K Number
K200516
Device Name
OCT-Camera ID 21101A3
Date Cleared
2020-09-02

(184 days)

Product Code
Regulation Number
886.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

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

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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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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.

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Subject DevicePredicate Device (K142953)Device Comparison
ManufacturerOptoMedical Technologies GmbH (GERMANY)
Trade NameOCT-Camera ID 21101A3OCT-Camera (ID 21101A1)
Product CodeOBOSame
Regulation Number886.1570Same
Regulation NameOphthalmoscopeSame
Professional UseYesSame
Indications for UseOptoMedical 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 OperationSpectral domain optical coherence tomography (SD-OCT)Same
SterilenoSame
Scanner ErgonomicsMounted to camera port of the surgical microscope HS Hi-R NEO 900A NIRSame
Patient InterfacenoneSame
Single-UsenoSame
Shelf Life10 yearsSame
Battery OperatednoSame
AC PoweredyesSame
Light Hazard ProtectionANSI Z80.36-2016ANSI Z80.36-2016Same
Electrical Safety TestingIEC 60601-1, IEC 60601-1-2Same
Laser Product Equipment
ClassificationOCT-Scanner and OCT-Camera equates to Laser Class 1Same
Subject DevicePredicate DeviceDevice Comparison
ManufacturerOptoMedical Technologies GmbH (GERMANY)
Trade NameOCT-Camera ID 21101A3OCT-Camera (ID 21101A1)
Technological characteristics
Light SourceSLEDSLEDSame
Light SourceClass 1 LEDClass 1 LEDSame
Classification
Laser830 nm840 nmSimilar
Optical Power≤1500 μW≤2350 μWSimilar
(OCT Light)at cornea during OCT scanat cornea during OCT scancomplies with
US-recognized
≤47 μWstandards IEC 60825-1 and
at cornea without scanningANSI Z80.36-2016.
Optical PowerN/A