OCT-Camera

K142953 · Optomedical Technologies GmbH · HLI · Mar 4, 2015 · Ophthalmic

Device Facts

• Record ID: K142953
• Device Name: OCT-Camera
• Applicant: Optomedical Technologies GmbH
• Product Code: HLI · Ophthalmic
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

OCT-Camera is an intraoperative SD-OCT system attaching to surgical microscope camera ports. It captures, processes, and displays real-time depth-resolved images of ocular tissue microstructure; enables visualization of surgical steps (e.g., membrane transplantation, micro-implants) without disrupting microscopic view. Operated by surgeons in OR settings. Input: SLED light source; output: live OCT images on display. Benefits: real-time intraoperative guidance for ocular microsurgery. System uses galvanometric mirror scanners and spectrometer-based detection.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including electrical safety, electromagnetic compatibility, risk management, and light hazard protection testing.

Technological Characteristics

Spectral Domain OCT; SLED light source (Class 1 LED); galvanometric mirror pair scanner; transmission grating spectrometer/line scan camera. Mounted to surgical microscope. 2.66 GHz Dual Core processor, 4 GB RAM, Windows XP. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 15004-2.

Indications for Use

Indicated for premature/neonatal infants to adults, ambulatory or confined, for aid in diagnosis of physiologic/pathologic eye conditions via non-contact SD-OCT imaging. Suitable for supine imaging under anesthesia when mounted to specified surgical microscope.

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

• Envisu™ SDOIS (K120057)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

for

# OCT-Camera

# K142953

# 1. Submission Sponsor

OptoMedical Technologies GmbH Maria-Goeppert-Strasse 1 Lübeck 23562 GERMANY Phone: [phone] Fax: [phone] Contact: Alexander HOLZHEY, Quality and Regulatory Affairs Manager

### 2. Submission Correspondent

Emergo Europe Consulting Prinsessegracht 20 2514AP The Hague The Netherlands Office Phone: [phone] Fax: [phone] Contact: Dirk Meier, Senior Consultant, QA Email: [e-mail]

### 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;<br>Tomography, Optical Coherence |
| Classification Regulation: | 886.1570 |
| Product Code: | HLI, OBO |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic |

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# 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<br>GmbH | Bioptigen | Significant<br>Differences |
| Trade Name | OCT-Camera<br>(subject) | SDOIS Envisu<br>(predicate) | |
| 510(k)<br>Number | N/A | K120057 | Same |
| Product Code | HLI, OBO | HLI, OBO | Same |
| Regulation<br>Number | 21 CFR 886.1570 | 21 CFR 886.1570 | Same |

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| Manufacturer | OptoMedical Technologies<br>GmbH | Bioptigen | Significant<br>Differences |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | OCT-Camera<br>(subject) | SDOIS Envisu<br>(predicate) | |
| Regulation<br>Name | Ophthalmoscope | Ophthalmoscope | Same |
| Indications for<br>Use | OptoMedical Technologies OCT-<br>Camera is intended to acquire,<br>process, display and save depth-<br>resolved images of ocular tissue<br>microstructure using Spectral<br>Domain Optical Coherence<br>Tomography (SD-OCT). The OCT-<br>Camera is indicated for the use as<br>an aid in the diagnosis of<br>physiologic and pathologic<br>conditions of the eye through non-<br>contact optical imaging. Imaging of<br>the various tissues of the eye is<br>supported through the use of<br>interchangeable lenses. It is<br>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<br>for use in supine imaging, mounted<br>to a surgical microscope HS Hi-R<br>NEO 900A NIR (Haag-Streit), and is<br>suited for imaging patients under<br>anesthesia. | Bioptigen Envisu™ SDOIS is intended to<br>acquire, process, display and save<br>depth-resolved images of ocular tissue<br>microstructure using Spectral Domain<br>Optical Coherence Tomography (SD-<br>OCT). The Envisu™ SDOIS is indicated<br>for the use as an aid in the diagnosis of<br>physiologic and pathologic conditions<br>of the eye through non-contact optical<br>imaging. Imaging of the various tissues<br>of the eye is supported through the<br>use of interchangeable lenses. It is<br>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 upright or supine imaging,<br>handheld or mounted, and is suited for<br>imaging patients under anesthesia. | Similar |
| Method of<br>Operation | SD-OCT | SD-OCT | Same |
| Light Source | SLED | SLED | Same |
| Light Source<br>Classification | Class 1 LED | Class 1 LED | Same |
| Optical Power<br>(OCT Light) | ≤2350 µW at cornea during OCT<br>scan<br>≤47 µW at cornea without scanning<br>Complies with the requirements of<br>IEC 60825-1:2007, Part 1 and 2 | ≤750 µW at cornea | Similar |
| Optical Power<br>(Pilot Light) | <50 µW at cornea | -option not available- | Similar |
| Resolution,<br>Lateral | Retina: 10.6 to 74 µm in tissue,<br>dependent on magnification of<br>microscope and its retina lens<br>Anterior Segment: 10.6 to 37 µm,<br>dependent on magnification of<br>microscope | Retina: 20 µm in tissue<br>Anterior Segment: 9, 12 and 25 µm | Similar |

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| Manufacturer | OptoMedical Technologies<br>GmbH | Bioptigen | Significant<br>Differences |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | OCT-Camera<br>(subject) | SDOIS Envisu<br>(predicate) | |
| Resolution,<br>Axial | $≤$ 7.5 µm in tissue | $≤$ 6 µm in tissue | Similar |
| Depth Range<br>(in tissue/in<br>air) | 3.1 / 4.2 mm | 1.7 / 2.3 mm | Similar |
| Scanner Type | Galvanometric Mirror Pair | Galvanometric Mirror Pair | same |
| Scan Patterns | Line, rectangular volume | Line, rectangular volume, circle,<br>concentric rings, radial lines | Similar |
| Scan Pixels | Axial (depth): 1024<br>Lateral: fixed to 1,000 A-Scans/B-<br>Scan<br>Max. 30,000 total A-Scans/Volume-<br>Scan | Axial (depth): 512 or 1024<br>Lateral: User Selectable<br>Max. 5,000 A-Scans/B-Scan<br>Max. 150,000 total A-Scans | Similar |
| Scan Rate | 15,000 A-Scans/s | 32,000 A-Scans/s | Similar |
| Detection | Transmission Grating,<br>Spectrometer / Line Scan Camera | Transmission Grating, Spectrometer /<br>Line Scan Camera | Same |
| Scanner<br>Ergonomics | Mounted to camera port of a<br>surgical microscope | Mounted (tabletop) or Handheld | Similar |
| Patient<br>Interface | Not required | Optional Chin Rest Assembly | Similar |
| Operating<br>System | Win XP | Win XP | Similar |
| Processor | 2.66 GHz Dual Core | Dual 2.0 GHz Quad Core | Similar |
| Memory | 4 GB | 4 GB | same |
| AC Powered | Yes | Yes | Same |
| Battery<br>Operated | No | No | Similar |
| Electrical<br>Safety Testing<br>Passed | IEC 60601-1, EN 60601-1-2 | IEC 60601-1, EN 60601-1-2 | Same |

# 9. 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.

In the following please find a listing of testing performed at OptoMedical Technologies GmbH all of which have been passed positively to demonstrate safety and effectiveness.

The following testing has been performed to support substantial equivalence:

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- . 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

# 10. Clinical Performance Data

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.

# 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the OCT-Camera and the predicate devices do not raise any questions regarding its safety and effectiveness. The OCT-Camera, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.