iExaminer System with Panoptic Plus
Device Facts
| Record ID | K223381 |
|---|---|
| Device Name | iExaminer System with Panoptic Plus |
| Applicant | Welch Allyn, Inc. |
| Product Code | HKI · Ophthalmic |
| Decision Date | Mar 15, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.
Device Story
System captures ocular images using PanOptic Plus ophthalmoscope, smart device attachment (SmartBracket/SmartClip), and compatible iPhone (X, 11 Pro, 11 Pro Max, 12 Pro) running iExaminer Pro app. Clinician mounts smartphone to ophthalmoscope; captures images of eye/surrounding area; stores/retrieves images via app. Used in clinical environments by trained personnel. Output provides visual documentation of ocular health to aid clinical evaluation; not intended as sole diagnostic tool. Benefits include improved documentation and potential for easier viewing via larger smartphone displays compared to predicate.
Clinical Evidence
Clinical evidence consists of an image comparison study comparing images from the iExaminer System with PanOptic Plus against the predicate (K121405). Study objective was to demonstrate equivalence in usefulness for documentation and clinical referrals. Results confirmed the device met all acceptance criteria and performed comparably to the predicate.
Technological Characteristics
System comprises PanOptic Plus ophthalmoscope (LED light source), SmartBracket/SmartClip attachment, and compatible iPhone. Complies with ISO 10940 (fundus cameras), ANSI Z80.36 (light hazard), ISO 10993-1 (biocompatibility), and IEC 60601-1-2 (EMC). Features 3mm minimum pupil diameter, 24.4mm working distance, 0.90 magnification, and -20D to +25D diopter compensation. Software-based image capture and storage.
Indications for Use
Indicated for clinicians to capture images of the eye and surrounding area for evaluation and documentation of ocular health in adult and pediatric patients. Not for use as a sole means of diagnosis.
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
- iExaminer with PanOptic (K121405)
Related Devices
- K121405 — PANOPTIC · Welch Allyn, Inc. · Dec 20, 2012
- K092565 — DIGITAL RETINAL CAMERA CX-1 · Canon Components, Inc. · Mar 18, 2010
- K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 · Optomed OY · Dec 18, 2013
- K161727 — Eyenez Ophthalmic Camera · Eyenez, LLC · Oct 4, 2016
- K052268 — VISUCAM PRO NM · Carl Zeiss Meditec, AG · Nov 2, 2005
Submission Summary (Full Text)
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March 15, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Welch Allyn, Inc. Jeffrey Thompson Manager, Regulatory Affairs (a subsidiary of Baxter Healthcare Corporation) 4341 State Street Road Skaneateles Falls, New York 13153
Re: K223381
Trade/Device Name: iExaminer System with Panoptic Plus Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: February 17, 2023 Received: February 17, 2023
Dear Jeffrey Thompson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K223381
Device Name iExaminer System with PanOptic Plus
#### Indications for Use (Describe)
The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.
Type of Use (Select one or both, as applicable)
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(k) Summary
#### DATE PREPARED: 09 MAR 2023
#### OWNER:
Welch Allyn Inc. (a subsidiary of Baxter Healthcare Corporation) 4341 State Street Road Skaneateles Falls, NY 13153-0220
### CONTACT PERSON:
Jeffrey E. Thompson Manager, Regulatory Affairs Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 T 224.270.3806
### IDENTIFICATION OF THE DEVICE:
Trade/Device Name: iExaminer System with PanOptic Plus Classification Panel: Ophthalmic Regulation Number: 21 CFR 886.1120 Regulation Name: Camera, Ophthalmic, Ac-Powered Regulatory Class: Class II Product Code: HKI
| Table 1. Proposed Model number for iExaminer System with PanOptic Plus | |
|------------------------------------------------------------------------|--|
|------------------------------------------------------------------------|--|
| Model Number | Name |
|--------------|-------------------------------------|
| 901161 | iExaminer System with PanOptic Plus |
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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is the logo for the healthcare company Baxter International.
#### Figure 1. Proposed Product Diagram for iExaminer System with PanOptic Plus
Image /page/4/Picture/2 description: The image shows a medical device with a smartphone attached to it. The device has a camera lens at the top, labeled as 1 and 2. The smartphone is mounted on the device and displays a medical image, labeled as 3 and 4. The device appears to be designed for capturing and displaying medical images, possibly for diagnostic purposes.
- 1. PanOptic Plus ophthalmoscope
- 2. Smart device attachment mechanism (made of SmartBracket and SmartClip)
- 3. Compatible Smart device
- 4. iExaminer Pro Software Application
#### Predicate Device
#### Table 2. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|----------------------------|-------------------|------------------|-------------------|
| iExaminer with<br>PanOptic | Welch Allyn, Inc. | K121405 | December 20, 2012 |
### Description of the Device
The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1):
- 1. PanOptic Plus Ophthalmoscope:
- a. Ophthalmoscope Head
- b. Compatible energy sources (i.e. battery handles or wall units)
- c. Optional Patient Eyecup
- 2. Smart device attachment instrument (made of SmartBracket and SmartClip);
- 3. Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
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- 4. iExaminer Pro Software Application.
