(27 days)
No
The document explicitly states that AI/ML is "Not Found" and focuses on the device's measurement capabilities and a new image capture feature, without mentioning any AI/ML-driven analysis or processing.
No.
The device is intended to acquire ocular measurements and perform calculations for determining appropriate intraocular lens power and type, which is a diagnostic and measurement function, not a therapeutic one.
Yes
Justification: The device is intended to acquire ocular measurements and perform calculations to determine appropriate intraocular lens power and type. This involves assessing a patient's current condition to guide treatment, which is a diagnostic function.
No
The device description explicitly states it is a modified version of a hardware device (ARGOS cleared under K150754) and mentions hardware specifications validation and input imaging modalities like SS-OCT and camera images, indicating it is not software-only.
Based on the provided text, the ARGOS device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- ARGOS Function: The ARGOS device is described as a non-invasive, non-contact biometer that acquires ocular measurements directly from the eye (in vivo). It uses optical coherence tomography (SS-OCT) and other imaging modalities.
- Intended Use: The intended use is to acquire ocular measurements and perform calculations for IOL power determination and reference image capture. This is a diagnostic and planning tool for ophthalmic procedures, not a test performed on a biological sample.
Therefore, the ARGOS device falls under the category of an ophthalmic diagnostic device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
Product codes
MXK
Device Description
The ARGOS is substantially equivalent to the predicate device identified previously:
- the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics
- the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission.
The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700).
The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are:
- An additional feature of reference image capture function ●
- Labeling change including change in the intended use adding the feature of reference . image capture.
- . This image can be transferred to image guided devices in order to support the execution of preoperative plan.
The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Swept-source optical coherence tomography (SS-OCT)
Anatomical Site
Ocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
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
Bench Test:
Performance of the ARGOS was evaluated by bench tests based on the relevant standards (ISO15004-1. ANSI.Z80-36. IEC 60825. ISO 10343).
Both ISO 15004-1 and ANSI.Z80-36, and IEC60825 tests prove the fundamental requirements for ophthalmic instruments and optical radiation safety of ARGOS are equivalent to predicate device. ISO 10343 tests results provided the required accuracy performance for ophthalmometer which measures corneal radii of curvature and angle of meridian with a certain cylinder (toroidal surface).
Hardware specifications were validated for axial/lateral distance measurement accuracy and range, signal-to-noise ratio, and depth attenuation, to prove that ARGOS meets the hardware performance requirements.
In addition, usability of the system including user interface software was evaluated and validated. Usability engineering conforms to IEC 62366, a collateral standard of ANSVAAMI ES 60601-1.
Software Verification and Validation:
Software verification and validation were performed according to ISO14971 and FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The verification results confirm the fulfillment of software requirement specifications.
Cybersecurity Review:
Cybersecurity hazard analysis and risk management were conducted according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Oct 2, 2014).
Conclusion: The summary of bench tests and software verification and validation showed that the ARGOS was substantially equivalent to the predicate ARGOS devices -Information was submitted to demonstrate that there are no significant differences in technological characteristics between the proposed ARGOS and the predicate ARGOS devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 16, 2019
Santec Corporation % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, NJ 07059
Re: K191051
Trade/Device Name: Argos Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: April 17, 2019 Received: April 19, 2019
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K191051
Device Name ARGOS (ARGOS ver1.5)
Indications for Use (Describe)
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
The information contained in this premarket notification 510(k) summary is submitted as required by 21 CFR 807.92:
1. Type of Submission
510k Traditional submission for New Devices
2. Applicant Company:
SANTEC CORPORATION 5823 Ohkusa-Nenjozaka, Komaki, Aichi 485-0802, JAPAN Phone: 81 (0568) 79 3535 www.santec.com
3. Applicant (Contact Person) Name:
Changho Chong
4. Date Summary Prepared:
May 15, 2019
5. Device Trade / Proprietary Name (Model name):
ARGOS (ARGOS ver1.5)
6. Common Name:
Optical Biometer
7. Regulation
Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Bio-Microscope Regulatory Class: Class II Product Code: MXK
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8. Indications for Use:
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K - values (Radii of flattest and steepest meridians). Astigmatism. White-to-white (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
The indications for use are similar between the proposed and predicate ARGOS devices. The proposed ARGOS device has additional reference image functionality as minor difference.
9. Device Descriptive
The ARGOS is substantially equivalent to the predicate device identified previously:
- the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics
- the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission.
