OCT-Camera ID 21101A3

K200516 · Optomedical Technologies GmbH · OBO · Sep 2, 2020 · Ophthalmic

Device Facts

• Record ID: K200516
• Device Name: OCT-Camera ID 21101A3
• Applicant: Optomedical Technologies GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Sep 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

Device is an intraoperative Optical Coherence Tomography (iOCT) system; attaches to surgical microscope camera port. Inputs: ocular tissue microstructure signals via Spectral Domain OCT (SD-OCT). Transformation: SLED light source (830 nm) scans tissue using galvanometric mirror pair; transmission grating/line scan camera detects backscattered light; software processes signals into depth-resolved images. Output: real-time visualization of surgical field/ocular tissue on display. Used in OR by surgeons; enables intraoperative imaging before, during, and after microsurgery without disrupting microscopic view. Benefits: real-time visualization of surgical steps; aids diagnosis of ocular conditions. No direct patient contact.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (ISO 10993-1), electrical safety (ANSI/AAMI ES 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), light hazard protection (ANSI Z80.36-2016), software verification/validation (IEC 62304), and usability engineering (IEC 62366-1).

Technological Characteristics

Spectral Domain OCT; SLED light source (830 nm); galvanometric mirror scanner. Axial resolution ≤7.5 μm; lateral resolution 10.6-74 μm. Scan patterns: line, rectangular volume, cross scan. Connectivity: surgical microscope camera port. Power: AC. Software: iOCT-Control3. Standards: ANSI Z80.36-2016, IEC 60601-1, IEC 60601-1-2, IEC 60825-1.

Indications for Use

Indicated for aid in diagnosis of physiologic and pathologic eye conditions via non-contact optical imaging. Suitable for all patient populations except premature and neonatal infants; includes ambulatory or confined patients. Used in supine imaging, mounted to surgical microscope HS Hi-R NEO 900A NIR, suitable for patients under anesthesia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OCT-Camera (ID 21101A1) (K142953)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

## OCT-Camera ID 21101A3

# K200516

#### 1. Submission Sponsor

OptoMedical Technologies GmbH

Maria-Goeppert-Strasse 9

23562 Luebeck, Germany

Phone: [phone]

Contact: Julia Behrens, Quality and Regulatory Affairs Manager

E-mail: [e-mail]

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] 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<br>OCT-Camera ID 21101A3 is intended<br>to acquire, process, display and save<br>depth-resolved images of ocular<br>tissue microstructure using Spectral<br>Domain Optical Coherence<br>Tomography (SD-OCT).<br>The OCT-Camera ID 21101A3 is<br>indicated for the use as an aid in the<br>diagnosis of physiologic and<br>pathologic conditions of the eye<br>through non-contact optical imaging.<br>Imaging of the various tissues of the<br>eye is supported through the use of<br>interchangeable lenses.<br>It is indicated for use on all patient<br>populations except premature and<br>neonatal infants, and is suitable for<br>patients ambulatory or confined.<br>The system is indicated for use in<br>supine imaging, mounted to the<br>surgical microscope HS Hi-R NEO 900A<br>NIR (Haag-Streit), and is suited for<br>imaging patients under anesthesia. | OptoMedical Technologies<br>OCT-Camera is intended<br>to acquire, process, display and save<br>depth-resolved images of ocular<br>tissue microstructure using Spectral<br>Domain Optical Coherence<br>Tomography (SD-OCT).<br>The OCT-Camera is indicated for the<br>use as an aid in the diagnosis of<br>physiologic and pathologic<br>conditions of the eye through non-contact optical imaging. Imaging of<br>the various tissues of the eye is<br>supported through the use of<br>interchangeable lenses.<br>It is indicated for use on patient<br>populations from premature and<br>neonatal infants to adult, and is<br>suitable for patients ambulatory or<br>confined. The system is indicated for<br>use in supine imaging, mounted to the<br>surgical microscope HS Hi-R NEO 900A<br>NIR (Haag-Streit), and is suited for<br>imaging patients under anesthesia. | Similar<br>Excluded target population of premature/<br>neonatal infants<br>as risks for those patient groups<br>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<br>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<br>US-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…