaminer (K121405) | Optomed Smartscope M5 with EY3(K110986) | KOWA Genesis- D (K080681) | EyeQuick EDOC- 1000 (HKI, K102412) | Welch Allyn 11800 Ophthalmoscope (K003376) | |------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|------------------------------------------|----------------------------------------------------------------| | Storage Media | As per iPhone 4 or 4S: Internal storage capacity. | Flash memory card | Flash memory card | Flash memory | NA | | Image data format | As per iPhone 4/4S: JPEG | JPEG, MPEG-4 (video) | JPEG and uncompressed format | JPEG | NA | | Weight | PanOptic: 350g iExaminer adapter: 40g iPhone: 4,137g– iPhone 4S 140g | Camera: 400g EY3: 180g | 1kg | 356g | 350g | | Power Consumption | As per iPhone 4/4S: Built in rechargeable Li-Ion battery As per PanOptic: Re- chargeable battery handle 3.5V | Re-chargeable Ni-MH battery 4.8V | 60VAC | Re-chargeable Welch Allyn 711 battery | Re-chargeable battery handle 3.5V | | Exposure parameters | As per PanOptic: Compliance with ISO 15004-2 | Group 1 instrument according to ISO 15004- 2 | LED is classified according to IEC 60825-1 | Meets ISO 10940 | Group I ophthalmic instrument compliant with ISO 15004-2 | 2012-12-11 K12/405 {8}------------------------------------------------ K121405 ### Clinical: Clinical data were collected to demonstrate substantial equivalence to establish the image quality as generated by the Welch Allyn iExaminer is accurate enough and carries sufficient imaging details to discern important clinical information. The clinical trial data established that the images as captured by the Welch Allyn iExaminer are accurate enough and carry sufficient imaging details to discern important clinical information. ### Conclusion: The differences between the iExaminer and Predicate devices as noted above in the summary tables do not impact safety and effectiveness based on the bench tests and clinical trial results. Based on the information presented in this 510(k) premarket notification, Welch Allyn's iExaminer is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed predicate devices. {9}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. December 20, 2012 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Welch Allyn, Inc. c/o Mr. Kevin Crossen Director, Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153 Re: K121405 Trade/Device Name: PanOptic iExaminer Regulation Number: 21 CFR 882.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: December 13, 2012 Received: December 17, 2012 Dear Mr. Crossen: 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. {10}------------------------------------------------ Page 2 - Mr. Kevin Crossen 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 (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 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/ResourcesforYou/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 {11}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K121405 Device Name: Welch Allyn PanOptic iExaminer · Indications for Use: The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment. Prescription Use AND/OR Over-The-Counter Use x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eyaluation (ODE) CLCY (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K121405 Page 1 of 1

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