The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700).
The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are:
- An additional feature of reference image capture function ●
- Labeling change including change in the intended use adding the feature of reference . image capture.
- . This image can be transferred to image guided devices in order to support the execution of preoperative plan.
5
The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.
| Compliant standard | Description | Classification |
|---|---|---|
| ANSI/AAMI ES 60601-1 | Electrical safety | Class 1 Type B |
| IEC 60601-1-2 | Electrical safety | Refer to Appendix 4 |
| IEC 60529 | Housing protection | IP20 |
| ANSI.Z80-36 | Ophthalmics - Light Hazard | |
| Protection For Ophthalmic | ||
| Instruments | Group 2 | |
| IEC 62471 | LED light hazard | Exempt group |
| IEC 60825-1 | Laser product safety | Laser Class 1 |
| ISO 10343 | Ophthalmometer |
10. Guidance on the Recognition and Use of Consensus Standards:
ARGOS complies with the requirements of listed FDA Recognized Consensus Standards
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11. Substantial equivalence to the predicate device
11.1 Comparisons of technological characteristics with Predicate ARGOS devices
| Table of Comparison between the ARGOS and the Predicate Device | |||||
|---|---|---|---|---|---|
| New Device (Subjective device) | Primary Predicate Device | Secondary Predicate device | Comparison | ||
| Manufacturer | santec corporation | santec corporation | Zeiss Meditech | - | |
| Model | ARGOS ver1.5 | ARGOS | IOLMaster 700 | - | |
| 510(k) number | K150754 | K143275, K170171 | - | ||
| Class | II | II | II | Same | |
| Classification | |||||
| panel | Ophthalmic device panel | Ophthalmic device panel | Ophthalmic device panel | Same | |
| Product code | MXK | MXK | HJO | Same | |
| Classification | |||||
| number | AC-Powered Slitlamp Bio- | ||||
| Microscope | Device, Analysis, Anterior | ||||
| Segment | AC-Powered Slitlamp Bio- | ||||
| Microscope | Same | ||||
| Type | Optical biometer | Optical biometer | Biometer | Same | |
| Intended Use | ARGOS is a non-invasive, non-contact | ||||
| biometer based on swept-source | |||||
| optical coherence tomography (SS- | |||||
| OCT). The device is intended to | |||||
| acquire ocular measurements as well | |||||
| as perform calculations to determine | |||||
| the appropriate intraocular lens (IOL) | |||||
| power and type for implantation during | |||||
| intraocular lens placement. ARGOS | |||||
| measures the following 9 parameters: | |||||
| Axial Length, Corneal Thickness, | |||||
| Anterior Chamber Depth, Lens | |||||
| Thickness, K-values (Radii of flattest | |||||
| and steepest meridians), Astigmatism, | |||||
| White-to-white (corneal diameter) and | |||||
| Pupil Size. The Reference Image | |||||
| functionality is intended for use as a | |||||
| preoperative and postoperative image | |||||
| capture tool. | |||||
| It is intended for use by | |||||
| ophthalmologists, physicians, and | |||||
| other eye-care professionals and may | |||||
| only be used under the supervision of | |||||
| a physician. | ARGOS is a non-invasive, non- | ||||
| contact biometer based on swept- | |||||
| source optical coherence | |||||
| tomography (SS-OCT). The device | |||||
| is intended to acquire ocular | |||||
| measurements as well as perform | |||||
| calculations to determine the | |||||
| appropriate intraocular lens (IOL) | |||||
| power and type for implantation | |||||
| during intraocular lens placement. | |||||
| ARGOS measures the following 9 | |||||
| parameters: Axial Length, Corneal | |||||
| Thickness, Anterior Chamber | |||||
| Depth, Lens Thickness, K-values | |||||
| (Radii of flattest and steepest | |||||
| meridians), Astigmatism, White-to- | |||||
| white (corneal diameter) and Pupil | |||||
| Size. | |||||
| lt is intended for use by | |||||
| ophthalmologists, physicians, and | |||||
