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 neibomian glands. The LipiFlow System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Console (Control component) 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 Activators (Disposable component). No changes to the Console are proposed in this 510(k). The Activator (Disposable) is a sterile; single-use. biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's eyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector. There are two models of the Activator (Disposable). Except for the addition of a memory device, Activator (Disposable) Models LFD-1000 (cleared under K093937) and LFD-1100 (modified under design controls) are equivalent with no difference in device performance, safety or effectiveness. This 510(k) submission is for a device modification of new materials for the LipiFlow Activator (Disposable). The proposed changes to the Activator (Disposable) are to provide a second source for the raw materials used in the eyecup bladder (diaphragm), lid warnier glue and heater components to facilitate manufacturing. The model numbers of the Activator (Disposable) will not change as a result of this change. The LipiFlow Activator (Disposable) with the new second source materials has the same intended use and same fundamental scientific technology as the predicate cleared device (LipiFlow® Activator (Disposable) with cleared materials, as described in K093937 and K.I. 2704). Accordingly, this 510(k) submission for a design change to use second source new materials in the Activator (Disposable) applies to both model numbers (LFD-1000 and LFD-1100) of the Disposable component.

AI/ML Overview

Below is a description of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance Study for LipiFlow® Thermal Pulsation System (K133127)

This 510(k) submission (K133127) describes a device modification involving new materials for the LipiFlow Activator (Disposable) component. The primary objective was to demonstrate that these material changes do not adversely affect the safety and effectiveness of the device, maintaining substantial equivalence to the predicate devices (K093937 and K112704).

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing focused on demonstrating conformance to special controls for an eyelid thermal pulsation system per 21 CFR 886.5200.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (New Activator Materials)
Special Controls (21 CFR 886.5200)
EMC and Safety	Testing to validate EMC and safety of exposure to non-ionizing radiation.	The LipiFlow System with the Activator with new materials passed all design verification and validation tests. This implies conformance to EMC and non-ionizing radiation safety, as these are typically part of a comprehensive safety validation.
Safeguards (Temp & Pressure)	Design, description, and performance data validating safeguards related to the temperature and pressure aspects of the device, including during fault conditions.	The temperature and pressure safeguards related to the Activator operate as designed and are substantially equivalent between the new and original materials. The material changes in the Activator do not affect any of the temperature or pressure safeguards. (Passed)
Sterility & Shelf-life	Performance data demonstrating the sterility of patient contacting components and the shelf-life of these components.	The text states the system passed all design verification and validation tests, which would include sterility and shelf-life of patient-contacting components. Although not explicitly detailed for this modification, it's inferred based on the overall "passed all tests" statement and the requirement of special controls.
Biocompatibility	Performance data demonstrating biocompatibility of patient contact materials.	The new second source materials for the eyecup bladder (diaphragm), lid warmer glue, and heater components were selected based on their similarities in material properties including biocompatibility. The system passed all design verification and validation tests, which confirms biocompatibility.
Effect of Tech Changes	Performance data demonstrating that any technological changes do not adversely affect safety and effectiveness. This implicitly includes demonstrating equivalent temperature and pressure performance to the predicate device specifications.	The temperature and pressure performance of the Activator with new second source materials is substantially equivalent to the predicate Activator with original materials. The Activator with new materials meets the same design requirements as the Activator with existing materials based on known safe and effective temperature and pressure specifications. These specifications were "previously validated in bench, animal and clinical studies of the LipiFlow System (refer to K093937 and K112704)."

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

The document primarily describes bench testing for design verification and validation of the material changes. There is no information provided regarding a specific "test set" of patient data or sample size in terms of human subjects for this 510(k) submission (K133127). The evaluation focused on engineering and material performance rather than clinical performance on a new patient cohort.

The data provenance for the original safety and effectiveness of the LipiFlow System (K093937 and K112704) involved "bench, animal and clinical studies." However, the details of these are not provided within this specific document, and they pertain to the predicate device, not directly to the current material modification under K133127.

