(302 days)
Not Found
No
The description focuses on pneumatic compression and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the treatment of various medical conditions such as lymphedema and edema, and it delivers compression therapy to affected regions of the body.
No
The Flexitouch® system is described as a treatment device for various conditions, including lymphedema and edema, using compression therapy. Its intended use focuses on treatment and assistance in healing, rather than diagnosing conditions.
No
The device description explicitly states it consists of a garment set and a pneumatic sequential controller, which are hardware components.
Based on the provided information, the Flexitouch® system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Flexitouch® System Function: The description clearly states that the Flexitouch® system is a pneumatic sequential compression device that applies pressure to affected body regions. It is a physical therapy device used for treatment, not for analyzing biological samples.
- Intended Use: The intended use is for the treatment of various conditions like lymphedema and edema, and for assisting in wound healing. This is a therapeutic application, not a diagnostic one.
- Device Description: The device consists of garments and a controller that inflates chambers with air. This mechanism is entirely external and does not involve the analysis of internal biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, using reagents, or providing diagnostic information based on biological markers.
Therefore, the Flexitouch® system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PPS, JOW
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.
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
patients ≥ 18 years of age
Intended User / Care Setting
medical professionals and patients who are under medical supervision
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and performance for the device met all pre-specified performance criteria and is substantially equivalent to the predicate device for its intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
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.
1
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
2
Indications for Use
510(k) Number (if known) K153311
Device Name Flexitouch System
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K153311: 510(k) Summary
| Submission Date: | 16 November 2015 |
|---|---|
| Submitter: | Thomas A. Dold |
| Vice President, Quality and Regulatory Affairs | |
| Tactile Systems Technology, Inc. (DBA Tactile Medical) | |
| 1331 Tyler Street NE, Suite 200 | |
| Minneapolis, MN 55413 | |
| Phone: (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
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.
Indications for Use:
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
4
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 Head
and Neck Garments
(Current Submission K153311) | Flexitouch System Predicate
Device
(K120972, K062818, K013061) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Flexitouch® system and
garments for legs, arms, trunk, and
chest are indicated 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. | The Flexitouch® system is
indicated 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 |
| FDA Classification | Class II | Class II |
| FDA Product Code | PPS (primary), JOW (secondary) | JOW |
| FDA Regulation | 21 CFR 870.5800 | 21 CFR 870.5800 |
| Prescription
Required | Yes | Yes |
5
| Controller Design | ||
|---|---|---|
| Size | 5.5" x 12.25" x 10.5" | 5.5" x 12.25" x 10.5" |
| Weight | 8 lbs | 8 lbs |
| Electrical | ||
| Requirements | 100-240 VAC, 1.0 A, 50/60 Hz | |
| UL/CUL | 100-240 VAC, 1.0 A, 50/60 Hz | |
| UL/CUL | ||
| Enclosure Material | Plastic construction | Plastic construction |
| Manifold | ||
| Assembly | Plastic construction with integrated | |
| air channels | Plastic construction with integrated | |
| air channels | ||
| User Interface | Tactile push buttons | Tactile push buttons |
| Software-concern | ||
| Level | Moderate | Moderate |
| Software/Hardware | Analog and digital electronics with | |
| microprocessor | Analog and digital electronics with | |
| microprocessor | ||
| Chambers | Up to 32 depending on garment size | |
| and type | Up to 32 depending on garment | |
| size and type | ||
| Pressure Range | 25-75 mmHg | 25-75 mmHg |
| Inflation time per | ||
| chamber | 1-6 seconds | 1-6 seconds |
| Output | Sequential/Intermittent | Sequential/Intermittent |
| Inflatable Garments | ||
| Material | Nylon outer layer, polyurethane inner | |
| layer | Nylon outer layer, polyurethane | |
| inner layer | ||
| Port Material | Polyurethane | Polyurethane |
| Garment | ||
| Connectors | Plastic construction | Plastic construction |
| Sterility | Non-sterile | Non-sterile |
| Garment Type and | ||
| Sizes | Arm - left or right, short or long | |
| Chest – left or right, 4 sizes | ||
| Trunk-thigh - left or right | ||
| Universal Trunk | ||
| Calf-foot - left or right, regular or | ||
| EXT | ||
| Trunk/thigh - left or right, short, long | ||
| or EXT | ||
| Full leg/trunk | ||
| Full leg – left or right, short medium, | ||
| long | ||
| Head and Neck Garment | Arm - left or right, short or long | |
| Chest – left or right, 4 sizes | ||
| Trunk-thigh - left or right | ||
| Universal Trunk | ||
| Calf-foot - left or right, regular or | ||
| EXT | ||
| Trunk/thigh – left or right, short, | ||
| long or EXT | ||
| Full leg/trunk | ||
| Full leg – left or right, short | ||
| medium, 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
6
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.