(67 days)
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.
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.
The provided document describes a 510(k) submission for the Bioptigen EnFocus™ 2300 and EnFocus™ 4400 devices, which are Spectral Domain Optical Coherence Tomography (SD-OCT) systems. The submission is for a modification to an already cleared device (K150722), involving repackaging optical and computing subsystems into a single enclosure.
The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to prove effectiveness against clinical outcomes in a new performance study. Therefore, traditional "acceptance criteria" for a new AI/CADe device, and a study proving those criteria, are not presented in the same way. Instead, the focus is on maintaining the safety and performance of the existing predicate device.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance (e.g., sensitivity, specificity for a diagnostic task) because this is a 510(k) for a hardware and software modification to maintain equivalence, not to establish new clinical performance.
Instead, the performance evaluation in this 510(k) is aimed at demonstrating that the modified device retains the same performance characteristics as the predicate device. The section "VII. Substantial Equivalence" provides a table comparing the predicate device and the subject (modified) device across various categories, noting "Same as predicate" for most performance metrics.
| Category | Acceptance Criteria (Implied: Same as Predicate) | Reported Device Performance (Subject - Modified EnFocus™) |
|---|---|---|
| Optical Power | < 750 µW | Same as predicate |
| Resolution, Lateral | < 31.0 µm (175 mm Obj., low NA) < 15.1 µm (175 mm Obj., high NA) < 35.4 µm (200 mm Obj., low NA) < 17.3 µm (200 mm Obj., high NA) | Same as predicate |
| Field of View, Lateral | ≥ 20 mm | Same as predicate |
| Resolution, Axial | Model 2300 VHR: < 4 µm in tissue Model 4400: < 9 µm in tissue | Same as predicate |
| Field of View, Longitudinal (Depth Range) (in tissue/air) | Model 2300: 2.5 / 3.4 mm Model 4400: 11.1 / 15.3 mm | Same as predicate |
| Scan Pixels (Axial) | Model 2300: 1024 Model 4400: 2048 | Same as predicate |
| Scan Rate | Model 2300: 32,000 A-scans/sec Model 4400: 18,000 A-scans/sec | Same as predicate |
| Software Version | InVivoVue™ (IVV) 2.6 (Predicate) | InVivoVue™ (IVV) 2.10 |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2 | Complies |
| Laser Safety | Compliance with IEC 60825-1 (Class 1 Laser Product) and ISO 15004-2 (Group 2 light hazard) for eye safety | Complies |
| Optical Performance | Maintains optical performance attributes equivalent to the original device. | Maintains equivalence |
| Image Quality | OCT image quality statistically equivalent to the original device. | Statistically equivalent |
| Video Compatibility | Capable of displaying digital video inputs to primary and secondary monitors. | Confirmed capable |
| Fundus Viewing System Compatibility | Compatible with qualified fundus viewing systems. | Validated compatible |
| Software Verification/Validation | In accordance with ISO 62304 | Verified and Validated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states under "IX. Non-Clinical Testing" that "Image quality testing validates that the OCT image quality of the modified EnFocus™ device is statistically equivalent to the original device." It does not specify the sample size of images used for this testing, nor does it mention the provenance (country of origin, retrospective/prospective) of these images. The study's primary goal was engineering validation of the modifications, not a new clinical performance study.
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)
No information is provided about experts establishing ground truth or their qualifications. The testing described focuses on technical performance metrics (electrical safety, optical performance, image quality equivalence), rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information about an adjudication method is provided, as the testing was not clinical diagnostic performance testing.
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
No MRMC study was performed or is mentioned. The device is an imaging system (SD-OCT), not an AI-assisted diagnostic tool, and the submission is for a modification to the device's hardware and software, not for a new AI feature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a diagnostic imaging instrument; its function is to acquire and display images for human interpretation, not to provide an automated diagnostic output. The "software" mentioned (InVivoVue™) controls data acquisition and imaging, not image analysis for diagnostic purposes in an AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the validation tests (electrical safety, optical performance, image quality equivalence), the "ground truth" would be established by technical measurement standards and comparison to the predicate device's measured performance. For "Image quality testing," it means establishing that the modified device's image quality metrics statistically match those of the predicate, rather than being compared against a clinical ground truth like pathology for a specific disease.
8. The sample size for the training set
This is not applicable since this is not an AI/machine learning device that requires a training set in that context. The "software" mentioned (InVivoVue™) is operating system and image acquisition/display software, not a deep learning model.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above.
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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
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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 Company633 Davis Drive, Suite 480Morrisville, NC 27560 |
|---|---|
| Contact Person: | Ravi KommineniDirector for Quality and Regulatory AffairsBioptigen, Inc.Phone: 919-348-6439Email: 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.
