(138 days)
No
The document describes a workflow integrating existing devices for image capture and surgical guidance. There is no mention of AI or ML in the intended use, device description, or performance studies. The guidance tools are described as graphical templates based on surgeon information, not learned patterns.
No
The device aids surgeons in performing procedures by providing measurements and guidance, but it does not directly treat a disease or condition itself.
Yes
The IOLMaster 500 component of the ZEISS Cataract Suite is explicitly stated to perform "biometric determination of ocular measurements" and "calculations to assist physicians in determining the appropriate IOL power and type for implantation," which are diagnostic functions.
No
The device is described as a "series of medical devices integrated into one workflow" and explicitly includes hardware components like the IOLMaster 500 (an optical biometric device) and the CALLISTO eye (an assistance system operating with surgical microscopes). While software is a critical part of the workflow, it is not the sole component.
Based on the provided information, the ZEISS Cataract Suite markerless workflow, as a whole, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ZEISS Cataract Suite markerless workflow is a system used during ophthalmic surgery to provide guidance and assistance to the surgeon. It uses pre-operative measurements and images of the eye itself (an in-vivo measurement), not samples taken from the body.
- Intended Use: The intended use clearly states its purpose is for "visualization and guidance during cataract surgery" and "aids the surgeon to insert, align, position, and register an artificial lens." This is a surgical assistance system, not a diagnostic test performed on a sample.
- Components: While the IOLMaster 500 performs biometric measurements of the eye, these are in-vivo measurements used for surgical planning and IOL power calculation, not diagnostic tests on bodily fluids or tissues. The CALLISTO eye is a surgical assistance system.
Therefore, the ZEISS Cataract Suite markerless workflow falls under the category of a surgical assistance or guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IOLMaster 500:
The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.
CALLISTO eye:
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.
The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis. The system utilizes surgeon information for position of graphical guidance tools.
Product codes (comma separated list FDA assigned to the subject device)
HJO, NFJ, HMR, EPT, HRM
Device Description
The markerless toric IOL alignment workflow provided with the ZEISS Cataract Suite markerless is a series of medical devices integrated into one workflow for use by a cataract surgeon. The workflow comprises an optical biometric device with green LED image capture from the IOLMaster 500 (K122418) with an optional accessory (Option Reference Image). The captured image is transferred to a cataract surgery assistance system, the CALLISTO eye (K123464), which operates in conjunction with ophthalmic surgical microscopes. Integrated or external data injection systems (IDIS or EDIS) are capable of displaying the graphical templates of the CALLISTO eye in the right ocular of the ophthalmic surgical microscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical biometric device with green LED image capture
Anatomical Site
ocular / eye / anterior segment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians and eye-care professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The IOLMaster 500 and CALLISTO eye software were tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. The software testing also followed the Carl Zeiss Meditec internal software development procedure that is in compliance with the IEC 62304:2006 - Medical device software - Software life cycle processes.
Electromagnetic compatibility and safety testing was conducted along with appropriate bench testing to verify changes to the devices.
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.
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
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Carl Zeiss Meditec, Inc. Ms. Sarah Harrington, M.S., MBA Staff Regulatory Specialist 5160 Hacienda Drive Dublin, CA 94568
Re: K141068
Trade/Device Name: Zeiss Cataract Suite markerless Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscope, Slit-Lamp, AC-powered Regulatory Class: Class II Product Code: HJO, NFJ, HMR, EPT, HRM Dated: July 29, 2014 Received: July 30, 2014
Dear Ms. Harrington:
This letter corrects our substantially equivalent letter of September 9, 2014.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/ResourcesforYou/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.
Sincerelv vours.
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
Enclosure
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1.0 INDICATIONS FOR USE - ZEISS CATARACT SUITE MARKERLESS
510(k) Number (if known):
ZEISS Cataract Suite markerless Device Name(s):
The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices:
Indications for Use:
IOLMaster 500
The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.
CALLISTO eve
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.
The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis. The system utilizes surgeon information for position of graphical guidance tools.
| 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)
Page
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2.0 510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
Submitter's name, address, telephone number, contact person, and date summary prepared:
| 1. Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Sarah Harrington, MS, MBA
Staff Regulatory Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
sarah.harrington@zeiss.com
Tel: (925) 560-5134
Fax: (925) 557-4259 |
Name of device, including trade name and classification name
| 1. | Trade/Proprietary Name: | a. IOLMaster / IOLMaster 500
b. CALLISTO eye
c. Opthalmic Surgical Microscopes |
|----|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Common/Usual Name: | a. Biometer
b. Picture Archiving and Communication System
c. Ophthalmic Surgical Microscope and accessories |
| 3. | Classification Name: | a. AC-powered slit lamp biomicroscope
b. System, Image management, Ophthalmic;
Ocular Marker; Surgical Microscope
c. Surgical Microscope, operating & accessories,
AC-powered, ophthalmic |
| 4. | Product Code and Class: | a. HJO - Class II
b. NFJ, HMR, EPT– Class II
c. HRM - Class I |
| 5. | Classification Number: | a. 21 CFR 886.1850
b. 21 CFR 892.2050
c. 21 CFR 878.4700 |
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Predicate Device
The ZEISS Cataract Suite markerless is similar in function and application in cataract surgery to the predicate device, the TrueVision 3D Visualization and Guidance System (K101861). The visualization system displays real-time images during ophthalmic surgery on a flat-panel digital display device positioned for live video image viewing by the surgeon in the operating room.
Device Description
The markerless toric IOL alignment workflow provided with the ZEISS Cataract Suite markerless is a series of medical devices integrated into one workflow for use by a cataract surgeon. The workflow comprises an optical biometric device with green LED image capture from the IOLMaster 500 (K122418) with an optional accessory (Option Reference Image). The captured image is transferred to a cataract surgery assistance system, the CALLISTO eye (K123464), which operates in conjunction with ophthalmic surgical microscopes. Integrated or external data injection systems (IDIS or EDIS) are capable of displaying the graphical templates of the CALLISTO eye in the right ocular of the ophthalmic surgical microscopes.
Indications for Use
The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices:
IOLMaster 500
The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.
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Indications for Use (cont.)
CALLISTO eye
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.
The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis. The svstem utilizes surgeon information for position of graphical guidance tools.
Comparison of Technological Characteristics
The ZEISS Cataract Suite markerless and the predicate device, the TrueVision 3D Visualization and Guidance System (K101861) share similar functional features and operating characteristics. The TrueVision system captures an image of the eye that is displayed by the 3D Visualization and Guidance System. As with the CALLISTO eye, the TrueVision 3D Visualization and Guidance System provides graphical templates and overlays that are viewed via an ophthalmic surgical microscope to aid the surgeon during cataract surgery.
Performance Data
The IOLMaster 500 and CALLISTO eye software were tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. The software testing also followed the Carl Zeiss Meditec internal software development procedure that is in compliance with the IEC 62304:2006 - Medical device software - Software life cycle processes.
Electromagnetic compatibility and safety testing was conducted along with appropriate bench testing to verify changes to the devices.
Conclusion
Based on the software verification and validation, safety testing and bench testing as well as the comparison to the predicate devices, the ZEISS Cataract Suite markerless as well as the contributing devices are safe and effective with respect to their Indications for Use.