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.

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.

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).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Preamble:

It's important to note that this document is a 510(k) summary for a premarket notification, where the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device. As such, the "study" described is primarily focused on demonstrating that a new model (LipiFlow® Console, Model LFTP-1000) is equivalent to a predicate model (LipiFlow® HCS, Model LFH-1000) and meets existing safety and performance standards for Eyelid Thermal Pulsation Systems. It's not a clinical trial establishing efficacy against a placebo or a direct standalone performance study in the way one might expect for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Requirement	Reported Device Performance (LipiFlow® Console)
Electrical Safety & EMC	Conformance to electrical safety and EMC performance standards (same as predicate HCS).	Console conforms to the same electrical safety and EMC performance standards as the HCS, supporting the change in power source (AC power instead of battery).
Temperature & Pressure	Equivalent temperature and pressure performance and safeguard functions as the HCS, including normal operation, fault conditions, and direct comparison during human eyelid treatment. Meets design requirements based on known safe and effective temperature and pressure specifications (previously validated in bench, animal, and clinical studies for predicate K093937).	Console shows equivalent temperature and pressure performance and safeguard functions as the HCS. Meets same design requirements. Minor improvements in treatment hardware (e.g., temperature/pressure sensing accuracy, redundant pressure sensor tracking) do not raise new questions of safety/effectiveness.
Sterility & Shelf-life	Meets performance standards for sterility and shelf-life testing of the Disposable.	Disposable (LFD-1000), used with both Console and HCS, meets performance standards for sterility and shelf-life testing.
Biocompatibility	Meets performance standards for biocompatibility of the Disposable.	Disposable (LFD-1000), used with both Console and HCS, meets performance standards for biocompatibility (referenced K093937).
Software V&V	Console software meets design input requirements and user needs. Usability validated to standards. Software does not control treatment; software failure would not affect hardware's treatment control or safety circuits.	Software verification and validation testing shows Console software meets design input requirements and user needs. Usability of Console bench-top design and user interface validated to usability standards. Software does not control treatment; failure would not affect hardware's treatment control or safety circuits.
Additional User Functions	Additional user functions (e.g., independent treatment of both eyes, modify pressure sequence) do not adversely affect safety and effectiveness.	Bench performance testing of additional user functions shows they do not adversely affect safety and effectiveness.

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

Sample Size: Not explicitly stated for specific tests (e.g., a "test set" in the context of AI/ML). The performance testing described is primarily bench performance testing and software verification/validation.
- For the "direct comparison during treatment of human eyelids" for temperature and pressure performance, the number of human eyelids or subjects tested is not specified.
Data Provenance: The studies mentioned for the predicate device (K093937) included "bench, animal and clinical studies." For the current submission, the testing type described is predominantly bench testing and software validation. There is no mention of country of origin, retrospective or prospective data collection specifically for this K112704 submission, beyond referencing the predicate's studies.

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

This documentation does not describe a traditional "test set" with ground truth established by experts in the context of classification or diagnostic performance (as one might find for an AI/ML diagnostic device).
The criteria are technical performance specifications (e.g., temperature accuracy, pressure consistency, electrical safety, software function). The "ground truth" here is adherence to engineering specifications, regulatory standards (e.g., 21 CFR 886.5200, electrical safety, EMC), and equivalence to the predicate device's proven performance.
The "experts" involved would implicitly be the engineers, software developers, and quality assurance personnel performing the verification and validation, as well as the regulatory reviewers at the FDA. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of expert adjudication for diagnostic accuracy. The testing described focuses on engineering performance, software validation, and comparison to a predicate device's established specifications. The "adjudication" would be a determination of whether the device meets the predefined technical and regulatory acceptance criteria.

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

No MRMC comparative effectiveness study was done. This device is a therapeutic device (applying heat and pressure), not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to its function.

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

Not applicable. This device is a physical therapeutic system with an operator (physician) in the loop, administering the treatment. While it has software, that software controls the hardware's treatment parameters, it does not function as a standalone diagnostic algorithm. The software is part of the overall system's function, not a separate "algorithm only" component. The document explicitly states: "Additionally, the Console's software does not control treatment, and a software failure would not affect the hardware's treatment control or the safety circuits." This implies the critical treatment control is hardware-based, with software for user interface, monitoring, and secondary functions.

7. The Type of Ground Truth Used

For the current submission (K112704), the "ground truth" is primarily based on:
- Engineering Specifications: Adherence to defined temperature, pressure, electrical, and mechanical criteria.
- Regulatory Standards: Conformance to relevant national and international standards (e.g., electrical safety, EMC, biocompatibility).
- Predicate Device Performance: Demonstrating substantial equivalence to the established safety and effectiveness profile of the predicate device (LipiFlow® HCS, K093937), which itself relied on prior "bench, animal and clinical studies."
- Design Input Requirements and User Needs: For software validation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set in the conventional sense for a diagnostic algorithm. The device's operational parameters (temperature, pressure profiles) were established through prior engineering design, bench testing, animal studies, and clinical studies for the predicate device.

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

Not applicable. Since there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The functional "ground truth" for the device's therapeutic parameters was established through the design and testing processes of the original predicate device, validated through various studies (bench, animal, clinical) to be safe and effective.

Summary

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K112704

DEC 1 9 2011

510(k) SUMMARY

PREPARATION DATE:	September 12, 2011
APPLICANT:	TearScience, Inc.5151 McCrimmon Parkway, Suite 250Morrisville, NC 27560
	Tel: (919) 467-4007Fax: (919) 467-3300
CONTACT PERSON:	Christy Stevens, OD, MPHVice President, Clinical and Regulatory Affairs
DEVICE TRADE NAME:	LipiFlow® Thermal Pulsation SystemModel LFTP-1000, Console andModel 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 SystemModel LFH-1000. Handheld Control System (HCS) andModel LFD-1000, DisposableClass II under 21 CFR 886.5200Applicant: TearScience, Inc.Cleared under K093937and Evaluation of Automatic Class IIDesignation on June 28, 2011

DEVICE DESCRIPTION:

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

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.
1. 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).
1. 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.
1. The biocompatibility of the Disposable, which is used with both the Console and HCS models, meets performance standards for biocompatibility (refer to K093937).
1. 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 (800) 638-2041 or (301) 796-7100 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.