LipiScan™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

Device Description

The LipiScan™ Dynamic Meibomian Imager (DMI) (Model DMI-1000) is a bench-top ophthalmic camera used to image the meibomian glands. LipiScan™ contains a computer system, electronics, chin and forehead rest, camera and attached lens, illuminator, touchscreen display, handheld near-infrared (IR) lid everter and power supply. The chin and forehead rest and handheld near IR lid everter are the only components of the device that contact the patient's intact skin. LipiScan™ uses near infrared (NIR) illumination and an NIR-sensitive high-resolution camera to image the meibomian glands. The tissue between the meibomian glands and the surface of the eyelid is transparent to NIR light; the glands reflect NIR wavelengths, allowing them to be imaged. The images of the glands may be viewed on the computer screen display and in a printed report.

AI/ML Overview

The provided text is a 510(k) Summary for the LipiScan™ Dynamic Meibomian Imager. It primarily focuses on demonstrating substantial equivalence to a predicate device (LipiView® II Ocular Surface Interferometer) rather than presenting a standalone study with specific acceptance criteria and detailed performance data against those criteria.

However, based on the information provided, I can infer the implied acceptance criteria, the general type of "study" conducted (performance testing to demonstrate substantial equivalence), and some details about the testing:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria and a direct performance table are not provided in the 510(k) summary, the acceptance criteria are implicitly defined by compliance with relevant standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is described in terms of meeting these standards and having equivalent functionality for its specific indications.

Acceptance Criteria Category (Implied)	Implied Acceptance Criteria	Reported Device Performance
Safety & Effectiveness	Demonstrated to be as safe and effective as the predicate device for imaging meibomian glands. Design differences do not raise new questions of safety and effectiveness.	"Design verification and validation and usability testing demonstrate that LipiScan™ DMI is as safe and effective as the predicate device for the intended use to image the Meibomian glands using near-infrared light." "Performance testing demonstrates that LipiScan™ DMI is substantially equivalent to the predicate device, and the design differences as compared to the predicate device do not raise new questions of safety and effectiveness."
Biocompatibility	Patient contact materials are biocompatible or identical to those of the cleared predicate device.	"The surface-contacting material composition and device manufacturing process are the same as those of the predicate LipiView® II device cleared in K152869; therefore, new biocompatibility testing is not needed."
Sterilization, Cleaning & Disinfection	Non-sterile device, proper disinfection methods for patient contact surfaces, and compatibility of materials with disinfectant.	"Patient contact surfaces are disinfected with 70-90% isopropyl alcohol prior to each patient use and prior to storage. The verification testing shows that the device patient contact materials are compatible with isopropyl alcohol disinfection."
Electrical Safety & EMC	Conformance to specified electrical safety and electromagnetic compatibility (EMC) standards.	Tested for conformance to: - ANSI AAMI ES60601-1 2005 /(R)2012 and A1:2012: C1:2009/(R)2012 and A2:2010/(R) - IEC 60601-1-2 2007
Light Hazard Protection	Conformance to specified light hazard protection standards, indicating no potential light hazard.	"LipiScan™ DMI meets Group 1 ophthalmic instruments as defined in the ISO 15004-2: 2007 and ANSI Z80.36:2016 standards for which no potential light hazard exists." (Note: Predicate meets Group 2, implying a higher hazard, but this difference for LipiScan is presented as a positive, not a deviation needing further evaluation).
Software	Software performance complies with specifications and requirements, and it is categorized as a Minor Level of Concern.	"Verification and Validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the LipiScan™ DMI software." "As for the predicate device, LipiScan™ DMI software is categorized as a Minor Level of Concern."
Imaging Functionality	Able to capture, archive, manipulate, and store digital images of the meibomian glands using NIR illumination. (Implied by the "Indications for Use" and "Technological Characteristics" sections).	Demonstrated through "Performance testing" and the comparison to the predicate, stating it has "the same principle of operation as an ophthalmic camera to image the meibomian glands using a LED light source in the near-infrared spectrum." The software features for real-time display, image storage, and export also confirm this functionality. Additionally, "Methods are equivalent. Motorized stages are not needed to capture and focus an image using LipiScan™, as shown by performance testing." indicating functionality.

