(122 days)
No
The device description and performance studies focus on pneumatic compression and standard software verification, with no mention of AI or ML technologies.
Yes.
The device's intended use clearly states its purpose is for the "treatment of many conditions such as Lymphedema, Primary lymphedema, Post mastectomy edema," among others, indicating its therapeutic function.
No
The "Intended Use / Indications for Use" section states the device is for "treatment of many conditions" and "delivering treatment," and the "Device Description" explains it uses pneumatic compression therapy. This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system consists of two main components: 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:
- Intended Use: The intended use describes the treatment of various conditions like lymphedema, edema, and ulcers through pneumatic compression therapy. This is a physical therapy/treatment method applied externally to the body.
- Device Description: The device description details a system of garments and a controller that applies air pressure to the body. This is a mechanical/physical intervention.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Flexitouch System does not involve the analysis of any bodily specimens.
The Flexitouch System is a therapeutic device that provides external pneumatic compression.
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 insufficiency
- · 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)
JOW, PPS
Device Description
The Flexitouch system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.
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
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 used to verify the equivalence between the Flexitouch PD32-G3, which is the subject of this submission and the predicate devices. The test results verify that the device met all pre-specified performance criteria and is substantially equivalent to the predicate devices for its intended use. Clinical testing was not required to establish substantial equivalence with the predicate devices.
The following non-clinical performance testing was performed in support of the substantial equivalence determination.
- Electrical safety and performance testing were according to standard IEC 60601-1: 2005 and standard IEC 60601-1-2:2014.
- Software verification and validation testing were conducted and documentation was provided ● as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Biocompatibility Testing - Cytotoxicity, Sensitization, Irritation per ISO 10993.
- Transportation Shipping Testing per ASTM D4169
- Device Storage Condition and Operational Condition Testing
- Pressure Verification Testing ●
Conclusion:
The data included in this submission demonstrates that the Flexitouch® PD32-G3 is substantially equivalent to the legally marketed predicate device, Flexitouch® PD32-U (K153311).
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
May 26, 2017
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 Street NE. Suite 200 Minneapolis, Minnesota 55413
Re: K170216
Trade/Device Name: Flexitouch® System, Model PD32-G3 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW, PPS Dated: April 21, 2017 Received: April 25, 2017
Dear Thomas 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 of medical device
1
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 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,
Fernando Aguel
Fernando Aguel
-s
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) K170216
Device Name
Flexitouch System, Model PD32-G3
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 insufficiency
- · 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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Image /page/3/Picture/0 description: The image is a logo for Tactile Medical. The logo features a stylized letter "T" in blue and gray, with the top of the "T" forming a roof-like shape. To the right of the "T" is the word "Tactile" in blue, with the letters in a bold, sans-serif font. Below "Tactile" is the word "MEDICAL" in gray, with the letters in a smaller, sans-serif font. A blue line underlines the word "MEDICAL".
Appendix A 510(k) Summary
| Date Prepared: | May 25, 2017 |
|---|---|
| Submitter: | Thomas Dold |
| Vice President, Quality and Regulatory Affairs | |
| Tactile Systems Technology, Inc. (DBA Tactile Medical) | |
| 1331 Tyler Street NE, Suite 200 | |
| Minneapolis, Mn 55413 | |
| 612-355-5100 | |
| Contact Person: | Thomas Dold |
| Name of Device: | Flexitouch® System PD32-G3 |
| Classification: | Sleeve, Limb, Compressible (21 CFR 870.5800) |
| Sleeve, Head, and Neck, Compressible (21 CFR 870.5800) | |
| Product Code(s): | JOW, PPS |
| Predicate Device: | Tactile Systems Technology, Inc. Flexitouch® System (K153311) |
| Reference Device: | Entré PD08-U (K143185) |
Description of Device:
The Flexitouch system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.
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 issues ●
- Post immobilization edema
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Image /page/4/Picture/0 description: The image contains the logo for Tactile Medical. The logo features a stylized letter "T" with a gray vertical bar on the left and a blue triangular roof on top. To the right of the "T" is the word "Tactile" in blue, with the letters slightly overlapping. Below "Tactile" is the word "MEDICAL" in gray, with a thin blue line underneath.
- Venous insufficiency
- Reducing wound healing time ●
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers ● 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.
Comparison to Technology Characteristics:
In addition to having the same indications for use, the Flexitouch® PD32-G3 has the same technology characteristics to the predicate devices with respect to design features, and operating principal as demonstrated in the table below.
The key differences between this device and the predicate Flexitouch® System PD32-U, include the use of pressure sensing technology rather than time based pressure control and a full color LCD user interface.
| Device
Characteristic | REFERENCE
Tactile Systems
Technology, Inc.
Entré PD08-U
(K143185) | PREDICATE
Tactile Systems Technology,
Inc. Flexitouch System®
PD32-U (K153311) | Tactile Systems Technology,
Inc. Flexitouch® System
PD32-G3
(New Device K170216) | Difference |
|-------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------|
| Electrical
Requirements | 100 VAC-264 VAC ~
50/60 Hz 14.4W | 100-240 VAC, 1.0 A, 50/ 60 Hz | 100–240 VAC 50/60 Hz | Same as PD32-U |
| Enclosure
material | All plastic construction | All plastic construction | All plastic construction | Same |
| Manifold
Assembly | Plastic construction with
integrated air channel | Plastic construction with
integrated air channel | Plastic construction with
integrated air channel | Same |
| User Interface | Tactile Pushbuttons | Tactile Pushbuttons | Tactile Pushbuttons | Same |
| Software/
Hardware | Analog and digital
electronic with
microprocessor | Analog and digital electronic with
microprocessor | Analog and digital electronic with
microprocessor | Same |
| Chambers | 8 Chambers | Up to 32 depending on garment
size and types | Up to 32 depending on garment
size and types | Same as PD32-U |
| Output | Sequential gradient
pressure | Sequential calibrated gradient
pressure | Sequential calibrated gradient
pressure | Same as PD32-U |
| Garment
Chamber
Pressure
Control | Pressure Based Control | Time Based Control | Pressure Based Control | Same as PD08-U |
5
Image /page/5/Picture/0 description: The image shows the logo for Tactile Medical. The logo features a stylized letter "T" that is partially gray and partially blue, with a blue triangle on top, resembling a house. To the right of the "T" is the word "Tactile" in blue, with the letters "MEDICAL" in gray underneath. There is a horizontal gray line under the word "MEDICAL".
Summary of Tests
Comparative performance testing was used to verify the equivalence between the Flexitouch PD32-G3, which is the subject of this submission and the predicate devices. The test results verify that the device met all pre-specified performance criteria and is substantially equivalent to the predicate devices for its intended use. Clinical testing was not required to establish substantial equivalence with the predicate devices.
The following non-clinical performance testing was performed in support of the substantial equivalence determination.
- Electrical safety and performance testing were according to standard IEC 60601-1: 2005 and standard IEC 60601-1-2:2014.
- Software verification and validation testing were conducted and documentation was provided ● as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Biocompatibility Testing - Cytotoxicity, Sensitization, Irritation per ISO 10993.
- Transportation Shipping Testing per ASTM D4169
- Device Storage Condition and Operational Condition Testing
- Pressure Verification Testing ●
Conclusion
The data included in this submission demonstrates that the Flexitouch® PD32-G3 is substantially equivalent to the legally marketed predicate device, Flexitouch® PD32-U (K153311).