(122 days)
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.
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.
The provided document does not contain information related to a study that uses a test set, expert adjudication, MRMC studies, or specific performance metrics with acceptance criteria for an AI/software-based medical device.
The document is a 510(k) premarket notification for the Flexitouch® System, Model PD32-G3, a pneumatic compression device. It focuses on demonstrating substantial equivalence to a predicate device (Flexitouch® System, K153311) based on existing technology characteristics and non-clinical performance testing.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.
The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices." This implies that the device's performance was not evaluated through a study involving human subjects or the kind of data analysis typically associated with AI/software device validation.
If the device were an AI/software product, the information you requested would be critical. However, for a physical medical device like the Flexitouch® System, substantial equivalence is often shown through comparisons of design, materials, electrical safety, software validation (general, not AI-specific), biocompatibility, and physical performance tests like pressure verification.
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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
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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
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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 DoldVice President, Quality and Regulatory AffairsTactile Systems Technology, Inc. (DBA Tactile Medical)1331 Tyler Street NE, Suite 200Minneapolis, Mn 55413612-355-5100 |
| 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.
| DeviceCharacteristic | REFERENCETactile SystemsTechnology, Inc.Entré PD08-U(K143185) | PREDICATETactile Systems Technology,Inc. Flexitouch System®PD32-U (K153311) | Tactile Systems Technology,Inc. Flexitouch® SystemPD32-G3(New Device K170216) | Difference |
|---|---|---|---|---|
| ElectricalRequirements | 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 |
| Enclosurematerial | All plastic construction | All plastic construction | All plastic construction | Same |
| ManifoldAssembly | Plastic construction withintegrated air channel | Plastic construction withintegrated air channel | Plastic construction withintegrated air channel | Same |
| User Interface | Tactile Pushbuttons | Tactile Pushbuttons | Tactile Pushbuttons | Same |
| Software/Hardware | Analog and digitalelectronic withmicroprocessor | Analog and digital electronic withmicroprocessor | Analog and digital electronic withmicroprocessor | Same |
| Chambers | 8 Chambers | Up to 32 depending on garmentsize and types | Up to 32 depending on garmentsize and types | Same as PD32-U |
| Output | Sequential gradientpressure | Sequential calibrated gradientpressure | Sequential calibrated gradientpressure | Same as PD32-U |
| GarmentChamberPressureControl | Pressure Based Control | Time Based Control | Pressure Based Control | Same as PD08-U |
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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).
§ 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).