ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02

K090921 · Beiersdorf, Inc. · DWL · Dec 18, 2009 · General Hospital

Device Facts

• Record ID: K090921
• Device Name: ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
• Applicant: Beiersdorf, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anti-Embolism Stockings: Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Over-the-Counter (OTC) Use .

Device Story

Anti-Embolism Stockings are compression garments for post-operative patients; constructed from 90% nylon and 10% spandex. Device utilizes graduated compression to manage venous blood flow; provides 18 mmHg pressure at ankle, 11 mmHg at calf, and 8 mmHg at thigh (thigh-length models). Manufactured via circular knitting machine with nylon yarns and in-laid nylon-covered spandex. Available in knee and thigh lengths with silicone bands on thigh models. Intended for OTC use to reduce edema and DVT risk associated with immobility.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Compression stockings composed of 90% nylon and 10% spandex; latex-free. Graduated compression design (18 mmHg ankle, 11 mmHg calf, 8 mmHg thigh). Manufactured via circular knitting process. Available in knee and thigh lengths; thigh models include silicone top band.

Indications for Use

Indicated for individuals subjected to immobility to help prevent edema, leg discomfort, and deep vein thrombosis (DVT).

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

• Flight Sock (K040353)
• Jobst Travel Socks (K032325)
• RX FIT Medical Stockings (K925643)
• VENES Anti-Embolism Stocking (K830696)
• Therafirm Anti-Embolism Stockings and Therafirm Men's Trouser Socks and Women's Trouser Socks (K091141)
• Kendall T.E.D. Anti-Embolism Stockings (510(k) number unknown)
• TRUFORM Anti-Embolism Stockings (510(k) number unknown)

Submission Summary (Full Text)

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K090921

# Attachment 2 - 510(k) Summary

510(k) Summary

General Information:

Date of Summary Preparation: December 16, 2009

DEC 1 8 2009

BDF����

Beiersdorf

Beiersdort Inc 187 Danbury Road Willon, CT 2G897 Telephone [phone]

Name and Address of Manufacturer: Beiersdorf, Inc.

187 Danbury Road

Wilton, Connecticut 06897

Contact Person:

Rosemary Barvenik

Manager, Regulatory Affairs

Telephone: [phone]

Fax: [phone]

- Trade Name: Anti-Embolism Stockings Medical Support Stocking Common Name: 21 CFR 880.5780(a) Regulation Number: Classification Name: Medical Support Stocking II Regulatory Class: Classification Panel: General Hospital Product Code: DWL
Traditional 510(k) Premarket Notification December 16, 2009

Company Confidential Page 7 of 16

[phone]

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Predicate Devices:

K040353 Flight Sock

K032325 Jobst Travel Socks

K925643 RX FIT Medical Stockings

K830696 VENES Anti-Embolism Stocking

K091141 Therafirm Anti-Embolism Stockings and Therafirm Men's Trouser Socks and Women's Trouser Socks

Kendall T.E.D. Anti-Embolism Stockings

(510(k) number unknown)

TRUFORM Anti-Embolism Stockings

(510(k) number unknown)

#### Indications for Use:

The Anti-Embolism Stockings:

- . Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
- Over-the-Counter (OTC) Use .

Device Description: The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes.

The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design.

The Anti-Embolism Stockings are not made with natural rubber latex.

Substantial Equivalence: The Anti-Embolism Stockings are substantially equivalent to predicates with respect to the intended use, indications for use, and the technological characteristics.

Traditional 510(k) Premarket Notification December 16, 2009

Company Confidential Page 8 of 16

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# DEC 1 8 2009

Ms. Rosemary Barvenik Regulatory Affairs Manager Beiersdorf, Incorporated 187 Danbury Road Wilton, Connecticut 06897

Re: K090921

Trade/Device Name: Anti-Embolism Stockings Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: December 3, 2009 Received: December 3, 2009

Dear Ms. Barvenik:

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 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

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Page 2- Ms. Barvenik

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 (OS) 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,

Svan Runow

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known): K090921

Device Name: Anti-Embolism Stockings -Models 71055-, 71057-, 71059-, 71064-, 71065-, 71068-00000-02

### Indications for Use:

The Anti-Embolism Stockings:

Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.

- Over-the-Counter (OTC) Use ●
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)

Austin For CIZ

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

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KOG1999 510(k) Number:

Traditional 510(k) Premarket Notification December 16, 2009

Company Confidential Page 6 of 16