The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:

Primary lymphedema .
Post mastectomy edema .
Edema following trauma and sports issues .
Post immobilization edema .
Venous insufficiencies .
Lymphedema .
. Reducing wound healing time
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers

Device Description

The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.

AI/ML Overview

The provided text is a 510(k) summary for the Flexitouch® system. It outlines the device's characteristics and its comparison to a predicate device but does not contain information about acceptance criteria or a specific study designed to prove the device meets acceptance criteria in the format typically associated with diagnostic or AI/ML device validation.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the primary "study" is a comparison to an already legally marketed device, asserting that the new device is as safe and effective as the existing one.

Therefore, the following table and explanations are derived from the available information and will highlight the absence of certain requested details, as they are not typically part of a 510(k) summary for this type of device.

Acceptance Criteria and Device Performance

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Technological Equivalence	The device should have the same technological characteristics (intended use, performance, design, materials, construction, energy source, sterility, labeling) as the predicate device, raising no new safety and/or effectiveness concerns.	The Flexitouch® system has the same technological characteristics as the predicate device and raises no new safety and/or effectiveness concerns.
Safety Standards	Compliance with relevant international safety and quality management standards (IEC 60601-1, EN 60601-1-2, ISO 13485, 93/42/EEC).	The Flexitouch® system has been tested and certified compliant to these standards.
Performance Testing	Successful completion of comparative performance testing to verify substantial equivalence, including: Software validation, Device performance testing, Device Hazard Analysis (Risk assessment, Design and process FMEA), Product shipping tests.	Comparative performance testing and evaluation was successfully completed to verify substantial equivalence, including all listed tests.

Study Details (Based on available 510(k) summary)

Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "Comparative performance testing and evaluation" but does not provide details on the number of devices, components, or clinical subjects involved in these tests. For a device like a pneumatic compression system, "performance testing" might involve bench testing or engineering verification rather than a traditional clinical test set of patient data.
- Data provenance: Not specified. Given the nature of a 510(k) for a physical medical device, the "data" would likely originate from internal engineering and manufacturing tests. No information about country of origin, retrospective or prospective data is provided, as these terms are more relevant to clinical studies involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for this type of device is typically established by engineering specifications, safety standards, and functional requirements, rather than expert clinical consensus on a "test set" of patient data. Performance is assessed against these established technical benchmarks.
Adjudication method for the test set:
- Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or diagnoses. This type of review is not relevant for the engineering and functional tests reported in this 510(k).
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. An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Flexitouch® system is a pneumatic compression device, not a diagnostic AI tool, so this type of study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to the Flexitouch® system. It is a physical medical device, not an algorithm. The "software validation testing" mentioned would focus on the correct functioning of the embedded software within the device to control its pneumatic operations, not on its performance as a standalone interpretive algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is implicitly engineering specifications, international safety standards, and the validated performance of the predicate device. For example, "software validation testing" would compare the software's output to its design requirements. "Device performance testing" would compare the physical performance (e.g., pressure, cycle times) to specified ranges and the predicate device's performance.
The sample size for the training set:
- Not applicable and not provided. This device does not use a "training set" in the machine learning sense. Its functionality is based on established engineering principles and control logic, not learned from data.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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APR 1 3 2012

K120972
pg 1 of 2

Section 5 - 510(k) Summary

Submission Date:	15 February 2012
Submitter:	Phillip R. RoseDirector of Quality Systems and Regulatory AffairsTactile Systems Technology, Inc.1331 Tyler Street NE, Suite 200Minneapolis, MN 55413Phone: (612) 355-5100
Contact person:	Phillip R. Rose
Name of Device:	Flexitouch® system
Classification:	Compressible Limb Sleeve (21 CFR 870.5800)
Predicate Device:	Tactile Systems Technology, Inc. Flexitouch® system ModelPD32-120 (K013061) and subsequent 510(k) (K062818) foradditional indication for use.

Description of Device:

Intended Use:

The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:

Primary lymphedema .
Post mastectomy edema .
Edema following trauma and sports issues .
Post immobilization edema .
Venous insufficiencies .
Lymphedema .
. Reducing wound healing time
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers

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

Comparison of Technological Characteristics:

The Flexitouch® system has the same technological characteristics to the predicate device with respect to:

intended use .
. performance
. design
materials used .
construction .
energy source .
sterility .
labeling .

and raises no new safety and/or effectiveness concerns.

Summary of Testing to Internationally Recognized Standards:

The Flexitouch® system has been tested and certified compliant to the following standards:

IEC 60601-1: Medical Electrical Equipment General Requirements for Safety .
EN 60601-1-2:Medical Electrical Equipment General Requirements for Safety . Electromagnetic Compatibility
ISO 13485: Medical Devices Quality Management Systems-● Requirements for Regulatory Purposes
93/42/EEC: Medical Devices Directive CE Marking .

Summary of Additional Performance Testing:

Comparative performance testing and evaluation was successfully completed to verify the substantial equivalence between the Flexitouch® system, and the predicate device. This includes:

Software validation testing, .
Device performance testing .
Device Hazard Analysis �
- o Risk assessment
- o Design and process FMEA.
Product shipping tests per ASTM D4169 .

Substantial Equivalence Conclusion:

Device testing and evaluation has demonstrated that the Flexitouch® system raises no new safety and/or effectiveness concerns and is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

APR 1 3 2012

Tactile System Technology, Inc. c/o Mr. Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K120972

Trade/Device Name: Flexitouch® System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW Dated: March 29, 2012 Received: April 2. 2012

Dear Mr. Devine:

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

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Page 2 - Mr. Ned Devine

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 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); 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 11 70 http://www.fda.gov/AboutFDA/CentersOffices/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 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/ReportalProblem/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 I va may overs 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.

M. A. Wilhelm

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

Indications for Use

K 120972

510(k) Number (if known):

Device Name: Flexitouch® system

Indications For Use:

The Flexitouch® system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:

Primary lymphedema ●
Post mastectomy edema .
Edema following trauma and sports injuries
Post immobilization edema ●
. Venous insufficiencies
Lymphedema. .
Reducing wound healing time .
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers

Prescription Use X (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

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

M & - William ----------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign-Off)
Division of Cardiovascular Devices

K120972 Page 7 of 120 510(k) Number

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).