MEDI BUTLER

{0}------------------------------------------------ K051324 # 2005 DEC 5 # MEDIVEN BUTLER 510(K) SUMMARY ## I. General Information on Submitter Name: medi USA L.P. Address: 6481 Franz Warner Parkway Whitsett, NC 27377 Telephone: (336) 449-4440 Fax: (336) 449-4495 Name of Contact Person: Scarlette Foust Date Summary Prepared: October 7, 2005 #### II. General Information on Device Trade Name: medi Butler Classification Name: Application Aid, Accessory to a Medical Support Stocking #### III. Predicate Devices 21 C.F.R. § 880.5780(a) #### IV. Description of the Device The Butler is a lightweight steel frame application aid that solves the often difficult problem of applying compression stockings. The application aid is suitable for all compression stocking sizes. ## V. Intended Use The medi Butler is indicated for use as an accessory to medical support stockings to prevent pooling of blood in the legs. The medi Butler aids in the application of medical support stockings to the legs. # VI. Technological Characteristics of Device Compared to Predicate Device The medi Butler consists of similar construction to other devices that have been used as accessories to medical support stockings. As per the FDA's request, because the Agency does not have a current 510(k) application on file for this class of accessory device, we have provided comparison information for the Jobst Stocking Donner, a Class I 510(k) exempt accessory to medical support stocking for general medical purposes, using welded steel alloy construction that has been painted. The medi Butler's steel alloy composition is designed to enhance the strength of the device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines extending from its head. The eagle is facing to the right. Public Health Service DEC 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medi USA, L.P. C/O Mr. Gary L. Yingling Kirkpatrick & Lockhart Nicholson Graham LLP 1800 Massachusetts Avenue, N.W. Washington, DC 20036 Re: K051324 Trade/Device Name: Med: Butler Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: November 4, 2005 Received: November 9, 2005 Dear Mr. Yingling: 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. {2}------------------------------------------------ Page 2 - Mr. Yingling Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DA s issuance of a baceaning that your device complies with other requirements mean that ITDA nas maco a deceminations administered by other Federal agencies. of the Act of ally I cucha statutes and reguraments, including, but not limited to: registration You must colliply with an the Act 3 requirements) ; good manufacturing practice and listing (21 CFR Part 807), labeling (21 CFR Pat 820), and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (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) I his letter will anow you to oven mainening your substantial equivalence of your device to a premarket notification. The PDF miaming of cassification 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), If you desire specific advice for your do records at (240) 276-0115. Also, please note the regulation Venese contact the Office of Compliance at (240) 276-0115. Also, pres 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 may obtain official information on the mational and Consumer Assistance at its toll-free Division of Chiasa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Ours Shin-Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ KOS 1324 # Indications for Use 510(k) Number: K051324 Device Name: medi Butler Indications for Use: Prescription > The medi Bulter is indicated for use as an accessory to medical support stockings. The The medi Butler is a lightweight steel frame aid for the application of medical support > medi Butler is a lightweight steel frame aid for the application of medical increase medi Butter is a lightweight stock interior in the for all compression stocking sizes. Prescription Use Yes (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO AND/OR (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) Page 1 of 1 (Posted November 13, 2003) xell For AMW "11/2/6 Anasthesiology, Gen