(11 days)
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.
The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures. With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor. The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT). The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.
The provided text is a 510(k) Summary for the Heidelberg Retina Angiograph 2 / Optical Coherence Tomograph (HRA 2 / OCT). This document focuses on demonstrating substantial equivalence to a predicate device (Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, K012727), rather than presenting a performance study with specific acceptance criteria as you might find for a novel device or a clinical trial.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies is not explicitly available within this 510(k) summary.
However, I can extract the information available and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not define specific numerical acceptance criteria for a performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device (Humphrey OCT3, K012727) based on technological characteristics, intended use, safety, and effectiveness.
The "reported device performance" is essentially that the HRA 2 / OCT was found to meet all requirements of safety standards and its images were comparable to the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (HRA 2 / OCT) |
|---|---|
| Safety: Compliance with relevant electrical safety and laser safety standards. | Passed IEC 60601-1 and IEC 60601-1-2. Classified as Class 1 laser product (21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001). |
| Technological Characteristics: Similarities in imaging principle, resolution, scanning capabilities, etc., compared to predicate. | Utilizes Spectral-Domain OCT (FD-OCT), offering high lateral (14 μm) and depth (6.9 μm) optical resolution. Acquires 2D and 3D scans. Comparisons to predicate device (OCT3) highlighted differences (e.g., FD-OCT vs Time Domain OCT) but overall equivalence for intended use. |
| Intended Use: Device performs its stated function for imaging and aiding in assessment of ocular diseases. | Intended for imaging of retina and retinal structures, aiding in assessment and management of AMD, diabetic retinopathy, and glaucoma. |
| Image Quality / Effectiveness: Images acquired are comparable to those from the predicate device and support the intended use. | "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." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "evaluation of the device and comparison of acquired images" but provides no details on the number of images or patients used for this comparison.
- Data Provenance: Not specified. It does not mention the country of origin of any data, nor whether it was retrospective or prospective. Given the context of a 510(k) for a medical imaging device, any "comparison of acquired images" implicitly refers to clinical or phantom data, but no specifics are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No. This 510(k) is for an imaging device (OCT) and does not involve AI or human-in-the-loop performance evaluation in the context of comparative effectiveness. It's a submission for the hardware and basic image acquisition software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This 510(k) is for the HRA 2 / OCT imaging device itself, not for an algorithm providing automated analysis or diagnosis.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. The summary mentions "comparison of acquired images." For an imaging device, the "ground truth" for image quality typically relies on expert assessment of image clarity, resolution, and ability to visualize relevant anatomical structures and pathologies, often compared against a known, established predicate device or other gold standard imaging. However, specific methods are not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes an imaging device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning algorithm described.
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510(k) Summary of Safety and Effectiveness
Manufacturer and Submitter
| Company Name: | Heidelberg Engineering GmbH |
|---|---|
| Company Address: | Tiergartenstrasse 15 |
| 69121 Heidelberg, Germany | |
| phone: +49 / 6221 / 64 643 0 | |
| fax: +49 / 6221 / 64 63 62 | |
| Contact Person: | Dr. Gerhard Zinser |
| Date Summary Prepared: | September 11, 2006 |
Device
Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:
HRA 2 / OCT Heidelberg Retina Angiograph / Optical Coherence Tomograph Opthalmoscope, AC-powered 21 CR 886.1570 HLI Ophthalmic Class II device
Substantial Equivalence
The OCT add-on to the HRA 2 is substantially equivalent to the Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, Humphrey OCT3, a 510 (k) cleared device ( K012727 ).
Device Description
The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures.
With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor.
The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT).
The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.
OCT 3 1 2006
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Intended Use
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.
