(86 days)
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.
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.
This document is a 510(k) premarket notification for the SL-OCT (Slitlamp Optical Coherence Tomography) device. It describes the device's intended use and compares its technological characteristics to a predicate device, the Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL, to demonstrate substantial equivalence.
This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a modern AI/ML device would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not applicable or explicitly stated in this type of regulatory document.
However, I can extract information related to the closest aspects of 'acceptance criteria' and 'study' as they appear in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting safety standards. The performance reported primarily involves comparisons of technical specifications.
| Acceptance Criteria (Implicit) | Reported Device Performance (SL-OCT) |
|---|---|
| Intended Use: Imaging and observation of the anterior segment of the eye for diagnostic purposes. | Intended Use: Imaging and observation of the anterior segment of the eye for diagnostic purposes. |
| Safety Standards: Compliance with relevant medical device safety and electromagnetic compatibility standards. | Tested according to IEC 60601-1 and IEC 60601-1-2, found to meet all requirements. Laser product of Class 1 according to 21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001. |
| Technological Characteristics: Similarities in key features to the predicate (Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL). | - Corneal contact: No (same as predicate) |
| - Working distance cornea to objective: Ca. 50 mm (same as predicate) | |
| - Adjustment direction: Horizontal (same as predicate) | |
| - Working position: Horizontal (same as predicate) | |
| - Optical setup: Conventional microscope (same as predicate) | |
| - Type of scanning aperture: Point (same as predicate) | |
| - Lateral optical resolution: 20 μm - 100 µm (Predicate: ca. 10 microns) - Note: SL-OCT range is broader with lower resolution than predicate | |
| - Axial optical resolution capacity: <25 µm (Predicate: ca. 1 micron) - Note: SL-OCT has lower resolution than predicate | |
| - Detector: InGaAs - photodiode (Predicate: Si-Photodiode) | |
| - Lateral field of view: Up to 15 mm (same as predicate) | |
| - Microscope lens magnification: Ca. 16x (same as predicate) | |
| - Magnification on screen: 300x (Predicate: ca. 100x) - Note: SL-OCT has higher magnification | |
| - Corneal profile measurement: Yes (Predicate: Cornea thickness measurement) |
2. Sample Size Used for the Test Set and the Data Provenance
This document is for a traditional medical device (Optical Coherence Tomography system), not an AI/ML device that would typically involve test sets of data for algorithm performance. The "testing" referred to is for electrical safety and electromagnetic compatibility, not clinical performance on a dataset. Therefore, there is no mention of a test set sample size or data provenance in the context of algorithm performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As noted above, this device predates modern AI/ML regulatory frameworks and does not involve performance studies on clinical datasets with ground truth established by experts.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable for the reasons stated above.
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 standalone imaging device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no "algorithm only" performance for this device in the context of image interpretation or diagnosis; it is an imaging system providing qualitative and quantitative data for human interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document does not describe the use of specific ground truth types for performance evaluation, as it's a hardware device demonstrating substantial equivalence, not a software algorithm being validated.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not use machine learning algorithms that require ground truth for a training set.
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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 3069221 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.
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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 CoherencePachymeter |
|---|---|---|
| k number | - | K030393 |
| Indications for use | Imaging and observation of theanterior segment of the eye fordiagnostic purposes. | Biometric diagnose of the anteriorsegment 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 contactsurface | Not applicable. | Not applicable. |
| Front surface area | Not applicable | Not applicable. |
| Focus | Not applicable | Not applicable. |
| Focus adjustmentrange | Not applicable | Not applicable. |
| Adjustment direction | Device is adjusted horizontallywhile the patient is sitting straightin front of the device. | Device is adjusted horizontally whilethe patient is sitting straight in frontof the device. |
| Working position | Horizontal | Horizontal |
| Optical setup | Conventional microscope | Conventional microscope. |
| Type of scanning ap-erture | Point. | Point. |
| Scanning means | Resonant and galvanometricscanning motor. | Rotating mirror. |
| Light source | SLD 1310nm Laser Class 1 | Laser Light in the visible infraredspectral 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:<25 µm | ca. 1 micron |
| Detector | InGaAs - photodiode. | Si-Photodiode |
| Lateral field of view | Up to 15 mm | Up to 15 mm. |
| Lateral digital resoluti-on | 20 µm - 100 µm |
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510(k) Summary of Safety and Effectiveness
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| Comparison items | SL-OCT | Optical Low Coherence Pachymeter |
|---|---|---|
| ity: 4 μm | Not applicable. | |
| Image acquisition time | 1s | Not applicable. |
| Acquisition of three-dimensional images | No | No |
| Microscope lens magnification | Ca. 16x | ca. 16x |
| Magnification on screen (15", 1024x768 pixels) | 300x | ca. 100x |
| Image storage | Directly into PC RAM, then to PC hard drive. | Not applicable. |
| Image compression method | Not applicable | Not applicable. |
| Corneal profile measurement | Yes | Cornea thickness measurement. |
| Operating and image management software | Custom | Not applicable. |
| Physical layout | Lift table, mount with headrest, optical head are separate components. | Lift table, mount with headrest, optical head are separate components. |
Conclusions from Performance Testing
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.
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
MAY 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heidelberg Engineering GmbH c/o Mr. Jeffrey D. Rongero Project Engineer Underwriters Laboratories, Inc 12 Laboratory Drive Research Triangle, NC 27709
Re: K052935
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
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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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Indication for Use
:
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:
| 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)
:
§ 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.