The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Device Description

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Control component (labeled as Console) provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Disposable component (labeled as Activator).

This 510(k) submission is for the device modification of new model of the Disposable component (labeled Activator II, Model LFD-2000), a new semi-permanent Cable (Model CBL-2000), and a hardware and software update to the Control component (labeled as Console, Model LFTP-1000). The modified LipiFlow® System has the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified version of the LipiFlow® Thermal Pulsation System. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy with novel acceptance criteria and studies demonstrating the device meets those criteria.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance (in the context of new clinical endpoints).
Sample sizes for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth for a test set in the context of proving new performance claims.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human readers with/without AI assistance.
Standalone algorithm performance studies.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for novel clinical claims.
Sample size for training sets.
How ground truth for training data was established.

Instead, the document focuses on demonstrating that the modified LipiFlow® System (specifically, changes to the disposable component, a new cable, and hardware/software updates to the console) is substantially equivalent to the predicate LipiFlow® System.

Here's what the document does provide regarding performance testing and conclusions:

Acceptance Criteria and Device Performance (in the context of substantial equivalence):

The performance testing focused on demonstrating that the modified device maintained the same safety and effectiveness as the predicate device, conforming to special controls. Instead of "acceptance criteria" in the sense of novel clinical endpoints, the "criteria" are essentially the established performance and safety profiles of the predicate device and relevant standards.

Feature/Aspect	Studied Conformance/Performance
Electrical Safety and EMC	Performance testing demonstrates that the modified LipiFlow® System conforms to the same electrical safety and EMC performance standards as for the predicate device.
Temperature and Pressure Performance/Safeguards	Performance testing shows that the modified LipiFlow® System has equivalent temperature and pressure performance and safeguard functions, including during fault conditions, as the predicate device. The modified device meets the same design requirements as the predicate device based on known safe and effective temperature and pressure specifications, previously validated in bench, animal, and clinical studies of the LipiFlow® System.
Packaging, Sterility, Shelf-life (Activator II)	The packaging, sterility, and shelf-life for the new Activator II model are the same as for the predicate Activator models. The new Activator II model meets the same performance standards for sterility and shelf-life as the predicate Activator models.
Biocompatibility (Activator II Patient Contact)	The patient contact materials for the new Activator II model are the same as for the predicate Activator models. Therefore, the new Activator II model meets the same biocompatibility performance standards as the predicate Activator models.
Effect on Safety and Effectiveness	Performance testing shows that the device modifications do not raise new questions of safety and effectiveness, and do not adversely affect safety and effectiveness of the device.
Software Verification & Validation	Conducted and documented as recommended by FDA guidance for "moderate" level of concern software.

Study Information Pertaining to Substantial Equivalence:

Study Type: The document describes "performance testing" rather than a clinical trial with novel efficacy endpoints. This testing aimed to demonstrate that the modifications did not alter the safety or effectiveness profile previously established for the predicate device.
Sample Sizes / Data Provenance / Ground Truth / Experts / Adjudication: These details are not provided because the submission is for device modification and substantial equivalence, not a new clinical efficacy study. The "ground truth" for the performance comparisons is implicitly the established performance of the predicate device and relevant industry standards.
MRMC / Standalone AI Performance: Not applicable, as this is not an AI/algorithm-focused submission. The device is a physical thermal pulsation system.
Training Set Sample Size/Ground Truth: Not applicable for this type of submission. The performance testing is about ensuring the modified device operates to the same specifications as the predicate. The "ground truth" for the predicate device's efficacy was established through previous bench, animal, and clinical studies, but details of those studies are not provided here.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

November 4, 2016

TearScience, Inc. Ms. Christy Coleman Vice President, Clinical, Quality and Regulatory Affairs 5151 McCrimmon Parkway Suite 250 Morrisville, NC 27560

Re: K161357

Trade/Device Name: Lipiflow® Thermal Pulsation System Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: October 4, 2016 Received: October 5, 2016

Dear Ms. 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 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

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 yours,

Kesia Alexander

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 LipiFlow® Thermal Pulsation System (Component Models LFTP-1000, LFD-1000, LFD-1100, LFD-2000 and CBL-2000)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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:	September 26, 2016
APPLICANT:	TearScience, Inc.5151 McCrimmon Parkway, Suite 250Morrisville, NC 27560Tel: (919) 467-4007Fax: (919) 467-3300
CONTACT PERSON:	Christy Coleman, OD, MPHVice President, Clinical, Quality & Regulatory Affairs
DEVICE TRADE NAME:	LipiFlow® Thermal Pulsation System• Console Model LFTP-1000• Activator (Disposable) Models LFD-1000, LFD-1100 and LFD-2000 with Cable Model CBL-2000
CLASSIFICATION NAME:	Eyelid Thermal Pulsation System
DEVICE CLASSIFICATION:	Class II; 21 CFR 886.5200
PRODUCT CODE:	ORZ
PREDICATE DEVICE:	LipiFlow® Thermal Pulsation SystemClass II under 21 CFR 886.5200Applicant: TearScience, Inc.Cleared under DEN100017 on June 28, 2011• Handheld Control System Model LFH-1000 and• Disposable Model LFD-1000Cleared under K112704 on December 19, 2011 (corrected letter received January 12, 2012)• Console Model LFTP-1000 and• Activator (Disposable)Model LFD-1000Cleared under K133127 on December 23, 2013• Console Model LFTP-1000 and• Activator (Disposable)Models LFD-1000 and LFD-1100

DEVICE DESCRIPTION:

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The new Activator II model (LFD-2000) is the same as the predicate Activator models (LFD-1000 and LFD-1100) except that the electrical and pneumatic connection point is moved closer to the patient interface. This allows the disposable portion of the device to be smaller and less wasteful. The predicate Activator models include a combined patient interface and permanently attached cable, which is connected to the Console and disposed of after each treatment. Conversely, the patient interface of the new Activator II model is used with a new semipermanent Cable, which connects the Activator II to the Console but is not disposed of after treatment. Compared to the predicate Activator models, the patient interface portion of the new Activator II model is identical in shape, size, patient contact materials, electrical safety, packaging, sterility, shelf-life, method of preventing re-use, and temperature and pressure performance and safety.

