Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of sequential chamber inflation and does not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is intended for the treatment of various medical conditions such as lymphedema and edema, which are therapeutic applications.

Diagnostic

No

The device is described as a treatment device (pneumatic compression device) that helps stimulate the lymphatic system and move excess fluid, not diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "pneumatic compression device" and describes the physical inflation and deflation of "garment chambers," indicating it is a hardware device with a mechanical function, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The Flexitouch Plus System is a pneumatic compression device that applies external pressure to the body to stimulate lymphatic flow. It does not involve testing samples taken from the body.
Intended Use: The intended use describes the treatment of various conditions by physically manipulating fluid within the body, not by analyzing biological samples.

Therefore, the Flexitouch Plus System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:

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

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 .

Product codes

JOW, PPS

Device Description

The Flexitouch Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

legs, arms, trunk, chest, head and neck

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals and patients who are under medical supervision; hospital, home, and clinic use (for predicate device)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Safety and performance data submitted for the previously cleared Flexitouch system (primary predicate device) supports the subject device. No testing was necessary to support substantial equivalence for the Flexitouch Plus system with the cancer contraindication removed.

Key Metrics

Not Found

Predicate Device(s)

Flexitouch System PD32-G3 (K170216), Lympha Press Optimal Plus System (K182003)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the acronym in a blue square.

December 20, 2020

Tactile Systems Technology, Inc. (DBA Tactile Medical) % Lauren Barnes Regulatory Consultant The Tamarack Group - MPLS, LLC 2584 Upton Avenue South Minneapolis, Minnesota 55405

Re: K203178

Trade/Device Name: Flexitouch Plus System (PD32-G3) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW, PPS Dated: October 22, 2020 Received: October 26, 2020

Dear Lauren Barnes:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known)

K203178

Device Name Flexitouch Plus System (PD32-G3)

Indications for Use (Describe)

The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as

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

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)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

3701 Wayzata Blvd, Suite 300 Minneapolis, MN 55416 USA T 612.355.5100 | F 612.355.5101 Toll Free Tel 833.382.2845 (833.3TACTILE) Toll Free Fax 866.435.3949 tactilemedical.com

510(k) Summary for the Flexitouch Plus System (PD32-G3)

Prepared December 16, 2020

Submitter

Manufacturer:

Tactile Systems Technology, Inc. (DBA Tactile Medical) 151 5th Ave NW Suite 100 New Brighton, MN 55112 612-355-5100

Contact Person:

Brett Demchuck Vice President, Quality and Regulatory Affairs 3701 Wayzata Blvd. Suite 300 Minneapolis, MN 55416 612-355-5100

General Information

Device Name:	Flexitouch Plus System PD32-G3
Common / Usual Name:	Compressive limb sleeve system
Classification Name:	Sleeve, Limb, Compressible (21 CFR 870.5800)
Sleeve, Head, and Neck, Compressible (21 CFR 870.5800)
Product Codes:	JOW, PPS
Device Class:	Class 2
Primary Predicate Device:	Flexitouch System PD32-G3 (K170216)
Secondary Predicate Device:	Lympha Press Optimal Plus System (K182003)

Device Description

The Flexitouch Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.

Indications for Use

The Flexitouch Plus System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:

Image /page/3/Picture/15 description: The image shows the logo for Tactile Medical. The word "Tactile" is in a dark blue, bold font, and the word "MEDICAL" is in a smaller, gray font below it. There is a registered trademark symbol to the right of the word "MEDICAL".

4

-Lymphedema -Primary lymphedema -Post mastectomy edema -Edema following trauma and sports issues -Post immobilization edema -Venous insufficiency -Reducing wound healing time -Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers -Lipedema -Phlebolymphedema

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

Intended Use

The intended use and contraindications for the subject and predicate devices are provided and compared in the table below. Compared to the primary predicate device, the contraindication for cancer is removed from the subject device labeling.

Removal of the cancer contraindication does not suggest a new disease, condition or patient population compared to the intended use of the secondary predicate device. Considering the current position of the International Society of Lymphology regarding this potential concern for cancer patients, and the fact that FDA has cleared the secondary predicate device with no cancer contraindication, the Flexitouch Plus System without the cancer contraindication poses no increased or different risk compared to the predicate devices, nor does this type of labeling change affect the indications for use in a way that could significantly affect the safety or effectiveness of the device and the intended users.

	Subject Device(s)	Primary Predicate(s)	Secondary Predicate	Comparison
Identification	Flexitouch Plus System
PD32-G3
(Rx)
510(k): K203178	Flexitouch System
PD32-G3
(Rx)
510(k): K170216	Lympha Press Optimal
Plus
(Rx)
510(k): K182003	Similar
Intended Use	The Flexitouch Plus
system and garments
for legs, arms, trunk,
and chest are intended
for use by medical
professionals and
patients who are under
medical supervision to
increase lymphatic flow
in the treatment of
many conditions such
as:
-Lymphedema
-Primary lymphedema	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	The device is intended
for use by medical
professionals, and
patients who are under
medical supervision in
treating many
conditions such as:
-Primary lymphedema
-Secondary
lymphedema
-Venous insufficiency
-Venous stasis ulcers
-Dysfunction of the
muscle pump	Compared to primary
predicate, subject
device adds clarifying
language to the
intended use, including
indications for
lipedema and
phlebolymphedema
and a phrase explaining
that the device
increases lymphatic
flow to treat the
conditions indicated.