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

The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or image analysis. The "performance testing" mentioned generally refers to design verification and validation, usability testing, and bench testing against standards.

The data provenance for any potential clinical images used in "performance testing" is also not specified. It is likely that such testing would involve capturing images from human subjects, but the details (e.g., country of origin, retrospective or prospective) are absent.

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

The document does not mention using experts to establish ground truth for a test set. This type of analysis (e.g., grading of meibomian gland images by experts) is not described in detail as part of the substantial equivalence claim.

4. Adjudication Method for the Test Set

Since the document does not describe the use of experts or a specific test set for diagnostic performance, an adjudication method is not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the document. The filing focuses on demonstrating substantial equivalence of the device's functionality and safety characteristics to a predicate, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No standalone algorithm performance study is explicitly described. The device is an "ophthalmic imaging device intended for use by a physician... to capture, archive, manipulate and store digital images." While it uses software, the primary evaluation is of the device's ability to acquire and manage images, rather than an AI algorithm making diagnostic decisions or segmentations independently. The software evaluation is focused on compliance with specifications and requirements, not standalone diagnostic performance.

7. The Type of Ground Truth Used

Given the nature of the device (an imager) and the focus on substantial equivalence for technical characteristics and image acquisition, the "ground truth" implicitly refers to:

Compliance with engineering and safety standards: The device passes tests against established standards for electrical safety, EMC, light hazard, and material flammability (e.g., ANSI, ISO, IEC, UL standards).
Functional equivalence to the predicate: The LipiScan™'s ability to capture images of meibomian glands is considered equivalent to the predicate device's capability, which serves as the established gold standard for this function.
Successful software verification and validation: The software performs according to its designed specifications.

8. The Sample Size for the Training Set

The document does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm that would typically require a training set for diagnostic or analytical tasks. The software development was largely based on existing software from the predicate device.

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

As no training set is mentioned in the context of an AI/ML algorithm, the method for establishing ground truth for a training set is not applicable/not provided.

Summary

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December 10, 2018

TearScience, Inc. Christy Coleman Vice President, Clinical & Regulatory Affairs 5151 McCrimmon Pkwy. Ste. 250 Morrisville, NC 27560

Re: K182506

Trade/Device Name: LipiScan Dynamic Meibomian Imager Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 11, 2018 Received: September 12, 2018

Dear Christy Coleman:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Bradley S. Cunningham -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) K182506

Device Name LipiScan™ Dynamic Meibomian Imager

Indications for Use (Describe)

LipiScar™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

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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510(k) SUMMARY

PREPARATION DATE:	November 6, 2018
APPLICANT:	TearScience, Inc.5151 McCrimmon Parkway, Suite 250Morrisville, NC 27560Tel: (919) 467-4007Fax: (919) 467-3300
CONTACT PERSON:	Christy Coleman, OD, MPHVice President, Clinical & Regulatory Affairs
DEVICE TRADE NAME:	LipiScan™ Dynamic Meibomian Imager
COMMON NAME:	Ophthalmic Imaging Device
CLASSIFICATION NAME:	Ophthalmic Camera
DEVICE CLASSIFICATION:	Class II; 21 CFR 886.1120
PRODUCT CODE:	HKI
PREDICATE DEVICE:	Trade/Device Name: LipiView® II Ocular SurfaceInterferometer (K152869)Regulation Number: 21 CFR 886.1120Regulation Name: Ophthalmic CameraRegulatory Class: Class IIProduct Code: HKI, HIO

DEVICE DESCRIPTION:

LipiScan™ uses near infrared (NIR) illumination and an NIR-sensitive high-resolution camera to image the meibomian glands. The tissue between the meibomian glands and the surface of the eyelid is transparent to NIR light; the glands reflect NIR wavelengths, allowing them to be imaged. The images of the glands may be viewed on the computer screen display and in a printed report.

