(224 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn iExaminer, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the comparative technical specifications and the "Summary of ISO 10940 performance" table. The device's performance is listed for the iPhone 4 Standard res, iPhone 4 High res, iPhone 4S Standard res, and iPhone 4S High res. Since the document states "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 implicit acceptance criteria is 'performs at least as well as the predicate device (Optomed Smartscope M5 EY3) for clinical utility.'
| Acceptance Criteria (Predicate: Optomed Smartscope M5 EY3/General Standards) | Reported iExaminer Performance (iPhone 4 / 4S) | Notes |
|---|---|---|
| Resolving power on fundus camera - Centre: ≥ 80 lp/mm - Middle (r/2): ≥ 60 lp/mm - Periphery (r): ≥ 40 lp/mm | iPhone 4 High res: - Centre: 82.94 lp/mm - Middle (r/2): 74.12 lp/mm - Periphery (r): 58.82 lp/mm | iExaminer (iPhone 4 High res) meets/exceeds all resolving power criteria. Predicate "Not possible to observe" for these. |
| Tolerance of angular field of view +/- 5% (against 25° claim) | -1.16 % (Measured 24.71° against 25° claim) | iExaminer (all iPhone versions) meets this criterion. Predicate (+10.5%) does not meet this specific tolerance. |
| Tolerance of pixel pitch on fundus +/- 7% (Implicit from predicate comparison) | iPhone 4: 16.25 um/pixel iPhone 4S: 4.25 um/pixel (Predicate: 8.77 um/pixel) | The document explicitly states "N.A. (Fundus camera on a digital sensor)" for magnification tolerance, and then introduces "Tolerance of pixel pitch on fundus" with a +/- 7% criterion. The various iPhone models show different pixel pitch values. To meet the tolerance, the measured pixel pitch should be within +/- 7% of an expected value, or be comparable to the predicate. With the predicate at 8.77 um/pixel, and the iExaminer at 5.37 um/pixel (iPhone 4 High res) and 4.25 um/pixel (iPhone 4S High res), these are different but not necessarily failing. The raw pixel pitch values alone don't directly indicate compliance without a target pixel pitch. However, the document's structure implies these are presented for comparison and general compliance. |
| Range of diopter adjustment of the optical finder -5D to +5D (General Standard) | -20D to +20D | iExaminer meets/exceeds the range. Predicate "At least -20D to +20D". |
| Range of focus adjustment for compensation of patient's refractive -15D to +15D (General Standard) | -20D to +20D | iExaminer meets/exceeds the range. Predicate "At least -20D to +20D". |
| Image Quality for Clinical Information "at least as accurate and adequate (carry sufficient imaging details) to discern important clinical information as the predicate Optomed device." | "images... are accurate enough and carry sufficient imaging details to discern important clinical information." | This is met based on the conclusion of the clinical trial. |
| Compliance to applicable standards: ISO 14971, Guidance on OTS Software, Guidance for Premarket Submission for software, ISO 10940, ISO 15004-1, ISO 15004-2, IEC 60601-1, IEC 60601-1-2 | "tested and found to be in compliance to applicable industry standards." | This is stated as met based on non-clinical tests. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or images for the clinical trial. The text says "Clinical data were collected" and refers to "the clinical trial data," but no specific sample size in terms of cases or participants is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study is referred to as "the clinical trial," suggesting it was a prospective study conducted for the purpose of this submission, but its geographical location is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The document states that the test established images had "sufficient detail to allow a trained professional to discern clinically important information," but it does not detail how many professionals were involved or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this does not appear to be an MRMC comparative effectiveness study involving AI assistance for human readers. This device is an ophthalmic camera attachment and software. Its primary function is to capture and transmit images, not to provide AI interpretation or assist human readers with diagnosis in a comparative effectiveness setting.
- Effect Size: Not applicable as it's not an AI-assisted diagnostic device in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the traditional sense of an AI algorithm providing diagnostic output. The device itself (iExaminer) is a standalone imaging and image management system. The "clinical study" confirmed the image quality was sufficient for a trained professional to discern clinical information. It does not suggest an AI algorithm was evaluating images without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth is indirectly implied as expert assessment of image quality for clinical utility. The clinical trial aimed to confirm that "images... are accurate enough and carry sufficient imaging details to discern important clinical information." This suggests that human experts, likely clinicians (ophthalmologists or similar specialists), evaluated the captured images to determine if they contained enough detail for clinical decision-making. There is no mention of pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set
This information is not applicable/not provided for a traditional training set as this is not an AI/Machine Learning diagnostic device at the time of FDA submission. The software's function is image capture, storage, and transfer, not automated interpretation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for a traditional training set as this is not an AI/Machine Learning diagnostic device.
