The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:

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

The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Device Description

The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Flexitouch System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria in a table format. Instead, it broadly states that "The test results verify that the safety and performance for the device met all pre-specified performance criteria and is substantially equivalent to the predicate device for its intended use."

However, based on the "Summary of Performance Testing" and "Summary of Clinical Evaluation", we can infer the reported device performance.

Criterion Type	Acceptance Criteria (Inferred)	Reported Device Performance
Non-Clinical	Equivalence in design, materials, construction, and functional parameters to the predicate device for the new anatomical location.	The Flexitouch® system has the same technological characteristics (design, materials, construction, controller design, weight, electrical requirements, enclosure material, manifold assembly, user interface, software concern level, software/hardware, chambers, pressure range, inflation time, output, inflatable garments material, port material, garment connectors, sterility) as the predicate device. Non-clinical testing (software verification and validation, garment inflation/deflation, garment pressure withstand testing) verified that safety and performance met pre-specified criteria and is substantially equivalent.
Clinical Efficacy	Reduction in head/neck lymphedema.	A majority of subjects experienced a decrease in facial composite score.
Clinical Safety	Device use in head and neck does not cause harm. Absence of adverse events.	The study confirmed that use of the device in the head and neck location does not cause harm. Adverse events related to the device safety profile were monitored. The benefit-risk profile is favorable.
Usability/Comfort	Ease of application, garment fit, garment comfort.	A majority of subjects were able to don and doff the device by the second attempt and reported that the garment was very/somewhat comfortable.

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

Sample Size for the Clinical Study (Test Set): Not explicitly stated, but described as a "single-arm, single-center study."
Data Provenance: Prospective, single-center study. The country of origin is not specified but given the FDA submission, it's typically a U.S.-based study or studies conducted under FDA guidelines.

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

The document does not mention the use of experts to establish "ground truth" for the clinical study directly. The assessment of lymphedema reduction (facial composite score) and adverse events would typically be performed by the medical professionals conducting the study. No specific number or qualifications of clinicians involved in assessing outcomes are provided beyond the study being supervised by "medical professionals."

4. Adjudication Method for the Test Set

Not applicable. This was a single-arm study evaluating the device's performance, not a comparative study requiring adjudication of diagnostic interpretations.

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. This device is a therapeutic system (compression therapy for lymphedema), not an AI-based diagnostic image analysis tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this submission.

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

Not applicable. The Flexitouch system is a physical medical device (pneumatic compression system) with software to control its operation, not a standalone algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the "ground truth" for efficacy was based on outcomes data, specifically:

Reduction in head/neck lymphedema (measured by "facial composite score").
Patient-reported comfort and ease of use.
Monitoring of device-related adverse events.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/Machine Learning algorithm that requires a separate training set. The software mentioned would have undergone typical software verification and validation, not model training.

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

Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth.

Summary

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

Tactile Systems Technology Inc (dba Tactile Medical) Thomas Dold Vice President, Quality and Regulatory Affairs 1331 Tyler St NE, Ste 200 Minneapolis, Minnesota 55413

Re: K153311

Trade/Device Name: Flexitouch System Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Head and Neck, Compressible Regulatory Class: Class II Product Code: PPS, JOW Dated: August 12, 2016 Received: August 15, 2016

Dear Mr. Dold:

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 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 devicerelated 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.

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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,

M.A. Hillebrenner

for

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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Indications for Use

510(k) Number (if known) K153311

Device Name Flexitouch System

Indications for Use (Describe)

Lymphedema
Primary lymphedema
· Post mastectomy edema
· Edema following trauma and sports injuries
· Post immobilization edema
· Venous insufficiencies
· Reducing wound healing time

· Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers

The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K153311: 510(k) Summary

Submission Date:	16 November 2015
Submitter:	Thomas A. DoldVice President, Quality and Regulatory AffairsTactile Systems Technology, Inc. (DBA Tactile Medical)1331 Tyler Street NE, Suite 200Minneapolis, MN 55413Phone: (612) 355-5100
Contact person:	Thomas A. Dold
Name of Device:	Flexitouch® system
FDA Regulation:	Sleeve, Head and Neck, Compressible (21 CFR 870.5800)
Device Classification:	Class II
Predicate Device:	Tactile Systems Technology, Inc. Flexitouch® system (K120972 K062818 & K013061)

Description of Device

Indications for Use:

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

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The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Comparison of Technological Characteristics:

The Flexitouch® system has the same technological characteristics to the predicate device with respect to, design, materials used, and construction. The head and neck garments referenced in this submission are indicated for use in head and neck lymphedema, a new anatomical location. The new garments use the same controller as the predicate device, with a separate program in the software specific for head and neck treatment. The table below summarizes the comparison of technological characteristics. Non-clinical and clinical testing results support use of the Flexitouch device in the new anatomical location, and demonstrate that no new questions of safety and effectiveness are raised.