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LipiScan™ complies with Group 1 requirements of both ISO 15004-2:2007 (Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection) and ANSI Z80.36-2016 (Light Hazard Protection for Ophthalmic Instruments). Group 1 is for ophthalmic instruments for which no potential light hazard exists.

LipiScan™ does not provide a diagnosis. The device has no treatment or life-sustaining functions and presents no potential for serious risk to health, welfare or safety of patients.

INDICATIONS FOR USE:

Indications for Use Statement: LipiScan™ Dynamic Meibomian Imager (DMI) is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

LipiScan™ DMI has the same Indications for Use to image the Meibomian glands as the predicate LipiView® II Ocular Surface Interferometer (K152869). Note that the predicate device has additional indications (i.e., tear film imaging and thickness measurement, and ocular surface imaging under white light), which are not included in the subject LipiScan™ DMI.

TECHNOLOGICAL CHARACTERISTICS:

LipiScan™ has the same fundamental scientific technology as the predicate LipiView® II Ocular Surface Interferometer. As summarized below, most of the technological characteristics are the same between devices. A comparison of the technology between LipiScan" and the predicate device is summarized below and in Table 1.

Similarities: The predicate LipiView® II device and LipiScan™ have the same principle of operation as an ophthalmic camera to image the meibomian glands using a LED light source in the near-infrared spectrum. Both bench-top devices have similar components including a computer system. electronics, chin and forehead rest, camera and lens, illuminator, touchscreen display, and handheld near IR lid everter. Both devices may be used with off-the-shelf (OTS) USB accessories, have connections for an external HDMI monitor, and operate wirelessly with networks.

Similar design features between LipiScan™ and the predicate device include: an adjustable chin and forehead rest; same patient contact materials and disinfection method; high definition digital camera; surface NIR illumination; and transillumination of the eyelid with the handheld near IR lid everter. Both devices comply with standards for light hazard protection. Both devices have an AC-power source in compliance with standards for electrical safety and electromagnetic compatibility (EMC). Both devices have flame retardant materials. Both devices have ambient temperature of parts of the device held by operator or accessible to the patient in compliance with standards.

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The software on both devices runs on a Microsoft Windows-based operating system with a touchscreen display graphical user interface. Similar software features include: password-protected user login: patient database entry; real-time display to acquire and view images; touchscreen user controls for camera; storage of images on the computer; printed or saved reports; and export of images to USB external media or electronic medical record system via a wireless network.

Differences: The predicate LipiView® II Interferometer has design features that are not included in LipiScan™ such as: a white light Class I LED illuminator; visible LED fixation light; full color images and video; pushbutton controls; and software designed for tear film and ocular imaging and lipid layer thickness measurement using interferometry. These features are necessary to support the additional indications of the predicate device but are not needed for meibomian gland imaging. Therefore, these additional design features to support additional indications for use in the predicate device do not affect safety and effectiveness of the LipiScan™ for imaging the meibomian glands.

The devices also use different but equivalent methods to position the camera and focus the image. The predicate device uses electromechanical stages. Conversely, LipiScan" uses a dual chinrest with a sensor. high-resolution camera capable of capturing the entire field of view, and an electronically controlled lens. Furthermore, unlike the predicate device, LipiScan™ is designed to be portable.

PERFORMANCE TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION:

Design verification and validation and usability testing demonstrate that LipiScan" DMI is as safe and effective as the predicate device for the intended use to image the Meibomian glands using near-infrared light. Performance testing demonstrates that LiviScan™ DMI is substantially equivalent to the predicate device, and the design differences as compared to the predicate device do not raise new questions of safety and effectiveness.