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K12/405
DEC 2 0 2012
:
510(k) Summary [As described in 21 CFR 807.92]
| Submitted by: | Welch Allyn Inc.4341 State Street RoadSkaneateles Falls, NY 13153-0220 |
|---|---|
| Contact Person: | Kevin Crossen, Director Regulatory AffairsPhone: (315) 685-2609Fax: (315) 685-2532E-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 ESOptomed Oy510(k) K110986KOWA Genesis-DKOWA CO.LTD510(k) K080681EyeQuickEyeQuick, LLC510(k) K102412Welch Allyn PanOptic #11800Welch Allyn, Inc.510(k) K003376 |
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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.
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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 M5EY3 | 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
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| Point of comparison | iPhone 4 | iPhone 4S | Optomed Smartscope M5EY3 | 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 ofdevices | literature and labeling ofdevices | literature | ||
| www.ephotozine.com. |
Summary of Pupil diameter size, working distance and magnification.
. •
| Point of Comparison | iExaminer | Optomed Smartscope M5with EY3 | EyeQuick - EDOC-1000 | KOWA Genesis D |
|---|---|---|---|---|
| Minimal Pupil DiameterSize | 2 mm(Per PanOpticOphthalmoscope) | 3.5 mm | Information notavailable | 8 mm recommended |
| Working Distance | 25.4mm(Pupil to first opticalsurface on the objectivelens. Per PanOpticOphthalmoscope) | 1 – 2 cm(from the surface of theeye) | 5mm(between top ofcornea andophthalmoscopefront) | 5mm(between eye andprism) |
| Pixel Pitch(Per ISO 10940,Magnification of image isonly applicable for funduscameras recording on film.Pixel pitch is theapplicable measurementfor fundus camerasrecording on a digitalsensor) | Measured 5.37 um/pixelfor iPhone 4 High res.4.25 um/pixel for iPhone4S High Res | Measured 8.77 um/pixel | Information notavailable | Information notavailable |
| Optical Magnification | 1.183(Per PanOpticOphthalmoscope,Magnification: M=h'/hThe Optical magnification(M) is defined by the ratiobetween the image size(h') and the object size(h). (h) = the object sizeof retinal detail (such as ablood vessel) (h') = theimage size of the retinaldetail (such as the imageof that blood vessel)) | Information not available | Information notavailable | Information notavailable |
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VelchAllyn
Summary of ISO 10940 performance (Predicate device comparison
| Requirement | iPhone 4Standardres | iPhone 4High res | iPhone 4SStandardres | iPhone 4SHigh res | OptomedSmartscopeM5 EY3 | ||
|---|---|---|---|---|---|---|---|
| Resolving power onfundus camera | Centre | ≥ 80 lp/mm | 82.94 lp/mm | Not possibleto observe | |||
| Fundus cameraField of view | Middle(r/2) | ≥ 60 lp/mm | 74.12 lp/mm | Not possibleto observe | |||
| Periphery(r) | ≥ 40 lp/mm | 58.82 lp/mm | Not possibleto observe | ||||
| Tolerance ofangular field ofview | +/- 5% | -1.16 %(Measured24.71°against 25°claim) | -1.16 %(Measured24.71°against 25°claim) | -1.16 %(Measured24.71°against 25°claim) | -1.16 %(Measured24.71°against 25°claim) | +10.5%(Measured44.23° against40°claim bymanufacturer) | |
| Tolerance ofmagnification ofimage | N.A. (Fundus cameraon a digital sensor) | NA | NA | NA | NA | NA | |
| Tolerance of pixelpitch on fundus | +/- 7% | Measured16.25 um/pixel | Measured5.37 um/pixel | Measured16.25 um/pixel | Measured4.25 um/pixel | Measured8.77 um/pixel | |
| Range of diopteradjustment of theoptical finder (whenoptical finder isattached) | -5D to +5D | -20D to +20D | At least -20Dto +20D | ||||
| Range of focusadjustment forcompensation ofpatient's refractive | -15D to +15D | -20D to +20D | At least -20Dto +20D |
echnical information was gathered from via engineer product literature, labeling of devices and by side-by-side comparison
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VelchAllyn
1
evice Comparison Tabl
| Point ofcomparison | iExaminer(K121405) | Optomed SmartscopeM5 with EY3(K110986) | KOWA Genesis-D(K080681) | EyeQuick EDOC-1000 (HKI, K102412) | Welch Allyn 11800Ophthalmoscope(K003376) |
|---|---|---|---|---|---|
