Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (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 use as an aid in the diagnosis of physiologic and pathologic 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 upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.

Device Description

The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye.

Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment.

The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (< 3.5 lbs), compact handheld scanner makes it possible to image pediatric patients, supine patients, or any patient that finds it difficult to sit upright or where it is clinically preferable to image without the constraint of a chin rest. Tabletop, chin-rest mediated imaging is enabled though a mounting accessory.

AI/ML Overview

The Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) (K120057) did not involve a clinical study to prove its acceptance criteria. Instead, the submission leveraged non-clinical performance and safety data, as well as a review of existing clinical literature, to establish substantial equivalence to a predicate device (K063343).

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this was a 510(k) submission based on substantial equivalence to a predicate device, the "acceptance criteria" were primarily defined by the performance characteristics of the predicate device. The "reported device performance" refers to the Envisu™ SDOIS meeting or exceeding these characteristics, with specific design modifications noted.

Acceptance Criteria (Predicate SDOIS)	Reported Device Performance (Envisu™ SDOIS)
Method of Operation: SD-OCT	Same as predicate
Light Source: SLED	Same as predicate
Light Source Class: Class 1 LED	HR: Same as predicate; VHR: Class 1 LED
Optical Power: < 750 µW at cornea	Same as predicate
Resolution, Lateral:
- Retina: 20 µm in tissue	Retina: same as predicate
- Anterior: ~25 um in tissue	Anterior Segment: 9, 12 and 25 um
Resolution, Axial: < 6 um in tissue	HR: Same as predicate; VHR: <4 µm in tissue
Depth Range (in tissue/air): 1.7 / 2.2 mm	Model C2200: 1.7 / 2.3 mm; Model C2300: 2.5 / 3.4 mm
Scanner Type: Galvanometric mirror pair	Same as predicate
Scan Patterns: Line, rectangular volume, circle, concentric rings, radial lines	Same as predicate
Scan Pixels: Axial (512 or 1024), Lateral (User Selectable)Max 5,000 A-scans/B-scanMax 150,000 total A-scans	Same as predicate
Scan Rate: 20,000 A-scans/s	32,000 A-scans/s (Improved)
Detection: Transmission Grating Spectrometer / Line-Scan Camera	Same as predicate
Scanner Ergonomics: Mounted (tabletop)	Same as predicate or handheld (New feature)
Patient Interface: Chin Rest Assembly	Same as predicate or None (Chin Rest Assembly now optional) (New flexibility)
Footprint: Stationary: 15" x 18" Engine, 12" x 15" scanner	Mobile: 24" x 22" x 37.5" (New feature)
Scanner Dimensions: 12" (h) x 6" (w) x 9" (d)	7" (h) x 3" (w) x 9" (d)h: incl handle / d: incl lensWeight: ≤ 3.5 lbs (Smaller and lighter)
Software: InVivoVue™ 1.5	InVivoVue™ Clinic 1.4 (Updated, with new features listed in the description)
Operating System: Windows XP	Same as predicate
Processor: Dual 3.4 GHz Xeon	Dual 2.0 GHz Quad Core (Improved processing speed)
Memory: 2 GB	4 GB (Increased memory)

2. Sample Size Used for the Test Set and the Data Provenance

No specific test set or data provenance (country, retrospective/prospective) explicitly described for a clinical study. The submission relies on:

Non-clinical performance and safety data: This involves testing under established protocols (e.g., IEC standards, image resolution, image comparison, software validation).
Clinical Literature Review: This review analyzed existing peer-reviewed publications on handheld SDOIS for pediatric populations, suggesting safety, non-invasiveness, and effectiveness.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a test set is described, as a clinical study was not performed by Bioptigen.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

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

Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or described.