5

| | -Post mastectomy
edema
-Edema following
trauma and sports
issues
-Post immobilization
edema
-Venous insufficiency
-Reducing wound
healing time
-Treatment and
assistance in healing | -Edema following
trauma and sports
issues
-Post immobilization
edema
-Venous insufficiency
-Reducing wound
healing time
-Treatment and
assistance in healing
stasis dermatitis,
venous stasis ulcers, | -Post mastectomy
edema
-Edema following
trauma and sports
issues
-Post immobilization
edema
-Reducing wound
healing time
-Reduction of pain and
swelling after injury
and surgery | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | stasis dermatitis,
venous stasis ulcers,
arterial ulcers, and
diabetic leg ulcers
-Lipedema | arterial ulcers, and
diabetic leg ulcers | -The device may also
be beneficial in the
management of
Lipoedema. | |
| | -Phlebolymphedema
The Flexitouch Plus
system and garments
for the head and neck
are intended for use by
medical professionals
and patients who are
under supervision for
the treatment of head
and neck
lymphedema. | The Flexitouch system
and garments for the
head and neck are
intended for use by
medical professionals
and patients who are
under supervision for
the treatment of head
and neck
lymphedema. | The device is intended
for hospital, home, and
clinic use. | |
| Contraindications | The
Flexitouch Plus system
should not be used if
you have one or more
of the following
conditions:
-Heart failure (acute | The Flexitouch system
should not be used if
you have one or more
of the following
conditions:
-Heart failure (acute
pulmonary edema, | Use of Lympha Press is
not recommended in
the presence of one or
more of the following
conditions:
-Known or suspected
deep vein thrombosis | Compared to the
primary predicate, the
subject device removes
the contraindication for
active cancer but
otherwise has an
identical list of
contraindications. |
| | pulmonary edema,
decompensated acute
heart failure)
-Acute venous disease
(acute
thrombophlebitis,
acute deep venous
thrombosis, acute
pulmonary embolism)
-Severe peripheral
artery disease (critical
limb ischemia including
ischemic rest pain,
arterial wounds, or
gangrene)
-Active skin or limb | decompensated acute
heart failure)
-Acute venous disease
(acute
thrombophlebitis,
acute deep venous
thrombosis, acute
pulmonary embolism)
-Severe peripheral
artery disease (critical
limb ischemia including
ischemic rest pain,
arterial wounds, or
gangrene)
-Active skin or limb
infection/inflammatory | (DVT) or
pulmonary embolus
-During the
inflammatory phlebitis
process
-Acute infection of the
affected limb
-Decompensated
cardiac failure
-Severe arteriosclerosis
or other ischemic
vascular disease
-Any circumstance
where increased
venous and lymphatic
return is undesirable | Neither the subject
device nor the
secondary predicate
has a contraindication
for patients with
cancer. |
| | infection/inflammatory
disease (acute cellulitis,
other
uncontrolled skin, or | disease (acute cellulitis,
other
uncontrolled skin, or
untreated | -Due to movement of
fluids in the body when
using the system,
exercise caution when | |

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| untreated
inflammatory skin
disease)
-Any circumstance
where increased
lymphatic or venous
return is undesirable
The Flexitouch trunk
accessory should not
be used during
pregnancy. | inflammatory skin
disease)
-Active cancer (cancer
that is currently under
treatment, but not yet
in remission)
-Any circumstance
where increased
lymphatic or venous
return is undesirable
The Flexitouch trunk
accessory should not
be used during
pregnancy. | using on patients with
heart disease.
-High pressure is not
recommended for
patients who
have peripheral
occlusion disease.
The abdominal area
should not be treated
during pregnancy. |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Technological Characteristics

There are no technology, engineering or performance differences between the subject device and the primary predicate device that require the submission of a new 510(k). They are the same in terms of control mechanisms, operating principle, energy type, sterilization, cleaning and disinfection, packaging, and expiration dating. No design changes made since the last Flexitouch 510(k) submission and clearance significantly affect use of the device. The manufacturer's risk assessment has not identified any new or significantly modified risks related to design changes. There have been no unexpected issues from verification and validation testing, nor has clinical data been necessary to support any design changes. Similarly, there are no materials differences between the subject device and the primary predicate device that require the submission of a new 510(k). The manufacturer's risk assessment has not identified any new or increased biocompatibility concerns related to materials changes since the last Flexitouch 510(k) submission and clearance. Thus, the subject device has no technological characteristics that raise different questions of safety or effectiveness compared to the predicate devices.

Safety and Performance Data

Safety and performance data submitted for the previously cleared Flexitouch system (primary predicate device) supports the subject device. No testing was necessary to support substantial equivalence for the Flexitouch Plus system with the cancer contraindication removed.

Substantial Equivalence Conclusion

The subject and primary predicate devices have intended use and apply similar technologies. They all automate manual lymphatic drainage and are used to reduce edema by compressing parts of the body to move lymphatic fluid. Compared to the primary predicate, there have been no changes to the materials, design, energy source or other features of the subject device that raise different questions of safety or effectiveness. Removing the contraindication for cancer agrees with secondary predicate device labeling and does not change the intended use compared to the predicate devices. Therefore, the subject device is substantially equivalent.