(86 days)
Not Found
No
The description focuses on data recording, display, control, and basic analysis of OCT images. There is no mention of AI/ML terms, image processing beyond basic display and measurement, or any description of training or test data sets which are typical for AI/ML devices.
No
The device is described for diagnostic purposes, enabling non-destructive in-depth measurements and imaging for qualitative and quantitative statements about the eye's anterior segment. It gathers information for diagnosis but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is used for diagnostic purposes."
No
The device description explicitly states that the SL-OCT is an "add on for a slit lamp biomicroscope" and describes it as an "examination system" that includes preinstalled software. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device 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.
- Device Function: The SL-OCT is described as a device that performs non-destructive in-depth measurements of the anterior segment of the eye in vivo (within the living body). It uses light to image structures within the eye.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
The SL-OCT is a medical device used for diagnostic imaging of the eye, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SL-OCT is intended as an aid for the quantitative analysis of structures and the diagnosis and assessment of structural changes in the anterior segment of the eye. The SL-OCT examination system is not intended for the analysis of the cross-sectional images to obtain quantitative measured values. Neither the obtained measured values nor the qualitative evaluation of the images should be used as the sole basis for therapy-related decisions.
The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
MXK, OBO
Device Description
The SL-OCT enables non-destructive in-depth measurements of the structure and/or form of the anterior segment of the human eye. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The information can be displayed, analysed and documented by the SL-OCT. To this end, a preinstalled software package - which may only be operated on this system - is supplied with the examination system. This software records and displays the data and controls the measurement process. In addition. the software allows subsequent editing and saving of data to a database provides no permanent and secure archiving of OCT measurement data. For the documentation, the data are printed out and attached to the patient's medical record. The images provided by the SL-OCT allow qualitative statements to be made about the dimensions and structures of the anterior segment and the dimensions of the identified structures to be quantified. The SL-OCT is particularly suitable for non-contact in vivo imaging of the chamber angle and the anterior chamber.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography
Anatomical Site
anterior segment of the eye, corneal epithelium to the posterior capsule
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The SL-OCT has been tested according to IEC 60601-1 and IEC 60601-1-2, and was found to meet all requirements. The system is a laser product of Class 1 according to 21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001. The evaluation of the device and comparison of acquired images resulted in substantial equivalence to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
JAN I 3 2006
510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
Manufacturer and Submitter
| Company Name: | Heidelberg Engineering GmbH |
|---|---|
| Company Address: | Gerhart-Hauptmann-Strasse 30 |
| 69221 Dossenheim, Germany | |
| phone: +49 / 6221 / 64 643 0 | |
| fax: +49 / 6221 / 64 63 62 | |
| Contact Person: | Dr. Gerhard Zinser |
| Date Summary Prepared: | August 15, 2004 |
Device
Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:
SL-OCT Slitlamp Optical Coherence Tomography AC-powered Slit-Lamp Biomicroscope 21 CR 886.1850 MXK Ophthalmic Class II device
Substantial Equivalence
The SL-OCT is substantially equivalent to the Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL
Device Description
The SL-OCT enables non-destructive in-depth measurements of the structure and/or form of the anterior segment of the human eye. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used.
The information can be displayed, analysed and documented by the SL-OCT. To this end, a preinstalled software package - which may only be operated on this system - is supplied with the examination system.
This software records and displays the data and controls the measurement process. In addition. the software allows subsequent editing and saving of data to a database provides no permanent and secure archiving of OCT measurement data. For the documentation, the data are printed out and attached to the patient's medical record.
The images provided by the SL-OCT allow qualitative statements to be made about the dimensions and structures of the anterior segment and the dimensions of the identified structures to be quantified.
The SL-OCT is particularly suitable for non-contact in vivo imaging of the chamber angle and the anterior chamber.
1
Intended Use
The SL-OCT is intended as an aid for the quantitative analysis of structures and the diagnosis and assessment of structural changes in the anterior segment of the eye. The SL-OCT examination system is not intended for the analysis of the cross-sectional images to obtain quantitative measured values. Neither the obtained measured values nor the qualitative evaluation of the images should be used as the sole basis for therapy-related decisions.
Technological Characteristics Compared to Predicate Device
Comparison of similarities and differences:
| Comparison items | SL-OCT | Optical Low Coherence
Pachymeter |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| k number | - | K030393 |
| Indications for use | Imaging and observation of the
anterior segment of the eye for
diagnostic purposes. | Biometric diagnose of the anterior
segment of the eye. |
| Corneal contact | No | No |
| Working distance cor-
nea to objective | Ca. 50 mm | ca. 50 mm |
| Corneal contact sens-
ing and warning fea-
ture | Not applicable. | Not applicable. |
| Pre-sterilized contact
surface | Not applicable. | Not applicable. |
| Front surface area | Not applicable | Not applicable. |
| Focus | Not applicable | Not applicable. |
| Focus adjustment
range | Not applicable | Not applicable. |
| Adjustment direction | Device is adjusted horizontally
while the patient is sitting straight
in front of the device. | Device is adjusted horizontally while
the patient is sitting straight in front
of the device. |
| Working position | Horizontal | Horizontal |
| Optical setup | Conventional microscope | Conventional microscope. |
| Type of scanning ap-
erture | Point. | Point. |
| Scanning means | Resonant and galvanometric
scanning motor. | Rotating mirror. |
| Light source | SLD 1310nm Laser Class 1 | Laser Light in the visible infrared
spectral regions |
| Microscope lens | Not applicable | Not applicable. |
| Lateral optical resolu-
tion | 20 μm - 100 µm | ca. 10 microns |
| Optical depth resolu-
tion | Axial optical resolution capacity:
Trade/Device Name: Heidelberg Retina Slitlamp-OCT (SL-OCT) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-powered Regulatory Class: II Product Code: OBO Dated: January 4, 2006 Received: January 10, 2006
Dear Mr. Rongero:
This letter updates our substantially equivalent letter of January 13, 2006.
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 (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 additional controls. Existing major regulations affecting your
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Page 2 - Mr. Jeffrey D. Rongero
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Ewenette W. Beens Ph.D
Image /page/4/Picture/7 description: The image contains the word "for" written in cursive. The word is written in black ink on a white background. The "f" is capitalized and has a loop at the top. The "o" and "r" are connected.
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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Image /page/5/Picture/0 description: The image contains the words "HEIDELBERG" on the top line and "ENGINEERING" on the bottom line. The text is in a bold, sans-serif font and is black in color. The words are stacked on top of each other, with "ENGINEERING" directly below "HEIDELBERG". The image appears to be a logo or a sign.
:
Indication for Use
:
.
·
:
| 510(k) Number (if known): | K052935 |
|---|---|
| Device Name: | SL-OCT |
| Indication for Use: | The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes. |
| Prescription Use | X | and / or | Over-The -Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K052935 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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