(257 days)
Not Found
No
The document describes standard image acquisition and processing techniques for OCT. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on the hardware and software for acquiring and displaying OCT images.
No
Explanation: The device is described as an imaging device intended to acquire, process, display, and save images for visualization. It is an aid in visualization and does not apply any therapy or treatment.
Yes
The device aids in the visualization of physiologic conditions of the eye and allows for measurement of features, which contributes to diagnosis.
No
The device description explicitly states that the EnFocus™ includes hardware components such as an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart, and objective lenses. While it includes software, it is not solely software.
Based on the provided information, the Bioptigen EnFocusTM device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EnFocusTM Function: The EnFocusTM device is a non-contact, noninvasive ophthalmic imaging device that uses light (SD-OCT) to acquire images of ocular tissue in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is to acquire, process, display, and save images of ocular tissue microstructure and aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. This is a diagnostic imaging function, not an in vitro diagnostic test.
Therefore, the Bioptigen EnFocusTM device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT).
The EnFocusTM is indicated for use as an aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient promotions from premature and neonant lintants to adult. The system is indicated for use in supine imaging, mounted to a superiod microscope, with coperative patients or patients under anesthesia.
Product codes
HLI, OBO
Device Description
The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the System Software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures.
The EnFocus is coupled to a surgical micrsoscope for OCT imaging during ophthalmic surgical procedures. The EnFocus has been validated and found to be compatible for use with the Leica M844 Surgical Microscope and the Insight Instruments Super View™ Wide Angle Viewing System™ for retina visualization.
The software, InVivoVue™ Version 2.6, works with the hardware and the hardware controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging.
The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed in the Leica M844 filter port to manage illumination glare artifacts when necessary.
Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Spectral Domain Optical Coherence Tomography (SDOCT)
Anatomical Site
Ocular tissue / eye
Indicated Patient Age Range
premature and neonatal infants to adult
Intended User / Care Setting
Not Found
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
Clinical data were collected in an IRB approved study. The study evaluated 24 eyes of twelve adult subjects. Subjects were imaged in an office setting beneath a Leica M844 microscope, without mydriasis. Images were coded and randomized. Following collection of images, three ophthalmic graders independently reviewed the images and documented evaluations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study: The study evaluated 24 eyes of twelve adult subjects.
- Ocular Physiology and Presence of Doppler Flow: Three ophthalmic graders evaluated four volumetric images acquired of each subject eye and identified the presence or absence of physiologic features in a binary test of agreement. Percent agreement with predicate for various features ranged from 57.7% to 100%.
- Caliper Measurements: Graders were asked to use InVivoVue calipers to measure a series of features in the same images. The images were presented as acquired, without magnification, or image processing or image enhancement. The caliper measurements from images acquired with each of the EnFocus 2300 and EnFocus 4400 were analyzed for agreement with images acquired with the predicate Envisu 2300. Agreement was tested against a target equivalence margin of +/- 15 um (0.015 mm) at the 95% confidence level. All measured features for both ENF2300 and ENF4400 showed the 95% CI met the equivalence margin. Linearity in agreement across measurements (20 um to 630 um) was also evaluated, with R^2 values of 99.8% for all comparisons (ENF23=f(Pred), ENF44=f(Pred), ENF44=f(ENF23)).
Non-clinical performance data:
- Medical Electrical Safety Testing: Complies with IEC 60601-1 and IEC 60601-1-2 standards, 30d edition.
- Optical Safety and Emissions: IEC 60825-1 Class 1 laser product safety testing and ISO 15004-2 Group 2 light hazard test results confirm the system to be eye safe.
- Software Verification and Validation Testing: Validated as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with ISO 62304.
- Key Performance Attributes: All testing demonstrated compliance with applicable product requirements.
- Surgical Microscope Compatibility: Evaluated with Leica M844 Surgical Microscope. All tests for compatibility passed acceptance criteria.
- Fundus Viewing System Compatibility: Demonstrated equivalent fundus imaging optical resolution with and without the EnFocus device installed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Percent Agreement with Predicate: Ranges from 57.7% to 100% for various ocular physiological features and Doppler flow.
- Mean Difference (Predicate - New Device (mm)) and 95% CI: For caliper measurements, all 95% CIs met the equivalence margin of +/- 0.015 mm.
- Correlation Coefficient (R^2): 99.8% for the linearity in agreement between measures comparing the new device models to the predicate, and comparing the two new device models.