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

Not applicable. This submission concerns material modifications evaluated through bench testing and engineering verification/validation, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set data was used for this specific 510(k) given the nature of the device modification (material change).

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

Not applicable. The LipiFlow System is a medical device for localized heat and pressure therapy, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The LipiFlow System is a physical device that performs a therapeutic action, not an algorithm. Performance was evaluated through the device's adherence to its operational specifications and safety parameters.

7. The Type of Ground Truth Used

For the material modifications in K133127, the "ground truth" was established based on:

Engineering specifications and design requirements: The new materials needed to meet the same physical, electrical, and performance specs as the original materials.
Biocompatibility standards: The new patient contact materials had to meet established biocompatibility requirements.
Safety standards: The device operating with new materials had to pass tests ensuring all safety safeguards (temperature, pressure) function correctly, even under fault conditions.

For the original LipiFlow System's safety and effectiveness (predicate device), the ground truth was established through "bench, animal and clinical studies" (as referenced in K093937 and K112704), which would have involved clinical outcomes and possibly expert assessment for efficacy, and direct measurement for safety parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for the device's performance would be the extensive design, engineering, and testing processes to ensure it meets its predefined specifications.

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

Not applicable, as this is not an AI/machine learning device with a training set. The "ground truth" for the device's design and operational parameters was established through established engineering principles, regulatory standards, and clinical validation studies for the original device.

Summary

{0}------------------------------------------------

K133127

Page 1 of 3

LIPIFLOW® SYSTEM: NEW ACTIVATOR MATERIALS Traditional Premarket Notification

510(k) SUMMARY

. DEC 2 3 2013

September 27, 2013 PREPARATION DATE:

APPLICANT:

TearScience, Inc. 5151 McCrimmon Parkway, Suite 250 Morrisville, NC 27560 .

Tel: (919) 467-4007 Fax: (919) 467-3300

Christy Stevens, OD, MPH

CONTACT PERSON:

DEVICE TRADE NAME:

LipiFlow Thermal Pulsation System Model LFTP-1000. Console and · Model LFD-100() & LFD-1100, Activator (Disposable)

Vice President. Clinical and Regulatory Affairs

CLASSIFICATION NAME: Eyelid Thermal Pulsation System

DEVICE CLASSIFICATION: Class II; 21 CFR 886.5200

PRODUCT CODE: ORZ

PREDICATE DEVICE:

LipiFlow Thermal Pulsation System Model LFH-1000, Handheld Control System and Model LFD-1000. Disposable Cleared under K093937and Evaluation of Automatic Class III Designation on June 28, 2011

Model LFTP-1000, Console and Model LFD-1000, Activator (Disposable) Class II under 21 CFR 886.5200 Applicant: TearScience, Inc. Cleared under K112704 on December 19, 2011 (corrected letter received January 12, 2012)

Class II under 21 CFR 886.5200 Applicant: TearScience, Inc

DEVICE DESCRIPTION:

{1}------------------------------------------------

LIPIFLOW SYSTEM: NEW ACTIVATOR MATERIALS TRADITIONAL PREMARKET NOTIFICATION

component) and a patient interface (Disposable component). The Console (Control component) 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 Activators (Disposable component). No changes to the Console are proposed in this 510(k).

The Activator (Disposable) is a sterile; single-use. biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's eyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector. There are two models of the Activator (Disposable). Except for the addition of a memory device, Activator (Disposable) Models LFD-1000 (cleared under K093937) and LFD-1100 (modified under design controls) are equivalent with no difference in device performance, safety or effectiveness.

This 510(k) submission is for a device modification of new materials for the LipiFlow Activator (Disposable). The proposed changes to the Activator (Disposable) are to provide a second source for the raw materials used in the eyecup bladder (diaphragm), lid warnier glue and heater components to facilitate manufacturing. The model numbers of the Activator (Disposable) will not change as a result of this change. The LipiFlow Activator (Disposable) with the new second source materials has the same intended use and same fundamental scientific technology as the predicate cleared device (LipiFlow® Activator (Disposable) with cleared materials, as described in K093937 and K.I. 2704). Accordingly, this 510(k) submission for a design change to use second source new materials in the Activator (Disposable) applies to both model numbers (LFD-1000 and LFD-1100) of the Disposable component.

