(150 days)
RESCAN 700 provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eve 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 the 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.
RESCAN 700 brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes (e.g. ARTEVO 800). Used in conjunction with the 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 surgical microscopes 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
This document is a 510(k) summary for the RESCAN 700 (SW 3.0), a medical device used for ophthalmic imaging. It outlines the reasons for the 510(k) submission, primarily focusing on minor software and component changes, and argues for its substantial equivalence to a previously cleared predicate device (RESCAN 700 Software Version 2.0).
Based on the provided text, the device in question (RESCAN 700 SW 3.0) is an imaging device that captures OCT (Optical Coherence Tomography) and biomicroscopic images of the eye. It is not an AI/ML-driven diagnostic device that would have acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers improving with AI assistance.
The 510(k) submission is for a software and minor component update to an already cleared device, arguing for substantial equivalence. Therefore, the "acceptance criteria" discussed in this document are primarily related to software verification and validation, electrical safety, and electromagnetic compatibility (EMC), ensuring that the updated device remains safe and effective with its existing intended use. It is not a de novo submission for a novel AI/ML algorithm.
Given this context, I will address your prompt based on the information available within the document, explaining why some of your requested points are not applicable to this type of regulatory submission and focusing on the relevant criteria and studies mentioned.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for RESCAN 700 (SW 3.0)
Context: The RESCAN 700 (SW 3.0) is an updated version of an already cleared ophthalmic imaging device. The 510(k) submission primarily addresses minor software changes and component updates. This is a substantial equivalence claim, not a new AI/ML diagnostic or assistive device that would typically involve comparative effectiveness studies with human readers or complex ground truth establishment for novel algorithms. The "acceptance criteria" here refer to regulatory and engineering standards rather than clinical diagnostic performance metrics for an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Study Outcome |
|---|---|---|
| Software Integrity | Compliance with IEC 62304:2006+AC:2008 + AC:2015 Medical device software life cycle processes. | Testing Passed |
| Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (June 2023). | Testing Passed | |
| Software Validation | Validation conducted according to IEC 62366. | Testing Passed |
| Cybersecurity | Followed recommendations in "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 27, 2023)." | Not explicitly "passed," but compliance with guidance followed. |
| Electrical Safety | Compliance with IEC 60601-1-2 standards. | Testing Passed |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2 standards. | Testing Passed |
| Substantial Equivalence | Device maintains identical Indications for Use and comparable technical characteristics to predicate device. | Deemed Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) summary. The document describes a software and hardware update for an imaging device, not a diagnostic AI/ML algorithm requiring a clinical test set of patient data with a specific sample size for performance evaluation (e.g., sensitivity, specificity). The "testing" referred to is primarily engineering verification and validation (V&V) of the software and hardware changes (e.g., unit testing, integration testing, system testing, safety testing), not clinical performance testing on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. As explained in point 2, this submission is for an updated imaging device, not a new AI/ML diagnostic algorithm that would require expert-established ground truth for its performance evaluation on a clinical test set. The validation focuses on engineering and regulatory compliance.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as points 2 and 3. There is no mention of "adjudication" in the context of a clinical test set for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The RESCAN 700 is an imaging device, providing high-resolution OCT and biomicroscopic images. It is used for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of ocular structures. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images. The document explicitly states that the "assistance system (CALLISTO eye)" provides "non-diagnostic video documentation and image capture."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The RESCAN 700 is an imaging system, not a standalone AI algorithm. Its function is to acquire images, not to provide automated diagnostic interpretations that would be evaluated for standalone performance.
7. The Type of Ground Truth Used
For software verification and validation, the "ground truth" implicitly used would be the functional and performance specifications of the software and hardware. For electrical safety and EMC, the "ground truth" is adherence to international consensus standards (IEC 60601-1-2). There is no patient-data derived "ground truth" (like expert consensus, pathology, or outcomes data) mentioned for the purpose of demonstrating the device's acceptable performance, as this is related to a software update for an imaging system, not a diagnostic AI.
8. The Sample Size for the Training Set
This is not applicable. The RESCAN 700 (SW 3.0) is not an AI/ML algorithm that requires a "training set" of data in the sense of machine learning model development. The software updates are described as "minor software changes" and "changes to components and parts," indicating traditional software development, testing, and hardware modifications, not the training of a learning algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no mention of a "training set" for an AI/ML algorithm. The "ground truth" for the device's functionality and safety would be established through engineering design specifications, adherence to quality system regulations, and compliance with relevant international standards.