Biocompatibility

The LipiScan™ DMI does not contact the patient's eye. LipiScan™ DMI directly contacts the patient's intact skin (surface-contacting device) for up to 15 minutes (limited (< 24 hours) contact duration). The surface-contacting material composition and device manufacturing process are the same as those of the predicate LipiView® II device cleared in K152869; therefore, new biocompatibility testing is not needed.

Sterilization. Cleaning and Disinfection

The LipiScan™ DMI is used non-sterile and sterilization is not applicable. Patient contact surfaces are disinfected with 70-90% isopropyl alcohol prior to each patient use and prior to storage. The verification testing shows that the device patient contact materials are compatible with isopropyl alcohol disinfection. Additionally, the Instructions for Use provide instructions for cleaning other surfaces of the device that the operator may contact during use but do not have direct patient contact.

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Electrical Safety and Electromagnetic Compatibility (EMC)

To support substantial equivalence in electrical safety and electromagnetic compatibility (EMC) to the predicate device, LipiScan " DMI was tested for conformance to the following standards:

. ANSI AAMI ES60601-1 2005 /(R)2012 and A1:2012: C1:2009/(R)2012 and A2:2010/(R) Consolidated Text Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD)
IEC 60601-1-2 2007: Medical electrical equipment Part 1-2: General . Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

Light Hazard Protection

LipiScan™ DMI uses near-infrared (NIR) illumination and an NIR-sensitive highresolution camera to image the meibomian glands and captures black and white still images. Whereas, the predicate device, LipiView® II, uses a white light Class I LED illuminator, visible LED fixation light and captures full color still images and video.

Both devices comply with standards for light hazard protection. LipiScan™ DMI meets Group 1 ophthalmic instruments as defined in the ISO 15004-2: 2007 and ANSI Z80.36:2016 standards for which no potential light hazard exists. The predicate LipiView® II device meets Group 2 ophthalmic instrument requirements for which a potential light hazard exists.

Software

LipiScan™ DMI is based on the same fundamental technology as the predicate device, LipiView® II Ocular Surface Interferometer. The LipiScan™ DMI software development was largely based on the LipiView® II gland imaging software. As for the predicate device, LipiScan™ DMI software is categorized as a Minor Level of Concern. The software documentation for the LipiScan™ DMI is provided per FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices (May 11, 2005). Verification and Validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the LipiScan" DMI software.

CONCLUSIONS:

The LipiScan" Dynamic Meibomian Imager has the same intended use, Indications for Use and fundamental scientific technology as the predicate device. Performance testing demonstrates that LipiScan" is substantially equivalent in intended use and technological characteristics to the predicate device. Based on performance testing, LipiScan" is at least as safe and effective as the predicate device.

