(11 days)
Not Found
No
The document describes a pneumatic compression system with a controller and garments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on software validation, device performance, and risk analysis, not AI/ML model evaluation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is for "treating many conditions" and lists various medical conditions, indicating a therapeutic purpose.
No
The Flexitouch® system is described as a treatment device (pneumatic compression system) for various medical conditions, not a device used to diagnose or identify medical conditions.
No
The device description explicitly states it consists of a "garment set and a pneumatic sequential controller," which are hardware components. The performance studies also include "Device performance testing" and "Product shipping tests," further indicating a physical device.
Based on the provided information, the Flexitouch® system 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.
- Flexitouch® System Function: The description clearly states that the Flexitouch® system is a pneumatic compression system that applies external pressure to the body using inflatable garments. It is a physical therapy device used for treating conditions like lymphedema and edema.
- Lack of Sample Analysis: There is no mention of the device collecting or analyzing any samples from the patient's body. Its function is entirely external and mechanical.
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 is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:
- Primary lymphedema .
- Post mastectomy edema .
- Edema following trauma and sports issues .
- Post immobilization edema .
- Venous insufficiencies .
- Lymphedema .
- . Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home 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 and evaluation was successfully completed to verify the substantial equivalence between the Flexitouch® system, and the predicate device. This includes:
- Software validation testing, .
- Device performance testing .
- Device Hazard Analysis
- o Risk assessment
- o Design and process FMEA.
- Product shipping tests per ASTM D4169 .
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
APR 1 3 2012
K120972
pg 1 of 2
Section 5 - 510(k) Summary
| Submission Date: | 15 February 2012 |
|---|---|
| Submitter: | Phillip R. Rose |
| Director of Quality Systems and Regulatory Affairs | |
| Tactile Systems Technology, Inc. | |
| 1331 Tyler Street NE, Suite 200 | |
| Minneapolis, MN 55413 | |
| Phone: (612) 355-5100 | |
| Contact person: | Phillip R. Rose |
| Name of Device: | Flexitouch® system |
| Classification: | Compressible Limb Sleeve (21 CFR 870.5800) |
| Predicate Device: | Tactile Systems Technology, Inc. Flexitouch® system Model |
| PD32-120 (K013061) and subsequent 510(k) (K062818) for | |
| additional indication for use. |
Description of Device:
The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.
Intended Use:
The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:
- Primary lymphedema .
- Post mastectomy edema .
- Edema following trauma and sports issues .
- Post immobilization edema .
- Venous insufficiencies .
- Lymphedema .
- . Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers
1
Comparison of Technological Characteristics:
The Flexitouch® system has the same technological characteristics to the predicate device with respect to:
- intended use .
- . performance
- . design
- materials used .
- construction .
- energy source .
- sterility .
- labeling .
and raises no new safety and/or effectiveness concerns.
Summary of Testing to Internationally Recognized Standards:
The Flexitouch® system has been tested and certified compliant to the following standards:
- IEC 60601-1: Medical Electrical Equipment General Requirements for Safety .
- EN 60601-1-2:Medical Electrical Equipment General Requirements for Safety . Electromagnetic Compatibility
- ISO 13485: Medical Devices Quality Management Systems-● Requirements for Regulatory Purposes
- 93/42/EEC: Medical Devices Directive CE Marking .
Summary of Additional Performance Testing:
Comparative performance testing and evaluation was successfully completed to verify the substantial equivalence between the Flexitouch® system, and the predicate device. This includes:
- Software validation testing, .
- Device performance testing .
- Device Hazard Analysis �
- o Risk assessment
- o Design and process FMEA.
- Product shipping tests per ASTM D4169 .
Substantial Equivalence Conclusion:
Device testing and evaluation has demonstrated that the Flexitouch® system raises no new safety and/or effectiveness concerns and is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 3 2012
Tactile System Technology, Inc. c/o Mr. Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K120972
Trade/Device Name: Flexitouch® System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW Dated: March 29, 2012 Received: April 2. 2012
Dear Mr. Devine:
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
3
Page 2 - Mr. Ned Devine
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 device-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 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 I va may overs International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. A. Wilhelm
- Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
Indications for Use
K 120972
510(k) Number (if known):
Device Name: Flexitouch® system
Indications For Use:
The Flexitouch® system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema ●
- Post mastectomy edema .
- Edema following trauma and sports injuries
- Post immobilization edema ●
- . Venous insufficiencies
- Lymphedema. .
- Reducing wound healing time .
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
Prescription Use X (Part 21 CFR 801 Subpart D)
OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
M & - William ----------------------------------------------------------------------------------------------------------------------------------------------
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
K120972 Page 7 of 120 510(k) Number