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March 8, 2024
Carl Zeiss Meditec AG % Aditya Rao Regulatory Affairs Specialist - USA Carl Zeiss Meditec, Inc 5300 Central Parkway Dublin, California 94568
Re: K233421
Trade/Device Name: Rescan 700 (SW 3.0) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: January 29, 2024 Received: January 30, 2024
Dear Aditya Rao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
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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)
Device Name
RESCAN 700 (SW 3.0)
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 eve 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 the 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)
△ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92 the 510(k) Summary for the RESCAN 700 is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 JenaGermany |
|---|---|
| Applicant Contact | Dr. Katrin FaberHead of RA/CA SPS+49 7364 20 1606 Phone E-mail: katrin.faber@zeiss.com |
| Primary Correspondent | Aditya RaoRegulatory Affairs Specialist - USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 549-9579 Phone (925) 557-4259 FaxE-mail: aditya.rao@zeiss.com (preferred) |
| Date Prepared: | March 08, 2024 |
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Page 2 of 8
RESCAN 700 (SW 3.0) Device Trade Name: 510(k) Number: K233421 21CFR886.1570 Tomography, Optical coherence Classification: Regulatory Class: Ⅱ OBO Product Code:
3. PREDICATE DEVICE
Predicate Device: RESCAN 700 (Software Version 2.0) 510(k) number K180229 Classification: 21CFR886.1570 Tomography, Optical coherence Regulatory Class: II Product Code: OBO
4. DEVICE DESCRIPTION
RESCAN 700 brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes (e.g. ARTEVO 800). Used in conjunction with the 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 surgical microscopes 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
INDICATIONS FOR USE ડ.
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 threedimensional 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 the 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.
This device is for Prescription Use (Rx) only.
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SUBSTANTIAL EQUIVALENCE 6.
Primary Predicate 6.1.
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| Subject Device (K233421) | Predicate Device (K180229) | EquivalencyAnalysis |
|---|---|---|
| RESCAN 700 provides non-contact, high resolution, opticalcoherence tomographic (OCT) andbiomicroscopic imaging of theanterior and posterior segment ofthe eye via an ophthalmic surgicalmicroscope. The RESCAN 700 isindicated for in vivo viewing, axialcross sectional, and three-dimensional imaging of posteriorocular structures, including retina,macula, and optic disc, as well asimaging of anterior ocularstructures, including the cornea,lens and anterior chamber angle. | RESCAN 700 provides non-contact, high resolution, opticalcoherence tomographic (OCT) andbiomicroscopic imaging of theanterior and posterior segment ofthe eye via an ophthalmic surgicalmicroscope. The RESCAN 700 isindicated for in vivo viewing, axialcross sectional, and three-dimensional imaging of posteriorocular structures, including retina,macula, and optic disc, as well asimaging of anterior ocularstructures, including the cornea,lens and anterior chamber angle. | Identical |
| RESCAN 700 uses the assistancesystem (CALLISTO eye) that providesnon-diagnostic video documentationand image capture for ophthalmicsurgeries. The assistance system allowsthe remote control of RESCAN 700 | RESCAN 700 uses the assistancesystem (CALLISTO eye) that providesnon-diagnostic video documentationand image capture for ophthalmicsurgeries. The assistance system allowsthe remote control of RESCAN 700 |
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
| Attribute | Subject Device(K422421) | Primary PredicateDevice (K180229) | EquivalencyAnalysis |
|---|---|---|---|
