(184 days)
OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
The OCT-Camera ID 21101A3 can connected via the camera port of surgical microscopes. The OCT-Camera ID 21101A3 is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. Individual steps of surgical procedures can be visualized in real time. The OCT-Camera ID 21101A3 by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera ID 21101A3, because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
The provided text describes a 510(k) submission for the OCT-Camera ID 21101A3, which is an ophthalmoscope using Spectral Domain Optical Coherence Tomography (SD-OCT). The submission aims to demonstrate substantial equivalence to a predicate device, the OCT-Camera (ID 21101A1).
The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study. The "acceptance criteria" presented are in the context of meeting internal and external regulatory standards, and the "study" referred to is a series of non-clinical performance and safety tests.
Therefore, many of the requested categories for a clinical study proving device performance are not applicable or cannot be extracted from this document, as it is a 510(k) summary for regulatory clearance based on substantial equivalence.
Here's the information that can be extracted and a breakdown of why some fields are not available:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical performance and safety tests that were passed, rather than clinical performance metrics. The acceptance criteria are "PASSED required testing" for each standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility evaluation per ISO 10993-1 | Demonstrated no direct patient-contacting materials (PASSED) |
| Electrical safety testing per ANSI/AAMI ES 60601-1 | PASSED required testing |
| Electromagnetic Compatibility per IEC 60601-1-2 | PASSED required testing |
| Laser Safety testing per IEC 60825-1 | PASSED required testing |
| Light Hazard Protection per ANSI Z80.36-2016 | PASSED required testing |
| Software V&V per IEC 62304/FDA Guidance, Moderate Concern | PASSED required testing (functional, system compatibility, risk analysis) |
| Usability engineering testing per IEC 62366-1 | PASSED required testing |
| Risk Management per EN ISO 14971 | All requirements met, risks reduced as far as possible |
The document also provides technological specifications as part of the comparison to the predicate, which can be seen as performance characteristics:
| Performance Characteristic | Subject Device (OCT-Camera ID 21101A3) | Predicate Device (OCT-Camera ID 21101A1) |
|---|---|---|
| Laser | 830 nm | 840 nm |
| Optical Power (OCT Light) | ≤1500 μW at cornea during OCT scan | ≤2350 μW at cornea during OCT scan |
| Resolution, Axial | ≤ 7.5 μm in tissue | ≤ 10 μm in tissue |
| Depth Range (in tissue) | 2.8 mm | 3.1 mm |
| Scan Rate | 35000 A-Scans/s | 15000 A-Scans/s |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document describes non-clinical engineering and safety tests, not a clinical study on a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. The document focuses on technical and safety compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No clinical test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not available. The device described is an imaging camera (OCT-Camera), not an AI-powered diagnostic algorithm designed to assist human readers, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-th e-loop performance) was done
This information is not available. The device is an imaging hardware system, not a standalone algorithm. Its function is to acquire, process, display, and save images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. As there is no clinical performance study on a test set mentioned, there is no discussion of ground truth for such a study. The "ground truth" in the context of this document is adherence to various engineering, safety, and regulatory standards.
8. The sample size for the training set
This information is not available. The device is a hardware imaging system, and while it includes software (iOCT-Control3), the document does not suggest the software involves machine learning or requires a "training set" in the AI sense. Software validation is mentioned on a functional level.
9. How the ground truth for the training set was established
This information is not available. As no training set for an AI algorithm is indicated, no ground truth for it would be established based on this document.
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September 2, 2020
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OptoMedical Technologies GmbH % Oliver Eikenberg Senior Consultant OA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K200516
Trade/Device Name: OCT-Camera ID 21101A3 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: July 27, 2020 Received: July 28, 2020
Dear Oliver Eikenberg:
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/cdrl/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 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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 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 OCT-Camera ID 21101A3
Indications for Use (Describe)
OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
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
OCT-Camera ID 21101A3
K200516
1. Submission Sponsor
OptoMedical Technologies GmbH
Maria-Goeppert-Strasse 9
23562 Luebeck, Germany
Phone: +49 451 160865 00
Contact: Julia Behrens, Quality and Regulatory Affairs Manager
E-mail: behrens@opmedt.com
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Oliver Eikenberg, PhD Title: Senior Consultant, Quality & Regulatory Affairs
3. Date Prepared
09/02/2020
4. Device Identification
Trade/Proprietary Name(s): OCT-Camera ID 21101A3 Common/Usual Name: intraoperative Optical Coherence Tomography (iOCT) Classification Name: Ophthalmoscope, AC-powered; Tomography, Optical Coherence Regulation number: 21 CFR 886.1570 Product Code: ОВО Device Class: Class II Classification Panel: Ophthalmic
Section 5
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5. Legally Marketed Predicate Device
K142953, OCT-Camera (ID21101A1), OptoMedical Technologies GmbH, GERMANY
6. Indication for Use Statement
OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT).
