(256 days)
Not Found
No
The device description and intended use describe a standard ophthalmoscope for visual examination, with no mention of AI/ML capabilities, image processing, or data analysis beyond direct observation. The performance studies focus on optical radiation and fundamental requirements, not algorithmic performance.
No
The device is described as being for examination of the eye, which is a diagnostic purpose, not a therapeutic one. It provides illumination and viewing optics to aid in examination.
Yes
The device is described as being "intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye," which is a diagnostic purpose to assess the health of the eye.
No
The device description explicitly states it is a "battery powered hand-held device" consisting of an "instrument head with bulb and a battery handle," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination of the media and retina of the eye. This is a direct examination of a living patient's anatomy.
- Device Description: The device is a hand-held ophthalmoscope used to illuminate and view the eye. It does not involve the testing of biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other typical components of an in vitro diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This device is a diagnostic tool used for direct observation of the eye.
N/A
Intended Use / Indications for Use
HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.
Product codes
HLJ
Device Description
HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
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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
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Summary of Performance Studies
The HEINE BETA 2008, BETA 200 S and K 180 Ophthalmoscopes are tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10942). Additional testing in accordance with applicable requirements of ISO 15004-2 "Ophthalmic instruments - Fundamental requirements and test methods" has been performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2015
HEINE Optotechnik GmbH & Co. KG c/o Ms. Belinda Labourdette Regulatory Affairs Liaison/Executive Assistant HEINE USA, Ltd. 10 Innovation Way Dover. NH 03830
Re: K142486
Trade/Device Name: HEINE BETA 200®, HEINE BETA 200 S®, and HEINE K 180® Direct Ophthalmoscopes Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: March 26, 2015 Received: April 10, 2015
Dear Ms. Labourdette:
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.
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.
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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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Kesia Y. Alexander -A
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) K142486
Device Name
HEINE BETA® 200 Ophthalmoscope HEINE BETA® 200S Ophthalmoscope HEINE K180® Ophthalmoscope
Indications for Use (Describe)
HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.
X 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 is of the HEINE company logo. The logo is an orange triangle with the word "HEINE" written in white, stylized font. A white medical symbol is also present in the logo, overlapping the text.
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, HEINE Optotechnik GmbH & Co. KG herewith submits a Summary of Safety and Effectiveness.
| Submitter Information: | HEINE Optotechnik GmbH & Co. KG
Kientalstr. 7
82211 Herrsching
Germany
Registration Number: 1000379039
Owner/Operator Number: 9003020 |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | Mrs. Bettina Seim
Director Regulatory Affairs
HEINE Optotechnik GmbH & Co. KG
Phone: +49 8152 38 0 |
| US Agent (Contact): | Belinda Labourdette
HEINE USA, Ltd.
10 Innovation Way
Dover, NH 03820 USA
Phone: +1 603 842-6605
E-mail: blab@heine-na.com |
| Date Prepared: | July 3rd, 2014 |
| Device(s) Identification:
Device Trade Name: | HEINE BETA® 200 Ophthalmoscope
HEINE BETA® 200S Ophthalmoscope
HEINE K180® Ophthalmoscope |
| Common Name: | (direct) Ophthalmoscope |
| Classification of the device:
Device Classification Name: | Ophthalmoscope |
| Product Code: | HLJ |
| Device Classification No.: | Part 886.1570 |
| Panel: | Ophthalmic Devices (86) |
| Regulatory Status: | Class II |
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Image /page/4/Picture/0 description: The image shows the logo for Heine Optotechnik, a German manufacturer of medical diagnostic instruments. The logo features an orange triangle with a white outline. Inside the triangle is a white caduceus symbol, which is a staff with two snakes coiled around it. The word "HEINE" is written in white, stylized letters across the center of the triangle, partially obscured by the caduceus.
HEINE
Device Description:
HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.
Intended Use:
HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vitreous humour) and retina of the eye.
Predicate Device:
| Device Trade Name: | HEINE mini 3000® LED Ophthalmoscope |
|---|---|
| Applicant: | HEINE Optotechnik GmbH & Co. KG |
| 510(k) No.: | K123587 (March 22, 2013) |
The HEINE BETA® 200, BETA 200S and K180 Ophthalmoscopes are considered substantially equivalent to the HEINE mini 3000º LED Ophthalmoscope (K123587). There is no significant difference in intended use or technology.
Summary of Non-Clinical Performance Testing:
The HEINE BETA 2008, BETA 200 S and K 180 Ophthalmoscopes are tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10942). Additional testing in accordance with applicable requirements of ISO 15004-2 "Ophthalmic instruments - Fundamental requirements and test methods" has been performed.
Conclusion
HEINE Optotechnik believes that the HEINE BETA 200®, BETA 200 S and K 180 Ophthalmoscopes are substantially equivalent to the currently legally marketed device HEINE mini3000® LED Ophthalmoscope (K123587). They do not introduce new indications for use, they have the same technological characteristics and they do not introduce new potential hazards or safety risks.