(55 days)
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 .
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.
The provided text is a 510(k) summary for the Flexitouch Plus System. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the removal of a cancer contraindication. The document explicitly states that no testing was necessary to support substantial equivalence for the Flexitouch Plus system with the cancer contraindication removed.
Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission relies on the existing safety and performance data of the previously cleared primary predicate device (Flexitouch System PD32-G3, K170216).
Here's a breakdown of why the requested information cannot be provided from this document:
- A table of acceptance criteria and the reported device performance: Not provided. The submission asserts that no new testing was needed because the technological characteristics are the same as the primary predicate device, and the only significant change (removal of a contraindication) aligns with a secondary predicate.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new testing was performed for this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new testing was performed for this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new testing was performed for this submission.
- 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 pneumatic compression pump, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pneumatic compression pump, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new testing was performed for this submission.
- The sample size for the training set: Not applicable, as no new testing was performed for this submission.
- How the ground truth for the training set was established: Not applicable, as no new testing was performed for this submission.
In summary, the 510(k) submission for the Flexitouch Plus System PD32-G3 (K203178) does not describe any new studies or testing to establish acceptance criteria or demonstrate performance. It relies on the substantial equivalence principle, stating that the device has the same technological characteristics as its primary predicate and aligns with a secondary predicate regarding the removed contraindication.
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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.
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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
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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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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".
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-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 SystemPD32-G3(Rx)510(k): K203178 | Flexitouch SystemPD32-G3(Rx)510(k): K170216 | Lympha Press OptimalPlus(Rx)510(k): K182003 | Similar |
| Intended Use | The Flexitouch Plussystem and garmentsfor legs, arms, trunk,and chest are intendedfor use by medicalprofessionals andpatients who are undermedical supervision toincrease lymphatic flowin the treatment ofmany conditions suchas:-Lymphedema-Primary lymphedema | The Flexitouch systemand garments for legs,arms, trunk, and chestare intended for use bymedical professionalsand patients who areunder medicalsupervision, for thetreatment of manyconditions such as:-Lymphedema-Primary lymphedema-Post mastectomyedema | The device is intendedfor use by medicalprofessionals, andpatients who are undermedical supervision intreating manyconditions such as:-Primary lymphedema-Secondarylymphedema-Venous insufficiency-Venous stasis ulcers-Dysfunction of themuscle pump | Compared to primarypredicate, subjectdevice adds clarifyinglanguage to theintended use, includingindications forlipedema andphlebolymphedemaand a phrase explainingthat the deviceincreases lymphaticflow to treat theconditions indicated. |
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| -Post mastectomyedema-Edema followingtrauma and sportsissues-Post immobilizationedema-Venous insufficiency-Reducing woundhealing time-Treatment andassistance in healing | -Edema followingtrauma and sportsissues-Post immobilizationedema-Venous insufficiency-Reducing woundhealing time-Treatment andassistance in healingstasis dermatitis,venous stasis ulcers, | -Post mastectomyedema-Edema followingtrauma and sportsissues-Post immobilizationedema-Reducing woundhealing time-Reduction of pain andswelling after injuryand surgery | ||
|---|---|---|---|---|
| stasis dermatitis,venous stasis ulcers,arterial ulcers, anddiabetic leg ulcers-Lipedema | arterial ulcers, anddiabetic leg ulcers | -The device may alsobe beneficial in themanagement ofLipoedema. | ||
| -PhlebolymphedemaThe Flexitouch Plussystem and garmentsfor the head and neckare intended for use bymedical professionalsand patients who areunder supervision forthe treatment of headand necklymphedema. | The Flexitouch systemand garments for thehead and neck areintended for use bymedical professionalsand patients who areunder supervision forthe treatment of headand necklymphedema. | The device is intendedfor hospital, home, andclinic use. | ||
| Contraindications | TheFlexitouch Plus systemshould not be used ifyou have one or moreof the followingconditions:-Heart failure (acute | The Flexitouch systemshould not be used ifyou have one or moreof the followingconditions:-Heart failure (acutepulmonary edema, | Use of Lympha Press isnot recommended inthe presence of one ormore of the followingconditions:-Known or suspecteddeep vein thrombosis | Compared to theprimary predicate, thesubject device removesthe contraindication foractive cancer butotherwise has anidentical list ofcontraindications. |
| pulmonary edema,decompensated acuteheart failure)-Acute venous disease(acutethrombophlebitis,acute deep venousthrombosis, acutepulmonary embolism)-Severe peripheralartery disease (criticallimb ischemia includingischemic rest pain,arterial wounds, organgrene)-Active skin or limb | decompensated acuteheart failure)-Acute venous disease(acutethrombophlebitis,acute deep venousthrombosis, acutepulmonary embolism)-Severe peripheralartery disease (criticallimb ischemia includingischemic rest pain,arterial wounds, organgrene)-Active skin or limbinfection/inflammatory | (DVT) orpulmonary embolus-During theinflammatory phlebitisprocess-Acute infection of theaffected limb-Decompensatedcardiac failure-Severe arteriosclerosisor other ischemicvascular disease-Any circumstancewhere increasedvenous and lymphaticreturn is undesirable | Neither the subjectdevice nor thesecondary predicatehas a contraindicationfor patients withcancer. | |
| infection/inflammatorydisease (acute cellulitis,otheruncontrolled skin, or | disease (acute cellulitis,otheruncontrolled skin, oruntreated | -Due to movement offluids in the body whenusing the system,exercise caution when |
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| untreatedinflammatory skindisease)-Any circumstancewhere increasedlymphatic or venousreturn is undesirableThe Flexitouch trunkaccessory should notbe used duringpregnancy. | inflammatory skindisease)-Active cancer (cancerthat is currently undertreatment, but not yetin remission)-Any circumstancewhere increasedlymphatic or venousreturn is undesirableThe Flexitouch trunkaccessory should notbe used duringpregnancy. | using on patients withheart disease.-High pressure is notrecommended forpatients whohave peripheralocclusion disease.The abdominal areashould not be treatedduring pregnancy. |
|---|---|---|
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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.
§ 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).