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TABLE 1. PREDICATE DEVICE COMPARISON TABLE
ComparisonFeature	LipiScan™ Dynamic Meibomian Imager(DMI)	Predicate LipiView® II Ocular SurfaceInterferometer (K152869)	Comparison
Intended Use per21 CFR 886.1120	Bench-top, AC-powered device intended totake photographs of the eye and thesurrounding area	Bench-top, AC-powered device intended to takephotographs of the eye and the surrounding area	Same intended use
Indications for Use	LipiScan™ Dynamic Meibomian Imager(DMI) is an ophthalmic imaging deviceintended for use by a physician in adultpatients to capture, archive, manipulate andstore digital images of the meibomianglands.	LipiView® II Ocular Surface Interferometer is anophthalmic imaging device intended for use by aphysician in adult patients to capture, archive,manipulate and store digital images of:• Meibomian glands under near-infrared (NIR)illumination.• Specular (interferometric) observations of the tearfilm. Using these images, LipiView® II measures theabsolute thickness of the tear film lipid layer.• The ocular surface and eyelids under whiteillumination.All of these image types can be photographicallydocumented and visually monitored.	Same Indications for Use by aphysician in adult patients tocapture, archive, manipulate andstore digital images of themeibomian glands.The predicate device has additionalindications that are not included inLipiScan™. Therefore, thisdifference does not raise newquestions of safety andeffectiveness for LipiScan™ for itsintended use.
Rx only/OTC	Prescription Device	Prescription Device	Same intended use
Operation Principle	Uses near infrared (NIR) illumination toimage the meibomian glands	Uses near infrared (NIR) illumination to image themeibomian glands	Same principle of operation
Components	Computer system, electronics, adjustable chinand forehead rest, high definition digitalcamera, lens, illuminator, touchscreen display,and handheld near IR lid everter	Computer system, electronics, adjustable chin andforehead rest, high definition digital camera, lens,illuminator, touchscreen display, and handheld nearIR lid everter	Same technologic characteristics
Accessory Support	• Support for OTS USB printer and mediacompatible with Windows 7 and USB2.0• External HDMI monitor connection• Operates with wireless networks	• Support for OTS USB printer and mediacompatible with Windows 7 and USB2.0• External HDMI monitor connection• Operates with wireless networks	Same technologic characteristics
Patient ContactMaterials	Chin and forehead rests and lid everter aremade of the same patient contact materialsand use the same disinfection method	Chin and forehead rests and lid everter are made ofthe same patient contact materials and use the samedisinfection method	Same technologic characteristics
TABLE 1. PREDICATE DEVICE COMPARISON TABLE
ComparisonFeature	LipiScan™ Dynamic Meibomian Imager(DMI)	Predicate LipiView® II Ocular SurfaceInterferometer (K152869)	Comparison
Illumination Source	• NIR LED surface illumination andtransillumination of the eyelid	• NIR LED surface illumination andtransillumination of the eyelid• Visible White Class I LED illumination• Visible LED fixation light	Both devices use NIR illumination.Predicate device has additionallight sources to support additionalindications and functionality thatare not in LipiScan™.
IlluminationExposure Parameters	Complies with ISO 15004-2:2007 and ANSIZ80.36:2016 Group 1 instrument	Complies with ISO 15004-2:2007 Group 2instrument	Both devices comply with standard
Electrical Safetyand EMC	Complies with ANSI AAMI ES60601-1:2005/ (R)2012 and A1:2012: C1:2009/(R)2012 and A2:2010/(R) and IEC 60601-1-2:2007	Complies with ANSI ES 60601-1:2005 (ThirdEdition) and IEC 60601-1-2: 2007 (Third Edition)	Both devices comply with standard
MaterialFlammability	Materials near light source and deviceenclosure comply with UL 94:2013	Materials near light source comply with UL 94:2013	Both devices comply with standard
Temperature ofHeld or AccessibleParts	Ambient temperature of parts of device heldby operator or accessible to patientcompliant to ISO 15004-1:2006	Ambient temperature of parts of device held byoperator or accessible to patient compliant to ISO15004-1:2006	Both devices comply with standard
Software Features	• Microsoft Windows Operating System• Touchscreen display GUI• Password-protected user login, patientdatabase entry, real-time display to acquireand view images, image storage and exportto external media, printed or saved reports• Touchscreen user controls• Black and white still images• Software module for gland imaging	• Microsoft Windows Operating System• Touchscreen display GUI• Password-protected user login, patient databaseentry, real-time display to acquire and view images,image storage and export to external media, printedor saved reports• Touchscreen and pushbutton user controls• Full color still images and video• Software modules for tear film and thicknessmeasurement, ocular imaging and gland imaging	Same technologic characteristics,except the predicate device alsohas pushbutton controls, full colorimages and video, and softwaredesigned for tear film and ocularimaging and lipid layer thicknessmeasurement. These additionalfeatures are needed to supportadditional indications for thepredicate device but are not neededfor meibomian gland imaging.
Camera Alignmentand Image FocusMethods	Dual chinrest with sensor and camera capableof capturing entire field of view to aligncamera to the patient's eye and electronicallycontrolled lens to focus the image	Electromechanical stages to align camera to patient'seye and focus the image	Methods are equivalent. Motorizedstages are not needed to captureand focus an image usingLipiScan™, as shown byperformance testing.

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Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.