ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

K123561 · Bsn Medical, Inc. · DWL · Dec 18, 2012 · General Hospital

Device Facts

• Record ID: K123561
• Device Name: ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
• Applicant: Bsn Medical, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the management of lymphedema and other edema.

Device Story

Elvarex, Elvarex Soft, and Elvarex Soft Seamless are medical support stockings designed for the management of lymphedema and other edema. These devices provide compression to the affected limb to assist in fluid reduction and management. They are intended for prescription use. The stockings function as passive mechanical compression garments, applying external pressure to the limb to support venous and lymphatic return. They are used in clinical or home settings as part of a patient's edema management plan, prescribed by healthcare professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical support stockings; passive compression garment; textile construction; non-sterile; no electronic components or software.

Indications for Use

Indicated for patients requiring management of lymphedema and other edema conditions.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

## December 18, 2012

Carroll D. Hoyle Global Regulatory Affairs BSN Medical, Incorporated 100 Beiersdorf Drive Rutherford College NC 28671

Re: K123561

Trade/Device Name: Elvarex / Elvarex Soft / Elvarex Soft Seamless Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: September 14, 2012 Received: November 19, 2012

Dear Mr. Hoyle:

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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## Page 2 - Ms. Hoyle

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 yours,

2012.12.14 Susan Runner DDS, MA -14:07:02 -05'00'

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Elvarex / Elvarex Soft / Elvarex Soft Seamless Device Name: _

Indications for Use:

For the management of lymphedema and other edema.

Prescription Use 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)

Digitally signed by Richard C. Chapman Date: 2012.12.18.09:04:50 -05'00'

(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division of Patcola.com/2019/09/1005

2256

510(k) Number;

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