Predicate Device(s)
Envisu™ SDOIS (Models C2200 and C2300) K120057
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2015
Bioptigen, Inc. Ms. Tammy B. Carrea Vice President, Quality and Regulatory Affairs 633 Davis Drive, Suite 480 Morrisville, North Carolina 27560
Re: K150722
Trade/Device Name: Enfocus 2300. Enfocus 4400 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI, OBO Dated: October 23, 2015 Received: October 29, 2015
Dear Ms. Carrea:
This letter corrects our substantially equivalent letter of December 12, 2015.
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 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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
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 -A
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) K150722
Device Name EnFocus
Indications for Use (Describe)
The Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT).
The EnFocusTM is indicated for use as an aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient promotions from premature and neonant lintants to adult. The system is indicated for use in supine imaging, mounted to a superiod microscope, with coperative patients or 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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Image /page/3/Picture/0 description: The image shows the logo for "bioptigen" with three horizontal bars in shades of blue and green to the left of the name. Below the logo is the text "510(k) SUMMARY (per 21 CFR 807.92)". The text is in bold font.
K150722
Date Prepared: November 24, 2015
SUBMITTER INFORMATION l.
| Sponsor: | Bioptigen, Inc. |
|---|---|
| Registration Number: | 3006809695 |
| Address: | 633 Davis Drive, Suite 480 |
| Morrisville, NC 27560 | |
| Phone: | 919-595-1260 |
| Contact Person: | Tammy B. Carrea |
| VP Quality and Regulatory Affairs |
II. DEVICE IDENTIFICATION
| Trade or proprietary name: | EnFocus™ |
|---|---|
| Common or usual name: | Optical Coherence Tomography |
| Classification Name: | Ophthalmoscope, AC Powered |
| Optical Coherence Tomography | |
| Regulation: | 21 CFR 886.1570 |
| Classification: | Class II |
| Product Codes: | HLI (Ophthalmoscope, AC-powered) |
| OBO (Tomography, Optical Coherence | |
| Classification Panel: | Ophthalmic |
PREDICATE DEVICE lll.
Envisu™ SDOIS (Models C2200 and C2300) K120057
IV. DEVICE DESCRIPTION
The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the System Software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures
The EnFocus is coupled to a surgical micrsoscope for OCT imaging during ophthalmic surgical procedures. The EnFocus has been validated and found to be compatible for use with the Leica
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Image /page/4/Picture/0 description: The image shows the logo for "bioptigen". The logo consists of a stylized "B" made of three horizontal bars in different shades of blue and green, followed by the word "bioptigen" in a bold, sans-serif font. The colors of the "B" are, from top to bottom, blue, teal, and green.
M844 Surgical Microscope and the Insight Instruments Super View™ Wide Angle Viewing System™ for retina visualization.
The software, InVivoVue™ Version 2.6, works with the hardware and the hardware controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging.
The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed in the Leica M844 filter port to manage illumination glare artifacts when necessary.
Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.
INDICATIONS FOR USE V.
The Bioptigen EnFocus™ device is intended to acquire, process, display and save depthresolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT).
The EnFocus™is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients under anesthesia.
VI. SUBSTANTIAL EQUIVALENCE
Like its predicate, the EnFocus™ is a non-contact, non-invasive 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 using SDOCT and a Class 1 near-infrared laser light source to capture depth-resolved images of ocular tissue microstructure. Both devices utilize SDOCT, include a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the InVivoVue System Software. The design modifications represented by the subject EnFocus are, as follows:
Scan Head
The scan head is mounted to the microscope's optical carrier using a mounting bracket that is bolt-secured to the carrier's accessory plate and shares an objective lens with the microscope.
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Image /page/5/Picture/0 description: The image shows the logo for bioptigen. The logo consists of a stylized graphic element on the left and the word "bioptigen" in bold, black font on the right. The graphic element is composed of three overlapping shapes in different shades of blue and green, creating a sense of depth and movement.
Focus and Zoom Control
The predicate device utilizes a manual system for focusing the OCT beam. Focus of the predicate device is manually achieved by mechanical displacement of lenses in the system objective lens, similar to manual operation of a SLR camera lens.
The subject device provides an electromechanical system for focusing the OCT beam and for changing the numerical aperture of the OCT beam. Focus and numerical aperture are usercontrolled via an input beam zoom setting that is accessed through the software user interface.
Retina Viewing Lens
Retina viewing with the predicate device is accomplished using the General Retina Lens, one of multiple lenses supplied by Bioptigen with the Envisu SDOIS system. Retina viewing with the EnFocus is accomplished using a commercially available Fundus (Retina) Viewing Lens.
Spectrometer
The predicate device is available with one of two spectrometers (2200 or 2300) and one of two internal light sources (HR or VHR). The EnFocus device is available in two models: EnFocus 2300 includes the 2300 spectrometer of the predicate and the VHR superluminescent diode (SLD) light source of the predicate. EnFocus 4400 includes a 4400 spectrometer and utilizes an HR superluminescent light source equivalent to the HR source available with the predicate.
