(280 days)
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.
This document is a 510(k) summary for ophthalmoscopes. It's a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the device's performance against specific acceptance criteria in a clinical trial or stand-alone testing. Therefore, many of the requested details, such as sample sizes, expert qualifications, and specific effectiveness metrics, are not applicable or available within this type of document.
However, I can extract information related to product specifications and how the device aims to meet the regulatory requirements for safety and effectiveness through comparison to predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission and not a clinical study report, formal "acceptance criteria" for performance metrics in the typical sense of a clinical trial are not presented. Instead, the document demonstrates substantial equivalence to predicate devices based on functional characteristics and intended use. The "reported device performance" is essentially its similarity to the predicate devices in the listed attributes.
| Feature / Criterion (Implicitly "Comparable to Predicate") | Piccolight® E50 Performance | Riester ophthalmoscopes Pendiza Scope® (K925757) (Predicate) | Piccolight® E56 Performance | Riester ophthalmoscope ri- mini® (K932503) (Predicate) | Eurolight® E10, E30 Performance | Riester ophthalmoscope UNI® II (K925756) (Predicate) | Eurolight® E36 Performance | HEINE BETA 200 S® ophthalmoscope (Predicate) |
|---|---|---|---|---|---|---|---|---|
| Intended Use | Examine cornea, aqueous, lens, vitreous, retina. | Same | Examine cornea, aqueous, lens, vitreous, retina. | Same | Examine cornea, aqueous, lens, vitreous, retina. | Same | Examine cornea, aqueous, lens, vitreous, retina. | Same |
| Method of Operation | Examine retina at specific distance. | Same | Examine retina at specific distance. | Same | Examine retina at specific distance. | Same | Examine retina at specific distance. | Same |
| Exposure Parameters | 2.5 V vacuum bulb | 2.7 V vacuum bulb | 2.5 V halogen bulb | 2.5 V halogen bulb | 2.5 V vacuum bulb | 2.7 V vacuum bulb, 2.5 V halogen, or 3.5 xenon bulb | 2.5 V halogen bulb | 2.5 V or 3.5 V xenon halogen bulb |
| Data Collection/Display (Dioptre Range) | -20 to +20 (specific steps) | Same | -20 to +20 (specific steps) | Same | -20 to +20 (specific steps) | Same | -20 to +20 (specific steps) | +1 to +10, 15, 20, 40; -1 to -10, 15, 20, 25, 35 |
| Flammability of Materials | Fibre-glass reinforced plastic Polyamide 6 GF30C | Same | Fibre-glass reinforced plastic Polyamide 6 GF30C | Same | Fibre-glass reinforced plastic Polyamide 6 GF30C | Metal housing | Fibre-glass reinforced plastic Polyamide 6 GF30C | Polycarbonate |
| Max Temperature (Device parts) | Ambient, Metal parts approx. max. 50°C | Same | Ambient, Metal parts approx. max. 50°C | Same | Ambient, Metal parts approx. max. 50°C | Same | Ambient, Metal parts approx. max. 50°C | Same |
| Brightness Controls | No | No | No | No | Various | Various | Various | Various |
| Supply Voltage | 2.5 V | 2.7 V | 2.5 V | 2.5 V | 2.5 V | 2.5 V | 2.5 V | 2.5 V or 3.5 V |
| Power Supply | Battery powered | Same | Battery powered | Same | Battery powered | Same | Battery powered | Same |
| Aperture | One (large circle) | Four (large, small, semi, large with fixing cross) | Six (slit, large, small, semi, red-free, large with fixing cross) | Four (large, small, semi, large with fixing cross; add red-free) | One (large circle) | One (large circle) | Six (similar to E56) | Six (similar to E56) |
| Safety/Effectiveness Conclusion | Comparable | N/A | Comparable | N/A | Comparable | N/A | Comparable | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe "test sets" in the sense of patient data for evaluating a diagnostic or therapeutic algorithm. The assessment is qualitative by comparing device specifications and intended use to predicate devices and adherence to recognized standards. Therefore, there is no sample size or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study assessing diagnostic performance against a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a submission for a medical device (ophthalmoscope) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This involves a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices and conformity to recognized international standards.
8. The sample size for the training set
Not applicable. There is no machine learning or AI algorithm described in this submission.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K070270". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the 'K' having a distinct shape.