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

Not applicable. This device is an imaging system, not an algorithm, and no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, in the context of this 510(k), was largely established by:

Engineering specifications and measurements: Demonstrating that the device's technical specifications met or exceeded those of the predicate device.
Compliance with recognized standards: Such as IEC-60601-1, IEC 60601-1-2, IEC 60825-1, and ISO 15004-2 for electrical, electromagnetic, optical emission, and safety.
Referencing existing clinical literature: To support the safety and effectiveness of the technology (SDOIS) for its intended use, particularly for handheld operation in different patient populations.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

Summary

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K120057

New Traditional 510(k)

bioptigen

MAY 1 1 2012

510(K) SUMMARY (PER 21 CFR 807.92) -

Date Prepared: December 23, 2011

SUBMITTER INFORMATION

510(k) Owner and Device Manufacturer:	Bioptigen, Inc.
Registration Number:	3006809695
Address:	104 T.W. Alexander, Building 2, Durham, NC 27709
Phone:	+1 919 314 5500
Fax:	+1 919 314 5501

Contact:

Dawn Reilly-O'Dell, RAC Full Circle Regulatory Consulting, LLC +1 919 410 7497 (Phone) dreilly@bioptigen.com (Email)

DEVICE IDENTIFICATION

Trade or proprietary name:

Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) Spectral Domain Optical Coherence Tomography (SD-OCT) Common or usual name: Ophthalmoscope, AC-powered; Classification name: Tomography, Optical Coherence ни, ово Product Codes: 886.1570 Regulation Number:

INTENDED USE

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New Traditional 510(k)

bioptigen

SUBSTANTIAL EQUIVALENCE

The Envisu™ SDOIS is substantially equivalent to the predicate SDOIS in technology, safety and effectiveness. The Envisu™ SDOIS incorporates a number of design changes, but it shares the same fundamental spectral domain optical coherence tomography imaging technology and incoherent superluminiscent light emitting diode technology as the predicate SDOIS. The differences between the 2006 predicate, K063343, and the current subject SDOIS are the following design modifications incorporated to enhance device usability and performance:

. Upgraded spectrometer line-scan camera allowing 32,000 A-scans/second for faster imaging speeds with no increase in patient irradiance
. Added VHR light source option for improved axial resolution without increase in patient irradiant exposure
. Revised scan head with enhanced ergonomics including handheld operation for improved clinical flexibility and patient comfort
Mobile transport cart with Uninterruptable Power Supply (UPS)
. Increased computer memory and processing speed
. Additional objective lens options for cornea and related anterior imaging
Updated Information for Use labeling to parallel the system changes and a new training manual to address use of the handheld scanner
Added spectrometer design option for increased imaging depth to 3.4 mm in air (2.5 mm in tissue) for greater depth of imaging field
. Upgraded IVVC software post-processing and visualization functionality including four new. features, which are the option to register and average multiple frames, the manual Onscreen Calipers, the 3D view and the option to generate Word-based reports

Predicate Device	510(k) Holder	510(k)	Clearance Date
Spectral Domain Ophthalmic Imaging System (SDOIS) .	Bioptigen, Inc.	K063343	December 13, 2006

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New Traditional 510(k)

Envisu SDOIS

bioptigen

Predicate

SDOIS

Technological Comparison:

Medical Device

Indications for Use

Spectral Domain Imaging The System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular microstructure tissue using Spectral Domain Optical Coherence Tomography (SD-OCT). It is primarily intended for the imaging of retinal tissue, but the cornea, sclera and conjunctiva can also be imaged by changing the focal position. Indications for use evaluation include the of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Subject Envisu™ SDOIS

Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging system is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The Envisu™ SDOIS is indicated for 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.

Specifications

SD-OCT	Same as predicate
SLED	SLED
High Resolution (HR)	HR: Same as predicateVHR: Very High Resolution
Class 1 LED	HR: Same as predicate
	VHR: Class 1 LED
< 750 µW at cornea	Same as predicate
Retina: 20 µm in tissueAnterior: ~25 um in tissue	Retina: same as predicateAnterior Segment: 9, 12 and 25 um
< 6 um in tissue	HR: Same as predicateVHR: <4 µm in tissue
1.7 / 2.2 mm	Model C2200: 1.7 /2.3Model C2300: 2.5 / 3.4 mm
Galvanometric mirror pair	Same as predicate

