(128 days)
No
The document describes a system for capturing images of the eye using an ophthalmoscope and a smartphone. It mentions an application for image capture but does not describe any features related to AI or ML for image analysis, interpretation, or processing beyond basic capture. The performance study focuses on image comparison for documentation and referral purposes, not on automated analysis.
No.
The device is intended to capture images for evaluation and documentation of ocular health, not to provide therapy.
No
The device description states that the images are "not intended to be used as a sole means of diagnosis." It explicitly says it captures images "as an aid to clinicians in the evaluation, and documentation of ocular health."
No
The device description explicitly lists hardware components (PanOptic Plus Ophthalmoscope, Smart device attachment instrument, compatible smart device) as part of the system, in addition to the software application.
Based on the provided information, the iExaminer system with PanOptic Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The iExaminer system captures images of the eye and surrounding area directly from the patient. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for capturing images as an aid to clinicians in the evaluation and documentation of ocular health. This is a function related to imaging and visualization, not the analysis of in vitro specimens.
- The device description clearly states it takes photographs of the eye and surrounding area. This reinforces its function as an imaging device.
Therefore, the iExaminer system with PanOptic Plus falls under the category of an imaging device used for clinical evaluation and documentation, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
HKI
Device Description
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):
-
- PanOptic Plus Ophthalmoscope:
- a. Ophthalmoscope Head
- b. Compatible energy sources (i.e. battery handles or wall units)
- c. Optional Patient Eyecup
-
- Smart device attachment instrument (made of SmartBracket and SmartClip);
-
- Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
-
- iExaminer Pro Software Application.
The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.
- iExaminer Pro Software Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular
Indicated Patient Age Range
Adult, Pediatric
Intended User / Care Setting
trained personnel within a medical or school environment; clinicians. For prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.
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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
1
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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right, giving it a dynamic appearance.
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.
-
- PanOptic Plus ophthalmoscope
-
- Smart device attachment mechanism (made of SmartBracket and SmartClip)
-
- Compatible Smart device
-
- iExaminer Pro Software Application
Predicate Device
Table 2. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| iExaminer with | |||
| 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):
-
- PanOptic Plus Ophthalmoscope:
- a. Ophthalmoscope Head
- b. Compatible energy sources (i.e. battery handles or wall units)
- c. Optional Patient Eyecup
-
- Smart device attachment instrument (made of SmartBracket and SmartClip);
-
- Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
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Image /page/5/Picture/0 description: The image contains the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif, and the letters are closely spaced together.
-
- iExaminer Pro Software Application.
The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.
- iExaminer Pro Software Application.
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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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the word stand out.
Device Comparison and Substantial Equivalence
| Characteristic | Predicate - iExaminer with PanOptic
(K121405) | Proposed Device - iExaminer System with
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
Use/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. | 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. | The proposed device uses similar
hardware components including
a different list of smart devices
as clearly listed in the Welch
Allyn® iExaminer® Pro
Ophthalmoscopes Instructions
for Use (IFU).
The proposed device IFU does
not constitute a new Intended
Use from the predicate device as
both the predicate and the
proposed devices are intended to
aid the clinician in the evaluation
and documentation of ocular
health. The use environment and
use conditions are the same as
the predicate device for which it
is intended to be used. |
| Components | Ophthalmoscope, adapter for aligning smart
device optics and ophthalmoscope optics,
smart device and the iExaminer software
application. | Same | N/A |
| Compatible
Smartphones | iPhone 4, iPhone 4S | iPhone X, iPhone 11 Pro, iPhone 11 Pro Max,
and iPhone 12 Pro | The proposed device uses
different list of smart devices as
clearly listed in the Welch
Allyn® iExaminer® Pro |
| Characteristic | Predicate - iExaminer with PanOptic
(K121405) | Proposed Device - iExaminer System with
PanOptic Plus | Discussion of Differences |
| | | | Ophthalmoscopes Instructions
for Use (IFU). The proposed
device IFU does not constitute a
new Intended Use from the
predicate device as both the
predicate device and the
proposed device are intended to
allow users to capture images of
the eye.