The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and neonatal infants, and is suitable for patients ambulatory or confined.
The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi - R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
7. Device Description
The OCT-Camera ID 21101A3 can connected via the camera port of surgical microscopes. The OCT-Camera ID 21101A3 is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. Individual steps of surgical procedures can be visualized in real time.
The OCT-Camera ID 21101A3 by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera ID 21101A3, because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
8. Substantial Equivalence Discussion
The following table compares the OCT-Camera ID 21101A3 to the predicate device OCT-Camera (ID 21101A1) with respect to indications for use, principles of operation, technological characteristics and performance specifications.
The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
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| Subject Device | Predicate Device (K142953) | Device Comparison | ||
|---|---|---|---|---|
| Manufacturer | OptoMedical Technologies GmbH (GERMANY) | |||
| Trade Name | OCT-Camera ID 21101A3 | OCT-Camera (ID 21101A1) | ||
| Product Code | OBO | Same | ||
| Regulation Number | 886.1570 | Same | ||
| Regulation Name | Ophthalmoscope | Same | ||
| Professional Use | Yes | Same | ||
| Indications for Use | OptoMedical TechnologiesOCT-Camera ID 21101A3 is intendedto acquire, process, display and savedepth-resolved images of oculartissue microstructure using SpectralDomain Optical CoherenceTomography (SD-OCT).The OCT-Camera ID 21101A3 isindicated for the use as an aid in thediagnosis of physiologic andpathologic conditions of the eyethrough non-contact optical imaging.Imaging of the various tissues of theeye is supported through the use ofinterchangeable lenses.It is indicated for use on all patientpopulations except premature andneonatal infants, and is suitable forpatients ambulatory or confined.The system is indicated for use insupine imaging, mounted to thesurgical microscope HS Hi-R NEO 900ANIR (Haag-Streit), and is suited forimaging patients under anesthesia. | OptoMedical TechnologiesOCT-Camera is intendedto acquire, process, display and savedepth-resolved images of oculartissue microstructure using SpectralDomain Optical CoherenceTomography (SD-OCT).The OCT-Camera is indicated for theuse as an aid in the diagnosis ofphysiologic and pathologicconditions of the eye through non-contact optical imaging. Imaging ofthe various tissues of the eye issupported through the use ofinterchangeable lenses.It is indicated for use on patientpopulations from premature andneonatal infants to adult, and issuitable for patients ambulatory orconfined. The system is indicated foruse in supine imaging, mounted to thesurgical microscope HS Hi-R NEO 900ANIR (Haag-Streit), and is suited forimaging patients under anesthesia. | SimilarExcluded target population of premature/neonatal infantsas risks for those patient groupswere not further evaluated for this target group. | |
| Method of Operation | Spectral domain optical coherence tomography (SD-OCT) | Same | ||
| Sterile | no | Same | ||
| Scanner Ergonomics | Mounted to camera port of the surgical microscope HS Hi-R NEO 900A NIR | Same | ||
| Patient Interface | none | Same | ||
| Single-Use | no | Same | ||
| Shelf Life | 10 years | Same | ||
| Battery Operated | no | Same | ||
| AC Powered | yes | Same | ||
| Light Hazard Protection | ANSI Z80.36-2016 | ANSI Z80.36-2016 | Same | |
| Electrical Safety Testing | IEC 60601-1, IEC 60601-1-2 | Same | ||
| Laser Product EquipmentClassification | OCT-Scanner and OCT-Camera equates to Laser Class 1 | Same | ||
| Subject Device | Predicate Device | Device Comparison | ||
| Manufacturer | OptoMedical Technologies GmbH (GERMANY) | |||
| Trade Name | OCT-Camera ID 21101A3 | OCT-Camera (ID 21101A1) | ||
| Technological characteristics | ||||
| Light Source | SLED | SLED | Same | |
| Light Source | Class 1 LED | Class 1 LED | Same | |
| Classification | ||||
| Laser | 830 nm | 840 nm | Similar | |
| Optical Power | ≤1500 μW | ≤2350 μW | Similar | |