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Scan Patterns Available	Line, rectangular volume, circle, concentric rings, radial lines	Same as predicate
Scan Pixels	Axial (depth): 512 or 1024Lateral : User SelectableMaximum 5,000 A-scans / B-scanMaximum 150,000 total A-scans	Same as predicate
Scan Rate	20,000 A-scans/s	32,000 A-scans/s
Detection	Transmission GratingSpectrometer / Line-Scan Camera	Same as predicate
Scanner Ergonomics	Mounted (tabletop)	Same as predicate or handheld
Patient Interface	Chin Rest Assembly	Same as predicate or None (ChinRest Assembly now optional)
Footprint	Stationary: 15" x 18"Engine, 12" x 15" scanner	Mobile: 24" x 22" x 37.5"
Scanner Dimensions	12" (h) x 6" (w) x 9"(d)	7" (h) x 3" (w) x 9" (d)h: incl handle / d: incl lensWeight: ≤ 3.5 lbs
Software	InVivoVue™ 1.5	InVivoVue™ Clinic 1.4
Operating System	Windows XP	Same as predicate
Processor	Dual 3.4 GHz Xeon	Dual 2.0 GHz Quad Core
Memory	2 GB	4 GB

DEVICE DESCRIPTION

New Traditional 510(k)

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Envisu™System	MaximumDetectorBandwidth (nm)	Maximum ImageDepth (mm intissue)1	Pixel Resolution(µm in tissue, 1024pixels full depth)	Detection Type
C2200	160	1.7	1.6	Transmission
C2300	110	2.5	2.4	Spectrometer,Line-scan Camera

NON-CLINICAL PERFORMANCE AND SAFETY DATA

IEC-60601-1 electrical, IEC 60601-1-2 electromagnetic compatibility, IEC 60825-1 and ISO 15004-2 Group I optical emission and Class 1 LED safety, image resolution, image comparison and software validation testing have been conducted in accordance with established protocols. All testing has demonstrated compliance with applicable product requirements.

CLINICAL LITERATURE REVIEW

A review of existing peer-reviewed clinical literature publications has been completed. Published clinical data reported that the handheld SDOIS is a safe, noninvasive and effective method for evaluation of the eye for pediatric populations. Clinical testing has not been conducted independently by Bioptigen.

CONCLUSION

New Traditional 510/k)

The Envisu™ SDOIS has the same fundamental technology, method of operation and technological characteristics as the predicate SDOIS. It introduces new characteristics of mobility and ergonomic utility, including handheld imaging operation, which impact indications for use. Results of performance and safety testing verify that these modifications present no new issues regarding the Envisu™'s safety or effectiveness, and that the Envisu™ SDOIS remains a Class 1 LED , group 1, nonhazardous device eye safe under all operating conditions. In conclusion, the Envisu™ SDOIS is substantially equivalent to the predicate SDOIS device when used as labeled.

1 Values are approximate, based on an average refractive index of 1.38

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2012

Bioptigen, Inc. c/o Ms. Dawn Reilly-O'Dell, RAC Principal Consultant Full Circle Regulatory Consulting, LLC 104 T.W. Alexander Drive, P.O. Box 13569 Durham, North Carolina 27709

Re: K120057

Trade/Device Name: Envisu Spectral Domain Opthalmic Imaging System (SDOIS) C2200 and C2300 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Codes: HLI, OBO Dated: May 4, 2012 Received: May 7, 2012

Dear Ms. Reilly-O'Dell:

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

机_

Sincerely yours,

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K120057

Device Name:

Envisu "M SDOIS (Spectral Domain Ophthalmic Imaging System)

Indications for Use:

Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (Envisu™ SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The Envisu™ SDOIS is indicated for 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K120057
310(k) Number

Bioptigen, Inc. ~ Confidential

Page 189 of 176

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.

510(K) SUMMARY (PER 21 CFR 807.92) -

SUBMITTER INFORMATION

DEVICE IDENTIFICATION

INTENDED USE

bioptigen

SUBSTANTIAL EQUIVALENCE

Envisu SDOIS

bioptigen

Technological Comparison:

Medical Device

Subject Envisu™ SDOIS

Categories

Specifications

DEVICE DESCRIPTION

NON-CLINICAL PERFORMANCE AND SAFETY DATA

CLINICAL LITERATURE REVIEW

CONCLUSION

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K120057

INDICATIONS FOR USE STATEMENT

§ 886.1570 Ophthalmoscope.