(145 days)
No
The summary describes standard image acquisition and processing for OCT, with no mention of AI, ML, or related concepts.
No
The device is described as an aid in diagnosis through non-contact optical imaging and visualization of surgical procedures, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "OCT-Camera is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye".
No
The device description clearly states it is a physical "OCT-Camera" that attaches to a surgical microscope and acquires images using SD-OCT, indicating it is a hardware device with integrated software.
Based on the provided information, the OptoMedical Technologies OCT-Camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- OCT-Camera Function: The OCT-Camera directly images ocular tissue in vivo (within the living body) using light. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it acquires, processes, displays, and saves images of ocular tissue microstructure using SD-OCT for non-contact optical imaging. This is a form of medical imaging, not in vitro testing.
Therefore, the OCT-Camera falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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 conditions of the eye through non-contact optical 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 a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
Product codes
HLI, OBO
Device Description
The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time.
The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera 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 microstructure / eye
Indicated Patient Age Range
premature and neonatal infants to adult
Intended User / Care Setting
Not Found
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
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Non-Clinical Performance Data: The OCT-Camara mets all the requirements for overall design, performance and electrical safety confirms that the output meets the design inputs and specifications. The OCT-Camara passed all testing and supports the claims of substantial equivalence and safe operation. The OCT-Camera complies with the applicable voluntary standards for light hazard protection and safe laser products. The device passed all the testing in accordance with national and international standards.
Testing performed:
- IEC 60601-1: 2005 Medical electrical equipment – Part 1-2, General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-2: 2007 Medical electrical equipment – Part 1-2, General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 14971: 2007 Medical devices -- Application of risk management to medical devices
- IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification and requirements
- ISO 15004-2: 2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
OptoMedical Technologies GmbH c/o Mr. Richard A. Vincins, CQA, CBA RAC (US, EU) Vice President, Quality Assurance Emergo Global Consulting Group 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K142953
Trade/Device Name: OCT-Camera, Model 21101A1 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLI, OBO Dated: January 27, 2015 Received: January 29, 2015
Dear Mr. Vincins:
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. 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.
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
1
Page 2 - Mr. Richard A. Vincins
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142953
Device Name OCT-Camera
Indications for Use (Describe)
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 conditions of the eye through non-contact optical 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 a 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)
2 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
for
OCT-Camera
K142953
1. Submission Sponsor
OptoMedical Technologies GmbH Maria-Goeppert-Strasse 1 Lübeck 23562 GERMANY Phone: 0049 451 2903 348 Fax: 0049 451 2903 333 Contact: Alexander HOLZHEY, Quality and Regulatory Affairs Manager
2. Submission Correspondent
Emergo Europe Consulting Prinsessegracht 20 2514AP The Hague The Netherlands Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Dirk Meier, Senior Consultant, QA Email: project.management@emergogroup.com
3. Date Prepared
2 March 2015
4. Device Identification
| Trade/Proprietary Name: | OCT-Camera |
|---|---|
| Common/Usual Name: | intraoperative Optical Coherence Tomography (iOCT) |
| Classification Name: | Ophthalmoscope, AC-powered; |
| Tomography, Optical Coherence | |
| Classification Regulation: | 886.1570 |
| Product Code: | HLI, OBO |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic |
4
5. Predicate Device
| Device trade name: | Envisu™ SDOIS |
|---|---|
| Manufacturer name: | Bioptigen Inc. |
| 510(k) number: | K120057 |
6. Device Description
The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time.
The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera 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.
7. Indication for Use Statement
OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depthresolved 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 a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
8. Substantial Equivalence Discussion
The following table compares the OCT-Camera to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Table 3A - Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | OptoMedical Technologies | ||
| GmbH | Bioptigen | Significant | |
| Differences | |||
| Trade Name | OCT-Camera | ||
| (subject) | SDOIS Envisu | ||
| (predicate) | |||
| 510(k) | |||
| Number | N/A | K120057 | Same |
| Product Code | HLI, OBO | HLI, OBO | Same |
| Regulation | |||
| Number | 21 CFR 886.1570 | 21 CFR 886.1570 | Same |
5
| Manufacturer | OptoMedical Technologies
GmbH | Bioptigen | Significant
Differences |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | OCT-Camera
(subject) | SDOIS Envisu
(predicate) | |
| Regulation
Name | Ophthalmoscope | Ophthalmoscope | Same |
| Indications for
Use | 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 a surgical microscope HS Hi-R
NEO 900A NIR (Haag-Streit), and is
suited for imaging patients under
anesthesia. | Bioptigen Envisu™ SDOIS is intended to
acquire, process, display and save
depth-resolved images of ocular tissue
microstructure using Spectral Domain
Optical Coherence Tomography (SD-
OCT). The Envisu™ SDOIS 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 upright or supine imaging,
handheld or mounted, and is suited for
imaging patients under anesthesia. | Similar |
| Method of
Operation | SD-OCT | SD-OCT | Same |
| Light Source | SLED | SLED | Same |
| Light Source
Classification | Class 1 LED | Class 1 LED | Same |
| Optical Power
(OCT Light) | ≤2350 µW at cornea during OCT
scan
≤47 µW at cornea without scanning
Complies with the requirements of
IEC 60825-1:2007, Part 1 and 2 | ≤750 µW at cornea | Similar |
| Optical Power
(Pilot Light) |