Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a manual ophthalmoscope with different aperture and handle options, focusing on physical components and power source. There is no mention of software, image processing, or AI/ML terms.

Therapeutic

No
The device is described as being used to examine parts of the eye, which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes

The device is an ophthalmoscope, which is used to examine parts of the eye (cornea, aqueous, lens, vitreous, and retina). Examination is a diagnostic step.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical hardware components (battery-powered handles made of PA 6 GF 30% or metal, and different head types) and mentions conformance to hardware-related standards (ISO 10942, IEC 60601-1, and IEC 60601-1-2).

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Ophthalmoscope Function: An ophthalmoscope is used to directly visualize the internal structures of the eye. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for examining the eye's internal structures, not for analyzing biological specimens.
Device Description: The description focuses on the physical components and power source, not on any methods for analyzing biological samples.
Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis, reagents, or any other typical characteristics of an IVD.

Therefore, based on the provided information, this ophthalmoscope is a medical device used for direct examination, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Product codes

HLJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cornea, aqueous, lens, vitreous and retina of the eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Non-Clinical Testing:
The ophthalmoscopes conform to ISO 10942; IEC 60601-1, and IEC 60601-1-2.

Clinical Testing:
Not applicable

Key Metrics

Not Found

Predicate Device(s)

Uni II (K925756), RI-MINI (K932503), Ophthalmoscope (K932503), Heine Beta 200S (Device Listed by Heine USA, Ltd., establishment registration number: 1054443)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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 the
510(k) submission: | Kirchner & Wilhelm GmbH & Co. KG

Eberhardstrasse 56
71679 Asperg
Germany |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Official contact person for all
correspondence: | Matthias Dubb
Phone: 49 7141 68188-70
Fax: 49 7141 68188-74
E-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 and
CFR Regulation Number: | Class II
HLJ
21 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.

l

1

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 Pendiza
Scope® (K925757) |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 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 vacuum bulb | Emission of 2.7 V vacuum 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 | Same |
| Flammability of
materials | Fibre-glass reinforced plastic
Polyamide 6 GF30C | Same |
| maximum
temperature of
parts of the
device held by
the operator or
accessible to
the patient | Ambient temperature
Metal parts around the bulb:
Approx. max. 50°C | Same |
| brightness
controls | No | No |
| Supply voltage | 2.5 V | 2.7 V |
| Power supply | Battery powered | Same |
| Aperture | One aperture (large circle) | four aperture (large circle, Small
circle, semi-circle, large circle
with 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 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

2

| Exposure

parameters	Emission of 2.5 V halogen bulb	Emission of 2.5 V 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	Same
Flammability of
materials	Fibre-glass reinforced plastic
Polyamide 6 GF30C	Same
maximum
temperature of
parts of the
device held by
the operator or
accessible to
the patient	Ambient temperature
Metal parts around the bulb:
Approx. max. 50°C	Same
brightness
controls	No	No
Supply voltage	2.5 V	2.5 V
Power supply	Battery powered	Same
Aperture	six aperture (slit diaphragm, large
circle, small circle, semi-circle,
red-free (green), large circle with
fixing cross)
Image: aperture options	four aperture (large circle, Small
circle, semi-circle, large circle
with fixing cross; additional red-
free (green))
	or
Image: 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® E10
EUROLIGHT® E30 | Riester ophthalmoscope UNI®
II (K925756) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 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 vacuum bulb | Emission of 2.7 V vacuum bulb,
2.5 V halogen bulb or 3.5 xenon
bulb |
| data collection
and/or display | Dioptre of used lens in steps:
-20, -15, -10, -8, -6, -4, -3, -2, -1 | Same |

and and the state

3

systems	0, 1, 2, 3, 4, 6, 8, 10, 15, 20
Flammability of
materials	Fibre-glass reinforced plastic
Polyamide 6 GF30C	Metal housing
maximum
temperature of
parts of the
device held by
the operator or
accessible to
the patient	Ambient temperature
Metal parts around the bulb:
Approx. max. 50°C	Same
brightness
controls	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 temperature
Metal parts around the bulb: Approx. max. 50°C | Same |
| brightness | Various | Various |

4

controls
Supply voltage	2.5 V	2.5 V or 3.5 V
Power supply	Battery powered	Same	Image: KaWe logo
KIRCHNER & WILHELL
GmbH + Co
Medizintechnik, Germany
Aperture	six aperture
Image: aperture settings or
Image: aperture settings	six aperture
Image: aperture settings or
Image: 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.

5

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.

6

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

7

INDICATIONS FOR USE

Page _ 1 _ of _ 1

K070270

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)