| other eye-care professionals and may | |||||
| only be used under the | |||||
| supervision of a physician. | The indications for use are identical | ||||
| between the subject and predicate | |||||
| IOLMaster 700 devices. | |||||
| The IOLMaster 700 is intended for | |||||
| biometric measurements and | |||||
| visualization of ocular structures. The | |||||
| measurements and visualization assist | |||||
| in the determination of the appropriate | |||||
| power and type of intraocular lens. | |||||
| The IOLMaster 700 measures: | |||||
| • Lens thickness | |||||
| • Corneal curvature and thickness | |||||
| • Axial length | |||||
| • Anterior chamber depth | |||||
| • Pupil diameter | |||||
| • White-to-white distance (WTW) | |||||
| For visualization, the IOLMaster 700 | |||||
| employs optical coherence | |||||
| tomography (OCT) to obtain two- | |||||
| dimensional images of ocular | |||||
| structures of the anterior and posterior | |||||
| segments of the eye. | |||||
| The Reference Image functionality is | |||||
| intended for use as a preoperative and | |||||
| postoperative image capture tool. | Similar to Primary, | ||||
| additional feature | |||||
| identical to | |||||
| secondary | |||||
| predicate | |||||
| Measured | |||||
| parameters | Axial Length, Corneal Thickness, | ||||
| Anterior Chamber Depth, Lens | |||||
| Thickness, K-values (Radii of | |||||
| flattest and steepest meridians), | |||||
| Astigmatism (Toric Angle), White- | |||||
| to-white (corneal diameter), and | |||||
| Pupil Size. | Axial Length, Corneal | ||||
| Thickness, Anterior Chamber | |||||
| Depth, Lens Thickness, K- | |||||
| values (Radii of flattest and | |||||
| steepest meridians), | |||||
| Astigmatism (Toric Angle), | |||||
| White-to-white (corneal | |||||
| diameter), and Pupil Size. | Lens thickness, Corneal | ||||
| curvature and thickness, Axial | |||||
| length, Anterior chamber | |||||
| depth, Pupil diameter, White-to- | |||||
| white distance (WTW) | Same parameters | ||||
| In-vivo | |||||
| repeatability | Axial length: range 14-38mm, SD | ||||
| 0.01mm | Axial length: range 14-38mm, | ||||
| SD 0.01mm | Axial length: range 14-38mm, | ||||
| SD 0.005mm | Same between | ||||
| subjective and | |||||
| primary, Similar | |||||
| between subjective | |||||
| and secondary | |||||
| predicate | |||||
| Corneal thickness: range 200- | |||||
| 120um, SD 10um | Corneal thickness: range 200- | ||||
| 120um, SD 10um | Corneal thickness: range 200- | ||||
| 120um, SD 2.5um | |||||
| Anterior Chamber Depth: range | |||||
| 0.7-8.0mm SD 0.01mm | Anterior Chamber Depth: | ||||
| range 0.7-8.0mm SD 0.01mm | Anterior Chamber Depth: range | ||||
| 0.7-8mm SD 0.007mm | |||||
| Lens Thickness: range 0.5- | |||||
| 10.0mm SD 0.02mm | Lens Thickness: range 0.5- | ||||
| 10.0mm SD 0.02mm | Lens Thickness: range 1-10.0mm | ||||
| SD 0.006mm | |||||
| Keratometry: range 5.5-10.0mm | |||||
| SD 0.02mm | Keratometry: range 5.5- | ||||
| 10.0mm SD 0.02mm | Keratometry: range 5-11.0mm SD | ||||
| 0.09D(~0.02mm) | |||||
| Astigmatism: range 0-180deg, SD | |||||
| 5deg (Cylinder>1D) | Astigmatism: range 0-180deg, | ||||
| SD 5deg (Cylinder>1D) | Astigmatism: range 0-180deg, SD | ||||
| 3.8deg (Cylinder>0.75D) | |||||
| Pupil size: range 2-13mm SD | |||||
| 0.09mm | Pupil size: range 2-13mm SD | ||||
| 0.09mm | Pupil size: (no specification | ||||
| available) | |||||
| White-to-White: range 7-15mm | |||||
| SD 0.06mm | White-to-White: range 7-15mm | ||||
| SD 0.06mm | White-to-White: range 8-16mm | ||||
| SD 0.044mm | |||||
| Method for | |||||
| biometry | Interferometry (SS-OCT) | Interferometry (SS-OCT) | Interferometry (SS-OCT) | Same | |
| Method for | |||||
| keratometry | Video keratometry (16 LED) | Video keratometry (16 LED) | Video keratometry (IR LED) | Same | |
| Optical | |||||
| radiation | |||||
| Type of light | |||||
| source | Wavelength swept laser (3kHz | ||||
| swept rate) | |||||
| Wavelength 1060nm | |||||
| Power |