(133 days)
Not Found
No
The summary describes an imaging system and an assistance system for ophthalmic surgery. There is no mention of AI, ML, or any advanced image processing techniques that would typically indicate the use of such technologies. The performance studies focus on functional testing, electrical safety, electromagnetic compatibility, and software verification/validation, not on the performance metrics commonly associated with AI/ML algorithms (e.g., sensitivity, specificity, AUC).
No
The device is described as an imaging system for viewing and imaging structures of the eye, not for treating any condition.
Yes
The RESCAN 700 provides high-resolution imaging of ocular structures (OCT and biomicroscopic imaging), which are standard diagnostic tools for eye conditions. Although it mentions the assistance system provides non-diagnostic video documentation, the primary function of imaging the anterior and posterior segments of the eye for "viewing, axial cross sectional, and three-dimensional imaging" aligns with diagnostic use.
No
The device description explicitly states that RESCAN 700 is Spectral Domain OCT technology integrated into a physical ophthalmic surgical microscope (Zeiss OPMI Lumera 700). While it uses software (CALLISTO eye) for control and image management, the core device includes hardware components for imaging.
Based on the provided information, the RESCAN 700 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the RESCAN 700 is for "in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures... as well as imaging of anterior ocular structures..." and provides "non-diagnostic video documentation and image capture for ophthalmic surgeries." This describes a device used for imaging and visualization within the living body (in vivo), not for testing samples outside the body (in vitro).
- Device Description: The description reinforces its use with a surgical microscope and its function in presenting and storing images taken intra operatively.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic results based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RESCAN 700's function is to provide visual information about the structure of the eye in situ.
N/A
Intended Use / Indications for Use
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses an assistance system (CALLISTO Eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
Product codes (comma separated list FDA assigned to the subject device)
OBO, NFJ, EPT
Device Description
RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with software version 3.2 of an assistance system, CALLISTO eye, OCT images taken intra operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.
RESCAN 700 is used with CALLISTO eye software version 3.2. A table comparing the features in each CALLISTO eye software version is provided on the following page for clarification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Biomicroscopic imaging
Anatomical Site
anterior and posterior segment of the eye, posterior ocular structures, including retina, macula, and optic disc, as well as anterior ocular structures, including the cornea, lens and anterior chamber angle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmic surgical microscope
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
Performance testing was conducted on RESCAN 700 and it was found to perform as intended. Each function and/or feature was tested by means of an appropriate test case or test specification.
Testing of the device with RESCAN 700, OPMI Lumera 700 and CALLISTO eye has been conducted to demonstrate conformance to the third edition of 60601-1 in addition to the IEC 60601-1-2 standard for electromagnetic compatibility. In addition to systems testing, software verification activities completed were divided into three phases:
- Tests accompanying development (including code inspections)
- Integration test phase - stabilization phase
- System verification
Validation and usability testing was conducted with RESCAN 700 in conjunction with CALLISTO eye to ensure that the medical device meets the product and user requirements and to support a determination of substantial equivalence to the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
RESCAN 700 was designed and tested to the applicable standards for electrical and optical safety and verified to established standards. Performance testing was conducted on RESCAN 700 and it was found to perform as intended. Each function and/or feature was tested by means of an appropriate test case or test specification.
Testing of the device with RESCAN 700, OPMI Lumera 700 and CALLISTO eye has been conducted to demonstrate conformance to the third edition of 60601-1 in addition to the IEC 60601-1-2 standard for electromagnetic compatibility. In addition to systems testing, software verification activities completed were divided into three phases:
- Tests accompanying development (including code inspections)
- Integration test phase - stabilization phase
- System verification
Validation and usability testing was conducted with RESCAN 700 in conjunction with CALLISTO eye to ensure that the medical device meets the product and user requirements and to support a determination of substantial equivalence to the predicate devices.