NOV - 5 2007
Image /page/0/Picture/3 description: The image is a logo for a company called "KaWe Medizintechnik". The logo is a black parallelogram with the word "KaWe" in white letters at the bottom. Above the word "KaWe" is the word "MEDIZINTECHNIK" in smaller white letters. The background of the parallelogram is black.
KIRCHNER & WILHELM
GmbH + Co.
| Name and address of sponsor of the510(k) submission: | Kirchner & Wilhelm GmbH & Co. KGEberhardstrasse 5671679 AspergGermany |
|---|---|
| Official contact person for allcorrespondence: | Matthias DubbPhone: 49 7141 68188-70Fax: 49 7141 68188-74E-mail: Matthias.dubb@Kirchner & Wilhelm med.de |
| Date Prepared: | January 26, 2007 |
| Device Name: | Piccolight® E50, Piccolight® E56, Eurolight® E10,Eurolight® E30, Eurolight® E36 |
| Generic name of the device: | Ophthalmoscope, battery-powered |
| Classification, Product Code andCFR Regulation Number: | Class IIHLJ21 CFR 886.1570 |
| Classification Panel: | Ophthalmic |
| Predicate Device Names and 510(k) numbers: | Uni II (K925756) |
| RI-MINI (K932503) | |
| Ophthalmoscope (K932503) | |
| Heine Beta 200S (Device Listed by Heine USA, Ltd.,establishment registration number: 1054443) |
510(k) Summary
Device Description:
All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.
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Image /page/1/Picture/0 description: The image is a logo for a company called "KaWe Medizintechnik". The logo is a square with the company name in bold, white letters at the bottom. The top of the square has the word "MEDIZINTECHNIK" in smaller letters. The background of the square is black.
Comparison with Predicate Device:
| KIRCHNER & WILHELM | |
|---|---|
| Piccolight® E50 | Riester ophthalmoscopes PendizaScope® (K925757) | |
|---|---|---|
| Intended use | An ophthalmoscope is intended tobe used to examine the cornea,aqueous, lens, vitreous and retinaof the eye. | Same |
| Method ofoperation | Used to examine the retina by anexaminer in a specific distance tothe eye. | Same |
| Exposureparameters | Emission of 2.5 V vacuum bulb | Emission of 2.7 V vacuum bulb |
| data collectionand/or displaysystems | Dioptre of used lens in steps:-20, -15, -10, -8, -6, -4,-3, -2, -1,0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Same |
| Flammability ofmaterials | Fibre-glass reinforced plasticPolyamide 6 GF30C | Same |
| maximumtemperature ofparts of thedevice held bythe operator oraccessible tothe patient | Ambient temperatureMetal parts around the bulb:Approx. max. 50°C | Same |
| brightnesscontrols | No | No |
| Supply voltage | 2.5 V | 2.7 V |
| Power supply | Battery powered | Same |
| Aperture | One aperture (large circle) | four aperture (large circle, Smallcircle, semi-circle, large circlewith fixing cross) |
All main aspects regarding the safety and effectiveness are comparable. The main difference is the difference in the number of apertures and that is not a significant difference.
| Piccolight® E56 | Riester ophthalmoscope ri- mini® (K932503) | |
|---|---|---|
| Intended use | An ophthalmoscope is intended tobe used to examine the cornea,aqueous, lens, vitreous and retinaof the eye. | same |
| Method ofoperation | Used to examine the retina by anexaminer in a specific distance tothe eye. | Same |
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| Exposureparameters | Emission of 2.5 V halogen bulb | Emission of 2.5 V halogen bulb | Image: KaWe logo |
|---|---|---|---|
| data collectionand/or displaysystems | Dioptre of used lens in steps:-20, -15, -10, -8, -6, -4,-3, -2, -1,0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Same | |
| Flammability ofmaterials | Fibre-glass reinforced plasticPolyamide 6 GF30C | Same | |
| maximumtemperature ofparts of thedevice held bythe operator oraccessible tothe patient | Ambient temperatureMetal parts around the bulb:Approx. max. 50°C | Same | |
| brightnesscontrols | No | No | |
| Supply voltage | 2.5 V | 2.5 V | |
| Power supply | Battery powered | Same | |
| Aperture | six aperture (slit diaphragm, largecircle, small circle, semi-circle,red-free (green), large circle withfixing cross)Image: aperture options | four aperture (large circle, Smallcircle, semi-circle, large circlewith fixing cross; additional red-free (green)) | |
| orImage: aperture options |
All main aspects regarding the safety and effectiveness are comparable. The main difference is the difference in the number of apertures with one more aperture being there in Piccolight. The additional slit diaphragm is used to differentiate the level differences (e.g, in the case of tumors or papilloedema). This has no effect on the security of the subject device as compared to the predicate.
