BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

K131496 · Bsn Medical, Inc. · DWL · Jul 10, 2013 · General Hospital

Device Facts

• Record ID: K131496
• Device Name: BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
• Applicant: Bsn Medical, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Jul 10, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema

Device Story

Bellavar, Custom Seamless Soft is a medical support stocking designed to provide graduated compression to the lower extremities. The device functions by applying external pressure to the limb to assist venous return and manage edema. It is intended for use in clinical or home settings to treat various venous conditions ranging from mild swelling to chronic venous insufficiency. The stocking is custom-fitted to the patient's limb dimensions. Healthcare providers prescribe the appropriate compression class (I, II, or III) based on the patient's specific diagnosis and severity of symptoms. The device helps alleviate symptoms such as aching legs and reduces the risk of complications like thrombosis or venous ulceration.

Clinical Evidence

bench testing only

Technological Characteristics

Medical support stocking; custom seamless construction; graduated compression levels (Class I, II, III); intended for external limb application.

Indications for Use

Indicated for patients requiring compression therapy for conditions including mild swelling, tired aching legs, thrombosis prophylaxis, minor to severe varices, varices with edema, varices with pregnancy, post-sclerotherapy, post venous ulceration, post-phlebitic syndrome, chronic venous insufficiency, phlebitis, and thrombophlebitis.

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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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design of an eagle or bird-like figure, rendered in black.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 10, 2013

BSN Medical, Incorporated C/O Mr. Carroll D. Hoyle Global Regulatory Affairs 100 Beiersdorf Drive RUTHERFORD COLLEGE NC 28671

Re: K131496

Trade/Device Name: Bellavar, Custom Seamless Soft Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: May 13, 2013 Received: June 11, 2013

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 - Мг. 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

Mary S. Runne 2013.07.10 12:36:4

Kwame Ulmer, M.S. Acting Division 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): K131496

Device Name: Bellavar, Custom Seamless Soft

Indications for Use:

Compression Class I

Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery

Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration

Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and 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)

.. . . . !

Richard C. Chapman 2013.07.10 10:27:16 -04'00'

... .

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

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510(k) Number: K131476