(79 days)
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Not Found
No
The summary describes a standard OCT imaging device and its intended use for diagnosis. There is no mention of AI/ML in the device description, intended use, or performance studies. The predicate devices are also standard OCT systems.
No
The device is described as a diagnostic imaging device used to aid in the detection and management of ocular diseases, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases..."
No
The device description explicitly states it is a "computerized instrument" that "acquires and analyzes" images using "non-invasive, non-contact, low-coherence interferometry." This indicates the device includes hardware components for image acquisition, not just software for processing or analysis.
Based on the provided information, the Cirrus™ HD-OCT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Cirrus™ HD-OCT Function: The description clearly states that the Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device that performs in vivo viewing and imaging of posterior ocular structures. It directly images the eye without taking any samples from the body.
Therefore, the Cirrus™ HD-OCT falls under the category of an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cirrus™ HD-OCT is intended for use in the viewing and axial cross sectional imaging of posterior ocular structures.
The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.
Product codes
HLI
Device Description
The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of posterior ocular structures (including retina, retinal nerve fiber layer, macula, and optic disc.). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc.
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
Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT.
Key Metrics
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Predicate Device(s)
Carl Zeiss Meditec, Inc. Stratus OCT™ with Retinal Nerve Fiber Layer Normative and Macula Database
Reference Device(s)
Carl Zeiss Meditec, Inc. Visante™ OCT
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510(K) SUMMARY
5. 510 (K) SUMMARY
| 510(k) SUMMARY | |||
|---|---|---|---|
| (per 21 CFR §807.92) | JAN 26 2007 | ||
| CIRRUS™ HD-OCT | |||
| GENERAL INFORMATION | |||
| Manufacturer: | Carl Zeiss Meditec Inc. | ||
| 5160 Hacienda Drive | |||
| Dublin, California 94568 | |||
| (925) 557-4616 (phone) | |||
| (925) 557-4481 (fax) | |||
| Est. Reg. No. 2918630 | |||
| Contact Person: | Judith A. Brimacombe, MA | ||
| Director, Regulatory/Clinical Affairs | |||
| Carl Zeiss Meditec, Inc. | |||
| 5160 Hacienda Drive | |||
| Dublin, California 94568 | |||
| (925) 557-4616 (phone) | |||
| (925) 557-4481 (fax) | |||
| Classification Name: | Ophthalmoscope | ||
| Classification: | Class II (acc. 21 CFR 886.1570) | ||
| Product Code: | 86 HLI | ||
| Trade/Proprietary Name: | Cirrus™ HD-OCT | ||
| PREDICATE DEVICE | |||
| Company: | |||
| Device: | Carl Zeiss Meditec, Inc. | ||
| Stratus OCT™ with Retinal Nerve Fiber Layer Normative | |||
| and Macula Database | |||
| Company: | |||
| Device: | Carl Zeiss Meditec, Inc. | ||
| Visante™ OCT | |||
| INTENDED USE |
The Cirrus™ HD-OCT is intended for use in the viewing and axial cross sectional imaging of posterior ocular structures.
:
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INDICATIONS FOR USE
The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.
DEVICE DESCRIPTION
The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of posterior ocular structures (including retina, retinal nerve fiber layer, macula, and optic disc.). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.
SUBSTANTIAL EQUIVALENCE
The Cirrus™ HD-OCT is substantially equivalent to the predicate devices identified previously. The Cirrus™ HD-OCT is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.
Evaluation performed on the Cirrus™ HD-OCT supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes.
CLINICAL EVALUATION
Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT.
CONCLUSION
As described in this 510(k) Summary, all testing deemed necessary was conducted on the Cirrus™ HD-OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carl Zeiss Meditec, Inc. c/o Judy Brimacombe Director, Regulatory/Clinical Affairs 5160 Hacienda Drive Dublin, CA 94568
JAN 26 2007
Re: K063378
Trade/Device Name: Cirrus HD-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLI Dated: November 6, 2006 Received: November 8, 2006
Dear Ms. Brimacombe:
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, RDA 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.
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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 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/industry/support/index.html.
Sincerely yours,
M.B. Eichelman Simd
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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4. INDICATIONS FOR USE STATEMENT
Device Name: Cirrus™ HD-OCT
Indications for Use:
The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clay R. Buttereau
510(k) Number K063378
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