(268 days)
The Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurcment of posterior ocular structures including: retina, macula, retinanserve fibre layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, corners and conjunctiva can be imaged with the system by changing the focal position.
The OPKO/OTI Spectral OCT/SLO is a computerized instrument that employs non-invasive, low-coherence interferometry to acquire simultaneous highresolution cross-sectional OCT (Optical Coherence Tomography) and confocal images of ocular structure, including retina, retinal nerve fiber layer, macula and optic disc of the eye.
The provided 510(k) summary for the OPKO/OTI Spectral OCT/SLO outlines certain performance data, but it does not specify formal acceptance criteria or a detailed study proving the device unequivocally meets such criteria in terms of diagnostic accuracy or clinical utility. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding measurement precision and agreement.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria (e.g., minimum sensitivity, specificity, or specific limits of agreement for clinical tasks) are not explicitly stated in the provided document. The performance evaluation primarily focuses on direct comparison with predicate devices for specific measurements.
| Performance Metric (Implicit) | Reported Device Performance | Comments |
|---|---|---|
| Precision | Equivalent or better than predicate device (Zeiss Stratus OCT) | The document states, "The Spectral OCT/SLO is equivalent or better in the precision tests when compares to the predicate device." No quantitative values for precision are given. |
| Agreement (Regression Analysis) | Substantially equivalent between test device and predicate device | The document states, "The regression analysis between the measurements are substantially equivalent between the test and the legally marketed predicate devices." No quantitative values or metrics for agreement are given. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Thirty-six (36) subjects.
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective comparative study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the use of "experts" to establish a ground truth for diagnostic accuracy, sensitivity, or specificity. The study described is a comparative one focusing on the precision and agreement of measurements of retinal, RNFL thickness, and optic nerve disc ratio between the new device and a predicate device. Ground truth for these measurements would typically be derived directly from the device's output, not independent expert interpretation in the way you might assess a diagnostic algorithm.
4. Adjudication Method for the Test Set
This information is not provided as the study design focuses on direct comparison of measurements rather than adjudicating diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study, as typically understood for evaluating reader performance with and without AI assistance for diagnostic tasks, was not conducted according to this document. The study described is a direct comparison of the device's measurements to a predicate device, not an evaluation of human readers' diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a measurement and imaging tool, not an AI algorithm that produces a diagnostic output in isolation. The "algorithm" here refers to the device's internal processing for image acquisition and measurement. The non-clinical tests included "software validation tests," but this is not equivalent to a standalone performance study for a diagnostic AI algorithm. The clinical test evaluated the device's performance in generating specific measurements.
7. The Type of Ground Truth Used
For the measurements evaluated (retinal, RNFL thickness, and optic nerve disc ratio), the "ground truth" was effectively established by the predicate device (Zeiss Stratus OCT), meaning the study sought to show that the new device's measurements correlated well with and were as precise as the existing, legally marketed device. The study's conclusion explicitly states, "The regression analysis between the measurements are substantially equivalent between the test and the legally marketed predicate devices." This implies that the predicate device served as the reference point for measurement comparison.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI/machine learning algorithm. The device, an OCT/SLO system, uses established physical principles (interferometry) and image processing, not a machine learning model that requires a discrete training phase with labeled data.
9. How the Ground Truth for the Training Set Was Established
As no training set (for a machine learning algorithm) is mentioned, this information is not applicable. The device's functionality relies on its optical and software design, validated through tests like accuracy, optical emissions, image comparison, and specifically, software validation.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for OPKO Instrumentation/OTI, which is a division of OPKO Health, Inc. The logo is black and white and features the text "OPKO" in bold letters, followed by a slash and "OTI" in a different font. Above the text is the number 14.
510(k) Summary October 1, 2008
NOV 1 4 2008
- Submitter Information
Name: OPKO Instrumentation/OTI 4400 Biscayne Boulevard Miami, FL 33137
| Telephone Number: | 305-575-6004 |
|---|---|
| Fax Number: | 305-575-6016 |
Contact Person: Jane Hsiao e-mail: jhsiao@opko.com
Date Submitted: October 1, 2008
-
- Name of Device
Trade Name: Spectral OCT/SLO Common Name: Ophthalmoscope using optical coherence tomography Classification Name: Ophthalmoscope, a-c powered, 800HE
- Name of Device
-
- Description
The OPKO/OTI Spectral OCT/SLO is a computerized instrument that employs non-invasive, low-coherence interferometry to acquire simultaneous highresolution cross-sectional OCT (Optical Coherence Tomography) and confocal images of ocular structure, including retina, retinal nerve fiber layer, macula and optic disc of the eye.
- Description
{1}------------------------------------------------
-
- Indication for Use:
The Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing. axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fibre lancer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, cornea, sclera and conjunctiva can be imaged with the system by changing the focal position.
- Indication for Use:
-
- Technological Characteristics:
The OPKO/OTI Spectral OCT/SLO and the predicate device, Zeiss Stratus OCT both utilize Optical Coherence Tomography, which relies upon interferometty of superluminescent diode light, reflected from the fundus of the eye, to produce cross-sectional image of the retina. Both systems have similar hardware system consist of an optical system, the light source, a power supply and a computer with software for data analysis and image processing. The two systems differ in the that OPKO/OTI Spectral OCT/SLO uses spectrometer with optical grading and Iinear CCD camera while Stratus OCT uses photo-detector to detect the regurn OCT light signal from the eve.
- Technological Characteristics:
-
- Performance Data
- a. Non-clinical tests
The Spectral OCT/SLO has had accuracy test, optical emissions analyses, image comparison, electrical safety test, electromagnetic compatibility test and software validation tests.
-
b. Clinical tests:
Thirty six subjects, including normal and patients with retinal or glaucoma pathologies, participated in a controlled prospective comparative study to evaluate the performance (precision and agreement) of Spectral OCT/SLO and the predicate device Stratus OCT in the measurement of retinal, RNFL thickness and optical nerve disc ratio. -
c. Conclusions
The Spectral OCT/SLO is equivalent or better in the precision tests when compares to the predicate device. The regression analysis between the measurements are substantially equivalent between the test and the legally marketed predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OPKO Health, Inc. c/o Jane Hsiao, Ph.D. OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137
NOV 1 4 2008
Re: K080460
Trade/Device Name: Spectral OCT/SLO Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: November 11, 2008 Received: November 12, 2008
Dear Dr. Hsiao:
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.
{3}------------------------------------------------
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 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 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 (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maling B. Egeratas, und
Malvina B. Eydelman, M.L Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K080460 Device Name: Spectral OCT/SLO
Indications For Use:
The Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurcment of posterior ocular structures including: retina, macula, retinanserve fibre layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, corners and conjunctiva can be imaged with the system by changing the focal position.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/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)
umtte
(Division Sign-Off)
Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number
§ 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.