Engine Control System
The predicate system relied on manual control functionality of reference arm path length, reference arm attenuation level and polarization balance through mechanical linkages in the system. The EnFocus replaces theses mechanical linkages with a motor-driven electromechanical system that can be controlled through a menu on the front panel of the EnFocus engine or through the software user interface.
Software User Interface and Function
No changes have been made to the predicate's underlying method of image acquisition, signal processing or display technology.
Software modifications include migration to the Microsoft 7 64-bit Operating System and simplification of both user interface and workflow. Examples of these simplifications include Office 2010 and 2013 support for reports, enabling simultaneous exporting of multiple exams, rearranging the user interface layout to follow standard workflows while reducing the steps to begin a new patient exam and associating an exam with patient demographic data.
Two new user interface features have been added including a configuration drop down menu and a prominently displayed "Quick Start" grid. The drop down menu simplifies switching
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Image /page/6/Picture/0 description: The image shows the logo for "bioptigen". The logo consists of a stylized "b" made up of three stacked, rounded rectangles in blue and green, followed by the word "bioptigen" in black, sans-serif font. The rectangles are arranged with the top one in blue, the middle one in a darker green, and the bottom one in a lighter green.
between system configurations for anterior and posterior imaging without requiring restarting InVivoVue software.
Any technological differences between the EnFocus and Envisu devices have been mitigated via bench testing or clinical testing.
VII. NON-CLINICAL PERFORMANCE DATA
Medical Electrical Safety Testing
Electrical safety and EMI/EMC testing were conducted on the EnFocus and demonstrate the system complies with the IEC 60601-1 and IEC 60601-1-2 standards, 30d edition. Testing included review of the software, risk management file, and usability file.
Optical Safety and Emissions
IEC 60825-1 Class 1 laser product safety testing and ISO 15004-2 Group 2 light hazard test results together confirm the system to be eye safe when used as labeled.
Software Verification and Validation Testing
Software testing was validated and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the software lifecycle requirements of ISO 62304.
Key Performance Attributes
Optical performance testing was conducted in accordance with established key performance attributes. All testing demonstrated compliance with applicable product requirements.
Surgical Microscope Compatibility
The EnFocus was connected to the microscope and the two EnFocus device models were evaluated for compatibility with the microscope. Compatibility was assessed by evaluating the ability of the microscope and EnFocus to work independently and by ensuring that the EnFocus did not result in any form of interference with the microscope that could impact surgical performance. The microscope and EnFocus were tested together for optical radiation safety to ISO 15004-2, mechanical connectivity, mechanical stability, ergonomics and working distance, and general safety. Microscope properties were evaluated for optical performance including illumination field of view, illumination uniformity, optical distortion, and glare. Installation and removal, including draping, were evaluated. The surgical microscope labeling was evaluated to ensure that the microscope was not contraindicated for pediatric use. Illumination field of view and uniformity were evaluated with and without the accessory glare masks installed. All tests for compatibility passed acceptance criteria.
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Image /page/7/Picture/0 description: The image shows the logo for Bioptigen. The logo consists of a blue and green graphic to the left of the word "bioptigen" in black font. The graphic is made up of three stacked shapes, with the top shape being blue, the middle shape being a darker green, and the bottom shape being a lighter green.
Fundus Viewing System Compatibility
The optical resolution of the surgical microscope with the fundus viewing system installed was evaluated with and without the EnFocus installed. Both of the two EnFocus objectives were evaluated at the maximum and minimum microscope magnifications demonstrated equivalent fundus imaging optical resolution with and without the EnFocus device installed.
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Image /page/8/Picture/0 description: The image shows the logo for "bioptigen". The logo consists of a stylized "b" symbol made up of three horizontal bars in different shades of blue and green, followed by the word "bioptigen" in a bold, sans-serif font. The color scheme is modern and professional, with the blue and green hues suggesting a connection to science or technology.
Performance Specifications
| Attribute | Predicate Envisu Device
K120057
Models 2200/2300 | Proposed EnFocus Device
K150722
Models 2300/4400 | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Bioptigen 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 in indicated for use as an aid in the diagnosis of physiological 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 population 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. | The Bioptigen EnFocus™ device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocus™ is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia. | |
| Regulation Number | 21 CFR 886.1570 | Same | |
| Class | II | Same | |
| Method of Operation | Spectral Domain Optical Coherence Tomography | Same | |
| Light Source | SLD
(Superluminescent diode) | Same | |
| Scanner Type | Galvonometric mirror pair | Same | |
| Optical Power |