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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 ofocular tissue microstructure using Spectral DomainOptical Coherence Tomography (SDOCT).The EnFocus™ is indicated for use as an aid in thevisualization of physiologic and pathologic conditions ofthe eye through noncontact optical imaging. It isindicated for use on patient populations from prematureand neonatal infants to adult. The system is indicatedfor use in supine imaging, mounted to a surgicalmicroscope, with cooperative patients or patients underanesthesia. | 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 ofcommon main objective surgical microscope. | Same as predicate |
| Energy Used and/orDelivered | 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 | < 750 µW | Same as predicate |
| PERFORMANCE | ||
| Resolution, Lateral | < 31.0 µm (175 mm Obj., low NA)< 15.1 µm (175 mm Obj., high NA)< 35.4 µm (200 mm Obj., low NA)< 17.3 µm (200 mm Obj., high NA) | Same as predicate |
| Field of View, Lateral | ≥ 20 mm | Same as predicate |
| Resolution, Axial | Model 2300 VHR: < 4 µm in tissueModel 4400: < 9 µm in tissue | Same as predicate |
| Field of View,Longitudinal(Depth Range)(in tissue/air) | Model 2300: 2.5 / 3.4 mmModel 4400: 11.1 / 15.3 mm | Same as predicate |
| Category | Predicate (EnFocus™ - K150722) | Subject (Modified EnFocus™) |
| Scanner Type | Galvanometric mirror pair | Same as predicate |
| Scan Patterns Available | Line, rectangular volume, circle, concentric rings(annular volume), radial lines (radial volume) | Same as predicate |
| Scan Pixels | Axial (depth) :Model 2300: 1024Model 4400: 2048Lateral: User SelectableMaximum A-scans / B-scan: 2000Maximum total A-scans/volume: 1,000,000 | Same as predicate |
| Scan Rate | Model 2300: 32,000 A-scans/secModel 4400: 18,000 A-scans/sec | Same as predicate |
| DIMENSIONS | ||
| System Footprint | Mobile Cart: 24" x 22" x 37.5" | Same as predicate |
| Subsystem Dimensions | Computer: 13" (w), 15.5" (l), 5.75" (h)Interface Box: 13" (w), 15.5" (l), 5.75" (h)OCT Engine: 17.75" (w), 17" (l), 7.5" (h) | Integrated Chassis:19" (w) x 10.5" (l) x 8.25" (h) |
| Scanner | Scan head: 3.2" (h) x 3.2" (od) | Same as predicate |
| Dimensions | Relay Arm: 10.9" (1) x 1.7" (od) Scanner Assembly: 2.2"(I) x 5.5" (w) x 8.0" (h)Mounting Adapter: 2.2" (l) x 2.8" (w) x 1.8" (h) | Same as predicate |
| ScannerErgonomics | Surgical Microscope Mounted | Same as predicate |
| SOFTWARE | ||
| Software | InVivoVue™ (IVV) 2.6 | InVivoVue™ (IVV) 2.10 |
| Scan Setting Procedures | Protocol Pre-Sets, Scan Pre-Sets, Custom Scandefinitions | Same as predicate |
| Measurements | Manual placement of on-screen calipers | Same as predicate |
| Doppler | Qualitative blood flow visualization with color DopplerOCT | Same as predicate |
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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 overlapping shapes in blue and green, followed by the word "bioptigen" in black sans-serif font. The logo is simple and modern, with a focus on the company name.
VIII. Performance
The modified EnFocus™ device is in compliance with the following recognized consensus standards:
| Standard | Version | Title |
|---|---|---|
| AAMI/ANSI60601-1 | 2005/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic safetyand essential performance |
| IEC 60601-1-2 | Edition 4.0 2014-02 | Medical electrical equipment - Part 1-2: General requirements for safety –Collateral Standard: Electromagnetic compatibility – Requirements and tests |
| ISO 62304 | 2015 | Medical device software - Software life-cycle processes |
| ISO 14971 | Second Edition2007-03-01 | Medical Devices - Application of Risk Management to Medical Device |
| IEC 60825-1 | Edition 2.0 2007-03 | Safety of laser products - Part 1:Equipment classification and requirements |
| ISO 15004-2 | 2007 | Ophthalmic Instruments - Fundamental Requirements And Test MethodsPart 2: Light Hazard Protection |
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Image /page/7/Picture/0 description: The image shows the logo for Bioptigen. The logo consists of a stylized "B" made up of three horizontal bars in different shades of blue and green. To the right of the "B" is the word "bioptigen" in a sans-serif font. The word is in black.
IX. Non-Clinical Testing
Safety
Electrical safety and EMC testing were conducted on the modified EnFocus™ device and demonstrate 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 together confirm the system to be eye safe when used as labeled.
Performance
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.
X. Clinical Testing
No clinical information is included in this submission.
XI. Conclusion
The results of verification and validation demonstrate that the modified device is as safe and effective as the predicate device and does not introduce new issues of safety and effectiveness. Therefore, the modified EnFocus™ is substantially equivalent to its cleared predicate device, EnFocus™ (K150722).
§ 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.