FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE

K123085 · 3M Company · DWL · Dec 20, 2012 · General Hospital

Device Facts

• Record ID: K123085
• Device Name: FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
• Applicant: 3M Company
• Product Code: DWL · General Hospital
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel.

Device Story

FUTURO™ Travel hosiery (knee-highs, socks, stockings, pantyhose) provides graduated compression to legs; higher compression at ankle, lower at calf/thigh. Manufactured via circular knitting machines using nylon and spandex blend. Available in two compression ranges: 15-20 mmHg (moderate) and 20-30 mmHg (firm). Used by individuals during travel or immobility to prevent blood pooling, edema, and deep vein thrombosis. Patient self-selects and wears hosiery; no external power or electronic components. Benefits include improved venous return and reduced risk of travel-related circulatory complications.

Clinical Evidence

Bench testing only. Performance testing demonstrated that the compression hosiery meets stated compression specification ranges and provides the same compression levels as the predicate devices.

Technological Characteristics

Graduated compression hosiery made of nylon and spandex blend. Produced on circular knitting machines. Provides 15-20 mmHg or 20-30 mmHg compression. No electronic components or software.

Indications for Use

Indicated for individuals subjected to immobility or long distance travel to help prevent edema, leg discomfort, and deep vein thrombosis. Available for over-the-counter use.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg. Medical support stocking for general medical purposes: A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b) *Medical support stocking for general medical purposes* —(1)*Identification.* A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2) *Classification.* Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Travel Sock - BSN-Jobst, Inc. (K032325)
• Shape to Fit Compression Socks - Tsung Hau Technology Company, Limited (K101906)

Submission Summary (Full Text)

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K123085

# 510(k) Summary

# DEC 2 0 2012

Date Prepared:

September 7, 2012

Name and Address of Manufacturer:

Contact Person:

Trade Name:

Common Name:

Regulation Number:

Classification Name:

Regulatory Class:

Classification Panel:

Product Code:

3M Company 2510 Conway Avenue St. Paul, MN 55144

Lisa Nelson Regulatory Affairs [phone] [e-mail]

FUTURO™ Travel Knee-Highs FUTURO™ Travel Socks FUTURO™ Travel Stocking FUTURO™ Travel Pantyhose

Stocking, medical support (to prevent pooling of blood in legs)

21 CFR 880.5780

Medical support stocking

II

General Hospital

DWL

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### Predicate Devices:

Travel Sock - BSN-Jobst, Inc. K032325 Shape to Fit Compression Socks - Tsung Hau Technology Company, Limited K101906

### Indications for use:

Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel.

Over the counter use.

#### Device Description:

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are made of a blend of nylon and spandex. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose provide graduated compression of the leg, with the higher compression in the ankle region and lower compression in the calf and the thigh (for the pantyhose only). Two compression ranges are available. Moderate. 15-20 mmHg. and Firm. 20-30mmHg. The compression hosiery products are produced on circular knitting machines. Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are substantially equivalent to the predicate products in product materials, mode of action, compression levels, function and indication for use, and as such, can be considered safe and effective as the referenced, predicate products. Like the products, the FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are available in a variety of colors and sizes for both men and women.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose differ from the predicate devices in the following aspects. Tsung Hau Technology Company, Limited, Shape to Fit, compression hosiery utilizes a "fresh weave odor control". The 3M FUTURO™ hosiery does not. Jobst's Travel Sock contains cotton yarn for comfort. The 3M FUTURO™ hosiery does not contain any cotton (with the exception of the cotton lined crotch in the pantyhose). No other significant differences are noted.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the figure. The text is in all caps and appears to be in a sans-serif font.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### December 20, 2012

Ms. Lisa Nelson Regulatory Affairs Specialist 3M Company 3M Consumer Health Care Division 2510 Conway Avenue St. Paul Minnesota 55144

Re: K123085

Trade/Device Name: FUTURO™ Travel Knee-Highs, FUTURO™ Travel Socks, FUTUROTM Travel Stocking, FUTUROTM Travel Pantyhose Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: October 1, 2012 Received: October 16, 2012

Dear Ms. Nelson:

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.

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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 go to 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony Lo m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement 5.0

510(k) Number: K123085

Device Name: FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose

Indications for Use:

Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (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)

Digitally signed by Richard C. Chapman Date: 2012.12.18 14:00:38 -05'00'

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

**510(k) Number:** K123085

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