(224 days)
K/DEN number: None
No
The description focuses on image capture, storage, and retrieval, with no mention of AI/ML for analysis or interpretation.
No
The device is described as an attachment and software used to capture, send, store, and retrieve images of the eye, which indicates an imaging or diagnostic purpose, not a therapeutic one.
No
The device is an attachment and software that allows users to capture, send, store, and retrieve images of the eye. Its intended use is to capture images, and the performance studies indicate that these images are sufficient to discern clinical information. However, the device itself does not perform any diagnostic function; it serves as a tool for image acquisition, which then can be used for diagnosis by trained personnel.
No
The device description explicitly states it is comprised of an adapter, the iPhone, and the software application, indicating it includes hardware components beyond just software.
Based on the provided information, the iExaminer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- iExaminer's function: The iExaminer is used to capture images of the eye directly using an ophthalmoscope. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for capturing, sending, storing, and retrieving images of the eye. This is an imaging device, not a diagnostic test performed on a sample.
Therefore, the iExaminer falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HKI
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye / Fundus of the human eye and surrounding area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained personnel within a medical or school environment.
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)
Clinical Testing
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optomed Smartscope M5 EY3, Smartscope M5 ES (K110986), KOWA Genesis-D (K080681), EyeQuick (K102412), Welch Allyn PanOptic #11800 (K003376)
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.
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
| 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 (