(27 days)
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.
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.
The provided document describes the ARGOS device, a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT), and its 510(k) submission for clearance. The document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the ARGOS ver1.5 which includes a new "Reference Image functionality."
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in terms of specific quantitative thresholds that the new ARGOS ver1.5 needs to meet for its added functionality. Instead, it argues for substantial equivalence primarily by:
- Comparing technological characteristics of the new ARGOS (ver1.5) with its primary predicate (ARGOS K150754) and a secondary predicate (IOLMaster 700 K143275, K170171).
- Stating that the new feature (reference image capture) is similar to a feature already present in a legally marketed predicate (IOLMaster 700).
- Referring to compliance with recognized consensus standards for performance and safety.
- Highlighting that the core biometry measurement capabilities did not change from the primary predicate. The in-vivo repeatability specifications for measured parameters (Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, Keratometry, Astigmatism, Pupil Size, White-to-White) are listed as identical to the primary predicate, implying these performance metrics were already accepted.
Implied Acceptance Criteria and Reported Performance (from comparison tables):
| Parameter / Characteristic | Acceptance Criteria (Implied - by being equivalent to Predicate ARGOS) | Reported Device Performance (ARGOS ver1.5) |
|---|---|---|
| Biometry Measurements | Identical to Predicate ARGOS (K150754) | Identical to Predicate ARGOS (K150754) |
| Axial Length Repeatability | SD 0.01mm (range 14-38mm) | SD 0.01mm (range 14-38mm) |
| Corneal Thickness Repeatability | SD 10um (range 200-120um) | SD 10um (range 200-120um) |
| Anterior Chamber Depth Repeatability | SD 0.01mm (range 0.7-8.0mm) | SD 0.01mm (range 0.7-8.0mm) |
| Lens Thickness Repeatability | SD 0.02mm (range 0.5-10.0mm) | SD 0.02mm (range 0.5-10.0mm) |
| Keratometry Repeatability | SD 0.02mm (range 5.5-10.0mm) | SD 0.02mm (range 5.5-10.0mm) |
| Astigmatism Repeatability | SD 5deg (Cylinder>1D) (range 0-180deg) | SD 5deg (Cylinder>1D) (range 0-180deg) |
| Pupil Size Repeatability | SD 0.09mm (range 2-13mm) | SD 0.09mm (range 2-13mm) |
| White-to-White Repeatability | SD 0.06mm (range 7-15mm) | SD 0.06mm (range 7-15mm) |
| Reference Image Functionality | Similar to IOLMaster 700 predicate | Implemented using white LED illumination |
| Electrical Safety | Compliance with ANSI/AAMI ES 60601-1, IEC 60601-1-2 | Compliant |
| Housing Protection | Compliance with IEC 60529 (IP20) | Compliant (IP20) |
| Light Hazard | Compliance with ANSI.Z80-36 (Group 2), IEC 62471 (Exempt group) | Compliant (Group 2 for SS-OCT, Exempt for LED illumination) |
| Laser Product Safety | Compliance with IEC 60825-1 (Laser Class 1) | Compliant (Laser Class 1) |
| Ophthalmometer Accuracy | Compliance with ISO 10343 | Compliant |
| Hardware Performance | Meet requirements for axial/lateral dist., SNR, depth attenuation | Met |
| Software Evaluation | Compliance with FDA guidance, IEC 62366, ISO 14971, cybersecurity guidance | Verified and Validated |
| Usability | Comparable to predicate Argos | Evaluated and found comparable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any clinical test set in terms of patient data. It primarily relies on bench testing and software verification/validation. The comparison of in-vivo repeatability values references the existing performance of the predicate device, not new clinical data for the ARGOS ver1.5 to prove equivalent clinical performance.
- Sample Size for Test Set: Not explicitly stated for patient data. The "Performance Testing" section refers to "bench tests" and "software verification and validation," which typically involve internal testing and simulations rather than patient samples for the new features. The existing in-vivo repeatability data cited appears to be from the primary predicate, not new testing on the modified device regarding its core measurement functions.