Design control activities have
been conducted and confirmed
that there is no impact to safety
or effectiveness for this
application. |
| Intended Population | Adult, Pediatric | Same | N/A |
| Characteristic | Predicate - iExaminer with PanOptic
(K121405) | Proposed Device - iExaminer System with
PanOptic Plus | Discussion of Differences |
| Prescription Use
Only | Yes | Same | N/A |
| Minimum Pupil
Diameter Size | 2mm (per PanOptic) | 3mm (per PanOptic Plus) | Both ophthalmoscopes provide
the ability to function on patients
with small pupil sizes. |
| Working Distance | 25.4mm | 24.4mm | Both ophthalmoscopes provide a
similar working distance. |
| Pixel Pitch | Measured
5.37 microns for iPhone 4 High Res
4.25 microns for iPhone 4S High Res | Measured
Approximately 2 microns for each of the
compatible smartphones | Both opthalmascopes provide the
appropriate pixel pitch based on
the models of iphones used. The
proposed device has a lower
pixel pitch due to advancements
in the resolution of the camera
and the telephoto lens. |
| Optical
Magnification | 1.183 (per PanOptic) | 0.90 (per PanOptic Plus) | Both ophthalmoscopes provide
similar magnification (~1x). |
| Data Output/ Output
Terminals | iExaminer App iOS (version 1.0) | iExaminer Pro App iOS (version 4.0.0.13) | Minor differences have been
made to the application since the
predicate device, but do not
impact the safety or effectiveness
of the product.
Design control activities have
been conducted and confirmed
that there is no impact to safety
or effectiveness for this
application. |
| Use Conditions | With or without mydriatic | Same | N/A |
| Characteristic | Predicate - iExaminer with PanOptic
(K121405) | Proposed Device - iExaminer System with
PanOptic Plus | Discussion of Differences |
| Photographic Light
Source | As per PanOptic observation light source:
Halogen lamp visible light | As per PanOptic Plus observation light
source: LED visible light | See "Observation Light Source"
in this table. |
| Observation Light
Source | As per PanOptic observation light source:
Halogen lamp visible light | As per PanOptic Plus observation light
source: LED visible light | Both provide a light output that
allows for the clinician to view
anatomy. Also see "Exposure
Parameters" in this table below |
| Observation and
display system | As per iPhone 4 or 4S: 3.5" screen size | iPhone X and 11 Pro - 5.8"inch screen size
iPhone 11 Pro Max – 6.5" inch screen size
iPhone 12 Pro - 6.1" inch screen size | The proposed system includes a
larger display, which should
permit easier viewing. Other
screen parameters of the user's
system are verified via the "Test
the Resolution" section of the
IFU. |
| Camera Spec | 5 megapixel / 8 megapixel | 12 megapixels | Both opthalmascopes provide the
appropriate camera spec based
on the models of iphones used.
The proposed device has a higher
camera spec due to
advancements in the resolution
of the camera. |
| Diopter
Compensation | As per PanOptic: -20D to +20D | As per PanOptic Plus: -20D to +25D | PanOptic Plus provides a wider
diopter range, which is a benefit
to the user. |
| Apertures | As per PanOptic: Multiple | Same | N/A |
| Picture Angle | 25 degrees | 20 degrees | Both provide a relatively large
field of view for performing eye
exams. |
| Characteristic | Predicate - iExaminer with PanOptic
(K121405) | Proposed Device - iExaminer System with
PanOptic Plus | Discussion of Differences |
| Storage Media | Internal storage capacity | Same | N/A |
| Exposure Parameters | As per PanOptic: Compliance with ISO 15004-
1 as Group 1 (ophthalmic instrument for which
no potential light hazard exists) | As per PanOptic Plus: Compliance with ANSI
Z80.36 as Group 2 (ophthalmic instrument for
which a potential light hazard exists.) | Both devices comply with
applicable eye safety standards
(e.g. ISO 15004-2 and ANSI
Z80.36: 2021) at the time of the
respective submission dates. |
| Image Data Format | JPEG | Same | N/A |
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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the word stand out.
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, giving it a sense of depth.
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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, giving it a sense of depth.
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Image /page/10/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly blurred, giving it a sense of depth. The background is plain white, which makes the blue text stand out.
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Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly italicized. The word is centered and takes up most of the image.
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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Image /page/12/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.
- . 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.