The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.
The device is for prescription use only.
#### Indications For Use
The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartBracket, SmartClip, iExaminer application, and one of the following: iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.
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## Device Comparison and Substantial Equivalence
| Characteristic | Predicate - iExaminer with PanOptic<br>(K121405) | Proposed Device - iExaminer System with<br>PanOptic Plus | Discussion of Differences |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product Code | HKI; Camera Ophthalmic, AC-Powered | Same | N/A |
| FDA Regulation # | 21 CFR 886.1120 | Same | N/A |
| Indications for<br>Use/Intended Use | The iExaminer is an attachment and software<br>used only with the iPhone 4 and iPhone 4S in<br>conjunction with the Welch Allyn PanOptic<br>Ophthalmoscope to allow users to capture,<br>send, store, and retrieve images of the eye. The<br>device is intended to be used by trained<br>personnel within a medical or school<br>environment. | The iExaminer system with PanOptic Plus,<br>consisting of PanOptic Plus, SmartBracket,<br>SmartClip, iExaminer application, and one of<br>the following: iPhone X, iPhone 11 Pro,<br>iPhone 11 Pro Max, iPhone 12 Pro, is<br>intended to be used to capture images as an<br>aid to clinicians in the evaluation, and<br>documentation of ocular health. The images<br>from the iExaminer System with PanOptic<br>Plus are not intended to be used as a sole<br>means of diagnosis. | The proposed device uses similar<br>hardware components including<br>a different list of smart devices<br>as clearly listed in the Welch<br>Allyn® iExaminer® Pro<br>Ophthalmoscopes Instructions<br>for Use (IFU).<br>The proposed device IFU does<br>not constitute a new Intended<br>Use from the predicate device as<br>both the predicate and the<br>proposed devices are intended to<br>aid the clinician in the evaluation<br>and documentation of ocular<br>health. The use environment and<br>use conditions are the same as<br>the predicate device for which it<br>is intended to be used. |
| Components | Ophthalmoscope, adapter for aligning smart<br>device optics and ophthalmoscope optics,<br>smart device and the iExaminer software<br>application. | Same | N/A |
| Compatible<br>Smartphones | iPhone 4, iPhone 4S | iPhone X, iPhone 11 Pro, iPhone 11 Pro Max,<br>and iPhone 12 Pro | The proposed device uses<br>different list of smart devices as<br>clearly listed in the Welch<br>Allyn® iExaminer® Pro |
| Characteristic | Predicate - iExaminer with PanOptic<br>(K121405) | Proposed Device - iExaminer System with<br>PanOptic Plus | Discussion of Differences |
| | | | Ophthalmoscopes Instructions<br>for Use (IFU). The proposed<br>device IFU does not constitute a<br>new Intended Use from the<br>predicate device as both the<br>predicate device and the<br>proposed device are intended to<br>allow users to capture images of<br>the eye.<br>Design control activities have<br>been conducted and confirmed<br>that there is no impact to safety<br>or effectiveness for this<br>application. |
| Intended Population | Adult, Pediatric | Same | N/A |
| Characteristic | Predicate - iExaminer with PanOptic<br>(K121405) | Proposed Device - iExaminer System with<br>PanOptic Plus | Discussion of Differences |
| Prescription Use<br>Only | Yes | Same | N/A |
| Minimum Pupil<br>Diameter Size | 2mm (per PanOptic) | 3mm (per PanOptic Plus) | Both ophthalmoscopes provide<br>the ability to function on patients<br>with small pupil sizes. |
| Working Distance | 25.4mm | 24.4mm | Both ophthalmoscopes provide a<br>similar working distance. |
| Pixel Pitch | Measured<br>5.37 microns for iPhone 4 High Res<br>4.25 microns for iPhone 4S High Res | Measured<br>Approximately 2 microns for each of the<br>compatible smartphones | Both opthalmascopes provide the<br>appropriate pixel pitch based on<br>the models of iphones used. The<br>proposed device has a lower<br>pixel pitch due to advancements<br>in the resolution of the camera<br>and the telephoto lens. |
| Optical<br>Magnification | 1.183 (per PanOptic) | 0.90 (per PanOptic Plus) | Both ophthalmoscopes provide<br>similar magnification (~1x). |
| Data Output/ Output<br>Terminals | iExaminer App iOS (version 1.0) | iExaminer Pro App iOS (version 4.0.0.13) | Minor differences have been<br>made to the application since the<br>predicate device, but do not<br>impact the safety or effectiveness<br>of the product.<br>Design control activities have<br>been conducted and confirmed<br>that there is no impact to safety<br>or effectiveness for this<br>application. |
| Use Conditions | With or without mydriatic | Same | N/A |
| Characteristic | Predicate - iExaminer with PanOptic<br>(K121405) | Proposed Device - iExaminer System with<br>PanOptic Plus | Discussion of Differences |
| Photographic Light<br>Source | As per PanOptic observation light source:<br>Halogen lamp visible light | As per PanOptic Plus observation light<br>source: LED visible light | See "Observation Light Source"<br>in this table. |
| Observation Light<br>Source | As per PanOptic observation light source:<br>Halogen lamp visible light | As per PanOptic Plus observation light<br>source: LED visible light | Both provide a light output that<br>allows for the clinician to view<br>anatomy. Also see "Exposure<br>Parameters" in this table below |
