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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the OptoMedical Technologies OCT-Camera. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, the Bioptigen Envisu™ SDOIS.

However, the document states that NO clinical performance data was required or performed for this device (OCT-Camera). Therefore, the device inherently does not have acceptance criteria or a study that proves it meets acceptance criteria in the way you've requested regarding performance metrics like accuracy, sensitivity, or specificity, which would typically come from clinical evaluations.

The "acceptance criteria" discussed in this document refer to the device meeting specific non-clinical requirements (e.g., electrical safety, compliance with laser safety standards, and overall design and performance functionality) to demonstrate substantial equivalence to the predicate device, not its diagnostic performance against a ground truth.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since no clinical performance study was conducted to establish diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), this table cannot be populated with such metrics. The acceptance criteria and "performance" are framed in terms of meeting regulatory and safety standards, and demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (as stated in the document)
Overall design, performance, and electrical safety requirements met	"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."
Compliance with light hazard protection	"The OCT-Camera complies with the applicable voluntary standards for light hazard protection and safe laser products."
Compliance with national and international standards	"The device passed all the testing in accordance with national and international standards."
Electrical Safety Testing	"IEC 60601-1, EN 60601-1-2" (Passed for both subject and predicate device)
Electromagnetic Compatibility	"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" and "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" (Passed)
Risk Management	"ISO 14971: 2007 Medical devices -- Application of risk management to medical devices" (Compliant)
Laser Product Safety	"IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification and requirements" (Compliant)
Ophthalmic Instrument Requirements	"ISO 15004-2: 2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection" (Compliant)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (no clinical testing was performed).
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. The device is not an AI-assisted diagnostic tool discussed in this context; it's an imaging device. The document explicitly states no clinical testing was required or performed.
Effect size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: No. The device is not an algorithm, but an imaging camera for human use. No clinical performance testing against ground truth was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Not applicable. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

Sample size for training set: Not applicable. The device is not described as an AI/ML algorithm that requires a training set in the context of diagnostic performance studies. Non-clinical testing was performed for safety and effectiveness, but this doesn't involve a "training set" in the AI sense.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K142953

Device Name OCT-Camera

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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: 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

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5. Predicate Device

Device trade name:	Envisu™ SDOIS
Manufacturer name:	Bioptigen Inc.
510(k) number:	K120057

6. Device Description

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 TechnologiesGmbH	Bioptigen	SignificantDifferences
Trade Name	OCT-Camera(subject)	SDOIS Envisu(predicate)
510(k)Number	N/A	K120057	Same
Product Code	HLI, OBO	HLI, OBO	Same
RegulationNumber	21 CFR 886.1570	21 CFR 886.1570	Same

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Manufacturer	OptoMedical TechnologiesGmbH	Bioptigen	SignificantDifferences
Trade Name	OCT-Camera(subject)	SDOIS Envisu(predicate)
RegulationName	Ophthalmoscope	Ophthalmoscope	Same
Indications forUse	OptoMedical Technologies OCT-Camera is intended to acquire,process, display and save depth-resolved images of ocular tissuemicrostructure using SpectralDomain Optical CoherenceTomography (SD-OCT). The OCT-Camera is indicated for the use asan aid in the diagnosis ofphysiologic and pathologicconditions of the eye through non-contact optical imaging. Imaging ofthe various tissues of the eye issupported through the use ofinterchangeable lenses. It isindicated for use on patientpopulations from premature andneonatal infants to adult, and issuitable for patients ambulatory orconfined. The system is indicatedfor use in supine imaging, mountedto a surgical microscope HS Hi-RNEO 900A NIR (Haag-Streit), and issuited for imaging patients underanesthesia.	Bioptigen Envisu™ SDOIS is intended toacquire, process, display and savedepth-resolved images of ocular tissuemicrostructure using Spectral DomainOptical Coherence Tomography (SD-OCT). The Envisu™ SDOIS is indicatedfor the use as an aid in the diagnosis ofphysiologic and pathologic conditionsof the eye through non-contact opticalimaging. Imaging of the various tissuesof the eye is supported through theuse of interchangeable lenses. It isindicated for use on patientpopulations from premature andneonatal infants to adult, and issuitable for patients ambulatory orconfined. The system is indicated foruse in upright or supine imaging,handheld or mounted, and is suited forimaging patients under anesthesia.	Similar
Method ofOperation	SD-OCT	SD-OCT	Same
Light Source	SLED	SLED	Same
Light SourceClassification	Class 1 LED	Class 1 LED	Same
Optical Power(OCT Light)	≤2350 µW at cornea during OCTscan≤47 µW at cornea without scanningComplies with the requirements ofIEC 60825-1:2007, Part 1 and 2	≤750 µW at cornea	Similar
Optical Power(Pilot Light)	<50 µW at cornea	-option not available-	Similar
Resolution,Lateral	Retina: 10.6 to 74 µm in tissue,dependent on magnification ofmicroscope and its retina lensAnterior Segment: 10.6 to 37 µm,dependent on magnification ofmicroscope	Retina: 20 µm in tissueAnterior Segment: 9, 12 and 25 µm	Similar

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Manufacturer	OptoMedical TechnologiesGmbH	Bioptigen	SignificantDifferences
Trade Name	OCT-Camera(subject)	SDOIS Envisu(predicate)
Resolution,Axial	$≤$ 7.5 µm in tissue	$≤$ 6 µm in tissue	Similar
Depth Range(in tissue/inair)	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,concentric rings, radial lines	Similar
Scan Pixels	Axial (depth): 1024Lateral: fixed to 1,000 A-Scans/B-ScanMax. 30,000 total A-Scans/Volume-Scan	Axial (depth): 512 or 1024Lateral: User SelectableMax. 5,000 A-Scans/B-ScanMax. 150,000 total A-Scans	Similar
Scan Rate	15,000 A-Scans/s	32,000 A-Scans/s	Similar
Detection	Transmission Grating,Spectrometer / Line Scan Camera	Transmission Grating, Spectrometer /Line Scan Camera	Same
ScannerErgonomics	Mounted to camera port of asurgical microscope	Mounted (tabletop) or Handheld	Similar
PatientInterface	Not required	Optional Chin Rest Assembly	Similar
OperatingSystem	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
BatteryOperated	No	No	Similar
ElectricalSafety TestingPassed	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.

Regulation Number and Section

§ 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.