(16 days)
Not Found
No
The device description focuses on a pneumatic system with inflatable chambers and a controller, with no mention of AI/ML terms or functionalities like image processing, data analysis for diagnosis, or adaptive algorithms based on patient data. The performance studies rely on substantial equivalence to predicate devices, not on AI/ML performance metrics.
Yes
The device is intended for treating various medical conditions and uses pneumatic massage to increase circulation, aiding in healing and symptom management.
No
The device is described as a powered inflatable tube massager that simulates kneading and stroking of tissues to increase circulation, which is a therapeutic function, not a diagnostic one. Its intended uses are for treating various conditions, not for diagnosing them.
No
The device description clearly states that the Flexitouch System includes a pneumatic sequential controller device and garments with inflatable chambers, which are hardware components.
Based on the provided information, the Flexitouch system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the treatment of various conditions related to edema and circulation issues. This involves applying physical pressure to the body.
- Device Description: The device description clearly states it's a "powered inflatable tube massager" that uses air pressure to simulate massage and increase circulation.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Flexitouch system interacts with the body externally.
- No Mention of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
The Flexitouch system is a therapeutic device that applies external physical therapy.
N/A
Intended Use / Indications for Use
The Flexitouch system is intended for use by medical professional 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
JOW, IRP
Device Description
The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary components of the System include a pneumatic sequential controller device that delivers air to garments with inflatable chambers to be worn over the patient's afflicted areas. The inflation and deflation of the chambers simulates kneading and stroking of the tissues with the hands in order to increase circulation.
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 professional 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)
Comparison of the functional and performance capabilities and specifications was made to the listed predicate devices and it is concluded that the device that is the subject of this 510(k) is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K062818
Page 1 of 2
STEMS TECHNOLOGY INC.
Corporate Office
4824 Park Glen Road
Minneapolis, MN 55416
Phone 952.224.4060 Fax 952.224.4061 www.flexitouch.com
OCT -6 2006
Aug 31, 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.
| Submitter: | Phillip R. Rose |
|---|---|
| Director of Quality Systems and Regulatory Affairs | |
| Tactile Systems Technology, Inc | |
| 4824 Park Glen Rd. | |
| Minneapolis, MN 55416 | |
| Phone: (952)2244060 Fax: (952) 224-4061 |
Contact person: Phillip R. Rose
Name of Device: Flexitouch® System
Powered Inflatable Tube Massager, Class II Classification:
Predicate Devices: Bio Compression Systems, Inc. Model SC-3008 Sequential Circulator (K043423)
Medical Compression Systems Ltd ActiveCare®++ System (K060146)
Tactile Systems Technology, Inc. Flexitouch® System (K013061)
Description of Device:
The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary components of the System include a pneumatic sequential controller device that delivers air to garments with inflatable chambers to be worn over the patient's afflicted areas. The inflation and deflation of the chambers simulates kneading and stroking of the tissues with the hands in order to increase circulation.
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K062818
Page 2 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Intended Use:
The Flexitouch system is intended for use by medical professional 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
Comparison of Technological Characteristics:
The Flexitouch System is substantially equivalent to devices reviewed under FDA's
product code JOW that have been cleared for the same intended use of primary or
adjunctive treatment of primary or secondary lymphedema and venous insufficiency using
the same technical technology. The predicates have also been cleared for treatment and
assistance in healing: stasis dermatitis, venous stasis ulcers; arterial and diabetic leg ulcers
and reducing healing time. The only reason for this submission is to include these
indications for the device's use.
Performance Comparison:
Comparison of the functional and performance capabilities and specifications was made to the listed predicate devices and it is concluded that the device that is the subject of this 510(k) is substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines above it, representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2006
Tactile Systems Technology, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 Aurora Road, Unit B7 Twinsburg, OH 44087
Re: K062818
Trade Name: Flexitouch® System Regulation Number: 21 CFR 870.5800 and 21 CFR 890.5650 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW and IRP Dated: September 19, 2006 Received: September 20, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Neil E. Devine, Jr.
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R.vuchner
Image /page/3/Picture/6 description: The image shows a signature. The signature is in black ink and appears to be handwritten. The signature is illegible, but it appears to be a stylized version of the letters 'S' and 'N'.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Kolo 2818
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 Usc X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
Page 1 of 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko 62818