LIPIFLOW THERMAL PULSATION SYSTEM

K112704 · Tearscience, Inc. · ORZ · Dec 19, 2011 · Ophthalmic

Device Facts

• Record ID: K112704
• Device Name: LIPIFLOW THERMAL PULSATION SYSTEM
• Applicant: Tearscience, Inc.
• Product Code: ORZ · Ophthalmic
• Decision Date: Dec 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5200
• Device Class: Class 2
• Attributes: Therapeutic

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 meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Device Story

LipiFlow Thermal Pulsation System (Console LFTP-1000 and Activator LFD-1000) provides localized heat and pressure therapy to eyelids. Physician-operated in-office procedure. System consists of console (control unit) and sterile, single-use polycarbonate/silicone Activator (eyepiece) inserted around patient eyelids. Console controls heat application to inner eyelid surface and intermittent pressure to outer eyelid to facilitate lipid release from meibomian glands. Console features Windows XP embedded computer, touchscreen GUI, and treatment hardware for simultaneous bilateral treatment. Console monitors treatment, controls pressure sequences, and includes safeguard circuitry. Output includes treatment monitoring data and patient records. Benefits patients by treating chronic cystic eyelid conditions/MGD. Console replaces handheld control system (HCS) predicate with bench-top design, AC power, and enhanced user interface.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by bench performance testing, software verification/validation, and reference to clinical studies previously validated for the predicate system (K093937). Testing confirmed equivalent temperature/pressure performance, safeguard functions, sterility, and biocompatibility.

Technological Characteristics

Bench-top console (AC-powered) and sterile polycarbonate/silicone disposable Activator. Sensing/actuation: pneumatic/electrical contacts for heat/pressure delivery. Connectivity: serial interface between console and treatment hardware. Software: Windows XP embedded, touchscreen GUI. Safeguards: redundant pressure sensors, back-up pressure relief, device self-tests. Sterilization: Disposable is sterile, single-use.

Indications for Use

Indicated for adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), evaporative dry eye, or lipid deficiency dry eye.

Regulatory Classification

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.

Special Controls

In addition to the general controls of the Act, the LipiFlow® Thermal Pulsation System is subject to the following special controls:

*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.

Predicate Devices

• LipiFlow® Thermal Pulsation System Model LFH-1000 (K093937)

Submission Summary (Full Text)

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K112704

# DEC 1 9 2011

# 510(k) SUMMARY

| PREPARATION DATE: | September 12, 2011 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | TearScience, Inc.<br>5151 McCrimmon Parkway, Suite 250<br>Morrisville, NC 27560 |
| | Tel: [phone]<br>Fax: [phone] |
| CONTACT PERSON: | Christy Stevens, OD, MPH<br>Vice President, Clinical and Regulatory Affairs |
| DEVICE TRADE NAME: | LipiFlow® Thermal Pulsation System<br>Model LFTP-1000, Console and<br>Model LFD-1000, Activator (Disposable) |
| CLASSIFICATION NAME: | Eyelid Thermal Pulsation System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 886.5200 |
| PRODUCT CODE: | ORZ |
| PREDICATE DEVICE: | LipiFlow® Thermal Pulsation System<br>Model LFH-1000. Handheld Control System (HCS) and<br>Model LFD-1000, Disposable<br>Class II under 21 CFR 886.5200<br>Applicant: TearScience, Inc.<br>Cleared under K093937and Evaluation of Automatic Class II<br>Designation on June 28, 2011 |

### 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 prossure the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow System is comprised of physician interface (Control component) and a patient interface (Disposable component). There are two models of the Control component: Model LFH-1000, Handheid Control System (HCS) and Model LFTP-1000, Console. The Console is a rhange in design from the HCS predicate device model. The LipiFlow® Console was developed fring the same treatment control technology as in the LipiFlow® FICS with enhancements in the user interface and power source. Both the Console and HCS work with the same Disposable component (Model LFD-1000), now labeled as Activator (Disposable).

The Activator (Disposable) is a sterile, single-use, biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's cyelids. 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.

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#### LIPIFLOW" SYSTEM (MODEL: LFTP-1000 & LFD-1000) TRADITIONAL PREMARKET NOTIFICATION

The Console is an AC-powered, bench-top device used by the physician to control the application of heat and pressure to the patient's eyelids. The Console consists of a Windows XP embedded computer subsystem with touchscreen display and a software graphical user interface; and treatment hardware for treatment of the patient's right and left eyes using two Activators (Disposables). The 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 Activators (Disposables).

