(184 days)
Not Found
No
The summary describes standard image acquisition and processing for OCT, and there is no mention of AI, ML, or related concepts.
No
The device is described as an aid in diagnosis and imaging, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "Camera" and is "completely integrated into the surgical procedure" by being "attached to the camera port of an operating microscope." This indicates a physical hardware component is central to the device's function, not just software.
Based on the provided information, the OptoMedical Technologies OCT-Camera ID 21101A3 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, processing, displaying, and saving images of ocular tissue microstructure to aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. This involves imaging the eye directly, not testing samples taken from the body.
- Device Description: The description emphasizes its integration into surgical procedures for real-time visualization of the surgical field. This is a direct imaging and visualization tool.
- Lack of mention of biological samples: There is no mention of the device being used to test biological samples such as blood, urine, tissue biopsies, etc., which is a defining characteristic of IVDs.
- Imaging Modality: Spectral Domain Optical Coherence Tomography (SD-OCT) is an imaging technique, not a method for analyzing biological samples.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device operates by directly imaging the eye, which is an in vivo process.
N/A
Intended Use / Indications for Use
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.
Product codes
OBO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Spectral Domain Optical Coherence Tomography (SD-OCT)
Anatomical Site
Ocular tissue / Eye
Indicated Patient Age Range
all patient populations except premature and neonatal infants
Intended User / Care Setting
Professional Use / mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit) and suited for imaging patients under anesthesia.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: 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.
Testing included:
- Biocompatibility evaluation per ISO 10993-1
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142953, OCT-Camera (ID21101A1)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
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
4
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.
5
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 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. | OptoMedical Technologies | |||
OCT-Camera 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 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 patient | ||||
populations from premature and | ||||
neonatal infants to adult, 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. | Similar | |||
Excluded target population of premature/ | ||||
neonatal infants | ||||
as risks for those patient groups | ||||
were 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 Equipment | ||||
Classification | 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 with | |
US-recognized | ||||
≤47 μW | standards IEC 60825-1 and | |||
at cornea without scanning | ANSI Z80.36-2016. | |||
Optical Power | N/A |