	Flexitouch System including Headand Neck Garments(Current Submission K153311)	Flexitouch System PredicateDevice(K120972, K062818, K013061)
Indications for Use	The Flexitouch® system andgarments for legs, arms, trunk, andchest are indicated for use by medicalprofessionals and patients who areunder medical supervision for thetreatment of many conditions such as:lymphedema, primary lymphedema,post mastectomy edema, edemafollowing trauma and sports injuries,post immobilization edema, venousinsufficiencies, reducing woundhealing time, treatment and assistancein healing stasis dermatitis; venousstasis ulcers, or arterial and diabeticleg ulcers.The Flexitouch® System andgarments for the head and neck areintended for use by medicalprofessionals and patients who areunder medical supervision for thetreatment of head and necklymphedema.	The Flexitouch® system isindicated for use by medicalprofessionals and patients who areunder medical supervision for thetreatment of many conditions suchas: lymphedema, primarylymphedema, post mastectomyedema, edema following traumaand sports injuries, postimmobilization edema, venousinsufficiencies, reducing woundhealing time, treatment andassistance in healing stasisdermatitis; venous stasis ulcers, orarterial and diabetic leg ulcers
FDA Classification	Class II	Class II
FDA Product Code	PPS (primary), JOW (secondary)	JOW
FDA Regulation	21 CFR 870.5800	21 CFR 870.5800
PrescriptionRequired	Yes	Yes

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Controller Design
Size	5.5" x 12.25" x 10.5"	5.5" x 12.25" x 10.5"
Weight	8 lbs	8 lbs
ElectricalRequirements	100-240 VAC, 1.0 A, 50/60 HzUL/CUL	100-240 VAC, 1.0 A, 50/60 HzUL/CUL
Enclosure Material	Plastic construction	Plastic construction
ManifoldAssembly	Plastic construction with integratedair channels	Plastic construction with integratedair channels
User Interface	Tactile push buttons	Tactile push buttons
Software-concernLevel	Moderate	Moderate
Software/Hardware	Analog and digital electronics withmicroprocessor	Analog and digital electronics withmicroprocessor
Chambers	Up to 32 depending on garment sizeand type	Up to 32 depending on garmentsize and type
Pressure Range	25-75 mmHg	25-75 mmHg
Inflation time perchamber	1-6 seconds	1-6 seconds
Output	Sequential/Intermittent	Sequential/Intermittent
Inflatable Garments
Material	Nylon outer layer, polyurethane innerlayer	Nylon outer layer, polyurethaneinner layer
Port Material	Polyurethane	Polyurethane
GarmentConnectors	Plastic construction	Plastic construction
Sterility	Non-sterile	Non-sterile
Garment Type andSizes	Arm - left or right, short or longChest – left or right, 4 sizesTrunk-thigh - left or rightUniversal TrunkCalf-foot - left or right, regular orEXTTrunk/thigh - left or right, short, longor EXTFull leg/trunkFull leg – left or right, short medium,longHead and Neck Garment	Arm - left or right, short or longChest – left or right, 4 sizesTrunk-thigh - left or rightUniversal TrunkCalf-foot - left or right, regular orEXTTrunk/thigh – left or right, short,long or EXTFull leg/trunkFull leg – left or right, shortmedium, long

Summary of Performance Testing:

Comparative performance testing was completed to verify the equivalence between the Flexitouch® system with head and neck garments, which is the subject of this submission, and the predicate device. Testing included software verification and validation, garment inflation/deflation, and garment pressure withstand testing. The test results verify that the safety

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and performance for the device met all pre-specified performance criteria and is substantially equivalent to the predicate device for its intended use.

Summary of Clinical Evaluation:

A prospective, single-arm, single-center study was conducted to evaluate ease of application, garment fit, garment comfort, and reduction in head/neck lymphedema in patients ≥ 18 years of age diagnosed with head and/or neck lymphedema without active cancer and at least 4 weeks post cancer treatment and/or radiation. Adverse events related to the device safety profile and facial and neck composite scores were monitored. The study confirmed that use of the device in the head and neck location does not cause harm and has the potential to perform as designed. A majority of subjects were able to don and doff the device by the second attempt, reported that the garment was very/somewhat comfortable, and experienced a decrease in facial composite score. The results indicate that the benefit-risk profile of the indication for use in the head and neck is favorable.

Conclusion:

The results from the nonclinical and clinical device evaluations, which are referenced herein, demonstrate that the Flexitouch® system is substantially equivalent to the predicate device.

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).