| (OCT Light) | at cornea during OCT scan | at cornea during OCT scan | complies withUS-recognized | |
| ≤47 μW | standards IEC 60825-1 and | |||
| at cornea without scanning | ANSI Z80.36-2016. | |||
| Optical Power | N/A | <50 μW at cornea | Similar | |
| (Pilot Light) | ||||
| Resolution, | Retina: 10.6 to 74 μm in tissue, | Retina: 10.6 to 74 μm in tissue, | Same | |
| Lateral | dependent on magnification of | dependent on magnification of | ||
| microscope and its retina lens | microscope and its retina lens | |||
| Anterior Segment: 10.6 to 37 μm, | Anterior Segment: 10.6 to 37 μm, | |||
| dependent on magnification of | dependent on magnification of | |||
| microscope | microscope | |||
| Resolution, Axial | ≤ 7.5 μm in tissue | ≤ 10 μm in tissue | Similar | |
| Depth Range(in tissue/in air) | 2.8 / 3.8 mm | 3.1 / 4.2 mm | Similar | |
| Scanner Type | Galvanometric Mirror Pair | Galvanometric Mirror Pair | Same | |
| Scan Patterns | Line, rectangular volume,crossscan | Line, rectangular volume | Similar | |
| Scan Pixels | Axial (depth): 1024 | Axial (depth): 1024 | Similar | |
| Lateral: fixed to 1000 A-Scans/B-Scan | Lateral: fixed to 1000 A-Scans/B-Scan | |||
| Max. 100000 | Max. 30000 | |||
| total A-Scans/Volume-Scan | total A-Scans/Volume-Scan | |||
| Scan Rate | 35000 A-Scans/s | 15000 A-Scans/s | ||
| Detection | Transmission Grating, | Transmission Grating, | Same | |
| Spectrometer / Line Scan Camera | Spectrometer / Line Scan Camera | |||
| Footprint | (H x W x D) 6.5" x 15.8" x 13.4" | (H x W x D) 6.5" x 15.8" x 13.4" | Same | |
| ScannerDimensions | (H x W x D) 3.5" x 2.4" x 6.7" | (H x W x D) 3.5" x 2.4" x 6.7" | Same | |
| Software | iOCT-Control3 | iOCT-Control3 | Same | |
| Operating System | Win7 | Win XP | Similar | |
| Processor(frequency) /Memory (RAM) | 3.1 GHz Core i7 Quad Core16 GB | 2.66 GHz Dual Core4 GB | Similar |
Table 5A – Comparison of Characteristics between Subject Device and Predicate Device
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Table 5A – Comparison of Technological Characteristics between Subject Device and Predicate Device
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9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of OCT-Camera ID 21101A3 and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Optomedical Technologies GmbH completed a number of non-clinical performance tests. The OCT-Camera ID 21101A3 meets all the requirements for overall design, function, performance and electrical safety as well as biocompatibility and internal requirements (incoming control, final release testing) confirming that the design output meets the design inputs and specifications for the device and to support substantial equivalence of the subject device.
OptoMedical Technologies GmbH passed all the following testing for OCT-Camera ID 21101A3 in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility evaluation per ISO 10993-1demonstrate that there is no direct patientcontacting materials
- Electrical safety testing per ANSI/AAMI ES 60601-1, PASSED required testing .
- Electromagnetic Compatibility testing per IEC 60601-1-2, PASSED required testing
- . Laser Safety testing per IEC 60825-1, PASSED required testing
- . Light Hazard Protection Testing for Ophthalmic Instrument per ANSI Z80.36-2016, PASSED required testing
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304/FDA Guidance, PASSED required testing
- Usability engineering testing per IEC 62366-1, PASSED required testing .
- . Risk Management per EN ISO 14971; all requirements were met and risks reduced as far as possible.
10. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the minor differences between the subject device OCT-Camera ID 21101A3 and the predicate device OCT-Camera (ID 21101A1) do not raise new or different questions of safety and effectiveness. Technical product characteristics, performance testing and compliance with voluntary standards demonstrate that the OCT-Camera ID 21101A3 device is substantially equivalent to the predicate device in terms of design, function, components, materials, principals of operation, performance characteristics, and intended use/indication.
§ 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.