Verification and validation activities were successfully completed and prove that RESCAN 700 and CALLISTO eye meet their requirements and perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Carl Zeiss Meditec AG c/o Ms. Mandy Ambrecht Carl Zeiss Meditec, Inc. Staff Regulatory Affairs Specialist 5160 Hacienda Drive Dublin, CA 94568
November 18, 2014
Re: K141844
Trade/Device Name: RESCAN 700 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: October 16, 2014 Received: October 17, 2014
Dear Ms. Ambrecht:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141844
Device Name RESCAN 700
Indications for Use (Describe)
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses an assistance system (CALLISTO Eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY
5. 510(k) Summary
510(k) SUMMARY (per 21 CFR §807.92)
RESCAN 700
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany
- 49 736420-9626 (phone)
- 49 736420-2035 (fax)
Establishment Registration Number: 9615030 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mandy Ambrecht
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
(925) 557-4561 Phone
(925) 557-4259 Fax
E-mail: mandy.ambrecht@zeiss.com |
| Date prepared: | November 17, 2014 |
| Trade/Proprietary Name: | RESCAN 700 |
| Common Name: | Tomography, Optical coherence
Picture Archiving and Communication System
Surgical microscope and accessories |
| Classification Name: | Ophthalmoscope
System, Image Management, Ophthalmic
Microscope, Surgical |
| Product Code and Class: | OBO - Class II
NFJ
EPT |
| Classification Number: | 21 CFR 886.1570 |
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510(K) SUMMARY
PREDICATE DEVICE:
| Company: | Carl Zeiss Meditec AG |
|---|---|
| Device: | CIRRUS photo |
| (K112184) | |
| Company: | Carl Zeiss Meditec AG |
| Device: | CALLISTO eye |
| (K123464) |
INDICATIONS FOR USE
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses an assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
DEVICE DESCRIPTION
RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with software version 3.2 of an assistance system, CALLISTO eye, OCT images taken intra operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.
RESCAN 700 is used with CALLISTO eye software version 3.2. A table comparing the features in each CALLISTO eye software version is provided on the following page for clarification.
SUBSTANTIAL EQUIVALENCE
RESCAN 700 is substantially equivalent to the CIRRUS photo (K112184) with regards to indications for use. RESCAN 700 and CIRRUS photo are both intended to provide OCT images of the anterior and posterior segment of the eye. RESCAN 700 is used with CALLISTO eye
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510(K) SUMMARY
software version 3.2. Both the proposed product, CALLISTO eye, and the predicate device, CALLISTO eye, provide non-diagnostic video documentation and image capture for ophthalmic surgeries and allow remote control of the surgical microscope.
| Functions | CALLISTO eye
SW Version 3.0 | CALLISTO eye
SW Version 3.1 | CALLISTO eye
SW Version 3.2 |
|--------------------------------------------------------------------------------------|--------------------------------|--------------------------------|--------------------------------|
| User Management | X | X | X |
| Patient management | X | X | X |
| Surgery (video) recording | X | X | X |
| Live video | X | X | X |
| Control center | X | X | X |
| Ophthalmic surgical microscope remote
control (OPMI Lumera 700) | X | X | X |
| Network connectivity | X | X | X |
| Import/Export of data via USB stick | X | X | X |
| Assistance functionalities Z ALIGN,
Rhexis, LRI/Incision, Reference and
KTrack | X | X | Not available |
| Control of the RESCAN 700 (OCT
Camera) connected to the OPMI Lumera
700 | | | X |
| Visualization of OCT data | | | X |
| Capture and Review of OCT datasets
(images and scans) | | | X |
PERFORMANCE DATA
RESCAN 700 was designed and tested to the applicable standards for electrical and optical safety and verified to established standards. Performance testing was conducted on RESCAN 700 and it was found to perform as intended. Each function and/or feature was tested by means of an appropriate test case or test specification.
Testing of the device with RESCAN 700, OPMI Lumera 700 and CALLISTO eye has been conducted to demonstrate conformance to the third edition of 60601-1 in addition to the IEC 60601-1-2 standard for electromagnetic compatibility. In addition to systems testing, software verification activities completed were divided into three phases:
- Tests accompanying development (including code inspections) ●
- Integration test phase - stabilization phase
- System verification
Validation and usability testing was conducted with RESCAN 700 in conjunction with CALLISTO eye to ensure that the medical device meets the product and user requirements and to support a determination of substantial equivalence to the predicate devices.
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Verification and validation activities were successfully completed and prove that RESCAN 700 and CALLISTO eye meet their requirements and perform as intended.
SUMMARY
As described in this 510(k) Summary, all testing deemed necessary was conducted on RESCAN 700 and CALLISTO eye to ensure that the device is as safe and effective as the predicate devices.