- Data Provenance: The document does not provide details on the country of origin of data or whether it was retrospective or prospective. Given the focus on substantial equivalence through design and testing against standards rather than new clinical trials for the added feature, such details are not expected to be prominent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. The document does not describe a clinical study involving human readers or expert-established ground truth for a test set, especially pertaining to the new "Reference Image functionality." The changes are assessed through engineering and software validation, and comparison to existing, already-cleared devices.
4. Adjudication Method for the Test Set
N/A. No clinical study with human readers and adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
N/A. No MRMC study is described. The device is not an AI/CADe device that assists human readers in diagnosis. It's a measurement device with an added image capture utility.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone measurement instrument. Its "performance" is its ability to accurately measure ocular parameters and capture images. The "Performance Testing" section (12.1 and 12.2) effectively describes this standalone performance evaluation, focusing on:
- Bench tests: ISO standards, hardware specifications (axial/lateral distance, SNR, depth attenuation).
- Software verification and validation: According to FDA guidance and ISO standards.
- Cybersecurity review.
These tests demonstrate the device's capability to function as intended without human intervention for the measurement process itself, or for the image capture function. The usability evaluation ensures the human-device interaction is acceptable.
7. The Type of Ground Truth Used
- For biometric measurements: The "ground truth" for proving performance (cited from the predicate) would typically be established based on highly accurate reference devices or physical models, although the document doesn't detail the predicate's original ground truth methodology. For the new device, the claim is that its measurement capabilities have not changed and are thus equivalent to the predicate.
- For reference image functionality: The ground truth for this new feature would be its ability to capture and transfer an image. This is validated by functional testing and comparison to the secondary predicate (IOLMaster 700), which already has this function. There isn't a "ground truth" in the clinical diagnostic sense for an image capture tool beyond its intended function of capturing an image.
- For safety and performance standards: The "ground truth" is compliance with the specifications and limits defined by the international and national consensus standards (e.g., ISO, IEC, ANSI/AAMI).
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device that requires a training set in the typical sense of machine learning. It's a measurement instrument. The "Vision Planner software package" and "Argos UI software" are traditional software applications that undergo verification and validation, not model training.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set is involved.
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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.
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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 HazardProtection For OphthalmicInstruments | 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 | |
| Classificationpanel | Ophthalmic device panel | Ophthalmic device panel | Ophthalmic device panel | Same | |
| Product code | MXK | MXK | HJO | Same | |
| Classificationnumber | AC-Powered Slitlamp Bio-Microscope | Device, Analysis, AnteriorSegment | AC-Powered Slitlamp Bio-Microscope | Same | |
| Type | Optical biometer | Optical biometer | Biometer | Same | |
| Intended Use | ARGOS is a non-invasive, non-contactbiometer based on swept-sourceoptical coherence tomography (SS-OCT). The device is intended toacquire ocular measurements as wellas perform calculations to determinethe appropriate intraocular lens (IOL)power and type for implantation duringintraocular lens placement. ARGOSmeasures the following 9 parameters:Axial Length, Corneal Thickness,Anterior Chamber Depth, LensThickness, K-values (Radii of flattestand steepest meridians), Astigmatism,White-to-white (corneal diameter) andPupil Size. The Reference Imagefunctionality is intended for use as apreoperative and postoperative imagecapture tool.It is intended for use byophthalmologists, physicians, andother eye-care professionals and mayonly be used under the supervision ofa