(80 days)
The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures, It is used for in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk. 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 edema, central serous retinopathy, and glaucoma. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially glaucoma.
The STRATUSOCT™ with RNFL Normative Database is a microprocessor-based low-coherence digital intrument employing low coherence interferometry to generate images of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using optical beam. Results obtained for Retinal Nerve Fiber Layer can be compared to a database of known normal human subjects.
{
"acceptance_criteria_study": {
"acceptance_criteria_and_performance_table": {
"headers": ["Acceptance Criteria", "Reported Device Performance"],
"rows": [
["Device is safe and effective for its intended use", "All testing deemed necessary was conducted to ensure the device is safe and effective."],
["Substantially equivalent to predicate device", "Substantially equivalent with regard to intended use, operating principle, function, and materials."],
["Supports expanded indications for use", "Clinical evaluation performed supports expanded indications for use statement."],
["Does not raise new questions regarding safety and effectiveness", "Demonstrates the device does not raise new questions regarding safety and effectiveness."]
]
},
"sample_size_test_set_data_provenance": "Clinical data was collected on a statistically significant number of normal human subjects. The provenance (country of origin, retrospective/prospective) is not specified.",
"number_of_experts_ground_truth_test_set": "Not specified in the provided text.",
"qualifications_of_experts_ground_truth_test_set": "Not specified in the provided text.",
"adjudication_method_test_set": "Not specified in the provided text.",
"mrmc_comparative_effectiveness_study": {
"performed": false,
"effect_size_human_readers_with_ai_vs_without_ai": "Not applicable, as no MRMC study with AI assistance is mentioned. The device itself is a diagnostic tool, not an AI assisting human readers in a comparative task."
},
"standalone_algorithm_performance": true,
"type_of_ground_truth_used": "Comparison to a database of known normal human subjects (implicitly, normal anatomical parameters for RNFL).",
"sample_size_training_set": "Not explicitly stated as 'training set' but the clinical evaluation involved a 'statistically significant number of normal human subjects' for the RNFL Normative Database. The exact number is not provided.",
"how_ground_truth_for_training_set_established": "The RNFL Normative Database was established by collecting and analyzing clinical data from a statistically significant number of human subjects identified as 'normal'."
}
}
{0}------------------------------------------------
MAY - 1 2003
K030433
510(k) Summary Carl Zeiss Meditec, Incorporated STRATUSocT™ with RNFL Normative Database
This 510(k) summary for the STRATUS cr™ with RNFL Normative Database is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4353 (phone)(925) 557-4481 (fax)Est. Reg. No. 2918630 |
|---|---|
| Contact Person: | R. Michael CromptonVice President, Regulatory / Clinical Affairsand Quality Assurance |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | STRATUSOCT™ with Retinal Nerve Fiber Layer Normative Database |
| Generic/Common Name: | Ophthalmoscope (21 CFR § 886.1570)Ultrasonic pulsed echo imaging system (21 CFR § 892.1560) |
PREDICATE DEVICE
- Humphrey® OCT 3 (K012727) (1)
INTENDED USE
The STRATUSocr™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk. 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 edema, central serous retinopathy, and glaucoma. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially glaucoma.
{1}------------------------------------------------
DEVICE DESCRIPTION
The STRATUSOCT™ with RNFL Normative Database is a microprocessor-based low-coherence digital intrument employing low coherence interferometry to generate images of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using optical beam. Results obtained for Retinal Nerve Fiber Layer can be compared to a database of known normal human subjects.
SUBSTANTIAL EQUIVALENCE
The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") Normative Database is substantially equivalent to the predicate device identified previously. The STRATUSOCT™ with RNFL Normative Database is substantially equivalent to the predicate device with regard to intended use, operating principle, function, and materials.
Clinical evaluation performed on the STRATUS oct™ with RNFL Normative Database supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes and ultrasonic pulsed echo imaging systems.
CLINICAL EVALUATION
Clinical data was collected on a statistically significant number of normal human subjects and analyzed to support the inclusion of the RNFL Normative Database on the STRATUSOCT™
CONCLUSION
As described in this 510(k) Summary, all testing deemed necessary was conducted on the STRATUSOCT™ with RNFL Normative Database 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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MAY 2 9 2007
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe 5160 Hacienda Drive Dublin, CA 94568
Trade/Device Name: STRATUSocn™ with Retinal Nerve Fiber Layer (RNFL) & Macula Normative Database Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: February 7, 2003 and September 26, 2003 Received: February 10, 2003 and September 30, 2003
Dear Ms. Brimacombe:
This letter updates our substantially equivalent letters of May 1, 2003 and April 20, 2004, respectively.
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 - Ms. Judith A. Brimacombe
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.
Everette W. Bees PhD
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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Statement of Indications for Use
510(k) Number (if known): K < 30 4 3 3
Device Name: STRATUSOCT™ with RNFL Normative Database
Indications for Use: The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures, It is used for in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk. 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 edema, central serous retinopathy, and glaucoma. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially glaucoma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Jan C Callaway
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
| 510(k) Number | K030433 |
|---|---|
| Prescription Use (Per 21 C.F.R. § 801.109) | ✓ |
| Over-the-Counter Use |
§ 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.