| Device name | RESCAN 700 (SW 3.0) | RESCAN 700 (SW2.0) | N/A |
| Software Version | 3.0 | 2.0 | N/A |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| 510(k) | TBD | K180229 | N/A |
| Classification ProductCode | OBO | OBO | Identical |
| Regulation # | 21CFR886.1570 | 21CFR886.1570 | Identical |
| Tomography, OpticalCoherence | Tomography, OpticalCoherence | ||
| Review Panel | Ophthalmic | Ophthalmic | Identical |
| Patient Contact | No | No | Identical |
| OCT methodology | Spectral Domain OCT | Spectral Domain OCT | Identical |
| 510(k) SummaryAttribute | Subject Device(K422421) | Primary PredicateDevice (K180229) | PageEquivalencyAnalysis |
| Optical source | Super LuminescentDiode (SLD) | Super LuminescentDiode (SLD) | Identical |
| Wavelength | 840 nm | 840 nm | Identical |
| Bandwith | 3 dB: 32 nm | 3 dB: 32 nm | Identical |
| Radiation power | < 4 mW | < 4 mW | Identical |
| Emission duration | > 16 min | > 16 min | Identical |
| Beam divergence | Colliminated beam | Colliminated beam | Identical |
| Optical power | 620 µW on cornea | 620 µW on cornea | Identical |
| OCT Scan Speed | 27,000 A-Scans persecond | 27,000 A-Scans persecond | Identical |
| OCT Scan Area | Scan area, after OCTtelescope,max. 38 x 36° x 38 x 36° | Scan area, after OCTtelescope,max. 38 x 36° x 38 x 36° | Identical |
| OCT Scan Dimensions(Posterior Segment) | 16 x16 mm (Cube scans)3 to 16 mm for line scans(in steps of 1 mm) | 16 x16 mm (Cube scans)3 to 16 mm for line scans(in steps of 1 mm) | Identical |
| A-Scan depth | 2.9 mm (in the tissue)5.8 mm (in the tissue) | 2.9 mm (in the tissue)5.8 mm (in the tissue) | Identical |
| Axial Resolution | 5.5 µm (in the tissue)at 2.9 mm scan depth11.0 µm (in the tissue)at 5.8mm scan depth | 5.5 µm (in the tissue)at 2.9 mm scan depth11.0 µm (in the tissue)at 5.8mm scan depth | Identical |
| Signal to noise ratio | >=26 dB | >=26 dB | Identical |
| Sensitivity noise level | <10 dB | <10 dB | Identical |
| Camera Resolution | 2048 pixel * 200microns | 2048 pixel * 20microns | EquivalentThe pixel width of200 micronscompared to 20microns does notimpact the axialresolution or signaquality |
| Traversal Resolution(OCT Scan) | 15 µm (in the tissue) | 15 µm (in the tissue) | Identical |
| Scan rotation | Adjustable 0 – 360° (stepwith 1°) | Adjustable 0 – 360° (stepwith 1°) | Identical |
| Scan Patterns(OCT Scan) | Single line, cross hair, 5-line scan, cube scan | Single line, cross hair, 5-line scan, cube scan | Identical |
| Scan Types | Live Capture | Live Capture | Identical forRESCAN 700 |
| 510(k) Summary | Page 5 of 8 | ||
| HD 1 Line HD 1 Line | HD 1 Line HD 1 Line | ||
| Abbreviation: | SD 1 Line SD 1 Line | SD 1 Line SD 1 Line | IFU reflects Scan |
| HD: High Definition | Mode that can be used | ||
| SD: Standard | HD 5 Line HD 5 Line | HD 5 Line HD 5 Line | within the whole |
| SD 5 Line SD 5 Line | SD 5 Line SD 5 Line | system | |
| HD 2 Line Cube Scan | HD 2 Line Cube Scan | ||
| SD 2 Line 200x200 | SD 2 Line 200x200 | ||
| Cube Scan | Cube Scan | ||
| 512x128 | 512x128 | ||
| (Note: The 2Line scan = | (Note: The 2Line scan = | ||
| Middle | Middle | ||
| Vertical &Middle | Vertical &Middle | ||
| HorizontalB-scans) | HorizontalB-scans) | ||
| Refresh rate | 5 Hz for each line in scantype | 5 Hz for each line in scantype | Identical |
| OCT focus | Adjustable independent | Adjustable independent | Identical |
| Attribute | Subject Device(K422421)of the microscope focus | Primary PredicateDevice (K180229)of the microscope focus | EquivalencyAnalysis |
| OCT Scan Pixels | 1024 axial, 200 - 4096transverse | 1024 axial, 200 - 4096transverse | Identical |
| Measurement of ocularstructures | No | No | Identical |
| NormativeDatabases | No | No | Identical |
| Configuration | OCT System (Box andOCT Scanning Unit)integrated into a surgicalMicroscope (e.g.ARTEVO 750/850).Connected toassistance system,CALLISTO eye,for display of images onmonitorand integratedtouchscreen with PC. | OCT System (Box andOCT Scanning Unit)integrated into a surgicalMicroscope (e.g.ARTEVO 800).Connected toassistance system,CALLISTO eye,for display of images onmonitorand integratedtouchscreen with PC. | Identical |