| EUROLIGHT® E10EUROLIGHT® E30 | Riester ophthalmoscope UNI®II (K925756) | |
|---|---|---|
| Intended use | An ophthalmoscope is intended tobe used to examine the cornea,aqueous, lens, vitreous and retinaof the eye. | Same |
| Method ofoperation | Used to examine the retina by anexaminer in a specific distance tothe eye. | Same |
| Exposureparameters | Emission of 2.5 V vacuum bulb | Emission of 2.7 V vacuum bulb,2.5 V halogen bulb or 3.5 xenonbulb |
| data collectionand/or display | Dioptre of used lens in steps:-20, -15, -10, -8, -6, -4, -3, -2, -1 | Same |
and and the state
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| systems | 0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Image: KaWe logo | |
|---|---|---|---|
| Flammability ofmaterials | Fibre-glass reinforced plasticPolyamide 6 GF30C | Metal housing | |
| maximumtemperature ofparts of thedevice held bythe operator oraccessible tothe patient | Ambient temperatureMetal parts around the bulb:Approx. max. 50°C | Same | |
| brightnesscontrols | Various | Various | |
| Supply voltage | 2.5 V | 2,5 V | |
| Power supply | Battery powered | Same | |
| Aperture | one aperture (large circle) | one aperture (large circle) |
All main aspects regarding the safety and effectiveness are comparable. The UNI II can also be used with halogen and xenon light. Both are brighter than light from vacuum bulb. Therefore the optical radiation exposure for the eye during the examination is higher than by using a vacuum bulb. The different housing materials are not relevant for the safety of the instrument. The temperature which gets generated during examination is not able to inflame the used materials.
| EUROLIGHT® E36 | HEINE BETA 200 S® ophthalmoscope | |
|---|---|---|
| Intended use | An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye. | Same |
| Method of operation | Used to examine the retina by an examiner in a specific distance to the eye. | Same |
| Exposure parameters | Emission of 2.5 V halogen bulb | Emission of 2.5 V or 3.5 V xenon halogen bulb |
| data collection and/or display systems | Dioptre of used lens in steps: -20, -15, -10, -8, -6, -4,-3, -2, -1, 0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Dioptre of used lens in steps: + in 1D step 1-10, 15, 20, 40- in 1D step 1-10, 15, 20, 25, 35 |
| Flammability of materials | Fibre-glass reinforced plastic Polyamide 6 GF30C | Polycarbonate |
| maximum temperature of parts of the device held by the operator or accessible to the patient | Ambient temperatureMetal parts around the bulb: Approx. max. 50°C | Same |
| brightness | Various | Various |
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| controls | |||
|---|---|---|---|
| Supply voltage | 2.5 V | 2.5 V or 3.5 V | |
| Power supply | Battery powered | Same | Image: KaWe logoKIRCHNER & WILHELLGmbH + CoMedizintechnik, Germany |
| Aperture | six apertureImage: aperture settings orImage: aperture settings | six apertureImage: aperture settings orImage: aperture settings |
All main aspects regarding the safety and effectiveness are comparable. The different housing materials are not relevant for the safety of the instrument.
Intended Use:
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
Non-Clinical Testing:
The ophthalmoscopes conform to ISO 10942; IEC 60601-1, and IEC 60601-1-2.
Clinical Testing:
Not applicable
Conclusion:
The ophthalmoscopes referred to in this 510(k) submission are substantially equivalent to the predicates and raise no issues of safety and effectiveness.
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Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2007
Kirchner & Wilhelm GmbH & CO. KG c/o Natalya Valerio mdi Consultants Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K070270
Trade/Device Name: Piccolight E50 & E56 and Eurolight E10, E30 & E36 Regulation Number: 21 CFR 886.1750 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: October 18, 2007 Received: October 26, 2007
Dear Ms. Valerio:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally promative hotification " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-(Woulear Do not responsible 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eglehus, MD
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
Page _ 1 _ of _ 1
510(k) Number (if known): Not Assigned as of this time
Device Name: Piccolight® E50, Piccolight® E56, Eurolight® E10, Eurolight® E30, Eurolight® E36 Ophthalmascopes
Indications for Use:
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
Danilu 10/31/2007
(Division Sion-Off) Division of Ophthalmic Ear, Nose and Throat 510(k) Number
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.