physician. | ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography (SS-OCT). The deviceis intended to acquire ocularmeasurements as well as performcalculations to determine theappropriate intraocular lens (IOL)power and type for implantationduring intraocular lens placement.ARGOS measures the following 9parameters: Axial Length, CornealThickness, Anterior ChamberDepth, Lens Thickness, K-values(Radii of flattest and steepestmeridians), Astigmatism, White-to-white (corneal diameter) and PupilSize.lt is intended for use byophthalmologists, physicians, andother eye-care professionals and mayonly be used under thesupervision of a physician. | The indications for use are identicalbetween the subject and predicateIOLMaster 700 devices.The IOLMaster 700 is intended forbiometric measurements andvisualization of ocular structures. Themeasurements and visualization assistin the determination of the appropriatepower 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 700employs optical coherencetomography (OCT) to obtain two-dimensional images of ocularstructures of the anterior and posteriorsegments of the eye.The Reference Image functionality isintended for use as a preoperative andpostoperative image capture tool. | Similar to Primary,additional featureidentical tosecondarypredicate | |
| Measuredparameters | Axial Length, Corneal Thickness,Anterior Chamber Depth, LensThickness, K-values (Radii offlattest and steepest meridians),Astigmatism (Toric Angle), White-to-white (corneal diameter), andPupil Size. | Axial Length, CornealThickness, Anterior ChamberDepth, Lens Thickness, K-values (Radii of flattest andsteepest meridians),Astigmatism (Toric Angle),White-to-white (cornealdiameter), and Pupil Size. | Lens thickness, Cornealcurvature and thickness, Axiallength, Anterior chamberdepth, Pupil diameter, White-to-white distance (WTW) | Same parameters | |
| In-vivorepeatability | Axial length: range 14-38mm, SD0.01mm | Axial length: range 14-38mm,SD 0.01mm | Axial length: range 14-38mm,SD 0.005mm | Same betweensubjective andprimary, Similarbetween subjectiveand secondarypredicate | |
| 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: range0.7-8.0mm SD 0.01mm | Anterior Chamber Depth:range 0.7-8.0mm SD 0.01mm | Anterior Chamber Depth: range0.7-8mm 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 1-10.0mmSD 0.006mm | |||
| Keratometry: range 5.5-10.0mmSD 0.02mm | Keratometry: range 5.5-10.0mm SD 0.02mm | Keratometry: range 5-11.0mm SD0.09D(~0.02mm) | |||
| Astigmatism: range 0-180deg, SD5deg (Cylinder>1D) | Astigmatism: range 0-180deg,SD 5deg (Cylinder>1D) | Astigmatism: range 0-180deg, SD3.8deg (Cylinder>0.75D) | |||
| Pupil size: range 2-13mm SD0.09mm | Pupil size: range 2-13mm SD0.09mm | Pupil size: (no specificationavailable) | |||
| White-to-White: range 7-15mmSD 0.06mm | White-to-White: range 7-15mmSD 0.06mm | White-to-White: range 8-16mmSD 0.044mm | |||
| Method forbiometry | Interferometry (SS-OCT) | Interferometry (SS-OCT) | Interferometry (SS-OCT) | Same | |
| Method forkeratometry | Video keratometry (16 LED) | Video keratometry (16 LED) | Video keratometry (IR LED) | Same | |
| Opticalradiation | |||||
| Type of lightsource | Wavelength swept laser (3kHzswept rate)Wavelength 1060nmPower <0.72mW (<0.1mWaverage at 1mm aperture duringB-scan) | Wavelength swept laser (3kHzswept rate)Wavelength 1060nmPower <0.72mW (<0.1mWaverage at 1mm apertureduring B-scan) | Wavelength swept laser (2kHzswept rate)Wavelength 1055nmunavailable | Same | |
| Laser class | Class 1 (IEC 60825)ANSI-Z80.36-2016 Group2 | Class 1 (IEC 60825)ISO15004-2 Group2 | Class 1 (IEC 60825)ISO15004-2 Group2 | Same(ANSI.Z80-36 isequivalent toISO15004-2) | |
| Keratometry | Light source: IR-LEDWavelength: 850nmdelivered power <0.02mW | Light source: IR-LEDWavelength: 850nmdelivered power <0.02mW | Light source: IR-LEDWavelength: 950nm | Same betweenPrimary andsubjective | |
| Illumination | The above (IR-LED)White LED for reference image | The above (IR-LED) | The above (IR-LED)Green LED(590nm) for referenceimage | Different | |
| Fixation light | Red(630nm) delivered power<10nW | Green LED (530nm) deliveredpower <10nW | Red(660nm) delivered power | Different | |
| Compliantstandards | ANSI/AAMI ES 60601-1ANSI.Z80-36, ISO62471,ISO60825, ISO 10343, IP20 | ANSI/AAMI ES 60601-1,ISO15004-2, ISO62471,ISO60825, ISO 10343, IP20 | ANSI/AAMI ES 60601-1,ISO15004-2, ISO60825 | Same | |
| Power supply | Input: 100-240V, 50/60Hz IANSI/AAMI ES 60601 compliantSecondary side: 24V | Input: 100-240V, 50/60HzANSI/AAMI ES 60601compliant Secondary side: 24V | Input: 100-240V, 50/60HzANSI/AAMI ES 60601 compliantSecondary side: 24V | Same | |