#### 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 meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

#### TECHNOLOGICAL CHARACTERISTICS:

Similarities: The Console and HCS models emplov the same principle of operation and work with the same Disposable component, which provides the same Disposable safety features and the same method to prevent re-use of the Disposable. Both models have the same pneumatic and electrical contacts that interface with the Disposable. The Console and HCS both uillize treatment hardware and safeguards to control the application of heat and pressure to the same safe and effective temperature and pressure specifications. Both models use the same 2-minute pressure profiles and same default pressure sequence. The Console provides the user with the same treatment monitoring capability and treatment control features as in the HCS. Both models perform self-tests to ensure proper operation of the Disposable and treatment hardware. Furthermore, the treatment hardware in both models is powered by DC power, and both models comply with the same standards for electrical safety and electromagnetic compatibility (EMC).

Differences: The Console's connector to the Disposable uses a different material than the HCS for more robust use. Compared to the HCS, the Console has minor improvements in the treatment hardware, including temperature and pressure sensing accuracy. redundant pressure sensor tracking, back-up pressure safeguard method, pressure relief, and device self-test features. The Console provides the user with the additional ability to perform independent treament of both eyes at the same time using two Disposables and to modify the pressure sequence. The Console is a bench-top enclosure; whereas, the HCS is a handheld device that can be placed on a bench-top using an accessory cradle. Compared to the hardware-only interface on the HCS. the Console has a software user interface with a patient database. support for printing and storage of patient records, and an enhanced treatment display format. Furthermore. the user interface and treatment hardware communication is a serial interface in the Console and hardwired in the HCS. The Console uses AC power in place of the battery power in the HCS.

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KI12704

### PERFORMANCE TESTING:

Performance testing was conducted to demonstrate substantial equivalence between the LipiFlow® Console and HCS models and conformance to the special controls for an eyelid thermal pulsation system per 21 CFR 886.5200.

- l ) The Console conforms to the same electrical safety and EMC performance standards as the HCS in support of the change in power source.
- 2) The Console shows equivalent temperature and pressure performance and safeguard functions as the HCS including in normal operation, during fault conditions and in a direct companison. during treatment of human eyelids. The Console meets the same design requirements as the HCS 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).
- 3) The sterility and shelf-life of the Disposable, which is used with both the Console and HCS models, meets performance standards for sterility and shelf-life testing.
- 4) The biocompatibility of the Disposable, which is used with both the Console and HCS models, meets performance standards for biocompatibility (refer to K093937).
- 5) Software verification and validation testing shows the Console software mects design input requirements and user needs. The usability of the Console bench-top design and user interface with touchscreen monitor has been validated to usability standards. Additionally, the Console's software does not control treatment, and a software failure would not offect the hardware's treatment control or the safety circuits.

Software verification and validation and bench performance testing of the additional user functions show that these functions do not adversely affect safety and effectiveness, and demonstrate substantial equivalence between the Console and HCS models.

Bench performance testing supports that the minor improvements in the treatment hardware in the Console model do not raise new questions of safety and effectiveness. The Console treatment hardware function was verified and validated to meet design requirements with substantially equivalent performance to the HCS.

## CONCLUSIONS:

The LipiFlow® Console and Disposable configuration (Model LFTP-1000 and LFD-1000) has the same intended use and indications for use as the predicate device, the LipiFlow HCS and Disposable configuration (Model LFH-1000 and LFD-1000). Performance testing demonstrates the Console model is substantially equivalent in technological characteristics to the HCS model. Testing shows that the technological differences between the Console and HCS do not raise now questions of safety and effectiveness, and do not adversely affect safety and effectiveness. Furthermore, performance testing confirms that the LipiFlow® Console and Diconvelle configuration is at least as safe and effective as the legally marketed LipiFlow Spandheld Control System and Disposable configuration.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three human profiles embedded within its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

TearScience, Inc. c/o Christy Stevens, O.D., M.P.H. Vice President, Clinical and Regulatory Affairs 5151 McCrimmon Parkway, Suite 250 Morrisville, NC 27560

JAN 12 2012

Re: K112704

Trade/Device Name: LipiFlow® Thermal Pulsation System, Models LFTP-1000 and LFD-1000 Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: November 15, 2011 Received: November 16, 2011

Dear Dr. Stevens:

This letter corrects our substantially equivalent letter of December 19, 2011.

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

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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 of Krat 607), aboning (21 CFR 803); good manufacturing practice requirements as set device-related daverse overse) (2) 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 11 you desire specific advice to: your do mtersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part now the 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Debra Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112704

:

# Indications for Use

510(k) Number (if known): K112704

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Device Name: LipiFlow Thermal Pulsation System, Models LFTP-1000 and LFD-1000

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

Prescription Use (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 IF NEEDED)

> ffice of Device Evaluation (ODE) Concyrrence of Q

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

510(k) Number K112704

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