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fechnological Characteristics Compared to Predicate Device
| Comparison itemsk number | HRA 2 / OCT | OCT 3K012727 | |
|---|---|---|---|
| Indications for use | The OCT add-on to the HRA 2 is a device for theoptical imaging of posterior ocular structures. | The Humphrey OCT3 is a high resolution tomographicdevice for the viewing and axial cross sectional imaging ofposterior ocular structures. | |
| The Device uses Optical Low CoherenceTomography technology for the axial crosssectional imaging of the retina. | It is used for the in vivo imagingand measurement of the retina, retina nerve fiber layer andoptic disk. It is intended for use as a diagnostic device to | ||
| The OCT add-on to the HRA 2 is intended for usefor the imaging of the retina and retinal structures,and for aiding in the assessment and managementof various diseases of the posterior segment, such | aid in the detection and management of ocular diseases, | ||
| like age-related macula degeneration, diabeticretinopathy, and glaucoma. | including but not limited to macular edema, central serousretinopathy and glaucoma. | ||
| Corneal contact | No | No | |
| Working distance cornea toobjective | Ca. 10 mm | No information | |
| Corneal contact sensing andwarning feature | No | No | |
| Pre-sterilized contact surface | No | No | |
| HRA 2 / OCT | OCT 3 | ||
| Comparison of similarities and differences continued:Comparison itemsk number | K012727 | ||
| Front surface area | 310 mm² | No information. | |
| Focus | Manually adjustable | Manually adjustable | |
| Focus adjustment range | Correction of patients refractive errors: -12 to +12diopters | Correction of patients refractive errors: -12 to +12diopters | |
| Alignment to patient | Device is adjusted horizontally and vertically whilethe patient is sitting straight in front of the device. | Device is adjusted horizontally and vertically while thepatient is sitting straight in front of the device. | |
| Working position | The patient is sitting straight in front of the device.The examiner is sitting opposite to the patient. | The patient is sitting straight in front of the device. Theexaminer is sitting opposite to the patient. | |
| Optical setup | Frequency (Fourier) Domain OCT | Time Domain OCT | |
| Type of scanning aperture | Point scan. | Point scan. | |
| Scanning means | Galvanometric scanning motor. | Galvanometric scanning motor | |
| Light source | SLD, 870 nm, Class 1 | SLD 820 nm, Class 1 | |
| Optical resolution, lateral | 14 μm | 20 μm in tissue(spot size in tissue) | |
| Optical resolution, depth | 6,9 μm | <10 μm in tissue | |
| Comparison of similarities and differences continued: | |||
| Comparison items | HRA 2 / OCT | OCT 3 | |
| k number | K012727 | ||
| Detector | Linear line array | Photodiode | |
| Lateral field of view | 2D Scan:3 mm to 9 mm, corresponding to 10° to 30° | 2D Scan:6 mm, corresponding to 20° | |
| 3D Scan:1,5 mm x 1,5 mm to 9 mm x 9 mm, corresponding to5° x 5° to 30° x 30° | |||
| Lateral digital resolution | 2D Scan:high resolution mode: 5 μmhigh speed mode:10 μm | 2D Scan:8 μm(768 A scan in 6 mm) | |
| 3D Scan:high resolution mode: 5 μmhigh speed mode:35 μmvideo mode:25 μm to 150 μm | |||
| Depth digital resolution | 3 μm(512 points in 1,5 mm in tissue) | 2 μm(1024 points in 2 mm in tissue) | |
| Comparison of similarities and differences continued: | |||
| Comparison items | HRA 2 / OCT | OCT 3 | |
| k number | K012727 | ||
| Image acquisition time | 2D Scan: | 2D Scan: | |
| high resolution mode: | 6 to 20 ms | 0,32 s to 1,92 s | |
| high speed mode: | 12 to 40 ms | (depends on no. of A-scan) | |
| 3D Scan: | |||
| high resolution mode: | 3,6 s | ||
| high speed mode: | 1,6 s | ||
| video mode: | 0,1 s | ||
| Acquisition of three-dimensional images | Yes | No | |
| Image storage | Directly into PC RAM, then to PC hard disk drive | No information | |
| Image compression method | Yes (without information loss) | No information | |
| Operating and image management software | Custom | Custom |
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| Comparison of similarities and differences continued: | ||
|---|---|---|
| Comparison items | HRA 2 / OCT | OCT 3 |
| number | K012727 | |
| Physical layout | - Mount with headrest- Optical head- Power supply and laser unit- Touchpanel- Computer with monitor, keyboard,- Mouse and printer- Lift table | - Imaging device with integrated headrest- Computer with monitor, keyboard,- Mouse and printer- Lift table |
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Conclusions from Performance Testing
The HRA 2 / 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/8/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three faces in profile, representing the department's focus on people. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the figure.
JUN 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heidelberg Engineering GmbH c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc 455 E. Trimble Road San Jose, CA 95131-1230
Re: K063191
Trade/Device Name: Heidelberg Retina Angiograph 2/ Optical Coherence Tomograph (HRA 2/OCT) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: October 18, 2006 Received: October 20, 2006
Dear Mr. Christensen:
This letter updates our substantially equivalent letter of October 31, 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. Morten Simon Christensen
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,
Eivenette R. Beens PhD
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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
510(k) Number (if known):
Device Name:
Heidelberg Retina Angiograph 2 / Optical Coherece Tomograph (HRA 2 / OCT)
Indication for Use
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like agerelated macula degeneration, diabetic retinopathy, and glaucoma.
Prescription Use
X
and / or
Over-The -Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Dennis L. McCarthy
(Division Sign Off)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Numbe
§ 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.