(67 days)
Not Found
No
The summary describes standard image acquisition and processing techniques (SD-OCT) and does not mention any AI or ML algorithms for image analysis, interpretation, or other functions. The performance studies focus on optical and image quality equivalence to a predicate device, not on the performance of any AI/ML component.
No.
The device is used for imaging (visualization) purposes to aid in the diagnosis of conditions, not to treat them.
Yes
The device is indicated as "an aid in the visualization of physiologic and pathologic conditions of the eye," which directly relates to diagnosing or assisting in the diagnosis of these conditions.
No
The device description explicitly states that the EnFocus™ includes an "OCT engine, a scan head and a system computer with system software," indicating the presence of hardware components beyond just software. It also mentions coupling to a surgical microscope and including objective lenses and accessory masks.
Based on the provided information, the Bioptigen EnFocus™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EnFocus™ device directly images ocular tissue in vivo (within the living body) using light. It does not analyze samples like blood, urine, or tissue biopsies that have been removed from the body.
- The intended use describes direct imaging of ocular tissue. The description clearly states the device is used to "acquire, process, display and save depth resolved images of ocular tissue microstructure" and is "indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging." This is consistent with an imaging device used on a living patient.
- The device description details a non-contact, noninvasive ophthalmic imaging device. This further supports its use for direct imaging of the eye, not for analyzing samples.
Therefore, the Bioptigen EnFocus™ is an ophthalmic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OBO
Device Description
The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT engine, a scan head and a system computer with 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 microscope for OCT imaging during ophthalmic surgical procedures. The software, InVivoVue™, works with the hardware and the 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 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 microstructure, Anterior and Posterior Segment of 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and EMC testing: demonstrates that the system complies with the IEC 60601-1 and IEC 60601-1-2 recognized standards.
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 when used as labeled.
Optical performance testing: demonstrates that the modified EnFocus™ maintains optical performance attributes equivalent to the original device.
Image quality testing: validates that the OCT image quality of the modified EnFocus™ device is statistically equivalent to the original device.
Video compatibility testing: confirms that the modified EnFocus™ hardware remains capable of displaying digital video inputs to primary and secondary monitors.
Fundus viewing system testing: validates that the modified EnFocus™ is compatible with qualified fundus viewing systems.
Software: InVivoVue™ software was verified and validated in accordance with the software lifecycle requirements of ISO 62304.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9. 2016
Bioptigen, Inc. Ravi Kommineni Director of Quality and Regulatory Affairs 633 Davis Drive, Suite 480 Morrisville, NC 27560
Re: K162783
Trade/Device Name: EnFocus 2300, EnFocus 4400 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: November 16, 2016 Received: November 17, 2016
Dear Mr. Kommineni:
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 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
1
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 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,
Denise L. Hampton -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)
Device Name EnFocusTM (EnFocus 2300, EnFocus 4400)
Indications for Use (Describe)
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 suping, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.
| Concession of the program of a concession of a concession of concession of concession a promote of consisted on annual consistence of consisted of consistences of consistence | |
|---|---|
| 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. The logo consists of a stylized symbol on the left, followed by the word "bioptigen" in a bold, sans-serif font. The symbol is made up of three stacked, horizontally oriented shapes in different shades of blue and green.
510(k) Summary
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92
l. General Information
| Manufacturer: | Bioptigen, Inc.
A Leica Microsystems Company
633 Davis Drive, Suite 480
Morrisville, NC 27560 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ravi Kommineni
Director for Quality and Regulatory Affairs
Bioptigen, Inc.
Phone: 919-348-6439
Email: ravi.kommineni@leica-microsystems.com |
- Date Prepared: 12/5/2016
II. Device Information
| Trade Name: | EnFocus 2300, EnFocus 4400 |
|---|---|
| Model Number(s): | 2300 (70-10091) |
| 4400 (70-10094) | |
| Common Name: | Spectral Domain Optical Coherence Tomography |
| Classification Name: | Tomography, Optical Coherence |
| Regulation Number: | 21 CFR § 886.1570 |
| Product Code: | OBO |
| Classification Panel: | Ophthalmology |
| Class: | II |
lll. Predicate Device
EnFocus (EnFocus 2300, EnFocus 4400) - K150722
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Image /page/4/Picture/0 description: The image shows the logo for "bioptigen". The logo consists of a stylized graphic to the left of the word "bioptigen". The graphic is made up of three stacked, rounded rectangles, with the top one being blue, the middle one being a darker shade of green, and the bottom one being a lighter shade of green. The word "bioptigen" is written in a bold, sans-serif font and is black.
Purpose of Special 510(k) IV.
The purpose of the special 510(k) submission is to gain clearance for the changes made to the EnFocus™ (K150722) cleared device. The EnFocus™ optical and computing subsystems are now repackaged into a single enclosure for improved manufacturing and servicing logistics. The associated hardware and software changes do not affect the intended use, functionality of the system nor alter the principle of operation of the EnFocus™ device.
> Indications for Use
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 under anesthesia.
VI. Device Description
The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT engine, a scan head and a system computer with 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 microscope for OCT imaging during ophthalmic surgical procedures. The software, InVivoVue™, works with the hardware and the 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 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.
5
Image /page/5/Picture/0 description: The image shows the logo for "bioptigen". The logo consists of a stylized graphic to the left of the word "bioptigen". The graphic is made up of three stacked, rounded shapes in blue, teal, and green. The word "bioptigen" is written in a bold, sans-serif font in black.
VII. Substantial Equivalence
The modified EnFocus™ device has the same intended use, indications for use, technological characteristics and principle of operation as the cleared EnFocus™ device (K150722) to which it is a modification.
| Category | Predicate (EnFocus™ - K150722) | Subject (Modified EnFocus™) |
|---|---|---|
| Indications for Use | 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 noncontact 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. | Same as predicate | |
| Target Population | • Premature and neonatal infants to adult | |
| • Supine | ||
| • Cooperative patients or patients under anesthesia | Same as predicate | |
| Anatomical Sites | Anterior and Posterior Segment of Eye | Same as predicate |
| Method of Operation | SD-OCT | Same as predicate |
| Principle of Operation | OCT dichroically coupled into collimated space of | |
| common main objective surgical microscope. | Same as predicate | |
| Energy Used and/or | ||
| Delivered | Near Infrared Optical Emissions | Same as predicate |
| Light Source | 800 nm band SLD: | |
| High Resolution (HR) | ||
| Very High Resolution (VHR) | Same as predicate | |
| Light Source Classification | Class 1 Laser Product | Same as predicate |
| Optical Power |