The LipiFlow® Console hardware was updated with a new equivalent computer to address computer obsolescence in the predicate device. To support the new computer, the Console was updated to a new Operating System and the software application was modified to support the hardware-specific driver differences in the Operating Systems.

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

The modified LipiFlow® Thermal Pulsation System has the same fundamental scientific technology as the predicate device, as described in DEN100017, K112704 and K133127. Most of the technological characteristics of the LipiFlow® System remain unchanged from the predicate device. The similarities and differences in technological characteristics are described below.

Similarities :

The modified device and the predicate device have the following same design features:

Both devices have the same principle of operation.
. Both devices have a single-use, hermetically sealed, biocompatible Disposable component, which has the same design features for temperature safety, pressure safety, mechanical safety, biocompatibility, sterility and method to prevent re-use.
Both devices use a Cable to join the patient interface (Disposable) to the physician interface ● (Console) that has the same electrical and pneumatic design requirements.

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. Both devices have a Control component with the same treatment hardware, treatment control, temperature and pressure specifications, safety features, device self-tests, software user interface and touchscreen display.
. Both devices comply with the same performance standards for electrical safety and electromagnetic compatibility (EMC).

Differences:

The differences between the new Activator II (Model LFD-2000) with the new semi-permanent Cable (Model CBL-2000) and the predicate Activator models (LFD-1000 and LFD-1100) include:

. Activator II does not have a permanently attached cable for air tubing and electrical wiring. Activator II has a new electrical and pneumatic connector located behind the patient interface area that attaches to the new semi-permanent Cable. The single-use fuse that disables the Disposable component after treatment to prevent re-use was moved from the cable connector in the predicate Activator model to the Activator II.
The new Cable is not disposable; it is semi-permanent and designed and tested for over 2,500 ● uses. A locking clip was added to the Cable connector to the Console to prevent accidental disposal of the Cable and to keep the connection with the Console secure. An electrical switch was added to the Cable connector to the Console, which when pressed will electrically disconnect the Cable from the Console facilitating self-test and troubleshooting system error messages. The Cable has a new electrical and pneumatic connector to attach to the Activator II. The Cable has three additional electrical conductors needed to detect when the Activator II is connected and to deactivate the Activator II when treatment is complete to prevent reuse. A new Cable holder was designed to store the Cable on the Console when not in use.

The differences between the modified Console and the predicate Console include:

. The modified Console hardware has a new equivalent computer because the computer in the predicate device became obsolete.
. The modified Console utilizes off-the-shelf Microsoft Windows 7 Embedded Operating System with drivers to support a new computer; whereas, the predicate device utilizes off-the-shelf Microsoft Windows XP Embedded Operating System.
. The modified LipiFlow® software application has been updated from the predicate software to support the hardware-specific driver differences in the Operating Systems.

PERFORMANCE TESTING:

Performance testing was conducted to demonstrate substantial equivalence of the modified LipiFlow® System to the predicate LipiFlow® System, and to validate continued conformance to the following special controls for an eyelid thermal pulsation system per 21 CFR 886.5200.

1. Performance testing demonstrates that the modified LipiFlow® System conforms to the same electrical safety and EMC performance standards as for the predicate device.

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1. Performance testing shows that the modified LipiFlow® System has equivalent temperature and pressure performance and safeguard functions, including during fault conditions, as the predicate device. The modified device meets the same design requirements as the predicate device based on known safe and effective temperature and pressure specifications, previously validated in bench, animal and clinical studies of the LipiFlow® System.
1. The packaging, sterility and shelf-life for the new Activator II model are the same as for the predicate Activator models. The new Activator II model meets the same performance standards for sterility and shelf-life as the predicate Activator models.
1. The patient contact materials for the new Activator II model are the same as for the predicate Activator models. Therefore, the new Activator II model meets the same biocompatibility performance standards as the predicate Activator models.
1. Performance testing shows that the device modifications do not raise new questions of safety and effectiveness, and do not adversely affect safety and effectiveness of the device.

Furthermore, software verification and validation testing were conducted and documentation was 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." The software for this device was considered as a "moderate" level of concern because the software is an accessory to a medical device that has a moderate level of concern. Prior to the mitigation of hazards, a failure of the device could result in minor injury to the patient or user.

CONCLUSIONS:

The modified LipiFlow® System has the same intended use and the same fundamental scientific technology as the predicate device. Performance testing demonstrates the modified LipiFlow® System is at least as safe and effective as the legally marketed LipiFlow® System. Therefore, the modified LipiFlow® System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 886.5200 Eyelid thermal pulsation system.

(a)
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;
(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(4) The device should be demonstrated to be biocompatible; and
(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.