| Indications foruse | The iExaminer is anattachment andsoftware used onlywith the iPhone 4 andiPhone 4S inconjunction with theWelch AllynPanOpticOphthalmoscope toallow users tocapture, send, storeand retrieve imagesof the eye. Thedevice is intended tobe used by trainedpersonnel within amedical or schoolenvironment. | Optomed SmartscopeM5 camera with opticsmodules EY3 and ES1 isa digital ophthalmoscopeintended to capturedigital images and videoof the fundus of thehuman eye andsurrounding area. | To capture andsave fundusimages withmydriatic | The EyeQuick DigitalOphthalmoscopeCamera is intended foruse in capturingapproximately 8degrees narrow anglefield of view imagesof the eyelids, retinaand anterior segmentof the eye. | The Welch Allyn model#11800 Ophthalmoscope isintended to be used toexamine the cornea,aqueous, lens, vitreous, andretina of the eye. It has thesame operating principlesand intended use as manycompetitiveophthalmoscopes alreadyin commercial distribution.The device is intended tobe used by trainedpersonnel within a medicalor school environment. |
| Data output /Output terminals | iExaminer App:Ability to Transferimages via email orprint (Performed bythe iPhone 4 / 4Soperating system) | Image data can betransferred to the PC byusing USB connection.USB 1.1 terminal.Compatible withWindows XP/Vista/7. | Image data can betransferred to thePC by using USBconnection.USB 1.1 terminal.Compatible withWindowsME/2000/XP. | Image data can betransferred to a PC viaa USB memory drive.USB 2.0 terminal | NA |
| Usage | Prescription Use.Trained personnelwithin medical orschool environment. | Prescription Use | Prescription Use | Prescription Use | Prescription Use. Trainedpersonnel within medicalor school environment. |
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2012-12-11
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| Point ofcomparison | iExaminer(K121405) | Optomed SmartscopeM5 with EY3(K110986) | KOWA Genesis-D(K080681) | EyeQuick EDOC-1000 (HKI, K102412) | Welch Allyn 11800Ophthalmoscope(K003376) |
|---|---|---|---|---|---|
| Use Conditions | school environment.With or withoutmydriatic | Intended to use withoutmydriatic but can beused also with mydriatic | With or withoutmydriatic | With or withoutmydriatic | With or without mydriatic |
| Observation lightsource | As per PanOptic:Halogen lamp, visiblelight | Visible and infraredLED | Visible LED | Welch Allyn Halogenlamp, visible light | Halogen lamp, visiblelight. Visible LED |
| Observation anddisplay system | As per iPhone 4 or4S:3.5" widescreendisplay. 960 x 640pixel resolution at326 ppi, 800:1contract ratio,500cd/m2 maxbrightness | 2.4" active matrix colorTFT LCD | Visualobservation | 1.75" LCD screen | Visual observation |
| Photographic lightsource | As per PanOpticobservation lightsource:Halogen lamp visiblelight | Visible and infraredLED | Xenon flash lamp | As per observationlight source:Welch Allyn Halogenlamp, visible light | NA |
| Camera spec | 5 megapixel / 8megapixel | 5 megapixel | 2 megapixel | Less than 1 megapixel | NA |
| Dioptercompensation | 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 30degree Vertical 25degree | 8 degrees | 25 degrees |
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| Point ofcomparison | iExaminer(K121405) | Optomed SmartscopeM5 with EY3(K110986) | KOWA Genesis-D(K080681) | EyeQuick EDOC-1000 (HKI, K102412) | Welch Allyn 11800Ophthalmoscope(K003376) |
|---|---|---|---|---|---|
| Storage Media | As per iPhone 4 or4S: Internal storagecapacity. | Flash memory card | Flash memorycard | Flash memory | NA |
| Image data format | As per iPhone 4/4S:JPEG | JPEG, MPEG-4 (video) | JPEG anduncompressedformat | JPEG | NA |
| Weight | PanOptic: 350giExaminer adapter:40giPhone: 4,137g–iPhone 4S140g | Camera: 400gEY3: 180g | 1kg | 356g | 350g |
| PowerConsumption | As per iPhone 4/4S:Built in rechargeableLi-Ion batteryAs per PanOptic: Re-chargeable batteryhandle 3.5V | Re-chargeable Ni-MHbattery 4.8V | 60VAC | Re-chargeable WelchAllyn 711 battery | Re-chargeable batteryhandle 3.5V |
| Exposureparameters | As per PanOptic:Compliance with ISO15004-2 | Group 1 instrumentaccording to ISO 15004-2 | LED is classifiedaccording to IEC60825-1 | Meets ISO 10940 | Group I ophthalmicinstrument compliant withISO 15004-2 |
2012-12-11
K12/405
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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.
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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.
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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
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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
§ 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.