| SurgicalMicroscopes+Software | ARTEVO 750/850CALLISTO eye 5.0(K232944) | OPMI LUMERA 700 or Equivalent.ARTEVO 800CALLISTO eye 3.6(K180858)/ CALLISTO eye 3.7 (K231676) | (Connectivity to OPMILUMERA 700 /ARTEVO 800 andprevious CALLISTOeye versions is nolonger supportedin RESCAN700 SW3.0 |
| Materials - PatientsContacting | None | None | Identical |
| 510(k) Summary | Page 6 of 8 | ||
| Electrical Requirements | Supplied by surgicalmicroscope:(115): 100 - 125 VAC,50-60 Hz(230): 220 - 240 VAC,50-60HzPower consumption:Max. 1200 VA | Supplied by surgicalmicroscope:(115): 100 - 125 VAC,50-60 Hz(230): 220 - 240 VAC,50-60HzPower consumption:Max. 1200 VA | Identical |
| Electrical SafetyParameters | Enclosure Protection:IP20Protection Class: 1Device Type (IEC | Enclosure Protection:IP20Protection Class: 1Device Type (IEC60601-1): no applied part 60601-1): no applied part | Identical |
| Ambient conditions forstorage and transport | Temp. -20° to +60° CRelative Humidity 10%to 90% (withoutcondensation)Atmospheric Pressure500 to 1060 hPa | Temp. -20° to +60° CRelative Humidity 10%to 90% (withoutcondensation)Atmospheric Pressure500 to 1060 hPa | Identical |
| Ambient conditions foroperation | Temp. +10 °C to +40 °CRelative Humidity 30 %to 75 % (excludingcondensation)700 to 1060 hPaAltitude up to 3,000mabove sea level | Temp. +10 °C to +40 °CRelative Humidity 30 %to 75 % (excludingcondensation)700 to 1060 hPaAltitude up to 3,000mabove sea level | Identical forRESCAN 700.IFU reflects ambientconditions for thewhole system. |
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510(k) Summary
Page 7 of 8
The proposed product, RESCAN 700, will be used with CALLISTO eye, Software version 5.0 (K232944). The predicate device, RESCAN 700, was used with CALLISTO eye Software version 3.6 (K180858) & CALLISTO eye Software version 3.7 (K231676).
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SUMMARY OF STUDIES 7.
Non-Clinical Performance Testing
Software Verification and Validation Testing
Rescan 700 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. ZEISS has followed the recommendations in the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov) (https://www.fda.gov/media/119933/download) guidance document (September 27, 2023). RESCAN 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (June 2023). In addition, the software testing also followed the Carl Zeiss Meditec internal software development procedure that follows the IEC 62304:2006+AC:2008 + AC:2015 - Medical device software life cycle processes. Validation has been conducted according to IEC 62366. Testing passed.
Electromagnetic compatibility (EMC) and Electrical Safety Testing
Electrical safety and EMC testing were conducted in accordance with IEC 60601-1-2, IEC 60601-1-2 6 standards. Testing passed.
Animal/Clinical Performance Testing
Animal and Clinical testing was not conducted.
8. REASONS FOR 510(k)
The subject device qualifies as a class II medical device and is therefore subject to a premarket notification.
The main purpose of this 510(k) is to bring FDA up to date on non-significant changes implemented since the last 510(k) clearance for RESCAN 700 SW 2.0 (K180229).
In summary, the changes include:
- Minor Software changes
- Changes to components and parts on the RESCAN 700 due to obsolescence reason, cost issues and minor improvements
- . Minor changes to the instruction for use.
9. CONCLUSION
The indications for use are equivalent to the indications for use of the predicate device and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Testing methods are equivalent to those of the predicate device; and therefore, and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Therefore, the subject device meets the requirements for substantial equivalence.
§ 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.