| Observation and<br>display system | As per iPhone 4 or 4S: 3.5" screen size | iPhone X and 11 Pro - 5.8"inch screen size<br>iPhone 11 Pro Max – 6.5" inch screen size<br>iPhone 12 Pro - 6.1" inch screen size | The proposed system includes a<br>larger display, which should<br>permit easier viewing. Other<br>screen parameters of the user's<br>system are verified via the "Test<br>the Resolution" section of the<br>IFU. |
| Camera Spec | 5 megapixel / 8 megapixel | 12 megapixels | Both opthalmascopes provide the<br>appropriate camera spec based<br>on the models of iphones used.<br>The proposed device has a higher<br>camera spec due to<br>advancements in the resolution<br>of the camera. |
| Diopter<br>Compensation | As per PanOptic: -20D to +20D | As per PanOptic Plus: -20D to +25D | PanOptic Plus provides a wider<br>diopter range, which is a benefit<br>to the user. |
| Apertures | As per PanOptic: Multiple | Same | N/A |
| Picture Angle | 25 degrees | 20 degrees | Both provide a relatively large<br>field of view for performing eye<br>exams. |
| Characteristic | Predicate - iExaminer with PanOptic<br>(K121405) | Proposed Device - iExaminer System with<br>PanOptic Plus | Discussion of Differences |
| Storage Media | Internal storage capacity | Same | N/A |
| Exposure Parameters | As per PanOptic: Compliance with ISO 15004-<br>1 as Group 1 (ophthalmic instrument for which<br>no potential light hazard exists) | As per PanOptic Plus: Compliance with ANSI<br>Z80.36 as Group 2 (ophthalmic instrument for<br>which a potential light hazard exists.) | Both devices comply with<br>applicable eye safety standards<br>(e.g. ISO 15004-2 and ANSI<br>Z80.36: 2021) at the time of the<br>respective submission dates. |
| Image Data Format | JPEG | Same | N/A |
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#### DISCUSSION OF NONCLINICAL TESTS:
Non-Clinical testing of the iExaminer System with PanOptic Plus has been performed against requirements for performance, physical attributes, environmental conditions and safety, and to provide objective evidence that the device's intended use is met. A summary of testing performed is identified in the summary below.
- . Software: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
- . Software: Guidance for Off-the-Shelf Software Use in Medical Devices. September 2019.
- Software: General Principles of Software Validation; January 2002.
- FDA Guidance on Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.
- . Biocompatibility: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016.
The iExaminer System with PanOptic Plus was tested to evaluate its safety and effectiveness based on the standards and associated methods below:
- . ISO 10940 (Second edition 2009-08-01) Ophthalmic Instruments—Fundus Cameras
- . ANSI Z80.36 (2021) American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments
- . EN/IEC 62304 (2006/A1:2016) Medical Device Software – Software Life Cycle Processes
- . EN/IEC 60601-1-60 (ED 3.1 2013-10) Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard Usability
- . IEC 62366-1 (2015+AMD1: 2020) Medical devices – Part 1: Application of usability engineering to medical devices
- . EN/ISO 10993-1 (Fifth edition 2018-08) Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
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- . EN ISO/ISO 15004-1 (Second edition 2020-5) Ophthalmic Instruments-Fundamental Requirements and Test Methods - Part 1: General Requirements Applicable to all Ophthalmic Instruments
- EN IEC 60601-1-2 (2014) Medical Electrical Equipment Part 1-2: General . Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility – Requirements and Tests
In addition to the above, and in consideration of IEC 62366-1: 2015+AMD1: 2020, Medical devices - Part 1: Application of usability engineering to medical devices as well as FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices - Guidance For Industry And Food And Drug Administration Staff (document Issued On: February 3, 2016), results demonstrated that the iExaminer System with PanOptic Plus is suitable for its intended use.
The results of verification and validation demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use. Based on the comparison analysis and test results, Welch Allyn has concluded that the iExaminer System with PanOptic Plus to be substantially equivalent to the predicate device.
### DISCUSSION OF CLINICAL TESTS:
Image Comparison Study: An image comparison study was performed on the iExaminer System with PanOptic Plus. The primary objective of this study was to demonstrate that the iExaminer System with PanOptic Plus images are substantially equivalent to the predicate device (i.e. PanOptic with iPhone 4/4S and iExaminer (version 1.0) FDA 510(k) K121405) images in their usefulness for documentation and clinical referrals.
The results of the image comparison study demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use. Based on the image comparison study results, Welch Allyn has concluded the iExaminer System with PanOptic Plus to be substantially equivalent to the predicate device.
#### CONCLUSION:
The iExaminer System with PanOptic Plus has been verified and validated against design input requirements, user needs and intended uses. The non-clinical and clinical testing (image comparison study) demonstrate that the subject device raises no new questions
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concerning safety and effectiveness, is substantially equivalent, and performs comparably to the predicate device that is currently marketed for the same intended use.