| Accessories | Calibration tool/ Dust cover | Calibration tool/ Dust cover | ---- | Same |
Table of Comparison between the ARGOS and the Predicate Device
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11.2 Summary of Differences
| 11.2 Summary of Differences | |||
|---|---|---|---|
| ModelIntended use | Proposed ARGOS | Predicate ARGOS | Secondary(IOLMaster700) |
| The Reference Imagefunctionality is intended for useas a preoperative andpostoperative image capture tool. | Camera image waspresent for alignmentpurpose but not forcapture. | The Reference Image functionalityis intended for use as apreoperative and postoperativeimage capture tool. | |
| Light source forillumination | LED 16 @ 850nmLED 8 @ white light | LED 16 @ 850nm | IR LEDs@ 950nmGreen LEDs @590nm |
| Fixation LED | LED @ 630nm | LED @ 530nm | LED @ 660nm |
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| Software difference between Proposed Arqos 1.5 and Predicate Argos | |
|---|---|
| -- | -------------------------------------------------------------------- |
| Model | Proposed ARGOS | Predicate ARGOS | Note |
|---|---|---|---|
| Softwarecomponents | Vision Planner softwarepackageArgos UI software | Argos UI software | Different |
| Interface UI | Patient planning(patientinformation entry, summary,IOL power calculation/setting)Constant optimization | Patient information entrySummaryIOL power calculation/settingConstant optimization | Similar |
| Measurement with referenceimage capture | Measurement | Different | |
| Analysis | Analysis | Same | |
| Connection toexternal device | Connectivity to Veriondevices, ORA system | n.a. | Different |
Analysis of Why These Differences Do Not Affect Safety or Effectiveness or Raise Different Questions of Safety or Effectiveness
| Differences | Analysis |
|---|---|
| Intended use adding Reference imagecapture | The Reference Image functionality is intended for use as apreoperative and postoperative image capture tool. This image isused for optional guidance for planning subsequent surgicalplanning, but no association to biometer measurement itself.Subjective quality check is done by the user and the user can repeatthe capture.Secondary predicate (IOLMaster700, K143275) has the samedescription of functionality in the intended use. |
| LED 8 @ white LED for the above referenceimage capture | For power level, duration of white flash illumination for the abovementioned reference image capture is very short (<0.25sec) andexposure is well below permissible exposure limits set by thestandards and all compliant with IEC60825, ANSI.Z80.36.Testing based on ANSI Z80.36 demonstrated that the ARGOSnear-infrared radiation from a swept source is below all of theapplicable exposure limits-including the guidelines for the Group1 ophthalmic instrument for normal use and Group 2 only forsingle fault case.This capture is done successively after biometry/keratometrymeasurement and has no effect on the measurement itself. |
| Fixation LED @630nm | Very low power, parts identified as exempt from ISO 62471. It isassured that the power level is within ANSI.Z80-36 criteria. |
| Software module | Vision Planner software package acts as interface for the proposedArgos ver1.5 but contains common functionalities (Patientinformation entry, IOL power calculation/setting, constantoptimization) found in Predicated Argos. Software integration withVision Planner software package and Argos software was validatedand its usability including reference image capture was evaluated. Itwas found to achieve comparable usability to predicate Argos.(Section 22 Performance Testing-Bench, Appendix 13 Usabilityevaluation report), Additional connectivity to external device isvalidated in system level test. (Appendix 12. Software Documents forVision Planner) |
11.3 Substantial Equivalence Conclusion
Comparisons and analysis of technological characteristics of the proposed ARGOS with Predicate ARGOS devices were performed and found to be substantially equivalent.
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12. Performance Testing
12.1 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.
12.2 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.
12.3 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).
12.4 Conclusion drawn from Performance Testing and Software verification and validation 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.
13. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, Santec Corporation concludes that the ARGOS is safe and effective, and substantially equivalent to predicate devices as described herein.
END OF SUMMARY
§ 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.