(89 days)
Not Found
No
The summary describes standard ophthalmic imaging technology using near-infrared light and a camera. There is no mention of AI, ML, or any advanced image analysis beyond basic manipulation and storage. The performance studies focus on equivalence to a predicate device using traditional methods, not AI/ML performance metrics.
No
The device is described as an "ophthalmic imaging device" used to "capture, archive, manipulate and store digital images of the meibomian glands." Its function is diagnostic imaging, not therapeutic intervention.
No
The device is described as an "ophthalmic imaging device" intended to "capture, archive, manipulate and store digital images of the meibomian glands." Its function is to image the glands, not to provide a diagnosis.
No
The device description explicitly lists multiple hardware components including a camera, lens, illuminator, touchscreen display, and a handheld near-infrared (IR) lid everter, indicating it is a hardware device with integrated software.
Based on the provided information, the LipiScan™ Dynamic Meibomian Imager is not an IVD (In Vitro Diagnostic).
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.
- LipiScan's Function: The LipiScan™ is an imaging device that directly images the meibomian glands within the patient's eyelid using near-infrared light. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "capture, archive, manipulate and store digital images of the meibomian glands," which is a direct imaging and documentation function, not a diagnostic test performed on a sample.
Therefore, the LipiScan™ falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HKI
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.
Mentions image processing
capture, archive, manipulate and store digital images of the meibomian glands.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
near infrared (NIR) illumination
Anatomical Site
meibomian glands, eye, ocular surface, eyelids
Indicated Patient Age Range
adult patients
Intended User / Care Setting
physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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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Image /page/3/Picture/1 description: The image shows the logo for TearScience. The logo consists of a stylized eye on the left and the word "TearScience" on the right. The eye is light blue, and the word "TearScience" is in a darker blue. There is a registered trademark symbol after the word "TearScience".
510(k) SUMMARY
| PREPARATION DATE: | November 6, 2018 |
|---|---|
| APPLICANT: | TearScience, Inc. |
| 5151 McCrimmon Parkway, Suite 250 | |
| Morrisville, NC 27560 | |
| Tel: (919) 467-4007 | |
| Fax: (919) 467-3300 | |
| CONTACT PERSON: | Christy Coleman, OD, MPH |
| Vice 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 Surface |
| Interferometer (K152869) | |
| Regulation Number: 21 CFR 886.1120 | |
| Regulation Name: Ophthalmic Camera | |
| Regulatory Class: Class II | |
| Product Code: HKI, HIO |
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.
4
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.
5
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 (