INTENDED USE:

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 meibonian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The Intended Use has not changed.

TECHNOLOGICAL CHARACTERISTICS:

Similarities: The new second source materials used in the fabrication of the Activator (Disposable) were selected based on their similarities in material properties including biocompatibility. The Activator (Disposable) fabricated with the new second source materials employs the same principle of operation to provide the same heat and pressure therapy to the eyelids. The Activator (Disposable) fabricated with the new second source materials is visually indistinguishable from the predicate device. The safety features incorporated in the existing Console and Activator (Disposable) configurations have not changed.

Differences: The patient contact biocompatible silicone material used to fabricate the bladder component of the Activator (Disposable) has changed to new second source

{2}------------------------------------------------

LIPIFLOW SYSTEM: NEW ACTIVATOR MATERIALS TRADITIONAL PREMARKET NOTIFICATION

biocompatible silicone materials. The new materials are self-bonding to the plastic substrate. The existing cleared materials require a bonding agent to be applied to the substrate prior to molding. The patient contact biocompatible UV-cured cyanoacrylate adhesive has changed to a lower viscosity version, allowing the adhesive to more readily be used in conjunction with automated equipment. The electrically conductive plastic used to fabricate the heater within the lid warmer has been second sourced from another plastic manufacturer.

PERFORMANCE TESTING:

Performance testing demonstrated conformance to the special controls for an evelid thermal pulsation system per 21 CFR 886.5200, which include:

1. Testing to validate EMC and safety of exposure to non-ionizing radiation.
1. Design, description, and performance data validating safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
1. Performance data demonstrating the sterility of patient contacting components and the shelf-life of these components.
1. Performance data demonstrating biocompatibility of patient contact materials.
1. Performance data demonstrating that any technological changes do not adversely affect safety and effectiveness.

The LibiFlow System with the Activator with new bladder, glue and heater materials passed all design verification and validation tests, including validation of the temperature and pressure performance and safeguards.

The temperature and pressure safeguards related to the Activator operate as designed . and are substantially equivalent between the new and original materials. The material changes in the Activator do not affect any of the temperature or pressure safeguards.
The temperature and pressure performance of the Activator with new second source . materials is substantially equivalent to the predicate Activator with original materials. The Activator with new materials meets the same design requirements as the Activator with existing materials based on known safe and effective temperature and pressure specifications, previously validated in bench, animal and clinical studies of the LipiFlow System (refer to K093937 and K112704).

CONCLUSIONS:

Neither the Intended Use nor the Indications For Use have changed as a result of the proposed second-source materials. The proposed second-source materials for the Activator (Disposable) conform to all required special controls, are substantially equivalent to the cleared predicate device, do not raise new questions of safety and effectiveness, and do not adversely affect safety and effectiveness of the device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 23, 2013

TearScience, Inc. % Christy Stevens, OD, MPH Vice President, Clinical and Regulatory Affairs 5151 McCrimmon Parkway, Suite 250 Morrisville, NC 27560

Re: K133127

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 24, 2013 Received: October 28, 2013

Dear Dr. Stevens:

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 reguirements for annual registration. Isting 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.

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

{4}------------------------------------------------

Page 2 - Dr. Christy Stevens

..............................................................................................................................................................................

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 (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Deborah L. Falls -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

{5}------------------------------------------------

LIPIFLOW® System: New Activator Materials Traditional Premarket Notification

INDICATIONS FOR USE

510(k) Number:

. .. ....

K133127

Device Name: LipiFlow® Thermal Pulsation System

Model Numbers: LFTP-1000, LFD-1000 and LFD-1100

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

J Angelo Green 2013.12.17 18:34:26 -05'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number_ K133127

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.